Glufosinate-P; Pesticide Tolerances, 85859-85867 [2024-24831]

Download as PDF Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations achieving EJ for people of color, lowincome populations and Indigenous peoples. This action is subject to the Congressional Review Act, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 30, 2024. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: October 23, 2024. Debra Shore, Regional Administrator, Region 5. For the reasons stated in the preamble, title 40 CFR part 52 is amended as follows: PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. 2. Section 52.2570 is amended by removing and reserving paragraphs (c) (13), (c)(14), (c)(15), (c)(22), (c)(27), (c)(28), (c)(30), (c)(32), (c)(33), (c)(34), (c)(36), (c)(39), (c)(40), (c)(41), (c)(42), (c)(43), (c)(45), (c)(49), (c)(72), (c)(78) and (c)(91), and by adding paragraph (c)(150) to read as follows: ■ khammond on DSKJM1Z7X2PROD with RULES § 52.2570 Identification of plan. * * * * * (c) * * * (150) On October 27, 2023, WDNR submitted a SIP revision request to align provisions approved in the Wisconsin SIP with current Wisconsin administrative rules and statutes. WDNR requested that certain provisions VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 previously approved into the Wisconsin SIP under now obsolete numbering schemes be renumbered to ensure citations in the Wisconsin SIP reflect the current numbering systems of the Wisconsin Administrative Code (WAC) and the Wisconsin Statutes (Wis. Stats.). WDNR also requested that EPA approve rule and statute provisions that have been revised since they were approved into the Wisconsin SIP. Finally, WDNR requested removal of rules and statutes from the Wisconsin SIP that are no longer in effect in Wisconsin. The rule and statute provisions that have been revised or removed were previously approved in paragraphs (c) (13), (c)(14), (c)(15), (c)(22), (c)(27), (c)(28), (c)(30), (c)(32), (c)(33), (c)(34), (c)(36), (c)(39), (c)(40), (c)(41), (c)(42), (c)(43), (c)(45), (c)(49), (c)(72), (c)(78) and (c)(91) of this section. Approval of these changes in the Wisconsin SIP will not impact the state’s air quality or ability to meet Clean Air Act requirements. (i) Incorporation by reference. (A) Wisconsin Administrative Code, NR 400, except Note, 400.01, 400.02 (19m), (27m), (107m), (123e), and (123s), 400.03(1)(a) through (cm) and (dm) through (m), and 400.03(4)(jp) and (js), as published in the Wisconsin Register, July 2022 No. 799, effective August 1, 2022. (B) Wisconsin Administrative Code, NR 415, except 415.01, 415.02(3) and (8), 415.075(1), (2)(a) intro, 1. through 4., 6. and 7., (b) and (c), (3)(a) through (e), (4), (5), and (6), 415.076, and 415.09(2) and (3)(a) through (c), as published in the Wisconsin Register, April 2023 No. 808, effective May 1, 2023. (C) Wisconsin Administrative Code, NR 417, except Note, 417.01(2), 417.03, 417.05, and 417.07(2)(e) and (f), as published in the Wisconsin Register, November 1999 No. 526, effective November 1, 1999. (D) Wisconsin Administrative Code, NR 431, only 431.03, 431.04 and 431.05, as published in the Wisconsin Register, November 2003 No. 574, effective November 1, 2003. (E) Wisconsin Administrative Code, NR 436, except 436.01(2), 436.03(2), and 436.05(5), as published in the Wisconsin Register, November 1999 No. 526, effective November 1, 1999. (F) Wisconsin Administrative Code, NR 445, only 445.16, as published in the Wisconsin Register, March 2016 No. 723, effective April 1, 2016. (G) Wisconsin Administrative Code, NR 447, only 447.02 intro, (6), (7), (16), (18) Note, and (31), 447.07 (3) intro, (a) and (d), 447.12 (3)(b) Note, 447.16 (2), and 447.18 intro and (1) Note, as published in the Wisconsin Register, PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 85859 June 2004 No. 582, effective July 1, 2004. (H) Wisconsin Administrative Code, NR 492, only 492.03, as published in the Wisconsin Register, April 2013 No. 688, effective May 1, 2013. (I) Wisconsin Administrative Code, NR 493, except Note and 493.01, as published in the Wisconsin Register, November 1999 No. 527. (J) Wisconsin Administrative Code, Chapter Trans 131, as published in the Wisconsin Register, July 2023 No. 811, effective August 1, 2023. (K) Wisconsin Statutes, Chapter 15, only 15.347(8), as revised by Updated 21–22 Wis. Stats., published October 4, 2023. (L) Wisconsin Statutes, Chapter 110, only 110.20, as revised by Updated 21– 22 Wis. Stats., published October 4, 2023. (M) Wisconsin Statutes, Chapter 285, 285.01 except (17m), (21), (28), (33), (35), (38), (39), (40); 285.11 except (12), (13), (15), (16), (17), (18), (19); 285.13 except (7); 285.17 only (1); 285.19; 285.21 except (4); 285.23 except (6); 285.27 except (2)(d) and (3); 285.30; 285.31 only (5); 285.33 only (1); 285.35; 285.60 except (1)(b)2., (2g), (5m), (6)(b) and (c), (8), (9), (10) and (11); 285.61 except (5)(a) and (b), (10) and (11); 285.62; 285.63 except (11); 285.65; 285.66; 285.68; 285.69 except (1)(c), (1d), (2)(a), (c) intro, (c)2., (d) and (e), (2e), (2m), (3), (5), (6), and (7); 285.79; 285.81 except (1m) and (4); 285.83 except (2); and 285.87 except (2), as revised by Updated 21–22 Wis. Stats., published October 4, 2023. (N) Wisconsin Statutes, Chapter 299, only 299.95, as revised by Updated 21– 22 Wis. Stats., published October 4, 2023. (ii) [Reserved] [FR Doc. 2024–25032 Filed 10–28–24; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2020–0250; EPA–HQ–OPP– 2020–0533; FRL–12339–01–OCSPP] Glufosinate-P; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of glufosinate-P in or on multiple commodities, which are identified and discussed later in this document. BASF Corporation and MITSUI Chemicals Crop & Life SUMMARY: E:\FR\FM\29OCR1.SGM 29OCR1 85860 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations Solutions, INC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 29, 2024. Objections and requests for hearings must be received on or before December 30, 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) number EPA–HQ–OPP–2020–0250 and EPA–HQ–OPP–2020–0533 is available at https://www.regulations.gov 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. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: 202–566–2427; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information khammond on DSKJM1Z7X2PROD with RULES 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 VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 the Federal Register Office’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–2020–0250 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 December 30, 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– 2020–0250, 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/where-sendcomments-epa-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 March 24, 2023 (88 FR 17778) (FRL–10579–02– 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 2F9021) by PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 BASF Corporation Agricultural Solutions, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.473 be amended by modifying the tolerances for residues of glufosinate to include residues of L-glufosinate ammonium, glufosinate-P-ammonium [(2S)-2-amino- 4(hydroxymethylphosphinyl) butanoic acid -monoammonium salt] as measured by the sum of glufosinate (2-amino-4(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid equivalents in or on canola, meal at 1.1 parts per million (ppm); cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field, grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30 ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 30 ppm; cotton, seed, subgroup 20C at 15.00 ppm; egg at 0.15 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grain aspirated fractions at 25.00 ppm; hog, fat at 0.40 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; milk at 0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at .15 ppm; poultry, meat byproducts at 0.60 ppm; rapeseed, subgroup 20A at 0.4 ppm; sheep, fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm and tolerances for indirect or inadvertent residues on barley, hay at 0.4 ppm; barley, straw at 0.4 ppm; buckwheat, fodder at 0.4 ppm; buckwheat, forage at 0.4 ppm; oat, forage at 0.4 ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 ppm; rye, forage at 0.4 ppm; rye, straw at 0.4 ppm; teosinte at 0.4 ppm; triticale at 0.4 ppm; wheat, forage at 0.4 ppm; wheat, hay at 0.4 ppm; and wheat, straw at 0.4 ppm. Also, in the Federal Register of December 21, 2020 (85 FR 82998) (FRL– 10016–93), 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 0F8842) by Meiji Seika Pharma Co., Ltd, c/o Landis International, Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603–5126. The petition requested to establish tolerance for residues of L- E:\FR\FM\29OCR1.SGM 29OCR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations glufosinate free acid, (2S)-2-amino-4[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and degradates, 2-(acetylamino)-4(hydroxymethyl phosphinyl) butanoic acid (NAG), and 3(hydroxymethylphosphinyl) propanoic acid (MPP), expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic acid equivalents in or on apple at 0.05 ppm; beet, sugar, molasses at 5.0 ppm; beet, sugar, roots at 0.9 ppm; beet, sugar, tops (leaves) at 1.5 ppm; bushberry subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola, seed at 0.40 ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field, grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30 ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 15 ppm; cotton, undelinted seed at 4.0 ppm; egg at 0.15 ppm; fruit, citrus, crop group 10– 10 at .15 ppm; fruit, pome, crop group 11–10 at .25 ppm; fruit, stone, crop group 12–12 at 0.30 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grape at 0.05 ppm; hog, fat at 0.40 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; milk at 0.15 ppm; nut, tree, crop group 14–12 at 0.50 ppm; olive at 0.50 ppm; potato at 0.80 ppm; potato, chips at 1.6 ppm; potato, granules/flakes at 2.0 ppm; poultry, fat at 0.15 ppm; poultry, meat at .15 ppm; poultry, meat byproducts at 0.60 ppm; sheep, fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm. These documents referenced summaries of the petitions prepared by BASF Corporation Agricultural Solutions and Meiji Seika Pharma Co., Ltd, (now known as MITSUI Chemicals Crop & Life Solutions), the petitioners, which are available in the docket, https://www.regulations.gov. One comment was received on the notice of filing for petition 0F8842. No comments were received on the notice of filing for petition 2F9021. EPA’s response to this comment is discussed in Unit IV.C. The tolerances EPA is establishing vary from what the petitioners have requested in a few ways, which are explained in greater detail in Unit IV.C. In sum, BASF Corporation Agricultural Solutions and MITSUI Chemicals Crop & Life Solutions have deleted crops from their initial request, the Agency will be establishing tolerances only on those crops as mentioned in Unit V. VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 Moreover, in order to align with the International Organization for Standardization (ISO) recognized nomenclature, EPA is establishing tolerances for glufosinate-P, which is the current standard name for Lglufosinate free acid. Because applications of glufosinate-Pammonium (also known as Lglufosinate-ammonium) result in residues of glufosinate-P on crops, EPA is setting the tolerance for glufosinate-P residues, which will cover any residues that remain on food from applications of pesticides with either form of the pesticide. 