Sodium Salt of Acifluorfen; Pesticide Tolerances, 48383-48388 [2023-15900]

Download as PDF 48383 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Rules and Regulations commercial operations or programs and policies.’’ The WVDEP did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples. B. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). C. Petitions for Judicial Review 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 September 25, 2023. 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, approving the West Virginia SIP revision updating its incorporation by reference of EPA’s NAAQS and associated ambient air monitoring reference methods and equivalent methods, 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, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Adam Ortiz, Regional Administrator, Region III. For the reasons stated in the preamble, the EPA amends 40 CFR part 52 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. Subpart XX—West Virginia 2. In § 52.2520, the table in paragraph (c) entitled ‘‘EPA-Approved Regulations in the West Virginia SIP’’ is amended by revising the entries for ‘‘Section 45–8– 1’’, ‘‘Section 45–8–2’’, ‘‘Section 45–8– 3’’, and ‘‘Section 45–8–4’’ under the heading ‘‘[45 CSR] Series 8 Ambient Air Quality Standards’’ to read as follows: ■ § 52.2520 * Identification of plan. * * (c) * * * * * EPA-APPROVED REGULATIONS IN THE WEST VIRGINIA SIP State citation [chapter 16–20 or 45 CSR] State effective date Title/subject * * Additional explanation/citation at 40 CFR 52.2565 EPA approval date * * * * * [45 CSR] Series 8 Ambient Air Quality Standards Section Section Section Section * 45–8–1 45–8–2 45–8–3 45–8–4 * .......... .......... .......... .......... General .................................... Definitions ................................ Adoption of Standards ............. Inconsistency Between Rules * * * * * * This regulation establishes tolerances for residues of sodium salt of acifluorfen in or on berry, low growing, subgroup 13–07G; soybean, vegetable, edible podded; and soybean, vegetable, succulent shelled. The Interregional Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 ddrumheller on DSK120RN23PROD with RULES1 * SUMMARY: BILLING CODE 6560–50–P [EPA–HQ–OPP–2022–0361; FRL–11130–01– OCSPP] Sodium Salt of Acifluorfen; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 16:11 Jul 26, 2023 7/27/23 [INSERT FEDERAL REGISTER CITATION] 7/27/23 [INSERT FEDERAL REGISTER CITATION] 7/27/23, [INSERT FEDERAL REGISTER CITATION] 7/27/23, [INSERT FEDERAL REGISTER CITATION] * [FR Doc. 2023–15810 Filed 7–26–23; 8:45 am] VerDate Sep<11>2014 4/1/22 4/1/22 4/1/22 4/1/22 Jkt 259001 This regulation is effective July 27, 2023. Objections and requests for hearings must be received on or before September 25, 2023, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 * .............. .............. ............. ............. Docket Docket Docket Docket #2022–0656. #2022–0656. #2022–0656. #2022–0656. * The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2022–0361, is available online at https:// www.regulations.gov or in-person at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP Docket is (202) 566–1744. For the latest status information on EPA/DC services, ADDRESSES: E:\FR\FM\27JYR1.SGM 27JYR1 48384 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Rules and Regulations docket access, visit https:// www.epa.gov/. FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–1030; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/ current/title-40. ddrumheller on DSK120RN23PROD with RULES1 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–2022–0361 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 September 25, 2023. 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 VerDate Sep<11>2014 16:11 Jul 26, 2023 Jkt 259001 (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– 2022–0361, 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/. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/. II. Summary of Petitioned-For Tolerance In the Federal Register of May 20, 2022 (87 FR 30855) (FRL–9410–13– OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petition (2E8987) by the Interregional Research Project No. 4 (IR– 4), Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.383 be amended to establish tolerances for residues of the herbicide sodium salt of acifluorfen, sodium 5-[2chloro-4-(trifluoromethyl)phenoxy]-2nitrobenzoate, and its metabolites (the corresponding acid, methyl ester, and amino analogues) in or on the following raw agricultural commodities: berry, low growing, subgroup 13–07G at 0.1 ppm; soybean, vegetable, edible podded at 0.09 ppm; and soybean, vegetable, succulent shelled at 0.09 ppm. The petition also requested that EPA remove the established