2026-13174: Bifenthrin; Pesticide Tolerances

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or [[Page 39494]] 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 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-2023-0555 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. 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.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as [[Page 39495]] 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 database of experimental toxicology studies available for bifenthrin provides a robust characterization of the hazard potential for adults and children. The bifenthrin database is considered complete for risk assessment. Bifenthrin has been evaluated for a variety of toxic effects in guideline experimental toxicity studies. Predominantly, behavioral changes characteristic of Type I pyrethroids, such as muscle tremors, were seen in most of the bifenthrin experimental toxicology studies, consistent with its mode-of-action (MOA) to activate sodium channels. This observation was noted in several bifenthrin toxicology studies across various species at different durations, and different routes of exposure and lifestages. The published acute Wolansky study provided robust data on locomotor activity, due to the fact that it utilized nine dose groups and a benchmark dose data analysis method to address dose spacing effects. The Wolansky study is considerably conservative, using the most sensitive rat strain, plus gavage dosing utilizing a vehicle and volume producing the most adverse responses (i.e., 1 mL/kg corn oil). Muscle tremors were observed in nearly all experimental studies in all species and durations; however, motor activity was not measured in most of these studies. The decreased locomotor activity observed in the acute Wolansky study was the most sensitive endpoint identified in the study and therefore, was selected as the endpoint for acute dietary and short-term incidental oral risk assessment. In the acute Wolansky study, tremors were not observed at doses less than 8 mg/kg of bifenthrin, while decreased motor activity was significant at doses of 4 mg/kg and above. Further, the Wolansky study monitored the toxicology at the time of peak effects, unlike most of the guideline studies. Additional effects seen in one or more studies included: muscle twitching, decreased grip strength, altered landing foot splay, depressed respiration, increased grooming counts, loss of muscle coordination, staggered gait, exaggerated hind limb flexion, and convulsions at high doses. Decreased body weight and food consumption were also noted in repeat-dosing dietary studies. There was no clear evidence in the database that either gender was more sensitive to bifenthrin. Clinical signs of neurotoxicity were also reported in the route- specific dermal and inhalation toxicity studies. In a 21-day dermal study in rabbits, loss of muscle coordination and increased incidence of tremors were seen at the highest dose tested (442 mg/kg/day) and in a 21-day dermal study in rats, a staggered gait and exaggerated limb flexion was noted at 93 mg/kg/day. In a 28-day inhalation study in rats, increased tremors and increased respiration were seen at the highest concentration tested (0.0196 mg/L/day). Bifenthrin has been evaluated for potential developmental effects in the rat (following gavage and dietary administration) and in the rabbit (gavage administration). Maternal toxicity included neurological effects (tremors in rats and rabbits; head and forelimb twitching in rabbits). There were no developmental effects of biological significance in either species. A Developmental Neurotoxicity (DNT) study is available, which establishes a clear no observed adverse effect level (NOAEL) for the adult