Afidopyropen; Pesticide Tolerance for Emergency Exemption

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2024-0223; FRL-12024-01-OCSPP]</DEPDOC> <SUBJECT>Afidopyropen; Pesticide Tolerance for Emergency 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 a time-limited tolerance for residues of afidopyropen, including its metabolites and degradates, in or on strawberry. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on field-grown strawberry. This regulation establishes a maximum permissible level for residues of afidopyropen in or on strawberry. The time-limited tolerance expires on December 31, 2027. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective June 20, 2024. Objections and requests for hearings must be received on or before August 19, 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-2024-0223, 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 20004. 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 Docket Public Reading Room 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 (7505P), 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 Federal Register 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2024-0223 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 August 19, 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-2024-0223, 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.</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 and Statutory Findings</HD> EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l <E T="03">)</E> (6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of afidopyropen, including its metabolites and degradates, in or on strawberry at 0.3 parts per million (ppm). This time-limited tolerance expires on December 31, 2027. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, <E T="03">i.e.,</E> without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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. 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 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166. <HD SOURCE="HD1">III. Emergency Exemption for Afidopyropen on Strawberry and FFDCA Tolerance</HD> The California Department of Pesticide Regulation (CDPR) has requested a specific emergency exemption for use of afidopyropen in field-grown strawberry to control lygus bugs (Western Tarnished Plant Bugs). The applicant asserts that significant losses have occurred due to unprecedented infestations of lygus bugs in California strawberry, and an urgent and nonroutine situation is occurring. The applicant cites various factors leading to the current situation, including lack of commercially and environmentally viable alternative controls due to restrictions for using neonicotinoid pesticides, and ongoing resistance development to pyrethroid pesticides. Additionally, extreme wet conditions over the last several years have contributed to higher levels of weeds in nearby areas, hosting high populations of lygus bugs which then migrate to the neighboring strawberry fields. Despite the use of available controls, the applicant states that lygus bugs have not been adequately controlled and strawberry growers are facing significant economic losses without an effective control, such as the requested afidopyropen. After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of afidopyropen on field-grown strawberry for control of lygus bug in California. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of afidopyropen in or on strawberry. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensu ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 41k characters. 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