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 in FFDCA section 408(b)(2)(D), 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 L-glufosinate, including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with L-glufosinate follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 85861 Glufosinate is racemic mixture comprised of D- and L-stereoisomers, and the D/L form of glufosinate (also referred to as the racemic glufosinate) is currently registered as a pesticide (herbicide) in the United States. The Lisomer is the herbicidally active part of D/L-glufosinate, and the D-isomer is herbicidally inactive. The L-isomer is referred to as L-glufosinate in this document and the supporting risk assessment documents and refers to the active moiety from both L-glufosinate ammonium and L-glufosinate acid, which are two forms of the L-isomer used in pesticide formulations. As mentioned above the Agency has received applications for both Lglufosinate ammonium and Lglufosinate acid. The International Organization for Standardization (ISO) has designated L-glufosinate ammonium as glufosinate-P-ammonium and Lglufosinate free acid as glufosinate-P, so EPA is establishing tolerances using that nomenclature; however, for consistency with EPA’s supporting risk assessments, this document is using the terms Lglufosinate ammonium and Lglufosinate acid. The available in vivo and in vitro data for comparison across L-glufosinate acid and L-glufosinate ammonium, and the in vitro and in vivo DNT data for D/Lglufosinate ammonium indicate no significant differences in oral toxicities for the most sensitive endpoint (i.e., neurotoxicity). As such, these databases are being considered together when assessing toxicity and selecting endpoints for pertinent exposures. Hence both L-glufosinate ammonium and L-glufosinate acid are considered toxicologically equivalent for oral and dermal exposure pathways. Also, Lglufosinate ammonium, when dissolved in water, dissociates to L-glufosinate acid. Therefore, the Agency considers glufosinate-P ammonium and glufosinate-P as functionally similar. The targets identified following oral exposure to L-glufosinate were the brain and peripheral nervous system (rats, mice, and dogs), kidney (rats and mice), thyroid (rats only), and the adrenals (mice only). Neurotoxicity was observed after acute, subchronic, and chronic exposures. Adverse findings included clinical signs indicative of neurotoxicity (i.e., tremors, clonic convulsions, inability to maintain body posture, etc.), increased motor activity, alterations in brain weight, and neuropathology of the brain, eye, and spinal cord. Kidney toxicity manifested as increased kidney weights, alterations in urinalysis parameters, and hypertrophy of the proximal tubular cells of the pars recta. Slight thyroid c-cell hyperplasia was E:\FR\FM\29OCR1.SGM 29OCR1 85862 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations observed in male rats, while in mice, microscopic findings of the adrenal and increased adrenal weight were noted. Increased quantitative susceptibility was observed in the L-glufosinate rat prenatal developmental toxicity study, the L-glufosinate range-finding developmental neurotoxicity (DNT) study, and the D/L-glufosinate DNT study. L-glufosinate is classified as ‘‘Not Likely to be Carcinogenic to Humans’’ based on a lack of treatment-related tumor response in both the L-glufosinate rat and mouse carcinogenicity studies. There is a low concern for mutagenicity for L-glufosinate. Specific information on the studies received and the nature of the adverse effects caused by L-glufosinate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document ‘‘LGlufosinate. Human Health Risk Assessment for New Active Ingredient Isomer’’ at 21–34 in docket ID number EPA–HQ–OPP–2020–0250. khammond on DSKJM1Z7X2PROD with RULES B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level, generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD), and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 For more detailed information on the toxicological endpoints for L-glufosinate used for human risk assessment can be found in the L-Glufosinate. Human Health Risk Assessment for New Active Ingredient Isomer in docket ID number EPA–HQ–OPP–2020–0250. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to L-glufosinate, EPA considered exposure to L-glufosinate under all tolerances established for racemic glufosinate as well as the petitioned-for tolerances in this rulemaking. EPA assessed dietary exposures from L-glufosinate in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for Lglufosinate. In conducting the acute dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food and Commodity Intake Database (DEEM–FCID) Version 3.16. This software uses the 2003–2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted an unrefined acute dietary exposure assessment for L-glufosinate assuming tolerance-level residues for Lglufosinate (scaled by 0.5X for application rate adjustment) and 100% CT assumptions for all crops and livestock commodities. The proposed uses of L-glufosinate exactly match the established uses of D/L-glufosinate in terms of crops, number of applications, retreatment intervals, and preharvest intervals; the only difference being that the use rate for L-glufosinate is one-half that of D/L-glufosinate, consistent with herbicidal activity residing primarily in the L-isomer. Since the rate of Lglufosinate is one-half that of D/Lglufosinate, the expected residues for Lglufosinate are one-half those of D/Lglufosinate. ii. Chronic exposure. The chronic dietary exposure assessment also uses the DEEM–FCID Version 3.16 software with the 2003–2008 NHANES/WWEIA data. As to residue levels in food, EPA conducted a partially refined chronic dietary exposure assessment using anticipated residues based on average field trial residue levels for plant commodities, average calculated PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 residues for livestock commodities, all foods scaled by 0.5X for application rate adjustment, and 100% CT. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that L-glufosinate does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of the 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. The Agency is not using percent crop treated estimates for assessing acute and chronic exposures. 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for L-glufosinate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of Lglufosinate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/ pesticide-science-and-assessingpesticide-risks/models-pesticide-riskassessment. Determination of the residues of concern for human health in drinking water included consideration of racemic glufosinate and the degradate, 3methylphosphinico-propionic acid (MPP). Although the chronic EDWCs for MPP are approximately 2× higher than the EDWCs for the racemic glufosinate, EPA has determined that using the EDWCs for the racemic glufosinate will be protective of effects that might occur from exposure to the degradate. This conclusion is based on a comparison of the toxicity databases for glufosinate and MPP, which indicate that glufosinate is more than twice as potent as MPP. Because the toxic effects from glufosinate and MPP are significantly E:\FR\FM\29OCR1.SGM 29OCR1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations different, an aggregate assessment of glufosinate and MPP is not appropriate. Based on the Pesticides in Water Calculator (PWC; version 1.52), the estimated drinking water concentrations (EDWCs) of D/L-glufosinate are estimated to be 201 parts per billion (ppb) for acute dietary exposures and 24.4 ppb for chronic dietary exposures. Surface water simulations resulted in the highest EDWCs. These values reflect application of D/ L-glufosinate and were scaled by half to reflect the reduced application rate and expected concentrations of L-glufosinate in water. The adjusted EDWCs were incorporated in the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCID) into the food categories ‘‘water, direct, all sources’’ and ‘‘water, indirect, all sources.’’ 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). L-glufosinate is not being proposed for residential uses. However, there are residential exposures to L-glufosinate as a result of the existing residential uses of the racemic glufosinate. These exposures have been assessed for Lglufosinate and are included in a shortterm aggregate assessment for Lglufosinate. For this assessment, the application rate was scaled by 0.5× to reflect residues of L-glufosinate only, and the application rate was converted to acid equivalents because the PODs are likewise expressed as acid equivalents. For currently registered uses of racemic glufosinate, residential handler and post-application dermal and inhalation risks are not of concern for L-glufosinate. The scenarios that are recommended to be considered for aggregate risk assessment are highcontact lawn activities for adults and children 1 to <2 years old and golfer activities for children 6 to <11 years old and children 11 to <16 years old. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ 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 VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 mechanism of toxicity finding as to Lglufosinate and any other substances and L-glufosinate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that L-glufosinate has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/pesticidecumulative-risk-assessment-framework. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10×) 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. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10×, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Increased quantitative susceptibility was observed in the L-glufosinate rat prenatal developmental toxicity study, the L-glufosinate range-finding DNT study, and the D/L-glufosinate DNT study. Quantitative susceptibility was observed in the developmental rat study in which decreased fetal body weight in both sexes was observed at the highest dose tested; however, no maternal toxicity was identified. Quantitative susceptibility was observed in a Lglufosinate dose-range finding DNT study in which maternal effects were not observed up to the highest dose tested while offspring toxicity manifested as decreased pup body weight and increased total and ambulatory motor activity counts in males. The D/L-glufosinate DNT study observed alterations in brain morphometrics (a decrease in the mean length of the ventral limb of the dentate hilus), an increase in motor activity, and a decrease in body weight for the offspring at a dose level that did not elicit maternal toxicity. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 85863 adequately protected if the FQPA SF were reduced to 1× for all exposure scenarios for glufosinate-P. That decision is based on the following findings: i. The toxicity database for Lglufosinate is complete, as a result of bridging data between the racemic glufosinate, L-glufosinate, and Lglufosinate ammonium databases. ii. Evidence of neurotoxicity was observed in the L-glufosinate database in both adults and early life stages. However, the concern is low because all selected endpoints are based on, and protective of, the most sensitive neurotoxic effects in the database, as indicated by the following: (1) the 17% increase in motor activity observed in females in the 28-day range-finding subchronic rat study occurred at a dose level that is approximately 13×–80× higher than the selected PODs; (2) the decreased brain weight and vacuolation of the cerebrum in the chronic mouse study occurred at dose levels approximately 11×–67× higher than the selected PODs; (3) the neuropathology observed in the subchronic neurotoxicity study occurred at a dose level approximately 29×–174× higher than the selected PODs; (4) the increased total and ambulatory motor activity counts in the range-finding DNT study occurred at a dose level approximately 27× higher than the selected PODs; and (5) the brain morphometric changes and increased motor activity observed in the offspring in the D/L-glufosinate DNT occurred at a dose level approximately 42× higher than the selected PODs for all relevant exposure scenarios. iii. As discussed in Unit III.D.2. above, increased quantitative susceptibility was observed in the Lglufosinate rat prenatal developmental toxicity study, the L-glufosinate rangefinding DNT study, and the D/Lglufosinate ammonium DNT study. However, the concern for the increased susceptibility is low, as clear NOAELs have been identified for those studies and all selected PODs are protective of the effects seen in those studies. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and conservative residue estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to L-glufosinate in drinking water. These assessments will not underestimate the exposure and risks posed by L-glufosinate. E:\FR\FM\29OCR1.SGM 29OCR1 85864 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term aggregate risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure to L-glufosinate from food and water will occupy 26% of the aPAD with the females 13 to 49 years old population subgroup. For all the other population subgroups, the most highly exposed population subgroup is all infants (<1 year old) at 4.7% of the aPAD. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to L-glufosinate from food and water will utilize 12% of the cPAD for children (1–2 years old), the population group receiving the highest exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,100 for adults, 2,600 for children (11 to <16 years old), 1,700 for children (6 to <11 years old) and 230 for children (1 to <2 years old), which are above the LOC (100) and are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, L-glufosinate is not registered for any use patterns that would result in intermediate-term residential exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of intermediate-term risk is necessary, and EPA relies on the VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 chronic dietary risk assessment for evaluating intermediate-term risk for Lglufosinate. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, L-glufosinate is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, 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 L-glufosinate residues. IV. Other Considerations A. Analytical Enforcement Methodology Two analytical methods have been validated by the Analytical Chemistry Branch (ACB) for enforcement of the currently established tolerances of D/Lglufosinate: (1) method HRAV–5A was validated by ACB for the determination of glufosinate and MPP in/on apple, grape, almond, soybean seed, corn grain, and corn forage and (2) method BK/01/ 99 was validated by ACB for determination of glufosinate, N-acetylglufosinate (NAG), and MPP in/on canola seed and sugar beet root. Based on the results from the petition method validations (PMVs) and the ability of the methods to detect both the D- and L- isomers of glufosinate, EPA concludes that adequate enforcement methods are available for L-glufosinate. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. 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 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for L-glufosinate. C. Response to Comments The Agency did receive one comment raising concerns that there are studies indicating that L-glufosinate is harmful and toxic to health of humans even in small doses. The commentor was also concerned over the use of L-glufosinate on corn, cotton and soybean which are staples of American diet. The commentor emphasized the role of EPA in reasonably assessing its analysis of pesticide tolerances, safety, and awareness of disproportionate effects of agricultural production, and its firm commitment to environmental justice. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that these glufosinate-P tolerances are safe. The commenter provided no information supporting a conclusion that glufosinate-P is not safe, nor did the commenter provide any basis for concluding that the tolerances would have a disproportionate effect on any population. D. Revisions to Petitioned-For Tolerances The Agency is establishing a tolerance for residues of glufosinate-P, including its metabolites and degradates, that result from applications of glufosinateP or glufosinate-P-ammonium, with compliance to be determined by measuring the sum of glufosinate (2amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolites, 2(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid equivalents. BASF Corporation had petitioned for expression of Lglufosinate-ammonium, glufosinate-Pammonium [(2S)-2-amino-4-(hydroxy methylphosphinyl) butanoic acid -monoammonium salt] as measured by the sum of glufosinate (2-amino-4(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3(hydroxymethylphosphinyl) propanoic E:\FR\FM\29OCR1.SGM 29OCR1 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES acid, expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid, and MITSUI Chemicals Crop & Life Solutions, Inc. had petitioned for expression of L-glufosinate free acid, (2S)-2-amino-4-[hydroxy(methyl) phosphinoyl]butyric acid, including its metabolites and degradates, 2(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid (NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed as 2amino-4-(hydroxymethylphosphinyl) butanoic acid equivalents. As discussed in Unit III.A, glufosinate-P-ammonium (also referred to as L-glufosinate ammonium) is the ammonium salt of glufosinate-P (also referred to as Lglufosinate acid). Since the glufosinateP-ammonium breaks down into residues of glufosinate-P, EPA is establishing the tolerances for residues of glufosinate-P including its metabolites and degradates, that may result from applications of either form of glufosinate-P. In addition, the petitioners have withdrawn their requests to establish tolerances on the following crops, so EPA is not establishing tolerances on those crops at this time: apple; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops (leaves); bushberry subgroup 13–07B; fruit, citrus, crop group 10–10; fruit, pome, crop group 11–10; fruit, stone, crop group 12–12; grape; nut, tree, crop group 14–12; olive; potato; potato, chips; and potato, granules/ flakes. Finally, EPA has applied its policy on OECD Rounding Classes to the petitioned-for tolerances to establish tolerances without trailing zeros after the decimal place. V. Conclusion Therefore, tolerances are established for residues of glufosinate-P including its metabolites and degradates in or on canola, meal at 1.1 parts per million (ppm); cattle, fat at 0.4 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6 ppm; corn, field, forage at 4 ppm; corn, field, grain at 0.2 ppm; corn, field, stover at 6 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.3 ppm; corn, sweet, stover at 6 ppm; cotton, gin byproducts at 30 ppm; cotton, seed, subgroup 20C at 15 ppm; egg at 0.15 ppm; goat, fat at 0.4 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6 ppm; grain aspirated fractions at 25 ppm; hog, fat at 0.4 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6 ppm; horse, fat at 0.4 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6 ppm; milk at 0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at 0.15 ppm; VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 poultry, meat byproducts at 0.6 ppm; rapeseed, subgroup 20A at 0.4 ppm; sheep, fat at 0.4 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6 ppm; soybean at 2 ppm; soybean, hulls at 10 ppm. In addition, tolerances are established for indirect or inadvertent residues of glufosinate-P including its metabolites and degradates in or on barley, hay at 0.4 ppm; barley, straw at 0.4 ppm; buckwheat, fodder at 0.4 ppm; buckwheat, forage at 0.4 ppm; oat, forage at 0.4 ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 ppm; rye, forage at 0.4 ppm; rye, straw at 0.4 ppm; teosinte at 0.4 ppm; triticale at 0.4 ppm; wheat, forage at 0.4 ppm; wheat, hay at 0.4ppm; and wheat, straw at 0.4 ppm. 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 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 85865 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: October 21, 2024. Elizabeth Vizard, Acting Director, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows: 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. Revise and republish § 180.473 to read as follows: ■ E:\FR\FM\29OCR1.SGM 29OCR1 85866 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations § 180.473 Glufosinate; tolerances for residues. (a) General. (1) Tolerances are established for residues of glufosinate, including its metabolites and degradates, in or on the commodities in table 1 to paragraph (a)(1). Compliance with the tolerance levels specified in table 1 to paragraph (a)(1) is to be determined by measuring the sum of glufosinate (2-amino-4-(hydroxy methylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic acid equivalents. TABLE 1 TO PARAGRAPH (a)(1) khammond on DSKJM1Z7X2PROD with RULES Commodity Parts per million Almond, hulls ........................ Banana 1 ............................... Beet, sugar, molasses .......... Beet, sugar, roots ................. Beet, sugar, tops (leaves) .... Bushberry subgroup 13–07B Canola, meal ........................ Cattle, fat .............................. Cattle, meat .......................... Cattle, meat byproducts ....... Corn, field forage .................. Corn, field, grain ................... Corn, field, stover ................. Corn, sweet, forage .............. Corn, sweet, kernels plus cob with husks removed ... Corn, sweet, stover .............. Cotton, gin byproducts ......... Cottonseed subgroup 20C ... Egg ....................................... Fig, dried ............................... Fruit, citrus, group 10–10 ..... Fruit, pome, group 11–10 ..... Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................... Fruit, stone, group 12–12 ..... Goat, fat ................................ Goat, meat ............................ Goat, meat byproducts ......... Grain aspirated fractions ...... Hog, fat ................................. Hog, meat ............................. Hog, meat byproducts .......... Hop, dried cones .................. Horse, fat .............................. Horse, meat .......................... Horse, meat byproducts ....... Melon subgroup 9A .............. Milk ....................................... Nut, tree, group 14–12 ......... Pepper/eggplant subgroup 8–10B ................................ Potato, chips ......................... Potato granules/flakes .......... Poultry, fat ............................ Poultry, meat ........................ Poultry, meat byproducts ...... Rapeseed subgroup 20A ...... Rice, grain ............................ VerDate Sep<11>2014 16:02 Oct 28, 2024 0.50 0.30 5.0 0.9 1.5 0.15 1.1 0.40 0.15 6.0 4.0 0.20 6.0 1.5 0.30 6.0 30 15 0.15 0.15 0.15 0.25 0.05 0.30 0.40 0.15 6.0 25 0.40 0.15 6.0 0.9 0.40 0.15 6.0 0.08 0.15 0.50 0.15 1.6 2.0 0.15 0.15 0.60 0.4 1.0 Jkt 265001 TABLE 1 TO PARAGRAPH (a)(1)— Continued TABLE 2 TO PARAGRAPH (a)(2)— Continued Parts per million Commodity Rice, hull ............................... Sheep, fat ............................. Sheep, meat ......................... Sheep, meat byproducts ...... Soybean ................................ Soybean, hulls ...................... Squash/cucumber subgroup 9B ...................................... Tomato, paste ....................... Tomato subgroup 8–10A ...... Tropical and subtropical, medium to large fruit, edible peel, subgroup 23B ........... Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B .................................... Tropical and subtropical, small fruit, edible peel, subgroup 23A .................... Tropical and subtropical, small fruit, inedible peel, subgroup 24A .................... Vegetable, tuberous and corm, subgroup 1C ........... 2.0 0.40 0.15 6.0 2.0 10 0.15 0.15 0.1 0.1 0.2 Commodity Hog, fat ................................. Hog, meat ............................. Hog, meat byproducts .......... Horse, fat .............................. Horse, meat .......................... Horse, meat byproducts ....... Milk ....................................... Poultry, fat ............................ Poultry, meat ........................ Poultry, meat byproducts ...... Rapeseed, subgroup 20A ..... Sheep, fat ............................. Sheep, meat ......................... Sheep, meat byproducts ...... Soybean ................................ Soybean, hulls ...................... Parts per million 0.4 0.15 6 0.4 0.15 6 0.15 0.15 0.15 0.6 0.4 0.4 0.15 6 2 10 0.5 (b) [Reserved] (c) Tolerances with regional 0.1 registrations. Tolerances with regional registrations are established for residues 0.8 of glufosinate, including its metabolites and degradates, in or on the (2) Tolerances are established for commodities in table 3 to paragraph (c). residues of glufosinate-P, including its Compliance with the tolerance levels metabolites and degradates, in or on the specified in table 3 to paragraph (c) is commodities in table 2 to paragraph to be determined by measuring the sum (a)(2), as a result of applications of of glufosinate, (2-amino-4-(hydroxy glufosinate-P or glufosinate-Pmethylphosphinyl)butanoic acid) and ammonium to those commodities. its metabolites, 2-(acetylamino)-4Compliance with the tolerance levels (hydroxymethyl phosphinyl) butanoic specified in table 2 to paragraph (a)(2) acid, and 3-(hydroxymethylphosphinyl) is to be determined by measuring the propanoic acid, expressed as 2-amino-4sum of glufosinate (2-amino-4-(hydroxy (hydroxymethylphosphinyl)butanoic methylphosphinyl) butanoic acid) and acid equivalents. its metabolites, 2-(acetylamino)-4(hydroxymethyl phosphinyl) butanoic TABLE 3 TO PARAGRAPH (c) acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4Parts per Commodity (hydroxymethylphosphinyl)butanoic million acid equivalents. Grass, forage ........................ Grass, hay ............................ TABLE 2 TO PARAGRAPH (a)(2) Parts per million Commodity Canola, meal ........................ Cattle, fat .............................. Cattle, meat .......................... Cattle, meat byproducts ....... Corn, field, forage ................. Corn, field, grain ................... Corn, field, stover ................. Corn, sweet, forage .............. Corn, sweet, kernels plus cob with husks removed ... Corn, sweet, stover .............. Cotton, gin byproducts ......... Cottonseed, subgroup 20C .. Egg ....................................... Goat, fat ................................ Goat, meat ............................ Goat, meat byproducts ......... Grain, aspirated fractions ..... PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 1.1 0.4 0.15 6 4 0.2 6 1.5 0.3 6 30 15 0.15 0.4 0.15 6 25 0.15 0.2 (d) Indirect or inadvertent residues. (1) Tolerances are established for indirect or inadvertent residues of glufosinate, including its metabolites and degradates, in or on the commodities in table 4 to paragraph (d)(1), as a result of the application of glufosinate to crops listed in paragraph (a) of this section. Compliance with the tolerance levels specified in table 4 to paragraph (d)(1) is to be determined by measuring the sum of glufosinate (2amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolite, 3(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid equivalents. E:\FR\FM\29OCR1.SGM 29OCR1 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations ACTION: TABLE 4 TO PARAGRAPH (d)(1) Commodity Parts per million Barley, hay ............................ Barley, straw ......................... Buckwheat, fodder ................ Buckwheat, forage ................ Oat, forage ............................ Oat, hay ................................ Oat, straw ............................. Rye, forage ........................... Rye, straw ............................. Teosinte ................................ Triticale ................................. Wheat, forage ....................... Wheat, hay ........................... Wheat, straw ......................... 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 0.40 (2) Tolerances are established for indirect or inadvertent residues of glufosinate-P, including its metabolites and degradates, in or on the commodities in table 5 to paragraph (d)(2), as a result of the application of glufosinate-P or glufosinate-Pammonium to crops listed in paragraph (a)(2) of this section. Compliance with the tolerance levels specified in table 5 to paragraph (d)(2) is to be determined by measuring the sum of glufosinate (2amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolite, 3(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid equivalents.’’ TABLE 5 TO PARAGRAPH (d)(2) Commodity Parts per million Barley, hay ............................ Barley, straw ......................... Buckwheat, fodder ................ Buckwheat, forage ................ Oat, forage ............................ Oat, hay ................................ Oat, straw ............................. Rye, forage ........................... Rye, straw ............................. Teosinte ................................ Triticale ................................. Wheat, forage ....................... Wheat, hay ........................... Wheat, straw ......................... 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 [FR Doc. 2024–24831 Filed 10–28–24; 8:45 am] BILLING CODE 6560–50–P khammond on DSKJM1Z7X2PROD with RULES CORPORATION FOR NATIONAL AND COMMUNITY SERVICE 45 CFR Part 2584 RIN 3045–AA60 Protection of Human Subjects Corporation for National and Community Service. AGENCY: VerDate Sep<11>2014 16:02 Oct 28, 2024 Jkt 265001 Final rule. The Corporation for National and Community Service (operating as AmeriCorps) is finalizing its adoption of the Federal Policy for Protection of Human Subjects (referred to as the Common Rule). The Common Rule outlines the basic ethical principles and procedures that an agency will abide by when conducting or sponsoring research involving human subjects. Among the procedures required by the Common Rule are use of institutional review boards (IRBs), obtaining informed consent of research subjects, and requiring submission of assurances of compliance with the rule. AmeriCorps is making the Common Rule applicable to itself, meaning that all research involving human subjects conducted, supported, or otherwise subject to regulation by AmeriCorps will be subject to the Common Rule’s ethical principles and procedures. DATES: This rule is effective on November 29, 2024. FOR FURTHER INFORMATION CONTACT: Mary Hyde, Ph.D., Director, AmeriCorps Office of Research and Evaluation, at (202) 606–6834 or mhyde@ americorps.gov. SUMMARY: SUPPLEMENTARY INFORMATION: I. Background II. This Final Rule III. Comments on and Finalization of the Proposed Rule IV. Regulatory Analyses A. Executive Orders 12866 and 13563 B. Regulatory Flexibility Act C. Unfunded Mandates Reform Act of 1995 D. Paperwork Reduction Act E. Federalism (E.O. 13132) F. Takings (E.O. 12630) G. Civil Justice Reform (E.O. 12988) H. Consultation With Indian Tribes (E.O. 13175) I. Background On June 18, 1991, the U.S. Department of Health and Human Services (HHS) issued a rule setting forth the Common Rule requirements for the protection of human subjects. (56 FR 28003). The HHS regulations are codified at 45 CFR part 46. At that time, 15 other agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46. The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an IRB, obtaining and documenting informed consent of human subjects, and submitting written assurance of institutional compliance with the Common Rule. On January 19, 2017 (82 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 85867 FR 7149), HHS issued a final rule revising the Common Rule, which, among other things, established new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process. At the time the Common Rule was first adopted in 1991, AmeriCorps had just been established as the Corporation for National and Community Service under the National and Community Service Act of 1990. AmeriCorps was not a participating agency in either that 1991 Common Rule rulemaking or in the subsequent amendments to the Common Rule; however, AmeriCorps believes it is important to adopt this standard framework for AmeriCorps research professionals, prospective and participating human subjects, and consistency among Federal agencies, as described above. This final rule provides the incentives of a mandatory procedural framework and provides human research subjects the assurance of protection offered by the Common Rule. II. Final Rule AmeriCorps is codifying the text of the revised Common Rule in its regulations at 45 CFR part 2584 (the proposed rule projected its placement at 45 CFR part 2558, but AmeriCorps has since determined that part 2584 is more appropriate given a planned improvement of chapter 25’s organization). This rule is substantively identical to the HHS regulations in 45 CFR part 46, subpart A, ensuring consistency across Federal agencies. With this codification, AmeriCorps would be subject to the same ethical principles and procedures that other agencies who have adopted the Common Rule are subject to when conducting or supporting research involving human subjects. The rule applies broadly; most relevant to AmeriCorps, it covers instances when an investigator conducting research obtains information through interaction with the individual and uses, studies, or analyzes the information. The rule also sets out certain research that is exempt from the rule. For any non-exempt research, under this rule AmeriCorps would: • Conduct or support non-exempt research only if the institution engaged in the research has provided an assurance that it will comply with the Common Rule, and • Conduct or support non-exempt research only if (when required by the rule) the institution has certified to AmeriCorps that the research has been reviewed and approved by an IRB. E:\FR\FM\29OCR1.SGM 29OCR1

