1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts; and 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, hydroxides, inner salts in Pesticide Formulations; Tolerance Exemptions

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2021-0613 and EPA-HQ-OPP-2023-0347; FRL-11898-01-OCSPP]</DEPDOC> <SUBJECT> 1-Propanaminium, 3-amino-N-(2-carboxyethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, inner salts; and 1-Propanaminium, 3-amino-N-(carboxymethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, hydroxides, inner salts in Pesticide Formulations; Tolerance Exemptions </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 1-propanaminium, 3-amino-N-(2-carboxyethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, inner salts (CAS Reg. No. 499781-63-4) when used as an inert ingredient (adjuvant or surfactant) on growing crops and raw agricultural commodities pre- and post-harvest. This regulation also establishes an exemption from the requirement of a tolerance for residues of 1-propanaminium, 3-amino-N-(carboxymethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, hydroxides, inner salts (CAS Reg. No. 61789-40-0), also known as cocamidopropyl betaine, when used as an inert ingredient (surfactant) on growing crops pre-harvest. Oxiteno USA, LLC and Bi-PA NV, respectively, each 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 for each of these substances. This regulation eliminates the need to establish a maximum permissible level for residues of 1-propanaminium, 3- amino-N-(2-carboxyethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, inner salts; and cocamidopropyl betaine when used in accordance with the terms of these exemptions. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective May 10, 2024. Objections and requests for hearings must be received on or before July 9, 2024 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 dockets for these actions, identified by docket identification (ID) numbers EPA-HQ-OPP-2021-0613 and EPA-HQ-OPP-2023-0347, are 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, 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. 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: <FP SOURCE="FP-1">• Crop production (NAICS code 111).</FP> <FP SOURCE="FP-1">• Animal production (NAICS code 112).</FP> <FP SOURCE="FP-1">• Food manufacturing (NAICS code 311).</FP> <FP SOURCE="FP-1">• Pesticide manufacturing (NAICS code 32532).</FP> <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 Office of the Federal Register's e-CFR site at <E T="03">https://www.ecfr.gov/current/title-40.</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-2021-0613 or EPA-HQ-OPP-2023-0347 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 July 9, 2024. 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-2021-0613 or EPA-HQ-OPP-2023-0347, 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 October 21, 2021 (86 FR 58239) (FRL-8792-04-OSCPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11550) by Spring Regulatory Sciences, on behalf of Oxiteno USA, LLC, 3200 Southwest Freeway, Suite 1200, Houston, TX 77027. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of 1-propanaminium, 3-amino-N-(2-carboxyethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, inner salts (CAS Reg. No. 499781-63-4) when used as an inert ingredient (adjuvant or surfactant) in pesticide formulations applied to growing crops or raw agricultural commodities pre- and post-harvest. This document referenced a summary of the petition prepared by Oxiteno USA, LLC, 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. In the <E T="04">Federal Register</E> of Wednesday, July 26, 2023 (88 FR 48179) (FRL-10579-06-OSCPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11782) by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of Bi-PA NV. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of cocamidopropyl betaine (CAS Reg. No. 61789-40-0) when used as an inert ingredient (surfactant) in pesticide formulations pre-harvest at levels up to 10% w/w in pesticide formulations. This document referenced a summary of the petition prepared by Bi-PA NV, 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. Based upon review of the data supporting the petitions and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing an exemption for residues of 1-propanaminium, 3-amino-N-(2-carboxyethyl)- <E T="03">N,N</E> -dimethyl-, N-coco acyl derivatives, inner salts that includes a limitation of 25% w/w in pesticide formulations to account for potential aquatic toxicity. A revised petition was submitted by Oxiteno USA, LLC, to support this change to the petitioned-for exemption. <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 SOURC ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 33k characters. 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