and offspring toxicity. The NOAEL in adults and offspring is similar in magnitude, and the lowest observed adverse effect level (LOAEL) are based on the clinical signs of neurotoxicity (dams had tremors and convulsions, offspring had increased grooming counts). Based on targeted testing in the DNT study for common endpoints for bifenthrin, there was no increase in sensitivity in rat pups. However, the Agency has reviewed existing pyrethroid data and concludes that the DNT is not a particularly sensitive study for comparing the sensitivity of young and adult animals to pyrethroids. The reproductive toxicity of bifenthrin was examined in a two-generation reproduction dietary study in the rat. Tremors were noted only in females of both generations, with one parental generation rat observed to have clonic convulsions, and no observed effects in the offspring. Overall, there is no indication of increased juvenile sensitivity specifically to bifenthrin. Bifenthrin has low acute toxicity via the dermal (Category III) and inhalation routes (Category III-IV) of exposure and has high acute toxicity via the oral route (Category I). It is not a skin irritant (Category IV) but is a moderate eye irritant (Category III) and is a dermal sensitizer. Bifenthrin is classified as ``Group C--Possible Human Carcinogen,'' based on an increased incidence of urinary bladder tumors in mice. However, EPA has determined that quantification of risk using a non- linear approach (i.e., reference dose (RfD)) will adequately account for all chronic toxicity, including potential carcinogenicity, that could result from exposure to bifenthrin for the following reasons. First, the bladder tumors may not be uncommon in Swiss Webster mice and are not likely to be malignant. Second, these tumors were observed only in male mice at the highest dose. Third, no evidence of carcinogenicity was observed in bifenthrin carcinogenicity studies in rats. Finally, there is a low concern for mutagenicity based on the overall results of the available mutagenicity tests of bifenthrin. Specific information on the studies received and the nature of the adverse effects caused by bifenthrin, as well as the NOAEL and the LOAEL from the toxicity studies, can be found at http://www.regulations.gov in the document titled ``Bifenthrin. Human Health Risk Assessment for the Section 3 Registration of Bifenthrin on Clover (Grown For Seed); Coffee; Fuzzy Kiwifruit; Safflower; Tropical And Subtropical Palm Fruit (Subgroup 23C); and Crop Group Expansions/ Conversions for Brassica, Head and Stem Vegetables (Group 5-16); Kohlrabi; Succulent Peas and Beans (Subgroups 6-22A, B, C, and D); Dried Beans and Peas (Subgroups 6-22E and F); Rapeseed (Subgroup 20A); Cottonseed (Subgroup 20C); Leaf Petiole Vegetables (Subgroup 22B); Celtuce; Florence Fennel; and Swiss Chard.'' in docket ID number EPA- HQ-OPP-2023-0555.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the NOAEL and 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 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. [[Page 39496]] A summary of the toxicological endpoints for bifenthrin used for human risk assessment can be found in the document titled ``Bifenthrin. Human Health Risk Assessment for the Section 3 Registration of Bifenthrin on Clover (Grown For Seed); Coffee; Fuzzy Kiwifruit; Safflower; Tropical And Subtropical Palm Fruit (Subgroup 23C); and Crop Group Expansions/Conversions for Brassica, Head and Stem Vegetables (Group 5-16); Kohlrabi; Succulent Peas and Beans (Subgroups 6-22A, B, C, and D); Dried Beans and Peas (Subgroups 6-22E and F); Rapeseed (Subgroup 20A); Cottonseed (Subgroup 20C); Leaf Petiole Vegetables (Subgroup 22B); Celtuce; Florence Fennel; and Swiss Chard.'' in docket ID number EPA-HQ-OPP-2023-0555.