tolerance for residues of sodium salt of acifluorfen in or on strawberry at 0.05 ppm. That document referenced a summary of the petition prepared by IR–4, the petitioner, which is available in the docket, https:// www.regulations.gov. There were no comments received on the notice of filing. PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for sodium salt of acifluorfen including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with sodium salt of acifluorfen 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. The toxicology database for sodium salt of acifluorfen is complete and considered adequate for risk assessment. EPA has waived the subchronic inhalation study, subchronic neurotoxicity studies, and the developmental neurotoxicity study. Hematological effects (such as decreases in erythrocyte count, hematocrit, and/or mean cell volume) were noted in dog, rat, and mice. The liver (dog, rat, and mouse) and kidney (rat and mouse) are also target organs of oral exposure, and effects in these organs were noted following both subchronic and chronic exposures. Indications of liver toxicity E:\FR\FM\27JYR1.SGM 27JYR1 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES1 included findings such as increased liver weight, hypertrophy, clinical chemistry findings, urinary urobilinogen, focal necrosis; proliferation of oval or bile duct cells, and fatty infiltration. Indications of kidney toxicity include increases in the following parameters: kidney weight; serum electrolytes, blood urea nitrogen (BUN), and creatinine; and urinary nitrate. There was quantitative fetal susceptibility demonstrated in the Sprague-Dawley rat developmental study, but no susceptibility in the Wistar rat or rabbit developmental studies, nor in the reproduction study. There are no genotoxicity, neurotoxicity or immunotoxicity concerns observed in the available toxicity studies. In the dermal toxicity test, skin irritation was observed at all doses, and systemic toxicity was noted at the limit dose. EPA has classified sodium salt of acifluorfen as ‘‘likely to be carcinogenic to humans at high enough doses to cause the biochemical and histopathological changes in livers of rodents, but unlikely to be carcinogenic at doses below those causing these changes’’. EPA determined that nonlinear extrapolation is appropriate for risk assessment purposes. The nonlinear reference dose (RfD) approach will be protective for chronic effects, including carcinogenicity. Sodium salt of acifluorfen has low acute toxicity by the oral and dermal exposure routes (Toxicity Category III). However, it is a severe eye irritant (Toxicity Category I) and moderate dermal irritant (Toxicity Category II). It is not considered a skin sensitizer. Specific information on the studies received and the nature of the adverse effects caused by sodium salt of acifluorfen as well as the no-observedadverse-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 titled ‘‘Sodium Acifluorfen. Human Health Risk Assessment of Proposed Tolerances and Uses on Edamame (Vegetable Soybean) and Crop Group Expansion and Use on Low-growing Berry Subgroup 13–07G’’ (hereinafter ‘‘Sodium Acifluorfen Human Health Risk Assessment’’) on pages 24–32 in docket ID number EPA– HQ–OPP–2022–0361. 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 VerDate Sep<11>2014 16:11 Jul 26, 2023 Jkt 259001 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/cumulativeassessment-risk-pesticides. A summary of the toxicological endpoints for sodium salt of acifluorfen used for human risk assessment can be found in the Sodium Acifluorfen Human Health Risk Assessment on pages 12–15. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sodium salt of acifluorfen, EPA considered exposure under the petitioned-for tolerances as well as all existing sodium salt of acifluorfen tolerances in 40 CFR 180.383. EPA assessed dietary exposures from sodium salt of acifluorfen 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 sodium salt of acifluorfen. In estimating the acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software using the Food Commodity Intake Database (DEEM–FCID) Version 4.02, which uses the 2005–2010 food consumption data from the United States Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The acute dietary exposure assessment assumes tolerance-level residues and 100% crop PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 48385 treated (PCT) for all commodities and incorporates default processing factors. