Cyantraniliprole; Pesticide Tolerances, 42382-42387 [2024-10490]

Download as PDF 42382 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations cyantraniliprole, including its metabolites and degradates, in or on multiple commodities which are identified and discussed later in this * * * * * document. The Interregional Project S Number 4 (IR–4) and the FMC Corporation requested these tolerances * * * * * [Revise the ‘‘Sectional Center Facility’’ under the Federal Food, Drug, and Cosmetic Act (FFDCA). line item to read as follows:] DATES: This regulation is effective May Sectional Center Facility (SCF)/Local 15, 2024. Objections and requests for Processing Center (LPC)/Regional hearings must be received on or before Processing & Distribution Center July 15, 2024, and must be filed in (RPDC), 246.4.0, 246.4.0, 266.5.0, accordance with the instructions 246.4.0, 266.5.0 provided in 40 CFR part 178 (see also * * * * * Unit I.C. of the SUPPLEMENTARY INFORMATION). USPS Marketing Mail, Flats ADDRESSES: The docket for this action, * * * * * identified by docket identification (ID) [Revise the entry line items under ‘‘USPS Marketing Mail, flats’’ to read as numbers EPA–HQ–OPP–2023–0078 and EPA–HQ–OPP–2022–0958, is available follows:] online at https://www.regulations.gov or DNDC/RPDC entry, 246.3.0 in-person at the Office of Pesticide DDU or S&DC entry, 246.5.0 Programs Regulatory Public Docket DSCF/LPC entry, 246.4.0 (OPP Docket) in the Environmental * * * * * Protection Agency Docket Center (EPA/ DC), West William Jefferson Clinton USPS Marketing Mail, Letters Bldg., Rm. 3334, 1301 Constitution Ave. * * * * * NW, Washington, DC 20460–0001. The [Revise the entry line items under Public Reading Room is open from 8:30 ‘‘USPS Marketing Mail, letters’’ to read a.m. to 4:30 p.m., Monday through as follows:] Friday, excluding legal holidays. The DNDC/RPDC entry, 246.3.0 telephone number for the Public DDU or S&DC entry, 246.5.0 Reading Room and the OPP Docket is DSCF/LPC entry, 246.4.0 (202) 566–1744. For the latest status information on EPA/DC services, docket * * * * * access, visit https://www.epa.gov/. USPS Marketing Mail, Parcels FOR FURTHER INFORMATION CONTACT: * * * * * Charles Smith, Director, Registration [Revise the entry line items under Division (7505T), Office of Pesticide ‘‘USPS Marketing Mail, parcels’’ to read Programs, Environmental Protection as follows:] Agency, 1200 Pennsylvania Ave. NW, DNDC/RPDC entry, 246.3.0 Washington, DC 20460–0001; main DDU or S&DC entry, 246.5.0 telephone number: (202) 566–1030; DSCF/RPDC entry, 246.4.0 email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: * * * * * Network Distribution Center (NDC)/ Regional Processing & Distribution Center (RPDC) Acceptance I. General Information Christopher Doyle, Attorney, Ethics and Legal Compliance. A. Does this action apply to me? [FR Doc. 2024–10668 Filed 5–14–24; 8:45 am] BILLING CODE 7710–12–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 lotter on DSK11XQN23PROD with RULES1 [EPA–HQ–OPP–2023–0078 and EPA–HQ– OPP–2022–0958; FRL–11941–01–OCSPP] Cyantraniliprole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes and modifies tolerances for residues of SUMMARY: VerDate Sep<11>2014 15:57 May 14, 2024 Jkt 262001 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). PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 B. How can I get electronic access to other related information? 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 eCFR site at https://www.ecfr.gov/ current/title-40. C. How can I file an objection or hearing request? 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–2023–0078 and EPA–HQ–OPP– 2022–0958 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 15, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). EPA’s Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See ‘‘Revised Order Urging Electronic Service and Filing’’, dated June 22, 2023, which can be found at https://www.epa.gov/system/files/ documents/2023-06/2023-06-22%20%20revised%20order%20urging %20electronic%20filing %20and%20service.pdf. Although EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https:// yosemite.epa.gov/OA/EAB/EAB-ALJ_ Upload.nsf/HomePage?ReadForm. 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 E:\FR\FM\15MYR1.SGM 15MYR1 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2023–0078 and EPA–HQ–OPP–2022– 0958, by one of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov. 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. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of July 26, 2023 (88 FR 48179) (FRL–10579–06– 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 (PP2E9041) by the Interregional Research Project No. 4 (IR– 4), North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to amend 40 CFR 180.672 by establishing tolerances for residues of cyantraniliprole, including its metabolites and degradates, in or on the following commodities: edible podded bean subgroup 6–22A at 2 parts per million (ppm); edible podded pea subgroup 6–22B at 2 ppm; field corn subgroup 15–22C at 0.01 ppm; forage and hay of legume vegetables (except soybeans) subgroup 7–22A at 40 ppm; herb fresh leaves subgroup 25A at 40 ppm; herb dried leaves subgroup 25B at 150 ppm; hops, dried cones at 70 ppm; papaya at 1.5 ppm; pulses, dried shelled bean, except soybean, subgroup 6–22E at 1 ppm; pulses, dried shelled pea subgroup 6–22F at 1 ppm; rice subgroup 15–22F at 0.02 ppm; spices crop group 26 at 80 ppm; succulent shelled bean subgroup 6–22C at 0.3 ppm; succulent shelled pea subgroup 6–22D at 0.3 ppm; and sweet corn subgroup 15–22D at 0.01 ppm. The petitioner proposed, upon the approval of the aforementioned tolerances, to remove established tolerances for residues of cyantraniliprole, including its metabolites and degradates, in or on the following commodities: vegetable, legume, dried shelled, except soybean, VerDate Sep<11>2014 15:57 May 14, 2024 Jkt 262001 subgroup 6C at 1.0 ppm; vegetable, legume, edible podded, subgroup 6A at 2.0 ppm; vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm; vegetable, foliage of legume, except soybean, group 7A at 40 ppm; corn, field, grain at 0.01 ppm; corn, pop, grain, at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and rice, grain at 0.02 ppm. That document referenced a summary of the petition prepared by IR–4, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received on the notice of filing. Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has made modifications to the proposed commodity definitions for most of the tolerances in this petition and is not establishing several of the petitioned-for tolerances because the petitioner withdrew them. The reasons for these changes are explained in Unit IV.D. In the Federal Register of February 23, 2023 (88 FR 11401) (FRL–10579–01– 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 (PP2E9032) by the FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104, requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of cyantraniliprole, including its metabolites and degradates in or on the following commodities: grape, table at 2.0 ppm (only for imported table grapes); avocado at 0.4 ppm (only for imported avocados); and mango at 0.7 ppm (only for imported mangos) and by revising the tolerance for imported olives from 1.5 ppm to 3.0 ppm and, upon the approval of the aforementioned tolerances, to remove established tolerances for residues of cyantraniliprole, including its metabolites and degradates, in or on olive oil at 2 ppm. That document referenced a summary of the petition prepared by FMC, the petitioner, which is available in the docket, https:// www.regulations.gov. A comment was received on the notice of filing. EPA’s response to the comment is discussed in Unit IV.C. Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has made modifications to two of the proposed tolerance values. The reason for these changes is explained in Unit IV.D. PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 42383 III. Aggregate Risk Assessment and Determination of Safety 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 cyantraniliprole including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with cyantraniliprole follows. In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, 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 tolerance rulemakings for cyantraniliprole in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to cyantraniliprole and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged. E:\FR\FM\15MYR1.SGM 15MYR1 lotter on DSK11XQN23PROD with RULES1 42384 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations Toxicological profile. For a discussion of the Toxicological Profile of cyantraniliprole, see Unit III.A. of the cyantraniliprole tolerance rulemaking published in the Federal Register of November 13, 2018 (83 FR 56262) (FRL– 9985–32). Toxicological points of departure/ Levels of concern. For a discussion of the Toxicological Points of Departure/ Levels of Concern used for the safety assessment of cyantraniliprole, see Unit III.B of the February 5, 2014, rulemaking (79 FR 6826) (FRL–9388–7). Dietary exposure assessment. Much of the exposure assessment for cyantraniliprole remains unchanged from the discussion in Unit III.C of the November 13, 2018, rulemaking, except as described below. EPA’s dietary exposure assessments have been updated to include the additional exposures from the tolerances established since the November 13, 2018, rulemaking and the petitioned-for tolerances excluding the crop subgroup expansions to field corn subgroup 15– 22C, sweet corn subgroup 15–22D and rice subgroup 15–22F. An acute dietary endpoint was not selected; therefore, an acute assessment was not performed. A refined chronic dietary (food and drinking water) exposure assessment was conducted using the Dietary Exposure Evaluation Model-Food Commodity Intake Database DEEM– FCID and assuming average field trial residues or mean residue values from the United States Department of Agriculture (USDA) Pesticide Data Program (PDP), empirical processing factors and/or HED’s default processing factors and assumed 100 percent crop treated (PCT). In some cases, data were translated from representative commodities of their crop group. Anticipated residue information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Drinking water and non-occupational exposures. The estimated drinking VerDate Sep<11>2014 15:57 May 14, 2024 Jkt 262001 water concentrations (EDWCs) have not changed since the 2018 rulemaking. For a detailed summary of the drinking water analysis for cyantraniliprole used for the human health risk assessment, see Unit III.C.2. of the November 13, 2018, tolerance rulemaking. There are no proposed residential uses or proposed uses intended for use by occupational handlers in residential settings for this action. However, there are residential exposures from currently registered uses of cyantraniliprole which have been previously assessed. The registered residential uses and exposures that are incorporated into the aggregate assessment are described in Unit III.C.3 of the November 13, 2018, final rule. Cumulative exposures. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to cyantraniliprole and any other substances and cyantraniliprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that cyantraniliprole has a common mechanism of toxicity with other substances. In 2016, EPA’s Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis https://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/ pesticide-cumulative-risk-assessmentframework. This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach beginning with the evaluation of available toxicological information and if necessary, followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups (CMG) and conducting cumulative risk assessments. Cyantraniliprole has been grouped with the diamide pesticide class. As part of the ongoing process to review registered pesticides, the Agency intends to apply this framework to determine if the available toxicological data for cyantraniliprole suggests a candidate CMG may be established with other pesticides. If a CMG is established, a screening-level toxicology and exposure analysis may be conducted to provide an initial screen for multiple pesticide exposure. Safety factor for infants and children. