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

Permethrin; Pesticide Tolerances

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

If you have any questions regarding the applicability of this proposed 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, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2024-0201 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 March 16, 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 instruction for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

II. Petitioned-For Tolerance

In the Federal Register of November 1, 2024 (89 FR 87321 (FRL-11682-08-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 4E9106) by the Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requests to amend 40 CFR 180.378 by establishing a tolerance for residues of the insecticide permethrin, cis - and trans -permethrin isomers [ cis -(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate] and [ trans -(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate], in or on the raw agricultural commodities: arugula at 50 parts per million (ppm); cress, garden at 50 ppm; cress, upland at 50 ppm; dragon fruit (pitaya) at 1.5 ppm; field corn subgroup 15-22C at 0.05 ppm; leafy greens subgroup 4-16A at 50 ppm; and sweet corn subgroup 15-22D at 0.1 ppm). Additionally, the petition requests, upon approval of the above tolerance, to remove the existing tolerances in 40 CFR 180.378 in or on the following agricultural commodities: corn, field, grain at 0.05 ppm; corn, pop, grain at 0.05 ppm; leafy green subgroup 4A at 20 ppm; lettuce, head at 20 ppm; spinach at 20 ppm; and corn, sweet, kernel plus cob with husks removed at 0.10 ppm. That document referenced a summary of the petition prepared by IR-4, the petitioner, which is available in the docket (ID number EPA-HQ-OPP-2024-0201) at http://www.regulations.gov. There was one comment received in response to the notice of filing. The comment stated that the commentor is in support of the guidelines.

In the Federal Register of January 13, 2025 (90 FR 2661 (FRL-11682-11-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 4E9106) by the Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requests to amend 40 CFR 180.378 by removing established tolerances for residues of the insecticide permethrin, cis - and trans -permethrin isomers [ cis -(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate] and [ trans -(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate], in or on the raw agricultural commodities: corn, field, grain at 0.05 ppm; corn, pop, grain at 0.05 ppm; corn, sweet, kernel plus cob with husks removed at 0.10 ppm; leafy greens subgroup 4A at 20 ppm; lettuce, head at 20 ppm; and spinach at 20 ppm. There were four comments received in response to the notice of filing. Three of the comments were in support of the rule. The fourth comment stated that "there are options for organic pesticides that have both long term economic[al] and ecological benefits despite upfront costs." Although the Agency recognizes that some individuals believe that organic pesticides should be used on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerances are 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 permethrin tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing a tolerance that varies from what was requested. The reason for this change is explained in Unit IV.D.

III. Final Tolerance Action

A. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is "safe." Section 408(b)(2)(A)(ii) of FFDCA defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . ."

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for permethrin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with permethrin follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination of the new rulemaking.

EPA has previously published a number of tolerance rulemakings for permethrin in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to permethrin and established a tolerance for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

B. Toxicological Profile

For a discussion of the Toxicological Profile of permethrin, see Unit III A. of the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45).

C. Toxicological Points of Departure/Levels of Concern

For a summary of the Toxicological Points of Departure/Levels of Concern for permethrin used for human health risk assessment, see Unit III.B. of the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45).

D. Exposure Assessment

Much of the exposure assessment remains the same, although updates have occurred to accommodate exposures from the petitioned-for tolerance. These updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit III.C. of the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45).

EPA's dietary exposure assessments have been updated to include the additional exposure from the new use of permethrin on dragon fruit and do not change the prior exposure estimates. This assessment was conducted with Dietary Exposure Evaluation Model software using the Food Commodity Intake Database (DEEM-FCID; Version 4.02), which uses the 2005-2010 food consumption data from the United States Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America. The assessment used the same assumptions as the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45).

1. Drinking water exposure. The new use does not result in an increase in the estimated residue levels in drinking water, so EPA used the same estimated drinking water concentrations in the acute and chronic dietary exposure assessments as identified in Unit III.C.2. of the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45). Permethrin is classified as "suggestive evidence of carcinogenic potential" based upon the lung adenomas in female mice. The Agency has determined that quantification of risk using a non-linear approach ( i.e., reference dose (RfD)) will adequately account for all toxicity, including carcinogenicity, that could result from exposure to permethrin. Additionally, there is no concern for mutagenicity based on the findings from the genotoxicity battery of studies.

2. Non-occupational exposure. The new uses do not impact residential/bystander exposures and thus the residential exposures have not changed since the last assessment described in the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45).

3. Cumulative exposure. 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 has determined that the pyrethroids and pyrethrins share a common mechanism of toxicity ( http://www.regulations.gov; EPA-HQ-OPP-2008-0489-0006).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 http://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 the proposed new use of permethrin on dragon fruit, crop group expansions to field corn subgroup 15-22C and sweet corn subgroup 15-22D, and crop group conversions to leafy greens subgroup 4-16A, including tolerances for arugula, garden cress, and upland cress. The proposed new use will not impact the results of the 2011 CRA. Therefore, the results of the 2011 CRA are still valid and there are no cumulative risks of concern for the pyrethroids/pyrethrins.

E. Safety Factor for Infants and Children

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 (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. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the July 28, 2020, rulemaking for a discussion of the Agency's rationale for that determination.

