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 might apply 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 ( printed page 53731) 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-2024-0548 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 19, 2026.

EPA's Administrative Law Judges Division (ALJD), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Order Urging Electronic Filing and Service,” dated December 3, 2025, which can be found at www.epa.gov/​system/​files/​documents/​2025-12/​2025-12-03-order-urging-electronic-filing-and-service.pdf. Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the ALJD electronically, a person should utilize the ALJD e-filing system at yosemite.epa.gov/​OA/​EAB/​EAB-ALJ_​Upload.nsf.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket at www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at www.epa.gov/​dockets/​commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

II. Petitioned-For Tolerance

In the Federal Register of January 13, 2025 (90 FR 2661, 2663 (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 4E9149) by the National Confectioners Association, 101 90th St. NW, Washington, DC 20007). The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide cypermethrin, including its metabolites and degradates, in or on the raw agricultural commodity cacao, dried bean, at 0.02 ppm and associated processed commodities. That document referenced a summary of the petition that was prepared by the petitioner and included in the docket.

During the public comment period for the notice of filing, which closed on February 12, 2025, no comments were received.

III. Final Tolerance Action

A. Aggregate Risk Assessment and Determination of Safety

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

Cypermethrin is a racemic mixture of eight isomers. Zeta- and alpha-cypermethrin are enrichments of the more insecticidally-potent isomers ( e.g., alpha-S and cis-2-R isomers). Each isomeric mixture is considered to be a separate active ingredient; as a result, there are three isomeric mixtures and three active ingredients (collectively, the “cypermethrins”). The toxicological database for the cypermethrins is complete for the establishment of a tolerance without U.S. registration. The cypermethrins are Type II pyrethroids that contain an alpha-cyano moiety. The adverse outcome pathway shared by pyrethroids involves the ability to interact with voltage-gated sodium channels in the central and peripheral nervous systems leading to changes in neuron firing and, ultimately, neurotoxicity. The database of experimental toxicology studies available for the cypermethrins is considered complete. While each active ingredient does not have its own complete database, studies have been bridged across the three isomeric mixtures and together are considered adequate for human health risk assessment. When evaluated together, the toxicity database for cypermethrin, zeta-cypermethrin, and alpha-cypermethrin can be used to characterize the overall suite of effects associated with cypermethrin exposure, including potential developmental and reproductive toxicity, immunotoxicity, and neurotoxicity.

As with other pyrethroids, metabolism data available for cypermethrin and alpha-cypermethrin in the rat show rapid absorption and clearance (M. Collantes, D425964, 12/21/2017). An in vivo dermal penetration study conducted in rats with alpha-cypermethrin provided the basis for refining the dermal assessment with the use of a dermal absorption factor of 13.4%. Though conducted with the alpha isomer, it is considered appropriate to use for the cypermethrin assessment. This study is considered more robust for risk assessment compared to use of the calculated value comparing oral and dermal studies used previously.

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 (LOC) 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 ( printed page 53732) exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see www.epa.gov/​pesticide-science-and-assessing-pesticide-risks.

A summary of the toxicological endpoints and PODs for cypermethrin used for human risk assessment can be found in the Cypermethrin Human Health Risk Assessment. (D. Dotson, TG00561548, 1/31/2025).

D. Exposure Assessment

A chronic dietary risk assessment is not required for the cypermethrins because repeated exposure does not result in a POD lower than that resulting from acute dietary exposure. Therefore, the acute dietary risk assessment is protective of chronic dietary risk. However, EPA performed a chronic dietary exposure assessment for use in the aggregate assessment, since there are residential exposures for the cypermethrins that need to be aggregated with background exposure from dietary sources. In the aggregate human health risk assessment, the chronic exposure estimates are combined with the appropriate residential exposure estimates to determine the aggregate risk estimates.

As a class of chemicals, the pyrethroids have low solubility in water and a high affinity to bind to soils. Given these physical/chemical properties, it is unlikely that oral exposure from drinking water will be a major pathway of exposure for the cypermethrins. The results of the dietary exposure assessments confirmed this expectation.

EPA estimated residues of the cypermethrins in drinking water from the use of zeta-cypermethrin and cypermethrin on cotton, and these estimated drinking water concentrations (EDWC) are considered appropriate for use in the current risk assessment.

EPA used the cotton surface water and groundwater concentrations calculated using the Surface Water Concentration Calculator and the Pesticide Root Zone Model for Groundwater. The EDWCs are very low, because of the cypermethrins' low water solubility and high affinity to bind to soils.

The recommended residential exposure for use in the adult aggregate assessment is inhalation handler exposure from applying cypermethrin with a sprinkler can to home gardens.

The recommended residential exposure for use in the children 1 to <2 years old aggregate assessment is dermal and incidental oral post-application exposure to pets treated with pet medallion/tag products formulated with cypermethrin.

In 2011, after establishing a common mechanism grouping for the pyrethroids and pyrethrins (the ability to interact with voltage-gated sodium channels leading to neurotoxicity), the Agency conducted a cumulative risk assessment (CRA) which is available at 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 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 those uses being granted.