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. EPA continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the Food Quality Protection Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for that decision are articulated in Unit III.D of the November 13, 2018, rulemaking. Aggregate risk and Determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute populationadjusted dose (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. An acute dietary exposure assessment was not performed as there were no indication of an adverse effects attributable to a single dose. Cyantraniliprole is not expected to pose an acute risk. Chronic dietary risks are below the Agency’s level of concern of 100% of the cPAD; they are 85% of the cPAD for children 1 to 2 years old, the most highly exposed population subgroup. The chronic aggregate risk assessment includes only long-term exposure to residues in food and drinking water since there are no residential scenarios that result in long-term exposure; therefore, the chronic aggregate risks are equivalent to the chronic dietary risks and are not of concern. There is potential for short-term aggregate exposure to cyantraniliprole via the dietary (food + drinking water) and residential pathways. Since there is no dermal endpoint, the short-term aggregate exposure assessment for children includes dietary (considered background) and incidental oral (primary) routes. For children 1 to 2 years old, the short-term aggregate risk estimates are not of concern. The aggregate MOE is 159, which is greater than the level of concern of 100. Intermediate-term aggregate assessments include exposures that will occur from 30 days to 6 months. Residential intermediate-term exposures are not expected for adults, however intermediate-term incidental oral postapplication exposures for children 1 to <2 years old are possible (i.e., from contact to treated carpet), due to the E:\FR\FM\15MYR1.SGM 15MYR1 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 persistence of cyantraniliprole. Since the incidental oral POD is the same for short-term and intermediate-term durations, the short-term aggregate risk estimates are protective of potential intermediate aggregate risks and are not of concern. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, cyantraniliprole is not expected to pose a cancer risk to humans. Based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to cyantraniliprole residues. More detailed information on this action can be found in the document titled ‘‘Cyantraniliprole: New Uses of Cyantraniliprole on Herb Group 25, Hops, Papaya and Spice Group 26; Amended Application Scenario for Lettuce (Greenhouse Application) and Strawberry (Reduction in Retreatment Interval); Crop Subgroup Expansions to Field Corn Subgroup 15–22C, Sweet Corn Subgroup 15–22D and Rice Subgroup 15–22F; and Crop Subgroup Conversion to Legume Vegetable Subgroup 6–22A–F and 7–22A.’’ in docket ID EPA–HQ–OPP–2023–0078, and the document titled ‘‘Cyantraniliprole. Human Health Risk Assessment for the Proposed Section 3 Tolerance Request without U.S. Registration for Grape (table), Avocado, Mango, and Olive to Replace Existing Import Tolerances on Olive and Olive, Oil’’ in docket ID EPA–HQ–OPP–2022– 0958. The rule is establishing tolerances from two separate petitions and summarizes information from both risk assessments. The dietary exposure estimates and MOE numbers referenced above are from the more recently conducted, comprehensive assessment titled ‘‘Cyantraniliprole. Human Health Risk Assessment for the Proposed Section 3 Tolerance Request without U.S. Registration for Grape (table), Avocado, Mango, and Olive to Replace Existing Import Tolerances on Olive and Olive, Oil’’, which includes the additional exposures described in the other risk assessment. IV. Other Considerations A. Analytical Enforcement Methodology For information about the available analytical enforcement method, see Unit IV.A of the November 13, 2018, rulemaking. VerDate Sep<11>2014 15:57 May 14, 2024 Jkt 262001 B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex does not have MRLs for residues of cyantraniliprole in/on herbs (fresh or dried), spices, hops, papaya, or the foliage of legume vegetables. The U.S. tolerances for residues of cyantraniliprole in or on subgroups 6– 22A (2 ppm), 6–22B (2 ppm), 6–22C (0.3 ppm), 6–22D (0.3 ppm), avocados (0.4 ppm), and grapes, table (2 ppm) and mango (0.7 ppm) are harmonized with the corresponding Codex MRLs. The U.S. tolerances for residues of cyantraniliprole in or on subgroups 6– 22E (1 ppm) and 6–22F (1 ppm) cannot be not harmonized with the Codex MRL of 0.3 ppm because decreasing the tolerance to harmonize would put U.S. growers at risk of having violative residues despite legal use of cyantraniliprole according to the label. The U.S. tolerance for residues of cyantraniliprole on olives (3 ppm) cannot be harmonized with the Codex MRL of 1 ppm because imported olives treated legally in the exporting country could have violative residues. C. Response to Comments There were no comments received on the notice of filing of pesticide petition PP2E9041 submitted by IR–4. One comment was received on the notice of filing of pesticide petition PP2E9032 submitted by the FMC Corporation. The comment is an inquiry from the People’s Republic of China, requesting that the Agency provide the test data used for risk assessment of the relevant commodities. The data supporting the avocado, grape, mango, and olive tolerances were submitted to the Agency and were reviewed and reported in the document titled ‘‘Cyantraniliprole. Human Health Risk Assessment for the PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 42385 Proposed Section 3 Tolerance Request without U.S. Registration for Grape (table), Avocado, Mango, and Olive to Replace Existing Import Tolerances on Olive and Olive, Oil.’’ This document can be found in docket ID number EPA– HQ–OPP–2022–0958. D. Revisions to Petitioned-For Tolerances The Agency is revising the commodity definitions for many of the tolerances to current agency nomenclature. EPA is also not establishing the requested tolerances of cyantraniliprole in/on the field corn subgroup 15–22C, sweet corn subgroup 15–22D and rice subgroup 15–22F because the petitioner withdrew the requested tolerances from the petition. EPA is establishing the tolerance for residues of cyantraniliprole in or on grape, table at 2 ppm rather than 2.0 ppm and the tolerance for olive at 3 ppm rather than 3.0 ppm to be consistent with EPA rounding practices. V. Conclusion Therefore, tolerances are established for residues of cyantraniliprole, including its metabolites and degradates, in or on the following commodities: herb, dried leaves, subgroup 25B at 150 ppm; herb, fresh leaves, subgroup 25A at 40 ppm; hop, dried cones at 70 ppm; papaya at 1.5 ppm; spice crop group 26 at 80 ppm; vegetable, legume, bean, edible podded, subgroup 6–22A at 2 ppm; vegetable, legume, bean, succulent shelled, subgroup 6–22C at 0.3 ppm; vegetable, legume, forage and hay, except soybean, subgroup 7–22A at 40 ppm; vegetable, legume, pea, edible podded, subgroup 6–22B at 2 ppm; vegetable, legume, pea, succulent shelled, subgroup 6–22D at 0.3 ppm; vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E at 1 ppm; and vegetable, legume, pulse, pea, dried shelled, subgroup 6– 22F at 1 ppm. EPA is removing the established