2026-13180: Diflufenican; 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 pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Crop production (NAICS code 111). Animal production (NAICS code 112). [[Page 39502]] 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-2021-0435 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 ``Revised Order Urging Electronic Filing and Service,'' dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.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. 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 diflufenican including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with diflufenican is as 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 hazard database for diflufenican indicates that the major toxicological effect in rodents is decreased body weight regardless of duration of exposure, and no clear target organ was identified. No dermal or inhalation toxicity data are available and therefore every effect specified is through the oral route. In the subchronic and chronic oral studies, decreased body weights were seen in both rats and mice, and adverse decreases in body weight occurred at doses lower than those causing additional toxicological effects. The rat appeared to be the most sensitive species tested, followed by the mouse. There were no adverse effects seen in the subchronic or chronic dog studies up to the limit dose of 1000 mg/kg/day. There did not appear to be a difference in toxicity by sex in any species. No evidence of increased quantitative or qualitative lifestage susceptibility was seen in rat or rabbit developmental toxicity studies or in the rat reproduction studies. There were no adverse maternal or developmental effects in the developmental rat or rabbit studies up to and exceeding the limit dose (>=1000 mg/kg/day). In the rat extended one-generation and two-generation reproduction studies, [[Page 39503]] adverse decreases in body weights in the parental animals and offspring were the most sensitive effect. Decreased body weights in the offspring were observed in the presence of decreased parental body weights, and there were no reproductive effects seen. There was low acute toxicity through oral, dermal, and inhalation routes. Diflufenican is not an ocular or dermal irritant, nor is it a dermal sensitizer. Diflufenican is classified as ``Not Likely to be Carcinogenic to Humans.'' No treatment-related increase in the incidence of tumors was observed in carcinogenicity studies in rats or mice at doses that were considered to be adequate. Additionally, there is no evidence of mutagenicity in vivo or in vitro. One of the plant metabolites of diflufenican (2,4-difluoroaniline malonate, hereafter referred to as BCS-BT38895) was found to be more toxic than the parent compound, with a different toxicological profile. A cursory analysis of the metabolite based on highly conservative assumptions is assessed separately in Appendix C (pages 96-99) of the Human Health Risk Assessment, in docket ID number EPA-HQ-OPP-2021-0435. Specific information on the studies received and the nature of the adverse effects caused by diflufenican as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Diflufenican. Human Health Risk Assessment for Diflufenican. New Active Ingredient'' at pages 16-25 in docket ID number EPA-HQ-OPP-2021-0435.

C. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. For more detailed information on the toxicological endpoints for diflufenican used for human risk assessment can be found in the ``Diflufenican. Human Health Risk Assessment for Diflufenican. New Active Ingredient'' at pages 22-23 in docket ID number EPA-HQ-OPP-2021- 0435.

1. Dietary exposure from food and feed uses. In evaluating dietary

exposure to diflufenican, EPA considered exposure under the petitioned- for tolerances. EPA assessed dietary exposures from diflufenican 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. No such effects were identified in the toxicological studies for diflufenican; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the 2005-2010 food consumption data from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA conducted an unrefined chronic dietary exposure risk assessment using 100 percent crop treated (PCT) and combined residues of diflufenican and DFF-amide (<0.02 ppm) in all samples of corn, field grain and soybean, except for soybean seed (average of diflufenican metabolite, BCS-BT38895, 0.011 ppm). The processing factor used for soybean flour was 1.3x, and the default processing factor was used for corn bran. Based on residues being above the limit of quantitation (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment. EPA calculated the estimated drinking water concentrations (EDWCs) of diflufenican Using the Pesticide Water Calculator (PWC) ver. 2.001. The modeling simulations for maximum label rates indicate that concentrations in ground water are expected to be higher than those in surface water. Therefore, the chronic value of 30.1 ppb was used to assess the dietary contribution from 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., products registered for direct application to lawns and for garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Diflufenican is not proposed for any specific use patterns that would result in direct applications in residential areas. 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.'' EPA has not found diflufenican to share a common mechanism of toxicity with any other substances, and diflufenican does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that diflufenican does not have a common mechanism of toxicity with [[Page 39504]] 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA

shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. No evidence of increased

quantitative or qualitative lifestage susceptibility was seen in rat or rabbit developmental toxicity studies or in the rat reproduction studies.

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. That decision is based on the following findings: i. The toxicity database for diflufenican is complete. ii. There is no indication that diflufenican is a neurotoxic chemical, and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that diflufenican results in increased quantitative or qualitative lifestage susceptibility in rat and rabbit developmental studies or in the rat reproduction toxicity studies. There were no maternal or developmental adverse effects observed in any of the developmental studies. In the reproduction toxicity studies, no reproductive effects were observed; however, decreased body weights were observed in the offspring and maternal animals at comparable dose levels. iv. There are no residual uncertainties identified in the exposure databases.

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 points of departure (POD) to ensure that an adequate margin of exposure (MOE) exists.

1. 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, diflufenican is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this

unit for chronic exposure, EPA has concluded that chronic exposure to diflufenican from food and water will utilize <1% of the cPAD for the general U.S. population, including children 1-2 years old (the most sensitive). Since there are no residential uses for diflufenican, aggregate exposure and risk are equivalent to chronic dietary (food and drinking water) exposure and risk, which are not of concern.

