Cyclobutrifluram; Pesticide Tolerances

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2022-0003; FRL-12872-01-OCSPP]</DEPDOC> <SUBJECT>Cyclobutrifluram; 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 cyclobutrifluram in or on the food and feed commodities of cotton, gin byproducts; cotton, undelinted seed; lettuce, leaf; soybean, seed. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Syngenta submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodities. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective on November 5, 2025. Objections and requests for hearings must be received on or before January 5, 2026 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.D. of this document). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2022-0003, 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, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-2427; 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 proposed 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-2022-0003 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 January 5, 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 <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 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 <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 at <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information of which the 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 May 20, 2022 (87 FR 30855) (FRL-9410-13-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 1F8954) by Syngenta, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide/nematicide cyclobutrifluram, in or on cotton at 0.010 parts per million (ppm); cotton, by-products at 0.010 ppm; lettuce, romaine at 0.015 ppm; and soybean at 0.010 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. <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 cyclobutrifluram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyclobutrifluram 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. Cyclobutrifluram is a novel pyridine-3-carboxamide nematicide/fungicide with a pesticidal mode of action that functions via inhibition of complex II succinate dehydrogenase, but the mammalian mode of action is not known at this time. Following the administration of cyclobutrifluram, the target organs include the liver (mouse) and thyroid (rat). In addition, decreased absolute body weight was observed in rats and dogs following subchronic administration of the test compound. No adverse effects were observed in the chronic/carcinogenicity toxicity study in rats and the carcinogenicity toxicity study in mice up to the highest doses tested (23/34 mg/kg/day (M/F) and 48/54 mg/kg/day (M/F), respectively). The thyroid is the most sensitive endpoint in the cyclobutrifluram toxicity database. Following subchronic exposure of rats to cyclobutrifluram, follicular cell hypertrophy in males and females was observed after 28- (331 mg/kg/day) and 90-day (187 mg/kg/day) exposures. Increased thyroid weights were observed in males of the F1 generation while follicular cell hypertrophy was observed in both sexes of the P generation and males of the F1 generation of the multigeneration reproductive toxicity study at 43 mg/kg/day. Maternal thyroid hormones levels (T3, T4, and TSH) were measured in the developmental rat toxicity study up to and including the highest dose tested (250 mg/kg/day) and no adverse changes were observed. Treatment-related effects to the liver and spleen (increased reticulocytes along with increased spleen weights and extramedullary hematopoiesis) were observed in mice following 28-day (338/334 mg/kg/day (M/F)) and 90-day (249/309 mg/kg/day (M/F)) exposures. Liver effects included liver hypertrophy, increased liver weights, incre ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 34k characters. 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