The recommended tolerance for dried cocoa beans will not significantly impact the cumulative assessment because dried cocoa makes an insignificant contribution to dietary exposure, and dietary exposures make a minor contribution to total pyrethroid exposure relative to residential exposures in the 2011 cumulative risk assessment; furthermore, the proposed tolerance is not associated with any increase in residential or non-occupational exposure. 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

1. In general. FFDCA section 408(b)(2)(C) 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.

2. Prenatal and postnatal sensitivity. There was no evidence of increased quantitative or qualitative susceptibility noted in the developmental or reproduction studies for the cypermethrins. However, body weight changes were seen in pups in the developmental neurotoxicity study with zeta-cypermethrin in the absence of treatment-related effects in maternal animals, suggesting quantitative susceptibility. The degree of concern for the observed susceptibility is low because there is a clear study NOAEL. The PODs used in the risk assessment are protective of the observed susceptibility.

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:

Previously, EPA retained a 3X FQPA SF (1X for pharmacodynamic (PD) and 3X for pharmacokinetic (PK) differences) for children <6 years old based on concerns for PK differences between adults and children. EPA has re-evaluated the need for an FQPA SF for human health risk assessments for pyrethroid pesticides based on a review of the available guideline and literature studies as well as data from the Council for the Advancement of Pyrethroid Human Risk Assessment program. Because no new information of suitable quality was available on the age-related PD properties of the pyrethroids, the PD contribution to the FQPA SF remains at 1X. Regarding PK, recent data including human physiologically-based pharmacokinetic models as well as in vivo and in vitro data on protein binding, enzyme ontogeny, and metabolic clearance, support the conclusion that the PK contribution to the FQPA SF can be reduced to 1X for all populations. (M. Collantes, D453647, 6/9/2020).

F. Aggregate Risk 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 the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate MOE exists. ( printed page 53733)

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to the cypermethrins are not of concern for the general U.S. population or any population subgroup.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that there is no chronic aggregate risk from exposure to the cypermethrins. Short-term aggregate risk is protective for long-term exposure.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Short-term aggregate risk from exposure to the cypermethrins results from exposure to residues in food, drinking water, and residential exposures. The chronic dietary exposure estimates served as background food and water exposure. The worst-case cypermethrin residential exposure scenario for adults resulted from applying cypermethrin with a sprinkler can to home gardens, and is not of concern. The adult dietary LOC is equal to 100, while the inhalation LOC is equal to 30. Therefore, the Aggregate Risk Index (ARI) approach was used to calculate aggregate exposure and risk for adults. An ARI ≥1 is not of concern. The adult aggregate risk estimate is an ARI of 4.5 and is not of concern. The worst-case residential exposures for children 1 to <2 years old, and is not of concern, resulted from dermal and incidental oral post-application exposure to pets treated with a pet medallion/tag. For children (1 to <2 years) the dermal and incidental oral LOC is 100. The short-term aggregate risk estimate is an MOE of 130 for children 1 to <2 years old and is not of concern. Based on pyrethroid toxicity, intermediate-term exposure is covered by short-term exposure.

4. Aggregate cancer risk for U.S. population. As the acute dietary exposure estimates are not of concern, the cancer risk is not of concern. EPA classified cypermethrin as a “Possible Human Carcinogen” and determined that a non-linear approach should be used for cancer assessment. This is considered protective for all chronic toxicity, including carcinogenicity, that could result from exposure to the cypermethrins because of increasing toxicity with increasing duration of exposure was not demonstrated.

5. Determination of safety. 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 cypermethrin residues. More detailed information on this action can be found in the 2025 Human Health Risk Assessment at www.regulations.gov in docket ID EPA-HQ-OPP-20-0548.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate tolerance-enforcement methods are available for determining residues of the cypermethrins in plant (Method I) and livestock (Method II) commodities. Both methods are gas chromatographic methods with electron-capture detection and have undergone successful Agency petition method validations. Method I has a limit of detection (LOD) of 0.01 ppm, and Method II has LODs of 0.005 ppm in milk and 0.01 ppm in livestock tissues. These methods are not stereospecific; therefore, no distinction is made between residues of cypermethrin (all 8 stereoisomers), zeta-cypermethrin (enriched in 4 isomers) and alpha-cypermethrin (enriched in 2 isomers).

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 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.

No Codex or Canadian MRLs are established for dried cacao bean or any of its processed commodities.

C. Effective and Expiration Date(s)

In general, a tolerance action is effective on the date of publication of the final rule in the Federal Register . For actions in the final rule that lower or revoke existing tolerances, EPA will set an expiration date for the existing tolerance of six months after the date of publication of the final rule in the Federal Register , in order to allow a reasonable interval for producers in exporting members of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements.

D. Revisions to Petitioned-For Tolerances

EPA is establishing at 0.05 ppm instead of at the proposed level of 0.02 ppm to align with the established food handling establishment tolerance which applies to all commodities. In addition, EPA is establishing the tolerance according to the correct commodity definition of Cacao, dried bean.

V. Conclusion

Therefore, a tolerance is established for residues of cypermethrin (CASRN 52315-07-8) in or on the food and feed commodity of Cacao, dried bean.

VI. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review

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

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

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

C. Paperwork Reduction Act (PRA)

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

D. Regulatory Flexibility Act (RFA)

Since tolerance actions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this action. ( printed page 53734)

E. Unfunded Mandates Reform Act (UMRA)

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

F. Executive Order 13132: Federalism

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

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

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

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

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

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

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

J. National Technology Transfer Advancement Act (NTTAA)

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

K. Congressional Review Act (CRA)

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

For the reasons set forth in the preamble, 40 CFR chapter I is amended as follows:

91 FR 53730