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). Because no short-term adverse effect was identified, diflufenican is not expected to pose a short-term risk.

4. Intermediate-term risk: Intermediate-term aggregate exposure

takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, diflufenican is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the lack of

evidence of carcinogenicity in two adequate rodent carcinogenicity studies, the diflufenican parent compound is not expected to pose a cancer risk to humans and is classified as ``Not Likely to be Carcinogenic to Humans.''

6. Metabolite BCS-BT38895. There is no expectation of exposure to

BCS-BT38895 from residential or occupational exposure scenarios. The only potential route of exposure to BCS-BT38895 is via the dietary route. The available data do not demonstrate a concern for effects attributable to a single exposure at this time; therefore, an acute non-cancer dietary assessment is not necessary for BCS-BT38895. Even with application of a 10X uncertainty factor to extrapolate from subchronic to chronic exposure duration, estimated chronic exposures to BCS-BT38895 are orders of magnitude below any potential chronic non- cancer reference dose for BCS-BT38895. Any chronic exposures to BCS- BT38895 residues are expected to be significantly lower than diflufenican-derived BCS-BT38895 residues based on diflufenican' s limited use patterns and lower tolerance-level residues. Therefore, a quantitative chronic non-cancer dietary risk assessment for BCS-BT38895 residues is not necessary to conclude with reasonable certainty that chronic exposures from BCS-BT38895 residues do not pose a non-cancer dietary risk. The highly refined estimated chronic exposure of the most highly exposed adult subpopulation (adults 20-48, 50+) to BCS-BT38895 (0.000005 mg/kg/day) results in an upper bound cancer risk estimate of 3 x 10-\8\, which is below the Agency's level of concern. Based again on diflufenican' s limited use patterns and lower tolerance-level residues, the Agency concludes that the cancer risk estimates for BCS-BT38895 residues indicate that there should not be any cancer risk from diflufenican-derived BCS-BT38895 residues.

7. 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 diflufenican residues.

A. Analytical Enforcement Methodology

Adequate enforcement methodology high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS), Method No. DC-003-P18-02 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]. [[Page 39505]]

B. International Residue Limits

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

C. Response to Comments

In the Federal Register of August 24, 2021 (86 FR 47275, FRL-8792- 02-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 1F8912) by Bayer CropScience, 800 N. Lindbergh Blvd., St. Louis, MO 63167. The Agency received three comments. Two of the comments (EPA-HQ- OPP-2021-0435-0004 and EPA-HQ-OPP-2021-0435-0005) were by the same private citizen raising concerns over the use of pesticides on corn and soybeans. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances 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 these diflufenican tolerances are safe. The same commenter further claims diflufenican contains fluoride and states fluoride to be toxic to insects, but provided no information supporting a conclusion that diflufenican is not safe, nor did the commenter provide any basis for concluding that tolerances would have a disproportionate effect on any population. A comprehensive database is available for diflufenican to support risk assessments that are protective of human health and the environment (including insects). The third comment (EPA-HQ-OPP-2021-0435-0006) was also from a private citizen which did not pertain to diflufenican. The comment addressed the Federal Aviation Administration proposed rule (FAA-2021-0793) which is not germane to this action.

D. Revisions to Petitioned-For Tolerances

FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a tolerance that varies from that sought by the petition. The petitioner initially requested tolerance levels of 0.015 ppm for soybean, forage and 0.02 ppm for soybean, hay. However, the Agency deems it appropriate to use the more conservative (i.e., results with the highest residue value) approach and as a result produced a recommended tolerance levels of 0.01 ppm for soybean, forage and 0.015 ppm for soybean, hay when entered into the Organization for Economic Cooperation and Development (OECD) calculator.

A. Executive Order 12866: Regulatory Planning and Review

This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866.

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

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

C. Paperwork Reduction Act (PRA)

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

D. Regulatory Flexibility Act (RFA)

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

E. Unfunded Mandates Reform Act (UMRA)

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

F. Executive Order 13132: Federalism

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

G. Executive Order 13175: Consultation and Coordination With Indian

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

H. Executive Order 13045: Protection of Children From Environmental

Health Risks and Safety Risks This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because tolerance actions like this one are exempt from review under Executive Order 12866. However, EPA's 2021 Policy on Children's Health applies to this action. [[Page 39506]] 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 documented in the pesticide-specific registration review documents, located in each chemical docket at https://www.regulations.gov.

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. Therefore, 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. Add Sec. 180.728 to subpart C to read as follows:

Sec. 180.728 Diflufenican; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide diflufenican, including its metabolites and degradates, in or on the commodities in Table 1 to this paragraph (a). Compliance with the tolerance levels specified in Table 1 to this paragraph (a) is to be determined by measuring only diflufenican, N-(2,4-difluorophenyl)-2- [3-(trifluoromethyl)phenoxy]-3-pyridinecarboxamide, in or on the following commodities. Table 1 to Paragraph (a) ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Corn, field, forage..................................... 0.01 Corn, field, grain...................................... 0.01 Corn, field, stover..................................... 0.01 Soybean, Forage......................................... 0.01 Soybean, Hay............................................ 0.015 Soybean, Seed........................................... 0.01 ------------------------------------------------------------------------ (b) [Reserved] [FR Doc. 2026-13180 Filed 6-29-26; 8:45 am] BILLING CODE 6560-50-P