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the 2005–2010 food consumption data from the USDA’s NHANES/WWEIA and DEEM–FCID; version 4.02. The chronic dietary exposure assessment assumes tolerancelevel residues and 100 PCT for all commodities and incorporates default processing factors. iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a fooduse pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that sodium salt of acifluorfen should be classified as ‘‘Likely to be Carcinogenic to Humans at high enough doses to cause the biochemical and histopathological changes in livers of rodents, but unlikely to be carcinogenic at doses below those causing these changes.’’ The non-linear RfD approach will be protective for chronic effects, including carcinogenicity. Cancer risk was quantified using the same estimates as discussed in Unit III.C.1.ii., chronic exposure. iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for sodium salt of acifluorfen. Tolerance level residues and/or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sodium salt of acifluorfen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sodium salt of acifluorfen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/ science-and-assessing-pesticide-risks/ pesticide-risk-assessment. Based on the groundwater modeling results from Pesticide Root Zone Model E:\FR\FM\27JYR1.SGM 27JYR1 ddrumheller on DSK120RN23PROD with RULES1 48386 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Rules and Regulations for Ground Water (PRZM–GW), the estimated drinking water concentrations (EDWCs) of sodium salt of acifluorfen for acute and chronic exposures are estimated to be 146 parts per billion (ppb) for ground water. These modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. 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). Sodium salt of acifluorfen is not registered for any specific use patterns that would result in residential exposure, and the new uses would not result in residential exposures; therefore, direct exposures in residential settings are not expected for adults and children. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/ operating-procedures-residentialpesticide. 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 sodium salt of acifluorfen and any other substances, and sodium salt of acifluorfen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that sodium salt of acifluorfen 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-scienceand-assessing-pesticide-risks/ cumulative-assessment-risk-pesticides. 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 VerDate Sep<11>2014 16:11 Jul 26, 2023 Jkt 259001 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 Food Quality Protection Act (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. There is evidence of increased susceptibility following in utero exposure to sodium salt of acifluorfen in the Sprague Dawley rat developmental toxicity study. However, there is low concern for developmental toxicity because the effects are well characterized with clear NOAEL/LOAEL values and the chosen points of departure for risk assessment for each scenario are protective of these effects. 3. Conclusion. EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10X to 1X. That decision is based on the following findings: i. The toxicity database for sodium salt of acifluorfen is complete. ii. The weight of evidence (WOE) suggests that sodium salt of acifluorfen is not neurotoxic. This conclusion is based on the following: (1) indications of treatment-related toxicity in the acute neurotoxicity study (ACN) are wellcharacterized, and the decreased motor activity observed could be an indication of systemic toxicity from the bolus dose; (2) the slight effect observed in fetuses in a developmental toxicity study with Sprague-Dawley rats (dilated brain ventricles) were not reproduced in another developmental toxicity study with Wistar rats nor in developmental toxicity studies with rabbits; and (3) there was no indication of treatmentrelated neurotoxicity observed in any studies for structurally-related chemicals (fomesafen, lactofen, and oxyfluorfen), except for decreased motor activity in an acute neurotoxicity study with fomesafen at the same dose where general systemic toxicity (body weight loss) was observed. No immunotoxicity was observed. In the dermal toxicity test, skin irritation was observed at all doses, and systemic toxicity was noted at the limit dose. iii. There is evidence that sodium salt of acifluorfen results in increased susceptibility following exposure in PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 utero rats in the Sprague Dawley rat prenatal developmental study. However, there is low concern because effects are well characterized with clear NOAEL/ LOAEL values and the chosen points of departure for risk assessment for each scenario are protective of these effects. iv. There are no residual uncertainties identified in the exposure database. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sodium salt of acifluorfen in drinking water. These assessments will not underestimate the exposure and risks posed by sodium salt of acifluorfen. