Sulfentrazone; Pesticide Tolerances

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2024-0169; FRL-12202-02-OCSPP]</DEPDOC> <SUBJECT>Sulfentrazone; 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> The Environmental Protection Agency (EPA or Agency) is finalizing tolerance actions it previously proposed on its own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) for residues of sulfentrazone in or on corn, pop, grain and corn, pop, stover. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective May 19, 2025. Objections and requests for hearings must be received on or before July 18, 2025, 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-2024-0169, 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: • 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 action is the Agency taking?</HD> EPA is finalizing tolerance actions that the Agency previously proposed on its own initiative under section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), for residues of the herbicide sulfentrazone in or on corn, pop, grain at 0.15 parts per million (ppm) and corn, pop, stover at 0.3 ppm. EPA had previously registered the use of sulfentrazone on field corn and established tolerances on corn, field, grain at 0.15 ppm, and corn, field, stover at 0.30 ppm. As part of that process, the use on popcorn was added to the sulfentrazone label (same use pattern as field corn), but, in error, separate tolerances on corn, pop, grain and corn, pop, stover were not established. EPA proposed establishing the tolerances required to support the use on popcorn in order to rectify this oversight as described in the proposed rule and is now finalizing that proposal in this rulemaking. Four comments were received in response to the proposed rule. EPA's response to these comments is discussed in Unit III.C. <HD SOURCE="HD2">C. What is EPA's authority for taking this action?</HD> FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance on its own initiative. FFDCA section 408(e)(2) requires EPA to issue a notice of proposed rulemaking for a 60-day public comment period, unless the Administrator for good cause finds that it would be in the public interest to have a shorter period and states the reasons in the rulemaking. 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">D. 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 include the chemical specific docket ID number as provided in the heading of this rulemaking as part of 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 July 18, 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. See “Revised Order Urging Electronic Service and Filing”, 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 for inclusion in the public docket through <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 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. Aggregate Risk Assessment and Determination of Safety</HD> Consistent with 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, consistent with FFDCA section 408(b)(2), for tolerances for residues of sulfentrazone on corn, pop, grain and corn, pop, stover. EPA's assessment of exposures and risks associated with establishing these tolerances follows. In an effort to streamline its publications in the <E T="04">Federal Register</E> , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking. EPA has previously published several tolerance rulemakings for sulfentrazone in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to sulfentrazone and established tolerances for residues of that chemical. EPA is incorporating previously published sections of those rulemakings that remain unchanged, as described further in this rulemaking. 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 sulfentrazone, can be found in the document titled “Sulfentrazone—Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Establishment of Tolerances for Residues in/on Pop Corn Commodities” which is available in the docket for this action at <E T="03">https://www.regulations.gov.</E> <E T="03">Toxicological profile.</E> For a discussion of the Toxicological Profile of sulfentrazone, see Unit III.A. of the rulemaking published in the <E T="04">Federal Register</E> of April 13, 2018 (83 FR 15977) (FRL-9975-77). <E T="03"> ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 25k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━