1. Dietary Exposure From Food and Feed Uses

In evaluating dietary exposure to bifenthrin, EPA considered exposure under the petitioned-for tolerances as well as all existing bifenthrin tolerances in 40 CFR 180.442. EPA assessed dietary exposures from bifenthrin in food as follows: i. Acute Exposure Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for bifenthrin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used USDA Pesticide Data Program (PDP) monitoring data, field trial data, and empirical processing factors, where available, and incorporated percent crop treated (PCT) estimates in the refined acute dietary exposure assessment. ii. Chronic Exposure A chronic dietary endpoint has not been selected for bifenthrin because repeated exposure does not result in a POD lower than that resulting from acute exposure; therefore, the acute dietary risk assessment is protective of chronic dietary risk. However, a refined chronic dietary exposure assessment was conducted to determine the background exposure of food plus drinking water to support the bifenthrin aggregate risk assessment. The assessment was refined using point estimates derived from PDP monitoring data, field trial data, PCT data, and empirical processing factors. iii. Cancer As discussed in Unit III.A., EPA has determined that the acute RfD will adequately account for all repeated exposure/chronic toxicity, including potential carcinogenicity, which could result from exposure to bifenthrin. A separate cancer exposure assessment was not conducted. iv. Anticipated Residue and Percent Crop Treated (Pct) Information Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: Condition A: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. Condition B: The exposure estimate does not underestimate exposure for any significant subpopulation group. Condition C: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The acute dietary assessment used the following maximum PCT estimates: almonds: 40%, apples: 10%; artichokes: 65%; avocados: 2.5%; beans (snap, bush, pole, string): 60%; blueberries: 40%; broccoli: 25%; cabbage: 45%; caneberries: 50%; canola (oil rapeseed): 25%; cantaloupes: 55%; carrots: 10%; cauliflower: 45%; celery: 45%; chicory: 10%; citron: 10%; citrus hybrids: 10%; corn: 15%; cotton: 25%; cucumbers: 35%; dry beans/peas: 10%; eggplants: 45%; grapefruit: 2.5%; grapes, raisin: 2.5%; grapes, table: 2.5%; grapes, wine: 10%; honeydew: 90%; kumquats: 10%; lemons: 2.5%; lettuce: 20%; lima beans: 40%; limes: 10%; pomelos: 10%; okra: 45%; oranges: 10%; peanuts: 20%; pears: 2.5%; peas (fresh/green/sweet): 50%; pecans: 20%; peppers: 35%; pistachios: 55%; pomegranates: 50%; potatoes: 15%; pumpkins: 30%; soybeans: 15%; spinach: 15%; squash: 25%; strawberries: 70%; sunflowers: 2.5%; sweet corn: 50%; tangerines: 5%; tomatoes: 45%; walnuts: 40%; watermelons: 30%. The following average PCT estimates for bifenthrin were used to refine the chronic dietary exposure assessment for the following crops: almonds: 35%, apples: 2.5%; artichokes: 35%; avocados: 1%; beans (snap, bush, pole, string): 40%; blueberries: 35%; broccoli: 15%; cabbage: 30%; caneberries: 30%; canola (oil rapeseed): 15%; cantaloupes: 45%; carrots: 2.5%; cauliflower: 15%; celery: 20%; chicory: 2.5%; citron: 2.5%; citrus hybrids: 2.5%; corn: 10%; cotton: 20%; cucumbers: 15%; dry beans/peas: 5%; eggplants: 35%; grapefruit: 1%; grapes, raisin: 1%; grapes, table: 1%; grapes, wine: 2.5%; honeydew: 80%; kumquats: 2.5%; lemons: 2.5%; lettuce: 10%; lima beans: 15%; limes: 2.5%; pomelos: 2.5%; okra: 35%; oranges: 2.5%; peanuts: 10%; pears: 1%; peas (fresh/ green/sweet): 25%; pecans: 10%; peppers: 20%; pistachios: 50%; pomegranates: 30%; potatoes: 10%; pumpkins: 15%; soybeans: 10%; spinach: 1%; squash: 20%; strawberries: 50%; sunflowers: 1%; sweet corn: 40%; tangerines: 2.5%; tomatoes: 35%; walnuts: 30%; watermelons: 15%. A default of 100% CT was used for all livestock and game commodities, freshwater finfish, and all other registered uses where no maximum/average PCT estimates were available. All other commodities included for depicting food handling establishment (FHE) uses were refined with the upper bound estimate of 4.65% for non-fumigant treatments made in FHEs. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis. The [[Page 39497]] average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%. The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition A, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions B and C, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have reliable information available on the regional consumption of food to which bifenthrin may be applied in a particular area.

2. Dietary Exposure From Drinking Water

The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for bifenthrin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of bifenthrin. 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. The estimated drinking water concentrations (EDWCs) were incorporated directly into the dietary assessment; water residues were incorporated in the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) into the food categories ``water, direct, all sources'' and ``water, indirect, all sources.'' Ground water EDWCs were calculated with Pesticide in Water Calculator (PWC) 2 for citrus as the highest exposure scenarios using chemical input parameters from previous drinking water assessments. Citrus continues to generate no breakthrough for EDWCs despite the increased annual application rates in the proposed labels. Therefore, the EDWC used in the dietary exposure assessment (acute and chronic) is the bifenthrin limit of solubility of 0.000014 ppm, i.e., the maximum possible residues that could occur in drinking water based on the chemical properties of the compound.