Agencies

[Federal Register Volume 89, Number 209 (Tuesday, October 29, 2024)]
[Rules and Regulations]
[Pages 85859-85867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24831]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0250; EPA-HQ-OPP-2020-0533; FRL-12339-01-OCSPP]


Glufosinate-P; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
glufosinate-P in or on multiple commodities, which are identified and 
discussed later in this document. BASF Corporation and MITSUI Chemicals 
Crop & Life

[[Page 85860]]

Solutions, INC requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 29, 2024. Objections and 
requests for hearings must be received on or before December 30, 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) number EPA-HQ-OPP-2020-0250 and EPA-HQ-OPP-2020-
0533 is available at https://www.regulations.gov 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. Please review the visitor instructions and additional 
information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: 202-566-2427; 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 Federal Register 
Office'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-2020-0250 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 
December 30, 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-2020-0250, 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/where-send-comments-epa-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 March 24, 2023 (88 FR 17778) (FRL-10579-
02-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 
2F9021) by BASF Corporation Agricultural Solutions, 26 Davis Drive, 
P.O. Box 13528, Research Triangle Park, NC 27709. The petition 
requested that 40 CFR 180.473 be amended by modifying the tolerances 
for residues of glufosinate to include residues of L-glufosinate 
ammonium, glufosinate-P-ammonium [(2S)-2-amino- 4-
(hydroxymethylphosphinyl) butanoic acid -monoammonium salt] as measured 
by the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)butanoic 
acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) 
butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, 
expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid 
equivalents in or on canola, meal at 1.1 parts per million (ppm); 
cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat 
byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field, 
grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage 
at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30 
ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 30 ppm; 
cotton, seed, subgroup 20C at 15.00 ppm; egg at 0.15 ppm; goat, fat at 
0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; 
grain aspirated fractions at 25.00 ppm; hog, fat at 0.40 ppm; hog, meat 
at 0.15 ppm; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; 
horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; milk at 
0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at .15 ppm; poultry, 
meat byproducts at 0.60 ppm; rapeseed, subgroup 20A at 0.4 ppm; sheep, 
fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 
ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm and tolerances for 
indirect or inadvertent residues on barley, hay at 0.4 ppm; barley, 
straw at 0.4 ppm; buckwheat, fodder at 0.4 ppm; buckwheat, forage at 
0.4 ppm; oat, forage at 0.4 ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 
ppm; rye, forage at 0.4 ppm; rye, straw at 0.4 ppm; teosinte at 0.4 
ppm; triticale at 0.4 ppm; wheat, forage at 0.4 ppm; wheat, hay at 0.4 
ppm; and wheat, straw at 0.4 ppm.
    Also, in the Federal Register of December 21, 2020 (85 FR 82998) 
(FRL-10016-93), 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 0F8842) by Meiji Seika Pharma Co., Ltd, c/o Landis 
International, Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 
31603-5126. The petition requested to establish tolerance for residues 
of L-

[[Page 85861]]

glufosinate free acid, (2S)-2-amino-4-
[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and 
degradates, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid 
(NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed 
as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or 
on apple at 0.05 ppm; beet, sugar, molasses at 5.0 ppm; beet, sugar, 
roots at 0.9 ppm; beet, sugar, tops (leaves) at 1.5 ppm; bushberry 
subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola, seed at 0.40 
ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat 
byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field, 
grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage 
at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30 
ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 15 ppm; 
cotton, undelinted seed at 4.0 ppm; egg at 0.15 ppm; fruit, citrus, 
crop group 10-10 at .15 ppm; fruit, pome, crop group 11-10 at .25 ppm; 
fruit, stone, crop group 12-12 at 0.30 ppm; goat, fat at 0.40 ppm; 
goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grape at 0.05 
ppm; hog, fat at 0.40 ppm; hog, meat at 0.15 ppm; hog, meat byproducts 
at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse, 
meat byproducts at 6.0 ppm; milk at 0.15 ppm; nut, tree, crop group 14-
12 at 0.50 ppm; olive at 0.50 ppm; potato at 0.80 ppm; potato, chips at 
1.6 ppm; potato, granules/flakes at 2.0 ppm; poultry, fat at 0.15 ppm; 
poultry, meat at .15 ppm; poultry, meat byproducts at 0.60 ppm; sheep, 
fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 
ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm.
    These documents referenced summaries of the petitions prepared by 
BASF Corporation Agricultural Solutions and Meiji Seika Pharma Co., 
Ltd, (now known as MITSUI Chemicals Crop & Life Solutions), the 
petitioners, which are available in the docket, https://www.regulations.gov. One comment was received on the notice of filing 
for petition 0F8842. No comments were received on the notice of filing 
for petition 2F9021. EPA's response to this comment is discussed in 
Unit IV.C.
    The tolerances EPA is establishing vary from what the petitioners 
have requested in a few ways, which are explained in greater detail in 
Unit IV.C. In sum, BASF Corporation Agricultural Solutions and MITSUI 
Chemicals Crop & Life Solutions have deleted crops from their initial 
request, the Agency will be establishing tolerances only on those crops 
as mentioned in Unit V. Moreover, in order to align with the 
International Organization for Standardization (ISO) recognized 
nomenclature, EPA is establishing tolerances for glufosinate-P, which 
is the current standard name for L-glufosinate free acid. Because 
applications of glufosinate-P-ammonium (also known as L-glufosinate-
ammonium) result in residues of glufosinate-P on crops, EPA is setting 
the tolerance for glufosinate-P residues, which will cover any residues 
that remain on food from applications of pesticides with either form of 
the pesticide.