tolerances for residues of cyantraniliprole, in or on the following commodities upon the establishment of the new tolerances: vegetable, foliage of legume, except soybean, group 7A at 40 ppm; vegetable, legume, dried shelled, except soybean, subgroup 6C at 1.0 ppm; vegetable, legume, edible podded, subgroup 6A at 2.0 ppm; and vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm. Additionally, tolerances are established for residues of cyantraniliprole, including its metabolites and degradates, in or on the following imported commodities: avocado at 0.4 ppm; grape, table at 2 E:\FR\FM\15MYR1.SGM 15MYR1 42386 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations ppm; and mango at 0.7 ppm. Finally, the tolerance for residues of cyantraniliprole, including its metabolites and degradates, in or on olive is revised from 1.5 ppm to 3 ppm and the tolerance for residues in or on olive, oil at 2.0 ppm is removed. VI. Statutory and Executive Order Reviews lotter on DSK11XQN23PROD with RULES1 This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA VerDate Sep<11>2014 15:57 May 14, 2024 Jkt 262001 section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 9, 2024. Charles Smith, Director, Registration Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.672, amend the table in paragraph (a) by: ■ a. Adding the table heading ‘‘Table 1 to Paragraph (a)’’; ■ b. Adding in alphabetical order the entries ‘‘Avocado2’’; ‘‘Grape, table2’’; ‘‘Herb, dried leaves, subgroup 25B’’; ‘‘Herb, fresh leaves, subgroup 25A’’; ‘‘Hop, dried cones’’; and ‘‘Mango 2’’; ■ c. Revising the entry for ‘‘Olive1’’; ■ d. Removing the entry for ‘‘Olive, oil1’’; ■ e. Adding in alphabetical order the entries ‘‘Papaya’’; and ‘‘Spice crop group 26’’; ■ f. Removing the entry for ‘‘Vegetable, foliage of legume, except soybean, group 7A’’; ■ g. Adding in alphabetical order the entries ‘‘Vegetable, legume, bean, edible podded, subgroup 6–22A’’; and ‘‘Vegetable, legume, bean, succulent shelled, subgroup 6–22C’’; ■ h. Removing the entries for ‘‘Vegetable, legume, dried shelled, except soybean, subgroup 6C’’; and ‘‘Vegetable, legume, edible podded, subgroup 6A’’; ■ i. Adding in alphabetical order the entries ‘‘Vegetable, legume, forage and hay, except soybean, subgroup 7–22A’’; ‘‘Vegetable, legume, pea, edible podded, subgroup 6–22B’’; ‘‘Vegetable, legume, pea, succulent shelled, subgroup 6– 22D’’; ‘‘Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E’’; and ‘‘Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F’’; and ■ j. Removing the entry for ‘‘Vegetable, legume, succulent shelled, subgroup 6B’’. The additions and revision read as follows: ■ § 180.672 Cyantraniliprole; tolerance for residues. (a) * * * E:\FR\FM\15MYR1.SGM 15MYR1 Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations TABLE 1 TO PARAGRAPH (a) Parts per million Commodity * * * * * * * 0.4 * Grape, table 2 .............................. * * * * * Herb, dried leaves, subgroup 25B .......................................... Herb, fresh leaves, subgroup 25A .......................................... Hop, dried cones ........................ * * * * * Mango 2 ....................................... * * * * * Olive 2 .......................................... * * * * Papaya ........................................ * * * * * Spice crop group 26 ................... * * * * * Vegetable, legume, bean, edible podded, subgroup 6–22A ....... Vegetable, legume, bean, succulent shelled, subgroup 6– 22C .......................................... Vegetable, legume, forage and hay, except soybean, subgroup 7–22A ........................... Vegetable, legume, pea, edible podded, subgroup 6–22B ....... Vegetable, legume, pea, succulent shelled, subgroup 6– 22D .......................................... Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E ...................... Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F lotter on DSK11XQN23PROD with RULES1 * * * * Environmental Protection Agency (EPA). 2 ACTION: Final rule. This regulation establishes tolerance for residues of tetraniliprole in or on tea, dried at 80 ppm. Bayer 150 CropScience LP requested this tolerance under the Federal Food, Drug, and 40 Cosmetic Act (FFDCA). 70 DATES: This regulation is effective May 15, 2024. Objections and requests for hearings must be received on or before July 15, 2024 and must be filed in 0.7 accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2021–0624, is 1.5 available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency 80 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., 2 Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP 0.3 Docket is (202) 566–1744. Please review the visitor instructions and additional 40 information about the docket available at https://www.epa.gov/dockets. 2 FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration Division (7505T), Office of Pesticide 0.3 Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main 1 telephone number: (202) 566–1030; 1 email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: * * * * * [FR Doc. 2024–10490 Filed 5–14–24; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 15:57 May 14, 2024 Jkt 262001 ADDRESSES: I. General Information 1 There are no U.S. registrations for these commodities. 2 There are no U.S. registrations for these commodities as of May 15, 2024. * Tetraniliprole; Pesticide Tolerances AGENCY: 3 * 40 CFR Part 180 [EPA–HQ–OPP–2021–0624; FRL–11958–01– OCSPP] * Avocado 2 .................................... * ENVIRONMENTAL PROTECTION AGENCY A. Does this action apply to me? 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 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 42387 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). B. How can I get electronic access to other related information? 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 eCFR site at https://www.ecfr.gov/ current/title-40. C. How can I file an objection or hearing request? 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–2021–0624 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 15, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). EPA’s Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See ‘‘Revised Order Urging Electronic Service and Filing’’, dated June 22, 2023, which can be found at https://www.epa.gov/system/files/ documents/2023-06/2023-06-22%20%20revised%20order%20urging %20electronic%20filing%20and %20service.pdf. Although EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/ eab/eab-alj_upload.nsf. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please E:\FR\FM\15MYR1.SGM 15MYR1