3. From Non-Dietary Exposure

The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Bifenthrin is currently registered for the following uses that could result in residential exposures: Lawns/turf, indoor environments, gardens/trees, pets (dog shampoo), termiticide and indoor/outdoor surface treatment for various residential and commercial premises. Residential exposures are not expected from the proposed new uses; however, there are existing residential uses that have been previously assessed. Non-occupational exposures from spray drift (dermal [adults and children] and incidental oral [children only]) are expected to be short-term (1 to 30 days) only. Occupational (dermal and inhalation) handler and post-application exposure is expected to be both short- and intermediate-term (1 to 6 months) based on information provided on the proposed labels. These uses were assessed previously, remain current, and are not of concern (i.e., margins of exposure (MOEs) > the level of concern (LOC)). A quantitative non-occupational spray drift assessment was not conducted for bifenthrin because the proposed use pattern is likely to result in spray drift exposures (i.e., aerial, groundboom, and airblast) that are equal to or less than those assessed in the previous bifenthrin exposure and risk assessment conducted in support of registration review. The previous spray drift assessment concluded that there were no risk estimates of concern at the edge of the field for bifenthrin based on the use patterns assessed and are protective of the currently proposed use patterns.

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.'' The Agency is required to consider the cumulative risks of chemicals sharing a common mechanism of toxicity. The Agency has determined that the pyrethroids and pyrethrins share a common mechanism of toxicity (https://www.regulations.gov; EPA-HQ-OPP-2008-0489-0006). As explained in that document, the members of this group share the ability to interact with voltage-gated sodium channels ultimately leading to neurotoxicity. In 2011, after establishing a common mechanism grouping for the pyrethroids and pyrethrins, the Agency conducted a cumulative risk assessment (CRA) which is available at https://www.regulations.gov; EPA-HQ-OPP-2011-0746. In that document, the Agency concluded that cumulative exposures to pyrethroids (based on pesticidal uses registered at the time the assessment was conducted) did not present risks of concern. For information regarding EPA's efforts to evaluate the risk of exposure to this class of chemicals, refer to https://www.epa.gov/ingredients-used-pesticide-products/pyrethrins-and-pyrethroids. Since the 2011 CRA, for each new pyrethroid and pyrethrin use, the Agency has conducted a screen to evaluate any potential impacts on the CRA prior to registration of that use. A new turf use for the pyrethroid, tau-fluvalinate, was assessed after completion of the cumulative, which did impact the worst-case non-dietary risk estimates identified in the 2011 CRA for the turf scenario (H. DeLeon, D450820, 16-DEC-2019). However, EPA has determined that the overall finding (i.e., that the pyrethroid cumulative risk is below the Agency's level of concern) would not change upon registration of this new use. The new uses of bifenthrin proposed by IR-4 will not significantly impact the cumulative assessment because dietary exposures make a minor contribution to total pyrethroid exposure relative to residential exposures in the 2011 cumulative risk assessment. Therefore, the results of the 2011 CRA are still valid and there are no cumulative risks [[Page 39498]] of concern for the pyrethroids/pyrethrins.

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 are available to EPA to support the choice of a different factor.

2. Prenatal and Postnatal Sensitivity

Bifenthrin has been evaluated for potential developmental effects in the rat (following gavage and dietary administration) and in the rabbit (gavage administration). Maternal toxicity included neurological effects (tremors in rats and rabbits; head and forelimb twitching in rabbits). There were no developmental effects of biological significance in either species. A DNT study was available, which establishes a clear NOAEL for the adult and offspring toxicity. The NOAEL in adults and offspring is similar in magnitude, and the LOAELs are based on the clinical signs of neurotoxicity (dams had tremors and convulsions, offspring had increased grooming counts). Based on targeted testing in the DNT study for common endpoints for bifenthrin, there was no increase in sensitivity in rat pups. However, the Agency has reviewed existing pyrethroid data and concludes that the DNT is not a particularly sensitive study for comparing the sensitivity of young and adult animals to pyrethroids. Some literature studies indicated susceptibility for other pyrethroids, but in context, these studies were conducted at relatively high doses, which may not reflect environmental exposures. The reproductive toxicity of bifenthrin was examined in a 2-generation reproduction dietary study in the rat. Tremors were noted only in females of both generations, with one parental generation rat observed to have clonic convulsions, and no observed effects in the offspring. Overall, there is no indication of increased juvenile sensitivity specifically to bifenthrin.

3. Conclusion

EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. No new information has been available since the last assessment; therefore the Agency concludes that the default 10X FQPA safety factor can be reduced to 1X for all populations for the pyrethroid pesticides. More information regarding the FQPA SF can be found in the 2021 rule (86 FR 68150) (FRL-8945-01-OCSPP).

