SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

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

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

If you have any questions regarding the applicability of this 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. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2025-0071 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 2, 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 ( printed page 48773) may be disclosed publicly by EPA without prior notice.

II. Petitioned-For Tolerance

In the Federal Register of July 3, 2025 (90 FR 29515 (FRL-12474-05-OCSPP)), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F9157) by the American Spice Trade Association, Inc. 1101 17th Street NW, Suite 700, Washington, DC 20036. The petition requests to amend 40 CFR 180.378 by establishing a tolerance for residues of the insecticide permethrin, measured as the sum of its 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 commodity black pepper at 0.1 ppm. That document referenced a summary of the petition prepared by the American Spice Trade Association, Inc., the petitioner, which is available in the docket (ID number EPA-HQ-OPP-2025-0071) at https://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing the proposed tolerance.

III. Final Tolerance Action

A. Aggregate Risk Assessment and Determination of Safety

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 are summarized in this unit.

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.

For a discussion of the toxicological profile of permethrin and specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by permethrin, refer to the document titled “Permethrin. Human Health Risk Assessment for Tolerance without U.S. Registration in/on Imported Black Pepper” (hereinafter “Permethrin Human Health Risk Assessment”), which is available in the docket for this action.

C. Toxicological Points of Departure/Levels of Concern

For a summary of the Toxicological Points of Departure (POD)/Levels of Concern for permethrin used for human health risk assessment, see “Permethrin Human Health Risk Assessment,” available in the docket for this action.

D. Exposure Assessment

EPA's dietary exposure assessments have been updated to include the additional exposure from the new use of permethrin on imported black pepper and do not change the prior exposure estimates. Acute and average (chronic) aggregate dietary (food and drinking water) exposure and risk assessments were conducted for permethrin using the 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 (USDA) National Health and Nutrition Examination Survey, What We Eat in America. Permethrin residue estimates used in the assessment are calculated as the sum of cis - and trans -permethrin, along with percent crop treated estimates reported by the Biological and Economic Analysis Division, USDA Pesticide Data Program monitoring data, both empirical and EPA's default processing factors, and a modeled estimated drinking water concentration. Risk estimates do not exceed EPA's level of concern (less than 100% of the acute population-adjusted dose (aPAD)) at the 99.9th exposure percentile for the general U.S. population (2.2% of the aPAD) and all population subgroups. The most highly exposed population subgroup is children 3-5 years old with a risk estimate of 4.3% of the aPAD at the 99.9th exposure percentile.

A chronic dietary endpoint has not been selected for permethrin because repeated exposures do 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, since there are residential uses of permethrin, a dietary exposure assessment was conducted to calculate average dietary (food and drinking water) exposure estimates to support the permethrin aggregate risk assessment. The population subgroup with the highest chronic dietary (food and drinking water) exposure estimate is children 1-2 years old (0.000780 mg/kg/day). Permethrin is classified as “suggestive evidence of carcinogenic potential” based upon 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. A separate cancer dietary exposure and risk assessment is not required.

1. Drinking water exposure. Although the proposed use will not affect drinking water, acute and average (chronic) aggregate dietary (which includes both food and drinking water) exposure and risk assessments were conducted using the DEEM-FCID; Version 4.02 as noted above.

2. Non-occupational exposure. There are no new residential uses of permethrin being proposed at this time. However, residential handler and post-application exposures are anticipated from the currently registered uses of permethrin and the recommended residential exposures to be included in the permethrin aggregate assessment remain unchanged; see “Permethrin Human Health Risk Assessment,” available in the docket for this action.

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 ( https://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 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. The recommended tolerance for permethrin on black pepper will not significantly ( printed page 48774) impact the results of the 2011 CRA because dietary exposures make a minor contribution to total pyrethroid exposure relative to residential exposures. 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 SF 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 FQPA SF from 10X to 1X. See “Permethrin Human Health Risk Assessment,” available in the docket for this action 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 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 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 POD 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 population subgroup with the highest chronic dietary (food and drinking water) exposure estimate is children 1-2 years old (0.000780 mg/kg/day).

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 levels of concern. ARIs that are greater than or equal to 1 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.

A chronic aggregate assessment was not conducted since single dose and repeat dosing permethrin 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 need to be conducted for permethrin, and these are protective of all other durations of exposure.

A cancer aggregate risk assessment was not necessary for permethrin since the quantification of risk using a non-linear RfD was determined to adequately account for all chronic toxicity, including carcinogenicity, that could result from exposures to permethrin.

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 “Permethrin Human Health Risk Assessment” in docket ID number EPA-HQ-OPP-2025-0071.

IV. Other Conclusions

A. Analytical Enforcement Methodology

Adequate gas chromatography electron capture detection (GC/ECD) methods are available for enforcing tolerances of permethrin and are listed in Pesticide Analytical Manual (PAM) Vol. II (Section 180.378). Method I is a GC/ECD method for determining permethrin in plant matrices and has a limit of quantitation (LOQ) of 0.05 ppm for each isomer. Method II is a GC/ECD method for determining permethrin in livestock matrices that has a LOQ of 0.01 ppm for each isomer. In addition, permethrin is completely recovered using FDA Multiresidue Methods (PAM Vol. I Sections 302 and 304).

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 (MRL) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).

Codex (0.05 ppm on pepper-spices), Canada (0.1 ppm on pepper-spices) and the European Union (0.1 ppm on peppercorn) have established MRLs for residues of permethrin in/on pepper, black. The EPA's proposed tolerance would harmonize the U.S. tolerance with the European Union tolerance at 0.1 ppm, which will promote global harmonization and facilitate trade. Based on the available residue data, harmonization with the Codex MRL was not possible.

V. Conclusion

Therefore, a tolerance is established for residues of permethrin (CASRN 52645-53-1) in/on black pepper at 0.1 ppm.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/​regulations/​laws-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 ( printed page 48775) exempted from review under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

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

D. Regulatory Flexibility Act (RFA)

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

E. Unfunded Mandates Reform Act (UMRA)

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

F. Executive Order 13132: Federalism

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

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

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

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

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because tolerance actions like this one are exempt from review under Executive Order 12866. However, EPA's 2026 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.E.

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

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

J. National Technology Transfer Advancement Act (NTTAA)

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

K. Congressional Review Act (CRA)

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

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

91 FR 48772