Agencies

[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Rules and Regulations]
[Pages 42382-42387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10490]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0078 and EPA-HQ-OPP-2022-0958; FRL-11941-01-OCSPP]


Cyantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and modifies tolerances for 
residues of cyantraniliprole, including its metabolites and degradates, 
in or on multiple commodities which are identified and discussed later 
in this document. The Interregional Project Number 4 (IR-4) and the FMC 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 15, 2024. Objections and 
requests for hearings must be received on or before July 15, 2024, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2023-0078 and EPA-HQ-OPP-2022-
0958, is available online at https://www.regulations.gov 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. 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 https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    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).

B. How can I get electronic access to other related information?

    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 https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    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-2023-0078 and EPA-HQ-OPP-2022-0958 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 15, 2024. Addresses for mail and hand 
delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    EPA's Office of Administrative Law Judges (OALJ), in which the 
Hearing Clerk is housed, urges parties to file and serve documents by 
electronic means only, notwithstanding any other particular 
requirements set forth in other procedural rules governing those 
proceedings. See ``Revised Order Urging Electronic Service and 
Filing'', dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. 
Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions; therefore, EPA believes the preference 
for submission via electronic means will not be prejudicial. When 
submitting documents to the OALJ electronically, a person should 
utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.
    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

[[Page 42383]]

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2023-0078 and EPA-HQ-OPP-2022-0958, by one of the following 
methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 26, 2023 (88 FR 48179) (FRL-10579-
06-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 
(PP2E9041) by the Interregional Research Project No. 4 (IR-4), North 
Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, 
Raleigh, NC 27606. The petition requested to amend 40 CFR 180.672 by 
establishing tolerances for residues of cyantraniliprole, including its 
metabolites and degradates, in or on the following commodities: edible 
podded bean subgroup 6-22A at 2 parts per million (ppm); edible podded 
pea subgroup 6-22B at 2 ppm; field corn subgroup 15-22C at 0.01 ppm; 
forage and hay of legume vegetables (except soybeans) subgroup 7-22A at 
40 ppm; herb fresh leaves subgroup 25A at 40 ppm; herb dried leaves 
subgroup 25B at 150 ppm; hops, dried cones at 70 ppm; papaya at 1.5 
ppm; pulses, dried shelled bean, except soybean, subgroup 6-22E at 1 
ppm; pulses, dried shelled pea subgroup 6-22F at 1 ppm; rice subgroup 
15-22F at 0.02 ppm; spices crop group 26 at 80 ppm; succulent shelled 
bean subgroup 6-22C at 0.3 ppm; succulent shelled pea subgroup 6-22D at 
0.3 ppm; and sweet corn subgroup 15-22D at 0.01 ppm. The petitioner 
proposed, upon the approval of the aforementioned tolerances, to remove 
established tolerances for residues of cyantraniliprole, including its 
metabolites and degradates, in or on the following commodities: 
vegetable, legume, dried shelled, except soybean, subgroup 6C at 1.0 
ppm; vegetable, legume, edible podded, subgroup 6A at 2.0 ppm; 
vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm; 
vegetable, foliage of legume, except soybean, group 7A at 40 ppm; corn, 
field, grain at 0.01 ppm; corn, pop, grain, at 0.01 ppm; corn, sweet, 
kernel plus cob with husks removed at 0.01 ppm; and rice, grain at 0.02 
ppm. That document referenced a summary of the petition prepared by IR-
4, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received on the notice of 
filing.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
has made modifications to the proposed commodity definitions for most 
of the tolerances in this petition and is not establishing several of 
the petitioned-for tolerances because the petitioner withdrew them. The 
reasons for these changes are explained in Unit IV.D.
    In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-
10579-01-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 (PP2E9032) by the FMC Corporation, 2929 Walnut Street, 
Philadelphia, PA 19104, requesting, pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
amend 40 CFR part 180 by establishing tolerances for residues of 
cyantraniliprole, including its metabolites and degradates in or on the 
following commodities: grape, table at 2.0 ppm (only for imported table 
grapes); avocado at 0.4 ppm (only for imported avocados); and mango at 
0.7 ppm (only for imported mangos) and by revising the tolerance for 
imported olives from 1.5 ppm to 3.0 ppm and, upon the approval of the 
aforementioned tolerances, to remove established tolerances for 
residues of cyantraniliprole, including its metabolites and degradates, 
in or on olive oil at 2 ppm. That document referenced a summary of the 
petition prepared by FMC, the petitioner, which is available in the 
docket, https://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to the comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
has made modifications to two of the proposed tolerance values. The 
reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    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 cyantraniliprole including exposure resulting 
from the tolerances established by this action. EPA's assessment of 
exposures and risks associated with cyantraniliprole follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemakings for the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings, 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 tolerance rulemakings for 
cyantraniliprole in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to cyantraniliprole and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from these rulemakings as described 
further in this rulemaking, as they remain unchanged.

