Phenol; Revoking Exemption From the Requirement of a Pesticide Tolerance

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0409; FRL-12214-01-OCSPP]</DEPDOC> <RIN>RIN 2070-ZA16</RIN> <SUBJECT>Phenol; Revoking Exemption From the Requirement of a Pesticide 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 revokes the tolerance exemption for residues of the antimicrobial pesticide ingredient phenol when used as an inert ingredient (solvent/cosolvent) in pesticide formulations applied to growing crops. This rulemaking is established on the Agency's own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) to implement a tolerance action the Agency determined was appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for phenol. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective February 26, 2025. Objections and requests for hearings must be received on or before October 29, 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-2023-0409, is available at <E T="03">https://www.regulations.gov</E> or in person 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. Additional instructions for visiting the docket, along with more information about dockets generally, is 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; 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: • Crop production (NAICS code 111), <E T="03">e.g.,</E> agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), <E T="03">e.g.,</E> cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), <E T="03">e.g.,</E> agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), <E T="03">e.g.,</E> agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. <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.</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-2023-0409 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 29, 2024. 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 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> 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-2023-0409, 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 August 22, 2023 (88 FR 57026) (FRL-11232-01-OSCPP), EPA proposed to revoke the tolerance exemption in 40 CFR 180.920 for residues of phenol when used as an inert ingredient (solvent/cosolvent) in pesticide formulations applied to growing crops. In the August 2020 <E T="03">Phenol and Salt Interim Registration Review Decision</E> (available at <E T="03">www.regulations.gov</E> in docket ID number EPA-HQ-OPP-2012-0810), EPA determined that there are no current registrations for pesticide products containing phenol as an inert ingredient (solvent/cosolvent) for use on growing crops, and therefore the tolerance exemption for phenol under 40 CFR 180.920 is not necessary and should be revoked. Additionally, the <E T="03">Registration Review Draft Risk Assessment for Phenol and Salts</E> indicated aggregate risks of concern are likely to result from exposures to phenol pesticide products. Updates have been made to phenol pesticide labels to reduce exposures to phenol through the dietary pathway by preventing the use of these products on food contact surfaces, thereby mitigating the aggregate risks of concern. Revoking phenol's inert tolerance exemption will ensure that dietary exposures do not result from the inert uses of phenol, further mitigating potential exposures that would contribute to aggregate risks of concern. Moreover, there have been no registrations for use associated with this tolerance exemption for many years. The Agency therefore believes that existing stocks of pesticide products containing phenol for the use associated with this tolerance exemption have been exhausted and that treated commodities have cleared the channels of trade. <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, modify, or revoke 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 August 22, 2023, and provided 60 days for public comment (until October 23, 2023). <HD SOURCE="HD2">C. When does this action become effective?</HD> EPA is establishing this rule with an effective date that is six months after the date of publication of the final rule in the <E T="04">Federal Register</E> (February 26, 2025). EPA is setting this effective date for this action to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements of the final rule. Any commodities treated with phenol in the channels of trade following the tolerance exemption revocation shall be subject to FFDCA section 408(l)(5), 21 U.S.C. 346a(l)(5). Under this section, any residues of this pesticide in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA and the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption, unless EPA determines that consumption of legally treated food during the period of its likely availability in commerce will pose unreasonable dietary risk. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food. <HD SOURCE="HD1">III. Final Rule</HD> <HD ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 19k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━