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 in FFDCA section 408(b)(2)(D), 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 L-glufosinate, including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with L-glufosinate 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Glufosinate is racemic mixture comprised of D- and L-stereoisomers, 
and the D/L form of glufosinate (also referred to as the racemic 
glufosinate) is currently registered as a pesticide (herbicide) in the 
United States. The L-isomer is the herbicidally active part of D/L-
glufosinate, and the D-isomer is herbicidally inactive. The L-isomer is 
referred to as L-glufosinate in this document and the supporting risk 
assessment documents and refers to the active moiety from both L-
glufosinate ammonium and L-glufosinate acid, which are two forms of the 
L-isomer used in pesticide formulations. As mentioned above the Agency 
has received applications for both L-glufosinate ammonium and L-
glufosinate acid. The International Organization for Standardization 
(ISO) has designated L-glufosinate ammonium as glufosinate-P-ammonium 
and L-glufosinate free acid as glufosinate-P, so EPA is establishing 
tolerances using that nomenclature; however, for consistency with EPA's 
supporting risk assessments, this document is using the terms L-
glufosinate ammonium and L-glufosinate acid.
    The available in vivo and in vitro data for comparison across L-
glufosinate acid and L-glufosinate ammonium, and the in vitro and in 
vivo DNT data for D/L-glufosinate ammonium indicate no significant 
differences in oral toxicities for the most sensitive endpoint (i.e., 
neurotoxicity). As such, these databases are being considered together 
when assessing toxicity and selecting endpoints for pertinent 
exposures. Hence both L-glufosinate ammonium and L-glufosinate acid are 
considered toxicologically equivalent for oral and dermal exposure 
pathways. Also, L-glufosinate ammonium, when dissolved in water, 
dissociates to L-glufosinate acid. Therefore, the Agency considers 
glufosinate-P ammonium and glufosinate-P as functionally similar.
    The targets identified following oral exposure to L-glufosinate 
were the brain and peripheral nervous system (rats, mice, and dogs), 
kidney (rats and mice), thyroid (rats only), and the adrenals (mice 
only). Neurotoxicity was observed after acute, subchronic, and chronic 
exposures. Adverse findings included clinical signs indicative of 
neurotoxicity (i.e., tremors, clonic convulsions, inability to maintain 
body posture, etc.), increased motor activity, alterations in brain 
weight, and neuropathology of the brain, eye, and spinal cord. Kidney 
toxicity manifested as increased kidney weights, alterations in 
urinalysis parameters, and hypertrophy of the proximal tubular cells of 
the pars recta. Slight thyroid c-cell hyperplasia was

[[Page 85862]]

observed in male rats, while in mice, microscopic findings of the 
adrenal and increased adrenal weight were noted.
    Increased quantitative susceptibility was observed in the L-
glufosinate rat prenatal developmental toxicity study, the L-
glufosinate range-finding developmental neurotoxicity (DNT) study, and 
the D/L-glufosinate DNT study.
    L-glufosinate is classified as ``Not Likely to be Carcinogenic to 
Humans'' based on a lack of treatment-related tumor response in both 
the L-glufosinate rat and mouse carcinogenicity studies. There is a low 
concern for mutagenicity for L-glufosinate.
    Specific information on the studies received and the nature of the 
adverse effects caused by L-glufosinate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``L-Glufosinate. Human Health Risk 
Assessment for New Active Ingredient Isomer'' at 21-34 in docket ID 
number EPA-HQ-OPP-2020-0250.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level, generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD), and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    For more detailed information on the toxicological endpoints for L-
glufosinate used for human risk assessment can be found in the L-
Glufosinate. Human Health Risk Assessment for New Active Ingredient 
Isomer in docket ID number EPA-HQ-OPP-2020-0250.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to L-glufosinate, EPA considered exposure to L-glufosinate 
under all tolerances established for racemic glufosinate as well as the 
petitioned-for tolerances in this rulemaking. EPA assessed dietary 
exposures from L-glufosinate in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for L-glufosinate. In conducting the 
acute dietary exposure assessment, EPA used the Dietary Exposure 
Evaluation Model software with the Food and Commodity Intake Database 
(DEEM-FCID) Version 3.16. This software uses the 2003-2008 food 
consumption data from the U.S. Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA conducted an 
unrefined acute dietary exposure assessment for L-glufosinate assuming 
tolerance-level residues for L-glufosinate (scaled by 0.5X for 
application rate adjustment) and 100% CT assumptions for all crops and 
livestock commodities. The proposed uses of L-glufosinate exactly match 
the established uses of D/L-glufosinate in terms of crops, number of 
applications, retreatment intervals, and preharvest intervals; the only 
difference being that the use rate for L-glufosinate is one-half that 
of D/L-glufosinate, consistent with herbicidal activity residing 
primarily in the L-isomer. Since the rate of L-glufosinate is one-half 
that of D/L-glufosinate, the expected residues for L-glufosinate are 
one-half those of D/L-glufosinate.
    ii. Chronic exposure. The chronic dietary exposure assessment also 
uses the DEEM-FCID Version 3.16 software with the 2003-2008 NHANES/
WWEIA data. As to residue levels in food, EPA conducted a partially 
refined chronic dietary exposure assessment using anticipated residues 
based on average field trial residue levels for plant commodities, 
average calculated residues for livestock commodities, all foods scaled 
by 0.5X for application rate adjustment, and 100% CT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that L-glufosinate does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
    Section 408(b)(2)(E) of the 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.
    The Agency is not using percent crop treated estimates for 
assessing acute and chronic exposures.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for L-glufosinate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of L-glufosinate. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    Determination of the residues of concern for human health in 
drinking water included consideration of racemic glufosinate and the 
degradate, 3-methylphosphinico-propionic acid (MPP). Although the 
chronic EDWCs for MPP are approximately 2x higher than the EDWCs for 
the racemic glufosinate, EPA has determined that using the EDWCs for 
the racemic glufosinate will be protective of effects that might occur 
from exposure to the degradate. This conclusion is based on a 
comparison of the toxicity databases for glufosinate and MPP, which 
indicate that glufosinate is more than twice as potent as MPP. Because 
the toxic effects from glufosinate and MPP are significantly

[[Page 85863]]

different, an aggregate assessment of glufosinate and MPP is not 
appropriate.
    Based on the Pesticides in Water Calculator (PWC; version 1.52), 
the estimated drinking water concentrations (EDWCs) of D/L-glufosinate 
are estimated to be 201 parts per billion (ppb) for acute dietary 
exposures and 24.4 ppb for chronic dietary exposures. Surface water 
simulations resulted in the highest EDWCs.
    These values reflect application of D/L-glufosinate and were scaled 
by half to reflect the reduced application rate and expected 
concentrations of L-glufosinate in water. The adjusted EDWCs were 
incorporated in the Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID) into the food categories 
``water, direct, all sources'' and ``water, indirect, all sources.''
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    L-glufosinate is not being proposed for residential uses. However, 
there are residential exposures to L-glufosinate as a result of the 
existing residential uses of the racemic glufosinate. These exposures 
have been assessed for L-glufosinate and are included in a short-term 
aggregate assessment for L-glufosinate. For this assessment, the 
application rate was scaled by 0.5x to reflect residues of L-
glufosinate only, and the application rate was converted to acid 
equivalents because the PODs are likewise expressed as acid 
equivalents. For currently registered uses of racemic glufosinate, 
residential handler and post-application dermal and inhalation risks 
are not of concern for L-glufosinate. The scenarios that are 
recommended to be considered for aggregate risk assessment are high-
contact lawn activities for adults and children 1 to <2 years old and 
golfer activities for children 6 to <11 years old and children 11 to 
<16 years old.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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 L-glufosinate and any 
other substances and L-glufosinate does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
action, therefore, EPA has not assumed that L-glufosinate has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