[[Page 42384]]

    Toxicological profile. For a discussion of the Toxicological 
Profile of cyantraniliprole, see Unit III.A. of the cyantraniliprole 
tolerance rulemaking published in the Federal Register of November 13, 
2018 (83 FR 56262) (FRL-9985-32).
    Toxicological points of departure/Levels of concern. For a 
discussion of the Toxicological Points of Departure/Levels of Concern 
used for the safety assessment of cyantraniliprole, see Unit III.B of 
the February 5, 2014, rulemaking (79 FR 6826) (FRL-9388-7).
    Dietary exposure assessment. Much of the exposure assessment for 
cyantraniliprole remains unchanged from the discussion in Unit III.C of 
the November 13, 2018, rulemaking, except as described below. EPA's 
dietary exposure assessments have been updated to include the 
additional exposures from the tolerances established since the November 
13, 2018, rulemaking and the petitioned-for tolerances excluding the 
crop subgroup expansions to field corn subgroup 15-22C, sweet corn 
subgroup 15-22D and rice subgroup 15-22F. An acute dietary endpoint was 
not selected; therefore, an acute assessment was not performed. A 
refined chronic dietary (food and drinking water) exposure assessment 
was conducted using the Dietary Exposure Evaluation Model-Food 
Commodity Intake Database DEEM-FCID and assuming average field trial 
residues or mean residue values from the United States Department of 
Agriculture (USDA) Pesticide Data Program (PDP), empirical processing 
factors and/or HED's default processing factors and assumed 100 percent 
crop treated (PCT). In some cases, data were translated from 
representative commodities of their crop group.
    Anticipated residue information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such data call-ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    Drinking water and non-occupational exposures. The estimated 
drinking water concentrations (EDWCs) have not changed since the 2018 
rulemaking. For a detailed summary of the drinking water analysis for 
cyantraniliprole used for the human health risk assessment, see Unit 
III.C.2. of the November 13, 2018, tolerance rulemaking. There are no 
proposed residential uses or proposed uses intended for use by 
occupational handlers in residential settings for this action. However, 
there are residential exposures from currently registered uses of 
cyantraniliprole which have been previously assessed. The registered 
residential uses and exposures that are incorporated into the aggregate 
assessment are described in Unit III.C.3 of the November 13, 2018, 
final rule.
    Cumulative exposures. Unlike other pesticides for which EPA has 
followed a cumulative risk approach based on a common mechanism of 
toxicity, EPA has not made a common mechanism of toxicity finding as to 
cyantraniliprole and any other substances and cyantraniliprole does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has not assumed 
that cyantraniliprole has a common mechanism of toxicity with other 
substances.
    In 2016, EPA's Office of Pesticide Programs released a guidance 
document entitled, Pesticide Cumulative Risk Assessment: Framework for 
Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This 
document provides guidance on how to screen groups of pesticides for 
cumulative evaluation using a two-step approach beginning with the 
evaluation of available toxicological information and if necessary, 
followed by a risk-based screening approach. This framework supplements 
the existing guidance documents for establishing common mechanism 
groups (CMG) and conducting cumulative risk assessments.
    Cyantraniliprole has been grouped with the diamide pesticide class. 
As part of the ongoing process to review registered pesticides, the 
Agency intends to apply this framework to determine if the available 
toxicological data for cyantraniliprole suggests a candidate CMG may be 
established with other pesticides. If a CMG is established, a 
screening-level toxicology and exposure analysis may be conducted to 
provide an initial screen for multiple pesticide exposure.
    Safety factor for infants and children. Section 408(b)(2)(C) of 
FFDCA provides that EPA shall apply an additional tenfold (10X) margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
database on toxicity and exposure unless EPA determines based on 
reliable data that a different margin of safety will be safe for 
infants and children. EPA continues to conclude that there is reliable 
data showing that the safety of infants and children would be 
adequately protected if the Food Quality Protection Act (FQPA) safety 
factor were reduced from 10X to 1X. The reasons for that decision are 
articulated in Unit III.D of the November 13, 2018, rulemaking.
    Aggregate risk and Determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
dietary exposure estimates to the acute population-adjusted dose (aPAD) 
and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks 
are evaluated by comparing the estimated total food, water, and 
residential exposure to the appropriate points of departure to ensure 
that an adequate margin of exposure (MOE) exists. An acute dietary 
exposure assessment was not performed as there were no indication of an 
adverse effects attributable to a single dose. Cyantraniliprole is not 
expected to pose an acute risk.
    Chronic dietary risks are below the Agency's level of concern of 
100% of the cPAD; they are 85% of the cPAD for children 1 to 2 years 
old, the most highly exposed population subgroup. The chronic aggregate 
risk assessment includes only long-term exposure to residues in food 
and drinking water since there are no residential scenarios that result 
in long-term exposure; therefore, the chronic aggregate risks are 
equivalent to the chronic dietary risks and are not of concern.
    There is potential for short-term aggregate exposure to 
cyantraniliprole via the dietary (food + drinking water) and 
residential pathways. Since there is no dermal endpoint, the short-term 
aggregate exposure assessment for children includes dietary (considered 
background) and incidental oral (primary) routes. For children 1 to 2 
years old, the short-term aggregate risk estimates are not of concern. 
The aggregate MOE is 159, which is greater than the level of concern of 
100.
    Intermediate-term aggregate assessments include exposures that will 
occur from 30 days to 6 months. Residential intermediate-term exposures 
are not expected for adults, however intermediate-term incidental oral 
post-application exposures for children 1 to <2 years old are possible 
(i.e., from contact to treated carpet), due to the