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk takes into account exposure estimated from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to sodium salt of acifluorfen will occupy less than 1% of the aPAD for all infants less than 1 year old, the population group receiving the greatest exposure. There are no registered residential uses of sodium salt of acifluorfen so acute aggregate risk is equivalent to acute dietary risk, which is not of concern. A separate, lower POD was selected for females 13 to 49 years old for which the estimated risk was 3.9% of the aPAD. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sodium salt of acifluorfen from food and water will utilize 87% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. There are no registered residential uses of sodium salt of acifluorfen, so chronic aggregate risk is equivalent to chronic dietary risk, which is not of concern. 3. Short-term/Intermediate-term risk. Short- and intermediate-term aggregate exposure take into account short- and intermediate-term residential exposure plus chronic exposure to food and water E:\FR\FM\27JYR1.SGM 27JYR1 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Rules and Regulations (considered to be a background exposure level). A short-term and an intermediate-term adverse effect were identified; however, sodium salt of acifluorfen is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- or intermediate-term risk), no further assessment of short- or intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for sodium salt of acifluorfen 4. Aggregate cancer risk for U.S. population. As explained in Unit III.A., sodium salt of acifluorfen is classified as ‘‘likely to be carcinogenic to humans at doses high enough to cause the biochemical and histopathological changes in livers of rodents, but unlikely to be carcinogenic at doses below those causing these changes.’’ EPA determined that the non-linear RfD approach will be protective for chronic effects, including carcinogenicity. Because the chronic risks are below EPA’s level of concern, sodium salt of acifluorfen is not expected to pose a cancer risk to humans. 5. 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 sodium salt of acifluorfen residues. IV. Other Considerations ddrumheller on DSK120RN23PROD with RULES1 A. Analytical Enforcement Methodology Adequate methods are available for enforcement of tolerances of sodium salt of acifluorfen in the Pesticide Analytical Manual (PAM) Volume II. PAM Volume II lists a gas chromatography/electron capture detector (GC/ECD) method, (Method I), for the determination of sodium salt of acifluorfen in/on plant commodities. Identifications are confirmed by gas chromatograph equipped with a mass spectroscopy (GC/MS), Method A in PAM II. 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 VerDate Sep<11>2014 16:11 Jul 26, 2023 Jkt 259001 practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex has not established any MRLs for sodium salt of acifluorfen; thus, harmonization is not an issue. V. Conclusion Therefore, tolerances are established for residues of sodium salt of acifluorfen, including its metabolites and degradates, in or on the following commodities: berry, low growing, subgroup 13–07G at 0.1 ppm; soybean, vegetable, edible podded at 0.09 ppm and soybean, vegetable, succulent shelled at 0.09 ppm. Additionally, EPA is removing the established tolerance for residues of sodium salt of acifluorfen in or on strawberry at 0.05 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 48387 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: July 19, 2023. Charles Smith, Director, Registration Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. E:\FR\FM\27JYR1.SGM 27JYR1 48388 Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / Rules and Regulations August 3, 2023 at 6 p.m. and implements a fishing period catch limit of 1,000 pounds (lb) (0.45 mt) dressed weight for all vessel size classes. This action is intended to conserve Pacific halibut and provide commercial fishing opportunity where available. DATES: Effective date: July 24, 2023, through December 31, 2023. FOR FURTHER INFORMATION CONTACT: Melissa Mandrup, 562–980–3231, Melissa.Mandrup@noaa.gov. SUPPLEMENTARY INFORMATION: On June 26, 2023, NMFS published a final rule implementing harvest specifications, § 180.383 Sodium salt of acifluorfen; fishing periods, and fishing period tolerances for residues. limits by vessel size class for the Area (a) * * * 2A non-tribal directed commercial Pacific halibut fishery (88 FR 41334), as TABLE 1 TO PARAGRAPH (a) authorized by the Northern Pacific Halibut Act of 1982 (16 U.S.C. 773– Parts per Commodity 773(k)). The Pacific Fishery million Management Council 2023 Catch Berry, low growing, subgroup Sharing Plan provides a recommended 13–07G ................................... 