Tiafenacil; Pesticide Tolerances

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0246; FRL-12678-01-OCSPP]</DEPDOC> <SUBJECT>Tiafenacil; 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 tolerances for residues of tiafenacil in or on multiple commodities. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This regulation is effective April 7, 2025. Objections and requests for hearings must be received on or before June 6, 2025 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the <E T="02">SUPPLEMENTARY INFORMATION</E> ). </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0246, is available online 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 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 <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) of 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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect a tolerance. EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), 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. . . .”Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” <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-2023-0246 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 June 6, 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 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 whose disclosure is restricted by statue. 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. Petition for Exemption</HD> In the <E T="04">Federal Register</E> of October 26, 2023 (88 FR 73571) (FRL-10579-09-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 2F9040) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. The petition requested that 40 CFR 180.713(a)(1) be amended by establishing tolerances for residues of the herbicide tiafenacil, including its metabolites and degradates, in or on Pulses, dried shelled bean, except soybean, subgroup 6-22E at 0.03 parts per million (ppm); Pulses, dried shelled pea, subgroup 6-22F at 0.05 ppm; Citrus fruit, group 10-10 at 0.01 ppm; Pome fruit, group 11-10 at 0.01 ppm; Stone fruit, group 12-12 at 0.01 ppm; Tree nut, group 14-12 at 0.01 ppm; Barley subgroup 15-22B at 0.015 ppm; Sweet corn subgroup 15-22D at 0.01 ppm; Grain sorghum and millet subgroup 15-22E at 0.01 ppm; Rapeseed, subgroup 20A at 0.015 ppm; and Peanut at 0.01 ppm. The petition also requested that 40 CFR 180.713(a)(2) be amended by establishing tolerances for residues of the herbicide tiafenacil, including its metabolites and degradates, in or on Almond hulls at 0.03 ppm; Barley, hay at 0.07 ppm; Barley, straw at 0.04 ppm; Corn, sweet, forage at 0.01 ppm; Corn, sweet, stover at 0.015 ppm; Pea, straw at 7 ppm; Sorghum, forage at 0.01 ppm; and Sorghum, stover at 0.015 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the petitioner, which is available in the docket (EPA-HQ-OPP-2023-0246), <E T="03">https://www.regulations.gov.</E> A comment was received in response to the notice of filing. EPA's response to this comment is discussed in Unit IV.C. Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has revised tolerance values and definitions for some commodities, and established tolerances on additional livestock feed commodities. The reasons for these changes are explained in Unit IV.D. <HD SOURCE="HD1">III. Aggregate Risk Assessment and Determination of Safety</HD> 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 relevan ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 34k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━