Lactic Acid and L-Lactic Acid; Exemption From the Requirement of a Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0455; FRL-12194-01-OCSPP]</DEPDOC> <SUBJECT>Lactic Acid and L-Lactic Acid; 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 removes the duplicative exemption from the requirement of a tolerance for residues of lactic acid and l-lactic acid, herein referred to as l-lactic acid, when applied/used in dairy processing equipment and food processing equipment and utensils. In addition, the Agency is amending an existing exemption from the requirement of a tolerance for lactic acid to also include l-lactic acid. The Agency is also establishing exemptions from the requirement of a tolerance for residues of l-lactic acid when used as a fruit and vegetable wash in or on all raw agricultural commodities, and for indirect or inadvertent residues of l-lactic acid in or on all livestock commodities, when residues are present therein as a result of animal drinking water coming into contact with hard non-porous surfaces treated with l-lactic acid ( <E T="03">i.e.,</E> troughs). These tolerance exemptions are established on the Agency's own initiative under the Federal, Food, Drug, and Cosmetic Act (FFDCA), in order to implement the tolerance actions EPA identified during its review of this chemical as part of the Agency's registration review program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective August 29, 2024. Objections and requests for hearings must be received on or before October 28, 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 docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0455, 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 for 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> Anita Pease, Antimicrobials Division (7510M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-0736; email address: <E T="03">pease.anita@epa.gov</E> or <E T="03">ADFRNotices@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: • Food manufacturing (NAICS code 311), • Pesticide manufacturing (NAICS code 32532), • Restaurant kitchen cleaning services (NAICS code 561720), • Milk production, dairy cattle (NAICS code 112120), • Food processing machinery and equipment wholesalers (NAICS code 423830). <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, 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-2023-0455 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 28, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). Notwithstanding the procedural requirements of 40 CFR 178.25(b), the Office of the Administrative Law Judges has issued an order urging parties to file and serve <FP> documents with the Tribunal by electronic means only. <E T="03">See Revised Order Urging Electronic Filing and Service</E> (dated June 22, 2023), <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> </FP> 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-2023-0455, 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/contacts.html.</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. Background</HD> <HD SOURCE="HD2">A. Proposed Rule</HD> In the <E T="04">Federal Register</E> of November 13, 2023 (88 FR 77544) (FRL-11520-01-OCSPP), EPA proposed to remove a duplicative exemption from the requirement of a tolerance for residues of L-lactic acid, referred to as lactic acid in the proposed rule, when applied to dairy-processing equipment and food-processing equipment and utensils. Specifically, the action proposed removing the duplicative entry at 40 CFR 180.940(b). In addition, EPA proposed an amendment to 40 CFR 180.1090 to establish exemptions from the requirement of a tolerance for residues of lactic acid when used as a fruit and vegetable wash in or on all agricultural commodities, and for indirect or inadvertent residues of lactic acid in or on all livestock commodities, when residues are present therein as a result of animal drinking water coming into contact with hard non-porous surfaces treated with lactic acid ( <E T="03">i.e.,</E> troughs). As noted in the proposal, the <E T="03">L-lactic Acid Interim Registration Review Decision</E> (L-lactic Acid ID) identified the need for these exemptions based on existing registered pesticide uses and concluded that there were no risks of concern associated with these uses. Consequently, EPA concluded that the exemptions from the requirement of a tolerance for residues of l-lactic acid, when used as a fruit and vegetable wash in or on all raw agricultural commodities, and for indirect or inadvertent residues of lactic acid in or on all livestock commodities, when residues are present therein as a result of animal drinking water coming into contact with hard non-porous surfaces treated with lactic acid ( <E T="03">i.e.,</E> troughs) would be safe. Electronic copies of the L-lactic Acid ID and other documents are available in EPA docket number EPA-HQ-OPP-2020-0552 at <E T="03">https://www.regulations.gov.</E> <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> Under section 408(e) of the FFDCA, EPA can establish an exemption from the requirement of a tolerance for residues of a pesticide chemical after publishing a proposed rule and providing 60-day period for public comment. 21 U.S.C. 346a(e). EPA published the proposed rule on May 5, 2023, and provided 60 days for public comment (until July 5, 2023). <HD SOURCE="HD1">III. Final Rule</HD> <HD SOURCE="HD2">A. Comments</HD> The proposed rule received one anonymous public comment requesting the Agency consider adding another CAS number for l-lactic acid. The comment can be accessed electronically via <E T="03">https://www.regulations.gov</E> using document ID EPA-HQ-OPP-2023-0455-0002. The proposed rule identified CAS # 50-21-5, which represents lactic acid. The commenter suggested adding CAS # 79-33-4, which represents lactic acid's biologically important stereoisomer, l-lactic acid, for clarity. L-lactic acid has two optical isomers. One is known as L-(+)-Lactic acid, and the other, its mirror image, is D-(−)-Lactic acid. L-(+)-Lactic acid is the isomer that imparts biocidal activity. This comment does not change any Agency analysis of ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 23k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━