[[Page 42385]]

persistence of cyantraniliprole. Since the incidental oral POD is the 
same for short-term and intermediate-term durations, the short-term 
aggregate risk estimates are protective of potential intermediate 
aggregate risks and are not of concern.
    Based on the lack of evidence of carcinogenicity in two adequate 
rodent carcinogenicity studies, cyantraniliprole is not expected to 
pose a cancer risk to humans.
    Based on the risk assessments and information described above, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to cyantraniliprole residues. More detailed information on 
this action can be found in the document titled ``Cyantraniliprole: New 
Uses of Cyantraniliprole on Herb Group 25, Hops, Papaya and Spice Group 
26; Amended Application Scenario for Lettuce (Greenhouse Application) 
and Strawberry (Reduction in Retreatment Interval); Crop Subgroup 
Expansions to Field Corn Subgroup 15-22C, Sweet Corn Subgroup 15-22D 
and Rice Subgroup 15-22F; and Crop Subgroup Conversion to Legume 
Vegetable Subgroup 6-22A-F and 7-22A.'' in docket ID EPA-HQ-OPP-2023-
0078, and the document titled ``Cyantraniliprole. Human Health Risk 
Assessment for the Proposed Section 3 Tolerance Request without U.S. 
Registration for Grape (table), Avocado, Mango, and Olive to Replace 
Existing Import Tolerances on Olive and Olive, Oil'' in docket ID EPA-
HQ-OPP-2022-0958. The rule is establishing tolerances from two separate 
petitions and summarizes information from both risk assessments. The 
dietary exposure estimates and MOE numbers referenced above are from 
the more recently conducted, comprehensive assessment titled 
``Cyantraniliprole. Human Health Risk Assessment for the Proposed 
Section 3 Tolerance Request without U.S. Registration for Grape 
(table), Avocado, Mango, and Olive to Replace Existing Import 
Tolerances on Olive and Olive, Oil'', which includes the additional 
exposures described in the other risk assessment.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For information about the available analytical enforcement method, 
see Unit IV.A of the November 13, 2018, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex does not have MRLs for residues of cyantraniliprole in/on 
herbs (fresh or dried), spices, hops, papaya, or the foliage of legume 
vegetables. The U.S. tolerances for residues of cyantraniliprole in or 
on subgroups 6-22A (2 ppm), 6-22B (2 ppm), 6-22C (0.3 ppm), 6-22D (0.3 
ppm), avocados (0.4 ppm), and grapes, table (2 ppm) and mango (0.7 ppm) 
are harmonized with the corresponding Codex MRLs. The U.S. tolerances 
for residues of cyantraniliprole in or on subgroups 6-22E (1 ppm) and 
6-22F (1 ppm) cannot be not harmonized with the Codex MRL of 0.3 ppm 
because decreasing the tolerance to harmonize would put U.S. growers at 
risk of having violative residues despite legal use of cyantraniliprole 
according to the label. The U.S. tolerance for residues of 
cyantraniliprole on olives (3 ppm) cannot be harmonized with the Codex 
MRL of 1 ppm because imported olives treated legally in the exporting 
country could have violative residues.

C. Response to Comments

    There were no comments received on the notice of filing of 
pesticide petition PP2E9041 submitted by IR-4. One comment was received 
on the notice of filing of pesticide petition PP2E9032 submitted by the 
FMC Corporation. The comment is an inquiry from the People's Republic 
of China, requesting that the Agency provide the test data used for 
risk assessment of the relevant commodities. The data supporting the 
avocado, grape, mango, and olive tolerances were submitted to the 
Agency and were reviewed and reported in the document titled 
``Cyantraniliprole. Human Health Risk Assessment for the Proposed 
Section 3 Tolerance Request without U.S. Registration for Grape 
(table), Avocado, Mango, and Olive to Replace Existing Import 
Tolerances on Olive and Olive, Oil.'' This document can be found in 
docket ID number EPA-HQ-OPP-2022-0958.

D. Revisions to Petitioned-For Tolerances

    The Agency is revising the commodity definitions for many of the 
tolerances to current agency nomenclature.
    EPA is also not establishing the requested tolerances of 
cyantraniliprole in/on the field corn subgroup 15-22C, sweet corn 
subgroup 15-22D and rice subgroup 15-22F because the petitioner 
withdrew the requested tolerances from the petition.
    EPA is establishing the tolerance for residues of cyantraniliprole 
in or on grape, table at 2 ppm rather than 2.0 ppm and the tolerance 
for olive at 3 ppm rather than 3.0 ppm to be consistent with EPA 
rounding practices.