D. Safety Factor for Infants and Children

    1. In general. 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. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Increased quantitative 
susceptibility was observed in the L-glufosinate rat prenatal 
developmental toxicity study, the L-glufosinate range-finding DNT 
study, and the D/L-glufosinate DNT study. Quantitative susceptibility 
was observed in the developmental rat study in which decreased fetal 
body weight in both sexes was observed at the highest dose tested; 
however, no maternal toxicity was identified. Quantitative 
susceptibility was observed in a L-glufosinate dose-range finding DNT 
study in which maternal effects were not observed up to the highest 
dose tested while offspring toxicity manifested as decreased pup body 
weight and increased total and ambulatory motor activity counts in 
males. The D/L-glufosinate DNT study observed alterations in brain 
morphometrics (a decrease in the mean length of the ventral limb of the 
dentate hilus), an increase in motor activity, and a decrease in body 
weight for the offspring at a dose level that did not elicit maternal 
toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x for all exposure scenarios for glufosinate-
P. That decision is based on the following findings:
    i. The toxicity database for L-glufosinate is complete, as a result 
of bridging data between the racemic glufosinate, L-glufosinate, and L-
glufosinate ammonium databases.
    ii. Evidence of neurotoxicity was observed in the L-glufosinate 
database in both adults and early life stages. However, the concern is 
low because all selected endpoints are based on, and protective of, the 
most sensitive neurotoxic effects in the database, as indicated by the 
following: (1) the 17% increase in motor activity observed in females 
in the 28-day range-finding subchronic rat study occurred at a dose 
level that is approximately 13x-80x higher than the selected PODs; (2) 
the decreased brain weight and vacuolation of the cerebrum in the 
chronic mouse study occurred at dose levels approximately 11x-67x 
higher than the selected PODs; (3) the neuropathology observed in the 
subchronic neurotoxicity study occurred at a dose level approximately 
29x-174x higher than the selected PODs; (4) the increased total and 
ambulatory motor activity counts in the range-finding DNT study 
occurred at a dose level approximately 27x higher than the selected 
PODs; and (5) the brain morphometric changes and increased motor 
activity observed in the offspring in the D/L-glufosinate DNT occurred 
at a dose level approximately 42x higher than the selected PODs for all 
relevant exposure scenarios.
    iii. As discussed in Unit III.D.2. above, increased quantitative 
susceptibility was observed in the L-glufosinate rat prenatal 
developmental toxicity study, the L-glufosinate range-finding DNT 
study, and the D/L-glufosinate ammonium DNT study. However, the concern 
for the increased susceptibility is low, as clear NOAELs have been 
identified for those studies and all selected PODs are protective of 
the effects seen in those studies.
    iv. There are no residual uncertainties identified in the exposure 
databases.
    The dietary food exposure assessments were performed based on 100% 
CT and conservative residue estimates. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to L-glufosinate in drinking water. These 
assessments will not underestimate the exposure and risks posed by L-
glufosinate.

[[Page 85864]]

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
aggregate risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the appropriate PODs to ensure 
that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure to L-glufosinate 
from food and water will occupy 26% of the aPAD with the females 13 to 
49 years old population subgroup. For all the other population 
subgroups, the most highly exposed population subgroup is all infants 
(<1 year old) at 4.7% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
L-glufosinate from food and water will utilize 12% of the cPAD for 
children (1-2 years old), the population group receiving the highest 
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 1,100 for adults, 2,600 for 
children (11 to <16 years old), 1,700 for children (6 to <11 years old) 
and 230 for children (1 to <2 years old), which are above the LOC (100) 
and are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, L-
glufosinate is not registered for any use patterns that would result in 
intermediate-term residential exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD, no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for L-glufosinate.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, L-glufosinate is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, 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 L-glufosinate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Two analytical methods have been validated by the Analytical 
Chemistry Branch (ACB) for enforcement of the currently established 
tolerances of D/L-glufosinate: (1) method HRAV-5A was validated by ACB 
for the determination of glufosinate and MPP in/on apple, grape, 
almond, soybean seed, corn grain, and corn forage and (2) method BK/01/
99 was validated by ACB for determination of glufosinate, N-acetyl-
glufosinate (NAG), and MPP in/on canola seed and sugar beet root.
    Based on the results from the petition method validations (PMVs) 
and the ability of the methods to detect both the D- and L- isomers of 
glufosinate, EPA concludes that adequate enforcement methods are 
available for L-glufosinate.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 has not established a MRL for L-glufosinate.

C. Response to Comments

    The Agency did receive one comment raising concerns that there are 
studies indicating that L-glufosinate is harmful and toxic to health of 
humans even in small doses. The commentor was also concerned over the 
use of L-glufosinate on corn, cotton and soybean which are staples of 
American diet. The commentor emphasized the role of EPA in reasonably 
assessing its analysis of pesticide tolerances, safety, and awareness 
of disproportionate effects of agricultural production, and its firm 
commitment to environmental justice.
    Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the FFDCA authorizes EPA to 
establish tolerances when it determines that the tolerance is safe. 
Upon consideration of the validity, completeness, and reliability of 
the available data as well as other factors the FFDCA requires EPA to 
consider, EPA has determined that these glufosinate-P tolerances are 
safe. The commenter provided no information supporting a conclusion 
that glufosinate-P is not safe, nor did the commenter provide any basis 
for concluding that the tolerances would have a disproportionate effect 
on any population.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing a tolerance for residues of glufosinate-
P, including its metabolites and degradates, that result from 
applications of glufosinate-P or glufosinate-P-ammonium, with 
compliance to be determined by measuring the sum of glufosinate (2-
amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents. BASF Corporation 
had petitioned for expression of L-glufosinate-ammonium, glufosinate-P-
ammonium [(2S)-2-amino-4-(hydroxymethylphosphinyl) butanoic acid -
monoammonium salt] as measured by the sum of glufosinate (2-amino-4-
(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic

[[Page 85865]]

acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid, 
and MITSUI Chemicals Crop & Life Solutions, Inc. had petitioned for 
expression of L-glufosinate free acid, (2S)-2-amino-4-
[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and 
degradates, 2-(acetylamino)-4-(hydroxymethylphosphinyl) butanoic acid 
(NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed 
as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents. As 
discussed in Unit III.A, glufosinate-P-ammonium (also referred to as L-
glufosinate ammonium) is the ammonium salt of glufosinate-P (also 
referred to as L-glufosinate acid). Since the glufosinate-P-ammonium 
breaks down into residues of glufosinate-P, EPA is establishing the 
tolerances for residues of glufosinate-P including its metabolites and 
degradates, that may result from applications of either form of 
glufosinate-P.
    In addition, the petitioners have withdrawn their requests to 
establish tolerances on the following crops, so EPA is not establishing 
tolerances on those crops at this time: apple; beet, sugar, molasses; 
beet, sugar, roots; beet, sugar, tops (leaves); bushberry subgroup 13-
07B; fruit, citrus, crop group 10-10; fruit, pome, crop group 11-10; 
fruit, stone, crop group 12-12; grape; nut, tree, crop group 14-12; 
olive; potato; potato, chips; and potato, granules/flakes.
    Finally, EPA has applied its policy on OECD Rounding Classes to the 
petitioned-for tolerances to establish tolerances without trailing 
zeros after the decimal place.

V. Conclusion

    Therefore, tolerances are established for residues of glufosinate-P 
including its metabolites and degradates in or on canola, meal at 1.1 
parts per million (ppm); cattle, fat at 0.4 ppm; cattle, meat at 0.15 
ppm; cattle, meat byproducts at 6 ppm; corn, field, forage at 4 ppm; 
corn, field, grain at 0.2 ppm; corn, field, stover at 6 ppm; corn, 
sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks 
removed at 0.3 ppm; corn, sweet, stover at 6 ppm; cotton, gin 
byproducts at 30 ppm; cotton, seed, subgroup 20C at 15 ppm; egg at 0.15 
ppm; goat, fat at 0.4 ppm; goat, meat at 0.15 ppm; goat, meat 
byproducts at 6 ppm; grain aspirated fractions at 25 ppm; hog, fat at 
0.4 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6 ppm; horse, 
fat at 0.4 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6 
ppm; milk at 0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at 0.15 
ppm; poultry, meat byproducts at 0.6 ppm; rapeseed, subgroup 20A at 0.4 
ppm; sheep, fat at 0.4 ppm; sheep, meat at 0.15 ppm; sheep, meat 
byproducts at 6 ppm; soybean at 2 ppm; soybean, hulls at 10 ppm.
    In addition, tolerances are established for indirect or inadvertent 
residues of glufosinate-P including its metabolites and degradates in 
or on barley, hay at 0.4 ppm; barley, straw at 0.4 ppm; buckwheat, 
fodder at 0.4 ppm; buckwheat, forage at 0.4 ppm; oat, forage at 0.4 
ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 ppm; rye, forage at 0.4 
ppm; rye, straw at 0.4 ppm; teosinte at 0.4 ppm; triticale at 0.4 ppm; 
wheat, forage at 0.4 ppm; wheat, hay at 0.4ppm; and wheat, straw at 0.4 
ppm.

