Fatty acids, C16-18 and C18-unsatd., esters With polyethylene glycol mono-Me ether in Pesticide Formulations; Tolerance Exemption

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0368; FRL-12393-01-OCSPP]</DEPDOC> <SUBJECT> Fatty acids, C <E T="0735">16-18</E> and C <E T="0735">18</E> -unsatd., esters With polyethylene glycol mono-Me ether in Pesticide Formulations; Tolerance Exemption </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 an exemption from the requirement of a tolerance for residues of fatty acids, C <E T="52">16-18</E> and C <E T="52">18</E> -unsatd., esters with polyethylene glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant and related adjuvant of surfactant) on growing crops and raw agricultural commodities pre- and post-harvest limited to 25% by weight in pesticide formulations. Spring Regulatory Sciences on behalf of Sasol Chemicals (USA) LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of fatty acids, C <E T="52">16-18</E> and C <E T="52">18</E> -unsatd., esters with polyethylene glycol mono-Me ether, when used in accordance with the terms of this exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective December 2, 2024. Objections and requests for hearings must be received on or before January 31, 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> ). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0368, is available at <E T="03">https://www.regulations.gov</E> or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP docket is (202) 566-1744. Please review the visitor instructions and additional information about the docket 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; 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. General Information</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). <HD SOURCE="HD2">B. How can I get electronic access to other related information?</HD> You may access a frequently updated electronic version of 40 CFR part 180 through the <E T="04">Federal Register</E> Office's e-CFR site at <E T="03">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.</E> <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. 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-2023-0368 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 31, 2025. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). 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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0368, by one of the following methods: • <E T="03">Federal eRulemaking Portal: 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. • <E T="03">Mail:</E> OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. • <E T="03">Hand Delivery:</E> To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at <E T="03">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.</E> Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/dockets.</E> <HD SOURCE="HD1">II. Petition for Exemption</HD> In the <E T="04">Federal Register</E> of September 19, 2023 (88 FR 64398, FRL-10579-08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11755) by Spring Regulatory Sciences (6620 Cypresswood Dr., Suite 250, Spring, TX 77379) on behalf of Sasol Chemicals (USA) LLC (12120 Wickchester Lane, Houston, TX 77224). The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of fatty acids, C <E T="52">16-18</E> and C <E T="52">18</E> -unsatd., esters with polyethylene glycol mono-Me ether (CAS Reg. No. 518299-31-5) when used as an inert ingredient (surfactant and related adjuvant of surfactant) in pesticide formulations applied to growing crops or raw agricultural commodities pre- and post-harvest limited to 25% by weight in pesticide formulations. That document referenced a summary of the petition prepared by Spring Regulatory Sciences on behalf of Sasol Chemicals (USA) LLC, the petitioner, which is available in the docket at <E T="03">https://www.regulations.gov.</E> There were no comments received in response to the notice of filing. <HD SOURCE="HD1">III. Inert Ingredient Definition</HD> Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. <HD SOURCE="HD1">IV. Aggregate Risk Assessment and Determination of Safety</HD> Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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. FFDCA section 408(c)(2)(B) directs EPA to take into account the considerations in section 408(b)(2)(C) and (D) when making a safety determination for an exemption from the requirement of a tolerance. 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 . . . ” Section 408(b)(2)(D) lists other factors for EPA consideration when making safety determinations, including the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances. EPA establishes exemptions from the requirement of a tolerance only in those cases ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 35k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━