Cypermethrin; Pesticide Tolerances

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2024-0220; FRL-12817-01-OCSPP]</DEPDOC> <SUBJECT>Cypermethrin; Pesticide Tolerances</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This regulation establishes a tolerance action for residues of cypermethrin (CASRN 52315-07-8) in or on the food and feed commodities of durian. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the United States Department of Agriculture (USDA) submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide on in or on the identified commodity(ies). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective on July 17, 2025. Objections and requests for hearings must be received on or before September 15, 2025 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of this document). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2024-0220, is available at <E T="03">https://www.regulations.gov.</E> Additional information about dockets generally, along with instructions for visiting the docket in person, is available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address: <E T="03">RDFRNotices@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> 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 <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What is EPA's authority for taking this action?</HD> 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 . . .” <HD SOURCE="HD2">C. How can I file an objection or hearing request?</HD> 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 docket ID number EPA-HQ-OPP-2024-0220 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 September 15, 2025. 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. <E T="03">See</E> “Revised Order Urging Electronic Filing and Service,” dated June 22, 2023, which can be found at <E T="03">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.</E> 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 OALJ electronically, a person should utilize the OALJ e-filing system at <E T="03">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.</E> 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. 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 <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets#rules</E> 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. <HD SOURCE="HD1">II. Petitioned-For Tolerance</HD> In the <E T="04">Federal Register</E> of August 8, 2024 (89 FR 64842 (FRL-11682-06-OSCPP)), 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 4E9129) by the United States Department of Agriculture (USDA), 1400 Independence Avenue SW, Washington, DC 20250-1032. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide cypermethrin in or on durian at 1.0 parts per million (ppm). That document referenced a summary of the petition that was prepared by the petitioner and included in the docket. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA is revising the tolerance definition for cypermethrin and setting a tolerance level for durian. <HD SOURCE="HD1">III. Final Tolerance Action</HD> <HD SOURCE="HD2">A. Aggregate Risk Assessment and Determination of Safety</HD> 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 follows. <HD SOURCE="HD2">B. Toxicological Profile</HD> 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 mixture of eight different isomers, all of which are present in equal amounts. Alpha-cypermethrin and zeta-cypermethrin are separate mixtures of the same isomers; however, they are enriched in the most insecticidally active isomers. All three have the same toxicological mode of action and are collectively grouped together as “the cypermethrins” for assessment purposes. 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 toxicology database for the cypermethrins is considered complete with respect to guideline toxicity studies. The cypermethrins affect the nervous system, and neurotoxicity is the most sensitive effect observed throughout the toxicology database. Clinical signs of neurotoxicity were seen for all three compounds across species, sexes, and routes of administration. The endpoints and points of departure (PODs) selected for risk assessment are based on neurotoxicity and are protective of all adverse effects observed in the database. The Health Effects Division (HED) determined that the acute toxicity of alpha-cypermethrin is higher than that of cypermethrin and zeta-cypermethrin. To account for this toxicity difference, HED applied a 5X toxicity factor to commodities that have established tolerances for alpha-cypermethrin. As the current tolerance petitions are for cypermethrin, the toxicity PODs for cypermethrin were used for risk assessment. There was no evidence of increased quantitative or ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 48k characters. 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