0.1 framework for NMFS’ management considerations and allocations based on * * * * * the 2023 Area 2A Pacific halibut catch Soybean, vegetable, edible podded .......................................... 0.09 limit of 1,520,000 pounds (lb) (689 metric tons (mt)) set by the International Soybean, vegetable, succulent shelled ..................................... 0.09 Pacific Halibut Commission (IPHC). The Area 2A catch limit and commercial fishery allocations were adopted by the * * * * * [FR Doc. 2023–15900 Filed 7–26–23; 8:45 am] IPHC and were published in the Federal Register on March 7, 2023 (88 FR BILLING CODE 6560–50–P 14066) after acceptance by the Secretary of State, with concurrence from the Secretary of Commerce, in accordance DEPARTMENT OF COMMERCE with 50 CFR 300.62. Per a final rule published on June 26, National Oceanic and Atmospheric 2023 (88 FR 41334), two fishing periods Administration were set for the 2023 directed commercial Pacific halibut fishery; the 50 CFR Part 300 first fishing period began on June 27, [Docket No. 230615–0151; RTID 0648– 2023 at 8 a.m. and closed on June 29 at XD142] 6 p.m. and the second fishing period opened on July 11, 2023 at 8 a.m. and Pacific Halibut Fisheries of the West closed on July 13 at 6 p.m. Fishing Coast; Inseason Action for the 2023 period limits for the fishing periods Area 2A Pacific Halibut Directed announced in the final rule varied by Commercial Fishery vessel size class, ranging from 2,716 lb AGENCY: National Marine Fisheries (1.23 mt) to 6,136 lb (2.78 mt). Federal Service (NMFS), National Oceanic and regulations at 50 CFR 300.63(e)(1)(iii), Atmospheric Administration (NOAA), ‘‘Inseason action to add fishing periods Commerce. and associated fishing period limits,’’ allow the NMFS Regional Administrator ACTION: Temporary rule; inseason to add fishing periods as needed to adjustment. attain the directed commercial fishery SUMMARY: NMFS announces an inseason allocation. Fishing period limits, for action for the 2023 non-tribal directed those fishing periods added inseason, commercial Pacific halibut fishery that are equal across all vessel size classes. operates south of Point Chehalis, Landings information at the Washington (lat. 46°53.30′ N) in the conclusion of the second fishing period International Pacific Halibut indicate that sufficient allocation Commission’s regulatory Area 2A off remains to warrant an additional fishing Washington, Oregon, and California. period without exceeding the allocation Specifically, this action adds an for the Area 2A directed commercial additional fishing period beginning on fishery. As stated above, inseason August 1, 2023 at 8 a.m. and closing on addition of fishing periods with fishing 2. In § 180.383, amend paragraph (a) by: ■ a. Designating the table to paragraph (a); and ■ b. In newly designated table 1 to paragraph (a): ■ i. Adding in alphabetical order the entries ‘‘Berry, low growing, subgroup 13–07G’’; ‘‘Soybean, vegetable, edible podded’’; and ‘‘Soybean, vegetable, succulent shelled’’; and ■ ii. Removing the entry for ‘‘Strawberry’’. The additions read as follows: ddrumheller on DSK120RN23PROD with RULES1 ■ VerDate Sep<11>2014 16:11 Jul 26, 2023 Jkt 259001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 period limits equal across all vessel size classes is authorized by Federal regulations at 50 CFR 300.63(e)(1)(iii) and was announced in the final rule (88 FR 41334, June 26, 2023). NMFS determined the following inseason action is necessary to meet the management objective of attaining the directed commercial fishery allocation, will not result in exceeding the allocation, and is consistent with the inseason management provisions allowing for additional fishing periods. Notice of this additional fishing period and fishing period limits will also be announced on the NMFS hotline at 206– 526–6667 or 800–662–9825. Inseason Action Description of the action: This inseason action implements an additional fishing period, beginning August 1, 2023 at 8 a.m. and ending on August 3, 2023 at 6 p.m. This inseason action also implements a fishing period catch limit of 1,000 lb (0.45 mt) dressed weight (880 lb (0.40 mt) net weight) for all vessel size classes. Reason for the action: The purpose of this inseason action is to provide additional opportunity for commercial halibut fishery participants in Area 2A. The first fishing period opened on June 27, 2023 at 8 a.m. and closed on June 29, 2023 at 6 p.m. The second fishing period opened on July 11, 2023 at 8 a.m. and closed on July 13, 2023 at 6 p.m. NMFS has determined that an additional fishing period is warranted because sufficient allocation remains