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute Risk

Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to bifenthrin will occupy 12% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure. The acute aggregate risk assessment combines exposures to bifenthrin in food and drinking water only and is equivalent to the acute dietary assessment. There are no acute aggregate risks estimates of concern.

2. Chronic Risk

The chronic dietary (food and drinking water) exposure assessment for bifenthrin was conducted solely for the purpose of obtaining an average dietary exposure estimate for use in the short-term aggregate assessment. The population subgroup with the highest chronic dietary exposure estimate is children 1 to 2 years old (0.000123 mg/kg/day). A chronic aggregate risk assessment was not conducted since single dose and repeat dosing bifenthrin studies show that repeat exposures do not result in lower PODs (i.e., there is no evidence of increasing toxicity with an increased duration of exposure). Therefore, only acute and short-term aggregate risk assessments are conducted for bifenthrin, and these are protective of scenarios in which exposure occurs for longer durations.

3. Short-Term Risk

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). Bifenthrin 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 bifenthrin. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 520 for adults (treated gardens). The short-term aggregate assessment for children 1 to less than 2 years old resulted in an MOE of 170 (high contact lawn activities). The short-term aggregate assessment for children 6 to less than 11 years old and children 11 to 16 years old resulted in MOEs of 1,600 (treated gardens) and 7,500 (golfing), respectively. Because EPA's level of concern for bifenthrin is an MOE of 100 or lower, 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). While there is potential intermediate-term residential exposure, because the single dose and repeat dosing bifenthrin studies show that repeat exposures do not result in lower points of departure, the residential assessments are conducted as a series of acute exposures, and the same endpoint is used regardless of duration. Therefore, the short-term aggregate assessment is considered protective of any intermediate-term exposures.

5. Aggregate Cancer Risk for U.S. Population

EPA has concluded that the acute RfD will adequately account for all repeated exposures, including carcinogenicity, which could result from exposure to bifenthrin.

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 bifenthrin residues. [[Page 39499]]

A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromatography with an electron capture detector (GC/ECD) analyses for determining bifenthrin residues in both plant and livestock commodities) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex 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. EPA is establishing tolerance levels that are not harmonized with Codex MRLs for the following commodities/subgroups: kohlrabi; vegetable, brassica, head and stem, group 5-16, except cabbage; and vegetable, legume, pea, edible podded, subgroup 6-22B. For kohlrabi, vegetable, brassica, head and stem, group 5-16, except cabbage, and vegetable, legume, pea, edible podded, subgroup 6- 22B tolerances, harmonization to the corresponding Codex MRLs is not possible as the Codex MRLs are lower than the established tolerances for these groups. Reducing the U.S. tolerance would put U.S. growers at risk of having violative residues despite legal use of the pesticide according to the label. EPA is establishing tolerances for cottonseed subgroup 20C; milk; milk fat; ruminant (cattle, goat, and sheep) and horse fat; ruminant and horse meat byproducts; rapeseed subgroup 20A; vegetable, legume, pea, succulent shelled, subgroup 6-22D; vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E; and vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F that are harmonized with the corresponding Codex MRLs.