V. Conclusion

    Therefore, tolerances are established for residues of 
cyantraniliprole, including its metabolites and degradates, in or on 
the following commodities: herb, dried leaves, subgroup 25B at 150 ppm; 
herb, fresh leaves, subgroup 25A at 40 ppm; hop, dried cones at 70 ppm; 
papaya at 1.5 ppm; spice crop group 26 at 80 ppm; vegetable, legume, 
bean, edible podded, subgroup 6-22A at 2 ppm; vegetable, legume, bean, 
succulent shelled, subgroup 6-22C at 0.3 ppm; vegetable, legume, forage 
and hay, except soybean, subgroup 7-22A at 40 ppm; vegetable, legume, 
pea, edible podded, subgroup 6-22B at 2 ppm; vegetable, legume, pea, 
succulent shelled, subgroup 6-22D at 0.3 ppm; vegetable, legume, pulse, 
bean, dried shelled, except soybean, subgroup 6-22E at 1 ppm; and 
vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 1 ppm. 
EPA is removing the established tolerances for residues of 
cyantraniliprole, in or on the following commodities upon the 
establishment of the new tolerances: vegetable, foliage of legume, 
except soybean, group 7A at 40 ppm; vegetable, legume, dried shelled, 
except soybean, subgroup 6C at 1.0 ppm; vegetable, legume, edible 
podded, subgroup 6A at 2.0 ppm; and vegetable, legume, succulent 
shelled, subgroup 6B at 0.20 ppm.
    Additionally, tolerances are established for residues of 
cyantraniliprole, including its metabolites and degradates, in or on 
the following imported commodities: avocado at 0.4 ppm; grape, table at 
2

[[Page 42386]]

ppm; and mango at 0.7 ppm. Finally, the tolerance for residues of 
cyantraniliprole, including its metabolites and degradates, in or on 
olive is revised from 1.5 ppm to 3 ppm and the tolerance for residues 
in or on olive, oil at 2.0 ppm is removed.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000), do not apply to this action. In addition, 
this action does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve 
any technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 9, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.672, amend the table in paragraph (a) by:
0
a. Adding the table heading ``Table 1 to Paragraph (a)'';
0
b. Adding in alphabetical order the entries ``Avocado\2\''; ``Grape, 
table\2\''; ``Herb, dried leaves, subgroup 25B''; ``Herb, fresh leaves, 
subgroup 25A''; ``Hop, dried cones''; and ``Mango \2\'';
0
c. Revising the entry for ``Olive\1\'';
0
d. Removing the entry for ``Olive, oil\1\'';
0
e. Adding in alphabetical order the entries ``Papaya''; and ``Spice 
crop group 26'';
0
f. Removing the entry for ``Vegetable, foliage of legume, except 
soybean, group 7A'';
0
g. Adding in alphabetical order the entries ``Vegetable, legume, bean, 
edible podded, subgroup 6-22A''; and ``Vegetable, legume, bean, 
succulent shelled, subgroup 6-22C'';
0
h. Removing the entries for ``Vegetable, legume, dried shelled, except 
soybean, subgroup 6C''; and ``Vegetable, legume, edible podded, 
subgroup 6A'';
0
i. Adding in alphabetical order the entries ``Vegetable, legume, forage 
and hay, except soybean, subgroup 7-22A''; ``Vegetable, legume, pea, 
edible podded, subgroup 6-22B''; ``Vegetable, legume, pea, succulent 
shelled, subgroup 6-22D''; ``Vegetable, legume, pulse, bean, dried 
shelled, except soybean, subgroup 6-22E''; and ``Vegetable, legume, 
pulse, pea, dried shelled, subgroup 6-22F''; and
0
j. Removing the entry for ``Vegetable, legume, succulent shelled, 
subgroup 6B''.
    The additions and revision read as follows:


Sec.  180.672  Cyantraniliprole; tolerance for residues.

    (a) * * *

[[Page 42387]]



                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Avocado \2\.................................................         0.4
 
                                * * * * *
Grape, table \2\............................................           2
 
                                * * * * *
Herb, dried leaves, subgroup 25B............................         150
Herb, fresh leaves, subgroup 25A............................          40
Hop, dried cones............................................          70
 
                                * * * * *
Mango \2\...................................................         0.7
 
                                * * * * *
Olive \2\...................................................           3
 
                                * * * * *
Papaya......................................................         1.5
 
                                * * * * *
Spice crop group 26.........................................          80
 
                                * * * * *
Vegetable, legume, bean, edible podded, subgroup 6-22A......           2
Vegetable, legume, bean, succulent shelled, subgroup 6-22C..         0.3
Vegetable, legume, forage and hay, except soybean, subgroup           40
 7-22A......................................................
Vegetable, legume, pea, edible podded, subgroup 6-22B.......           2
Vegetable, legume, pea, succulent shelled, subgroup 6-22D...         0.3
Vegetable, legume, pulse, bean, dried shelled, except                  1
 soybean, subgroup 6-22E....................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F           1
 
                               * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities.
\2\ There are no U.S. registrations for these commodities as of May 15,
  2024.

* * * * *

[FR Doc. 2024-10490 Filed 5-14-24; 8:45 am]
BILLING CODE 6560-50-P


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