Ethyl Formate; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2024-0426; FRL-12782-01-OCSPP]</DEPDOC> <SUBJECT>Ethyl Formate; Exemption From the Requirement of a Tolerance</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 ethyl formate in or on citrus (10-10), kiwifruit (fuzzy and hardy), and table grapes when used as a fumigant in accordance with label directions and good agricultural practices. VPTox LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) on behalf of Draslovka Services Pty Ltd, requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethyl formate in or on citrus, crop group 10-10; kiwifruit, fuzzy; kiwifruit, hardy, and grape, table in accordance with the terms of the exemption. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective August 6, 2025. Objections and requests for hearings must be received on or before October 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> ). </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2024-0426, 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> Sydnie Vergara, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1606; email address: <E T="03">BPPDFRNotices@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. • 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(c)(2)(A)(i) 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 exemption is “safe.” FFDCA section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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, 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-2024-0426 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 October 6, 2025. 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 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 Exemption</HD> In the <E T="04">Federal Register</E> of November 12, 2024 (89 FR 88948) (FRL-11682-09-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 tolerance petition (PP 0F8850) by VPTox LLC, on behalf of Draslovka Services Pty Ltd., 21320 Sweet Clover Place, Ashburn, VA 20147. The petitioner requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of ethyl formate. The petition did not specify any limit on the food commodities for the tolerance exemption, and EPA's notice indicated that the petition requested the exemption for all food commodities. The document referenced a summary of the petition prepared by the petitioner, Draslovka Services, which is available in the docket, <E T="03">https://www.regulations.gov</E> . Comments were received on the notice of filing. One comment was in support of this regulation and was submitted by the California Citrus Quality Council (CCQC). Three comments were not substantive, and one comment was for a different chemical (submitted to this docket in error). <HD SOURCE="HD1">III. Final Tolerance Actions</HD> <HD SOURCE="HD2">A. EPA's Safety Determination</HD> Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 to ethyl formate, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with ethyl formate are summarized in this Unit. <HD SOURCE="HD2">B. Toxicological Profile</HD> Ethyl formate is of low acute and subchronic toxicity. All acute toxicity data demonstrate that ethyl formate has low to negligible toxicity. For most routes of exposure (acute dermal, acute inhalation, primary eye irritation, and primary dermal irritation), ethyl formate is classified as Toxicity Category IV. For acute oral toxicity, it is classified as Toxicity Category III. It is not a dermal sensitizer. All data and information submitted to address the subchronic data requirements (90-day oral, 90-day dermal, 90-day inhalation, genotoxicity, prenatal developmental, and maternal toxicity) are acceptable. For the 90-day oral toxicity, the study indicated the no-observable-adverse-effect-level (NOAEL) is 1,000 mg/kg/day (limit dose), and a lowest-observable-adverse-effect-level (LOAEL) is therefore not established. The 90-day dermal toxicity was addressed by scientific rationales since dermal exposure to ethyl formate is not expected. For the 90-day inhalation toxicity, the study indicated the NOAEL is equal ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 24k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━