F. Aggregate Risks and Determination of Safety

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

Acute dietary risks are below the Agency's level of concern of 100% of the aPAD. They are 4.3% of the aPAD for children 3 to 5 years old, the population subgroup with the highest exposure estimate. A chronic dietary endpoint has not been selected for permethrin because repeated exposure does not result in a point of departure lower than that resulting from acute exposure. Therefore, the acute dietary risk assessment is protective of chronic dietary risk. However, since there are residential uses of permethrin, a highly refined chronic dietary (food and drinking water) exposure assessment was conducted to calculate chronic dietary exposure estimates to support the permethrin aggregate risk assessment.

The short-term aggregate risk assessment combines exposures to permethrin from the registered residential uses and the dietary (food and drinking water) risk assessment. An aggregate risk index (ARI) approach was used for the short-term aggregate risk assessment since the oral and inhalation endpoints have different level of concerns. ARIs that are greater than or equal to 1 and are not of concern. The short-term aggregate assessment for children 1 to less than 2 years old was conducted using the ARI approach for consistency purposes, even though only oral post-application exposures are anticipated for the selected residential scenario. The short-term aggregate assessment for adults resulted in an ARI of 76 and, for children 1 to less than 2 years old, the result is an ARI of 3.0. Since the ARIs are greater than 1, there are no short-term aggregate risks of concern for permethrin.

Residential exposures are not expected to occur from the newly proposed uses since none are residential use sites. For more details on residential exposure, see III.C.3 of the July 28, 2020, rulemaking (85 FR 45329) (FRL-10009-45).

Permethrin is classified as showing "suggestive evidence of carcinogenic potential" based upon the lung adenomas in female mice. The Agency has determined that quantification of risk using a non-linear approach ( i.e., reference dose (RfD)) will adequately account for all toxicity, including carcinogenicity, that could result from exposure to permethrin. Additionally, there is no concern for mutagenicity based on the findings from the genotoxicity battery of studies.

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to permethrin residues. More detailed information about the Agency's analysis can be found at https://www.regulations.gov in the document titled "Permethrin. Human Health Risk Assessment for Proposed Usage on Dragon Fruit, Crop Group Expansions to Field Corn Subgroup 15-22C and Sweet Corn Subgroup 15-22D, and Crop Group Conversions to Leafy Greens Subgroup 4-16A, Including Tolerances for Orphan Crops Arugula, Garden Cress, and Upland Cress" in docket ID number EPA-HQ-OPP-2024-0201.

IV. Other Conclusions

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method, see Unit IV.A of the July 28, 2020 rulemaking (85 FR 45329) (FRL-10009-45).

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international 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 Canadian and Codex MRLs are expressed in terms of total permethrin. The U.S. residue definition is harmonized with Canada and Codex. Mexico adopts U.S. tolerances. When the U.S. tolerance is higher, harmonization is not feasible because the tolerances are based on field trial data that resulted in residues that necessitated the higher limit. For some cases, such as corn grain, EPA establishes a different U.S. tolerance (0.05 ppm) than the Codex tolerance (2 ppm) due to differences in use patterns.

C. Revisions to Petitioned-For Tolerances

A tolerance of 3 ppm is being established for dragon fruit rather than 1.5 ppm as requested. The petitioner reported the proposed tolerance based on the average cis - and trans -permethrin residue ( cis - and trans -permethrin residues were not combined). EPA is establishing a tolerance for residues of permethrin cis- and trans- isomers in/on dragon fruit, based on the per-trial average total cis - and trans -permethrin residue, derived using the Organization for Economic Cooperation and Development (OECD) MRL calculation procedures. The OECD tolerance calculation when using the per-trial average is 3 ppm for dragon fruit. Also, tolerances are currently established for residues in leafy greens subgroup 4A at 20 ppm. A tolerance of 50 ppm is being established for residues in leafy greens subgroup 4-16A commodities as part of the crop group conversion. The increased tolerance level is due to data that were received in response to the data requests in the permethrin data call-in (GDCI-109701-26467). Additionally, as part of the crop group conversion, arugula, garden cress, and upland cress have moved to crop group 4-16B. EPA is establishing individual tolerances for residues in these commodities at 50 ppm to ensure that previously established tolerances associated with phase four revisions are not inadvertently lost during crop group conversion requests.

V. Conclusion

Therefore, tolerances are established for residues of permethrin in or on arugula at 50 ppm; cress, garden at 50 ppm; cress, upland at 50 ppm; dragon fruit at 3 ppm; field corn subgroup 15-22C at 0.05 ppm; leafy greens subgroup 4-16A at 50 ppm; and sweet corn subgroup 15-22D at 0.1 ppm. In addition, the rule removes the established tolerances for residues of permethrin in or on corn, field, grain at 0.05 ppm; corn, pop, grain at 0.05 ppm; leafy greens subgroup 4A at 20 ppm; lettuce, head at 20 ppm; spinach at 20 ppm; and corn, sweet, kernel plus cob with husks at 0.10 ppm.

VI. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review

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

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

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

C. Paperwork Reduction Act (PRA)

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

D. Regulatory Flexibility Act (RFA)

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

E. Unfunded Mandates Reform Act (UMRA)

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

F. Executive Order 13132: Federalism

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

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

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

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because tolerance actions like this one are exempt from review under Executive Order 12866. However, EPA's 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . ." (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.E.

I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer Advancement Act (NTTAA)

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

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a "major rule" as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

PART 180-TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

[FR Doc. 2026-00545 Filed 1-13-26; 8:45 am]

BILLING CODE 6560-50-P