C. Revisions to Petitioned-For Tolerances

Several revisions to the petitioned-for tolerances are explained in this section. Tolerance determinations were based on use of the Organization for Economic Cooperation and Development (OECD) Maximum Residue Limit (MRL) calculation procedures for plant commodities or anticipated residue calculations for livestock commodities. Additionally, international harmonization and data translations were considered where appropriate. Following the OECD Rounding Classes, EPA is establishing a tolerance of 0.8 ppm for fruit, citrus, group 10-10, oil rather than the proposed tolerance of 0.75 ppm. Also, EPA is establishing the tolerance for tropical and subtropical, palm fruit, edible peel, subgroup 23C based on the date field trials, which differs from the proposed tolerance. Because the decline data for date showed increasing residues past the label-indicated preharvest interval (PHI), the highest residue, found at the 20-day PHI, was selected for use in tolerance determination for that trial; this resulted in a tolerance of 4 ppm, rather than the proposed tolerance of 3 ppm. Several commodity definitions have also been updated to align with the U.S. EPA Health Effects Division (HED) Preferred Tolerance Vocabulary, including fennel, florence, fresh leaves and stalk; fruit, citrus, group 10-10, oil; safflower, seed; vegetable, brassica, head and stem, group 5-16, except cabbage; vegetable, legume, bean, edible podded, subgroup 6-22A; vegetable, legume, bean, succulent shelled, subgroup 6-22C; vegetable, legume, pea, edible podded, subgroup 6-22B; vegetable, legume, pea, succulent shelled, subgroup 6-22D; vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E; and vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F. EPA is establishing the tolerance at different levels than requested for: kohlrabi; vegetable, brassica, head and stem, group 5- 16, except cabbage; vegetable, legume, bean, edible podded, subgroup 6- 22A; and vegetable, legume, pea, edible podded, subgroup 6-22B, to harmonize with the corresponding Canadian MRLs. The proposed tolerance for kohlrabi is 0.6 ppm; EPA is establishing the tolerance at 0.9 ppm. For crop group 5-16, the proposed tolerance is 0.6 ppm; EPA is establishing the tolerance at 0.9 ppm. For both subgroup 6-22A and subgroup 6-22B, the proposed tolerance is 0.6 ppm; EPA is establishing the tolerance for both subgroups at 0.8 ppm. Finally, EPA is increasing the tolerances for milk, milk fat, ruminant and horse fat, and ruminant and horse meat byproducts due to the increased dietary burden resulting from the new uses. Although adjustments to these tolerances were not requested in the petition submitted, EPA has stated that before establishing tolerances in raw agricultural commodities, EPA considers the possibility of residues in livestock commodities, e.g., meat, and meat byproducts, from animals eating those treated commodities (40 CFR 180.6(a)). Where the data show that there are residues in livestock feed commodities, EPA will establish the tolerances on the raw agricultural feed item only where the tolerances can be established on the livestock items at the same time (40 CFR 180.6(b)). The commodity definitions for milk and milk fat have also been separated and updated to align with the HED Preferred Tolerance vocabulary. More information on these tolerance determinations can be found in the document titled ``Bifenthrin. Human Health Risk Assessment for the Section 3 Registration of Bifenthrin on Clover (Grown For Seed); Coffee; Fuzzy Kiwifruit; Safflower; Tropical And Subtropical Palm Fruit (Subgroup 23C); and Crop Group Expansions/ Conversions for Brassica, Head and Stem Vegetables (Group 5-16); Kohlrabi; Succulent Peas and Beans (Subgroups 6-22A, B, C, and D); Dried Beans and Peas (Subgroups 6-22E and F); Rapeseed (Subgroup 20A); Cottonseed (Subgroup 20C); Leaf Petiole Vegetables (Subgroup 22B); Celtuce; Florence Fennel; and Swiss Chard.'' in docket ID number EPA- HQ-OPP-2023-0555.

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.D.

I. Executive Order 13211: Actions Concerning Regulations That

Significantly Affect Energy Supply, Distribution or Use This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer Advancement Act (NTTAA)

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

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 26, 2026. Charles Smith, Director, Registration Division, Office of Pesticide Programs. For the reasons set forth in the preamble, 40 CFR chapter I is amended as follows: PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 0