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: October 21, 2024.
Elizabeth Vizard,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended 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. Revise and republish Sec.  180.473 to read as follows:

[[Page 85866]]

Sec.  180.473   Glufosinate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
glufosinate, including its metabolites and degradates, in or on the 
commodities in table 1 to paragraph (a)(1). Compliance with the 
tolerance levels specified in table 1 to paragraph (a)(1) is to be 
determined by measuring the sum of glufosinate (2-amino-4-
(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................            0.50
Banana \1\..............................................            0.30
Beet, sugar, molasses...................................             5.0
Beet, sugar, roots......................................             0.9
Beet, sugar, tops (leaves)..............................             1.5
Bushberry subgroup 13-07B...............................            0.15
Canola, meal............................................             1.1
Cattle, fat.............................................            0.40
Cattle, meat............................................            0.15
Cattle, meat byproducts.................................             6.0
Corn, field forage......................................             4.0
Corn, field, grain......................................            0.20
Corn, field, stover.....................................             6.0
Corn, sweet, forage.....................................             1.5
Corn, sweet, kernels plus cob with husks removed........            0.30
Corn, sweet, stover.....................................             6.0
Cotton, gin byproducts..................................              30
Cottonseed subgroup 20C.................................              15
Egg.....................................................            0.15
Fig, dried..............................................            0.15
Fruit, citrus, group 10-10..............................            0.15
Fruit, pome, group 11-10................................            0.25
Fruit, small, vine climbing, except fuzzy kiwifruit,                0.05
 subgroup 13-07F........................................
Fruit, stone, group 12-12...............................            0.30
Goat, fat...............................................            0.40
Goat, meat..............................................            0.15
Goat, meat byproducts...................................             6.0
Grain aspirated fractions...............................              25
Hog, fat................................................            0.40
Hog, meat...............................................            0.15
Hog, meat byproducts....................................             6.0
Hop, dried cones........................................             0.9
Horse, fat..............................................            0.40
Horse, meat.............................................            0.15
Horse, meat byproducts..................................             6.0
Melon subgroup 9A.......................................            0.08
Milk....................................................            0.15
Nut, tree, group 14-12..................................            0.50
Pepper/eggplant subgroup 8-10B..........................            0.15
Potato, chips...........................................             1.6
Potato granules/flakes..................................             2.0
Poultry, fat............................................            0.15
Poultry, meat...........................................            0.15
Poultry, meat byproducts................................            0.60
Rapeseed subgroup 20A...................................             0.4
Rice, grain.............................................             1.0
Rice, hull..............................................             2.0
Sheep, fat..............................................            0.40
Sheep, meat.............................................            0.15
Sheep, meat byproducts..................................             6.0
Soybean.................................................             2.0
Soybean, hulls..........................................              10
Squash/cucumber subgroup 9B.............................            0.15
Tomato, paste...........................................            0.15
Tomato subgroup 8-10A...................................             0.1
Tropical and subtropical, medium to large fruit, edible              0.1
 peel, subgroup 23B.....................................
Tropical and subtropical, medium to large fruit, smooth,             0.2
 inedible peel, subgroup 24B............................
Tropical and subtropical, small fruit, edible peel,                  0.5
 subgroup 23A...........................................
Tropical and subtropical, small fruit, inedible peel,                0.1
 subgroup 24A...........................................
Vegetable, tuberous and corm, subgroup 1C...............             0.8
------------------------------------------------------------------------

    (2) Tolerances are established for residues of glufosinate-P, 
including its metabolites and degradates, in or on the commodities in 
table 2 to paragraph (a)(2), as a result of applications of 
glufosinate-P or glufosinate-P-ammonium to those commodities. 
Compliance with the tolerance levels specified in table 2 to paragraph 
(a)(2) is to be determined by measuring the sum of glufosinate (2-
amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolites, 
2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Canola, meal............................................             1.1
Cattle, fat.............................................             0.4
Cattle, meat............................................            0.15
Cattle, meat byproducts.................................               6
Corn, field, forage.....................................               4
Corn, field, grain......................................             0.2
Corn, field, stover.....................................               6
Corn, sweet, forage.....................................             1.5
Corn, sweet, kernels plus cob with husks removed........             0.3
Corn, sweet, stover.....................................               6
Cotton, gin byproducts..................................              30
Cottonseed, subgroup 20C................................              15
Egg.....................................................            0.15
Goat, fat...............................................             0.4
Goat, meat..............................................            0.15
Goat, meat byproducts...................................               6
Grain, aspirated fractions..............................              25
Hog, fat................................................             0.4
Hog, meat...............................................            0.15
Hog, meat byproducts....................................               6
Horse, fat..............................................             0.4
Horse, meat.............................................            0.15
Horse, meat byproducts..................................               6
Milk....................................................            0.15
Poultry, fat............................................            0.15
Poultry, meat...........................................            0.15
Poultry, meat byproducts................................             0.6
Rapeseed, subgroup 20A..................................             0.4
Sheep, fat..............................................             0.4
Sheep, meat.............................................            0.15
Sheep, meat byproducts..................................               6
Soybean.................................................               2
Soybean, hulls..........................................              10
------------------------------------------------------------------------

    (b) [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of glufosinate, 
including its metabolites and degradates, in or on the commodities in 
table 3 to paragraph (c). Compliance with the tolerance levels 
specified in table 3 to paragraph (c) is to be determined by measuring 
the sum of glufosinate, (2-amino-4-(hydroxymethylphosphinyl)butanoic 
acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) 
butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, 
expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid 
equivalents.

                        Table 3 to Paragraph (c)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grass, forage...........................................            0.15
Grass, hay..............................................             0.2
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. (1) Tolerances are 
established for indirect or inadvertent residues of glufosinate, 
including its metabolites and degradates, in or on the commodities in 
table 4 to paragraph (d)(1), as a result of the application of 
glufosinate to crops listed in paragraph (a) of this section. 
Compliance with the tolerance levels specified in table 4 to paragraph 
(d)(1) is to be determined by measuring the sum of glufosinate (2-
amino-4-(hydroxymethylphosphinyl) butanoic acid) and its metabolite, 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.

[[Page 85867]]



                       Table 4 to Paragraph (d)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Barley, hay.............................................            0.40
Barley, straw...........................................            0.40
Buckwheat, fodder.......................................            0.40
Buckwheat, forage.......................................            0.40
Oat, forage.............................................            0.40
Oat, hay................................................            0.40
Oat, straw..............................................            0.40
Rye, forage.............................................            0.40
Rye, straw..............................................            0.40
Teosinte................................................            0.40
Triticale...............................................            0.40
Wheat, forage...........................................            0.40
Wheat, hay..............................................            0.40
Wheat, straw............................................            0.40
------------------------------------------------------------------------

    (2) Tolerances are established for indirect or inadvertent residues 
of glufosinate-P, including its metabolites and degradates, in or on 
the commodities in table 5 to paragraph (d)(2), as a result of the 
application of glufosinate-P or glufosinate-P-ammonium to crops listed 
in paragraph (a)(2) of this section. Compliance with the tolerance 
levels specified in table 5 to paragraph (d)(2) is to be determined by 
measuring the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl) 
butanoic acid) and its metabolite, 3-(hydroxymethylphosphinyl) 
propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents.''

                       Table 5 to Paragraph (d)(2)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Barley, hay.............................................             0.4
Barley, straw...........................................             0.4
Buckwheat, fodder.......................................             0.4
Buckwheat, forage.......................................             0.4
Oat, forage.............................................             0.4
Oat, hay................................................             0.4
Oat, straw..............................................             0.4
Rye, forage.............................................             0.4
Rye, straw..............................................             0.4
Teosinte................................................             0.4
Triticale...............................................             0.4
Wheat, forage...........................................             0.4
Wheat, hay..............................................             0.4
Wheat, straw............................................             0.4
------------------------------------------------------------------------

[FR Doc. 2024-24831 Filed 10-28-24; 8:45 am]
BILLING CODE 6560-50-P


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