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Final Rule

Indoxacarb; Pesticide Tolerances

In Plain English

What is this Federal Register notice?

This is a final rule published in the Federal Register by Environmental Protection Agency. Final rules have completed the public comment process and establish legally binding requirements.

Is this rule final?

Yes. This rule has been finalized. It has completed the notice-and-comment process required under the Administrative Procedure Act.

Who does this apply to?

Consult the full text of this document for specific applicability provisions. The affected parties depend on the regulatory scope defined within.

When does it take effect?

This document has been effective since August 8, 2024.

Why it matters: This final rule amends regulations in 40 CFR Part 180.

Document Details

Document Number2024-17371
TypeFinal Rule
PublishedAug 8, 2024
Effective DateAug 8, 2024
RIN-
Docket IDEPA-HQ-OPP-2023-0079
Text FetchedYes

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Full Document Text (4,688 words · ~24 min read)

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<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180</CFR> <DEPDOC>[EPA-HQ-OPP-2023-0079; FRL-11964-01-OCSPP]</DEPDOC> <SUBJECT>Indoxacarb; Pesticide Tolerances</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 tolerances for residues of indoxacarb in or on multiple crops listed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This regulation is effective August 8, 2024. Objections and requests for hearings must be received on or before October 7, 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-2023-0079, 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 the OPP Docket is (202) 566-1744. For the latest status information on EPA/DC services, docket access, visit <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: • 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 EPA's tolerance regulations at 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-2023-0079 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 7, 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-2023-0079, 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, are available at <E T="03">https://www.epa.gov/dockets.</E> <HD SOURCE="HD1">II. Summary of Petitioned-For Tolerance</HD> In the <E T="04">Federal Register</E> of February 29, 2024 (89 FR 14795) (FRL-11682-01-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 petition (PP 2E9044) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to amend 40 CFR part 180 by establishing tolerances for residues of indoxacarb in or on the raw agricultural commodities <E T="03">Brassica,</E> leafy greens, subgroup 4-16B at 12 parts per million (ppm); Celtuce at 14 ppm; Chickpea, dry seed at 0.2 ppm; Coffee, green bean at 0.03 ppm; Cottonseed subgroup 20C at 2 ppm; Fennel, florence, fresh leaves and stalk at 14 ppm; Field corn subgroup 15-22C at 0.02 ppm; Fruit, pome, group 11-10, except pear at 1 ppm; Fruit, stone, group 12-12 at 1 ppm; Kohlrabi at 12 ppm; Leaf petiole vegetable subgroup 22B at 14 ppm; Leafy greens subgroup 4-16A at 14 ppm; Pear, asian at 0.2 ppm; Strawberry at 4 ppm; Sunflower subgroup 20B at 1.5 ppm; Sweet corn subgroup 15-22D at 0.02 ppm; Vegetable, <E T="03">brassica,</E> head and stem, group 5-16 at 12 ppm; Vegetable, legume, bean, edible podded, subgroup 6-22A at 0.9 ppm; Vegetable, legume, bean, succulent shelled, subgroup 6-22C at 0.9 ppm; Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.2 ppm; and Vegetable, fruiting, group 8-10 at 0.5 ppm. The petition also proposed to remove established tolerances for residues of indoxacarb in or on the following: Bean, dry seed; Bean, succulent; Corn, field, grain; Corn, pop, grain; Corn, sweet, kernel plus cob with husk removed; Cotton, undelinted seed; Fruit, pome, except pear, group 11; Fruit, stone, group 12; Okra; Pea, southern, seed; Pear, oriental; Turnip, greens; Vegetable, <E T="03">Brassica,</E> leafy, group 5; Vegetable, fruiting, group 8; and Vegetable, leafy, except <E T="03">Brassica,</E> group 4. That document referenced a summary of the petition, which is available in the docket, <E T="03">https://www.regulations.gov.</E> There were no comments received in response to the notice. <HD SOURCE="HD1">III. Aggregate Risk Assessment and Determination of Safety</HD> 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 . . . .” Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, 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 for indoxacarb including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indoxacarb follows. In an effort to streamline its publications in the <E T="04">Federal Register</E> , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking. EPA has previously published several tolerance rulemakings for indoxacarb, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to indoxacarb and established tolerances for residues of that chemical. EPA is incorporating previously published sections of those rulemakings that remain unchanged, as described further in this rulemaking. Specific information on the risk assessment conducted in support of this action, includin ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 34k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
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