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371. 0

2. Amend Sec. 180.442 by revising the table in paragraphs (a)(1) and

(c) to read as follows: Sec. 180.442 Bifenthrin; tolerances for residues. (a) * * * (1) * * * [[Page 39501]] Table 1 to Paragraph (a)(1) ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Almond, hulls........................................... 2.0 Apple, wet pomace....................................... 1.5 Artichoke, globe........................................ 1.0 Avocado................................................. 0.5 Banana \1\.............................................. 0.1 Beet, garden, roots..................................... 0.45 Beet, garden, tops...................................... 15 Berry, low growing, subgroup 13-07G..................... 3 Brassica, leafy greens, subgroup 4-16B.................. 4 Bushberry subgroup 13-07B............................... 1.8 Cabbage................................................. 4.0 Caneberry subgroup 13-07A............................... 1 Cattle, fat............................................. 3 Cattle, meat byproducts................................. 0.2 Cattle, meat............................................ 0.5 Celtuce................................................. 3 Coffee, green bean...................................... 0.05 Coriander, dried leaves................................. 25 Coriander, leaves....................................... 6.0 Coriander, seed......................................... 5.0 Corn, field, forage..................................... 3.0 Corn, field, grain...................................... 0.05 Corn, field, stover..................................... 5.0 Corn, pop, grain........................................ 0.05 Corn, pop, stover....................................... 5.0 Corn, sweet, forage..................................... 3.0 Corn, sweet, kernel plus cob with husk removed.......... 0.05 Corn, sweet, stover..................................... 5.0 Cottonseed subgroup 20C................................. 0.5 Egg..................................................... 0.05 Fennel, florence, fresh leaves and stalk................ 3 Fruit, citrus, group 10-10.............................. 0.05 Fruit, citrus, group 10-10, oil......................... 0.8 Fruit, pome, group 11-10, except mayhaw................. 0.9 Fruit, small, vine climbing, except fuzzy kiwifruit, 0.3 subgroup 13-07F........................................ Goat, fat............................................... 3 Goat, meat byproducts................................... 0.2 Goat, meat.............................................. 0.5 Grain, aspirated fractions.............................. 70 Herb subgroup 19A....................................... 0.05 Hog, fat................................................ 1.0 Hog, meat byproducts.................................... 0.10 Hog, meat............................................... 0.5 Hop, dried cones........................................ 10.0 Horse, fat.............................................. 3 Horse, meat byproducts.................................. 0.2 Horse, meat............................................. 0.5 Kiwifruit, fuzzy........................................ 1.5 Kohlrabi................................................ 0.9 Leaf petiole vegetable subgroup 22B..................... 3 Lettuce, head........................................... 3.0 Mayhaw.................................................. 1.4 Milk.................................................... 0.2 Milk, fat............................................... 3 Nut, tree, group 14-12.................................. 0.05 Peach subgroup 12-12B................................... 0.7 Peanut.................................................. 0.05 Pepper/eggplant subgroup 8-10B.......................... 0.5 Pomegranate............................................. 0.5 Poultry, fat............................................ 0.05 Poultry, meat byproducts................................ 0.05 Poultry, meat........................................... 0.05 Radish, tops............................................ 4.5 Rapeseed subgroup 20A................................... 0.05 Safflower, seed......................................... 0.2 Sheep, fat.............................................. 3 Sheep, meat byproducts.................................. 0.2 Sheep, meat............................................. 0.5 Soybean, hulls.......................................... 0.50 Soybean, refined oil.................................... 0.30 Soybean, seed........................................... 0.2 Spinach................................................. 0.2 Sunflower subgroup 20B.................................. 0.05 Swiss chard............................................. 3 Tea, dried \1\.......................................... 30 Tomato subgroup 8-10A................................... 0.3 Tropical and subtropical, palm fruit, edible peel, 4 subgroup 23C........................................... Vegetable, brassica, head and stem, group 5-16, except 0.9 cabbage................................................ Vegetable, cucurbit, group 9............................ 0.4 Vegetable, legume, bean, edible podded, subgroup 6-22A.. 0.8 Vegetable, legume, bean, succulent shelled, subgroup 6- 0.05 22C.................................................... Vegetable, legume, pea, edible podded, subgroup 6-22B... 0.8 Vegetable, legume, pea, succulent shelled, subgroup 6- 0.05 22D.................................................... Vegetable, legume, pulse, bean, dried shelled, except 0.3 soybean, subgroup 6-22E................................ Vegetable, legume, pulse, pea, dried shelled, subgroup 6- 0.3 22F.................................................... Vegetable, root, subgroup 1B except sugar beet and 0.10 garden beet............................................ Vegetable, tuberous and corm, subgroup 1C............... 0.05 ------------------------------------------------------------------------ \1\ There are no U.S. registrations. * * * * * (c) * * * Table 2 to Paragraph (c) ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Clover, forage.......................................... 7 Clover, hay............................................. 30 Grass, forage........................................... 4.0 Grass, hay.............................................. 15 ------------------------------------------------------------------------ * * * * * [FR Doc. 2026-13174 Filed 6-29-26; 8:45 am] BILLING CODE 6560-50-P