and that a substantial amount of the allocation will go unharvested without an additional fishing period. As of July 19, approximately 223,261 lb (101.27 mt), net weight, have been harvested of the 257,819 lb (116.95 mt) allocation (87 percent), leaving 34,558 lb (15.68 mt) remaining (13 percent). With little risk of the directed commercial fishery allocation being exceeded, an additional fishing period is warranted for participants in the directed commercial fishery. Therefore, through this action, NMFS is adding one fishing period not previously implemented in the final rule on June 26, 2023 (88 FR 41334). Specifically, an additional fishing period is announced for August 1, 2023 at 8 a.m. until August 3, 2023 at 6 p.m. Fishing period limits for the two fishing periods, implemented in the final rule (88 FR 41334, June 26, 2023), varied across vessel size classes, ranging from 2,715 lbs. (1.23 mt) to 6,135 lbs. (2.78 mt), and were based on the number of permits issued and the allocation. Fishing period limits implemented through inseason action E:\FR\FM\27JYR1.SGM 27JYR1

Agencies

[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Rules and Regulations]
[Pages 48383-48388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15900]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0361; FRL-11130-01-OCSPP]


Sodium Salt of Acifluorfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of sodium 
salt of acifluorfen in or on berry, low growing, subgroup 13-07G; 
soybean, vegetable, edible podded; and soybean, vegetable, succulent 
shelled. The Interregional Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 27, 2023. Objections and 
requests for hearings must be received on or before September 25, 2023, 
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-2022-0361, is available online at 
https://www.regulations.gov or in-person at the Office of Pesticide 
Programs Regulatory Public Docket (OPP Docket) in the Environmental 
Protection Agency Docket Center (EPA/DC), West William Jefferson 
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room and the OPP Docket is (202) 566-
1744. For the latest status information on EPA/DC services,

[[Page 48384]]

docket access, visit https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2022-0361 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 
September 25, 2023. 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-2022-0361, 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/. Additional instructions on 
commenting or visiting the docket, along with more information about 
dockets generally, is available at https://www.epa.gov/.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 20, 2022 (87 FR 30855) (FRL-9410-13-
OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (2E8987) 
by the Interregional Research Project No. 4 (IR-4), Project 
Headquarters, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 
40 CFR 180.383 be amended to establish tolerances for residues of the 
herbicide sodium salt of acifluorfen, sodium 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its metabolites (the 
corresponding acid, methyl ester, and amino analogues) in or on the 
following raw agricultural commodities: berry, low growing, subgroup 
13-07G at 0.1 ppm; soybean, vegetable, edible podded at 0.09 ppm; and 
soybean, vegetable, succulent shelled at 0.09 ppm. The petition also 
requested that EPA remove the established tolerance for residues of 
sodium salt of acifluorfen in or on strawberry at 0.05 ppm. That 
document referenced a summary of the petition prepared by IR-4, the 
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received on the notice of 
filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified therein, EPA has reviewed the available scientific data and 
other relevant information in support of this action. EPA has 
sufficient data to assess the hazards of and to make a determination on 
aggregate exposure for sodium salt of acifluorfen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with sodium salt of 
acifluorfen 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.
    The toxicology database for sodium salt of acifluorfen is complete 
and considered adequate for risk assessment. EPA has waived the 
subchronic inhalation study, subchronic neurotoxicity studies, and the 
developmental neurotoxicity study. Hematological effects (such as 
decreases in erythrocyte count, hematocrit, and/or mean cell volume) 
were noted in dog, rat, and mice. The liver (dog, rat, and mouse) and 
kidney (rat and mouse) are also target organs of oral exposure, and 
effects in these organs were noted following both subchronic and 
chronic exposures. Indications of liver toxicity

[[Page 48385]]

included findings such as increased liver weight, hypertrophy, clinical 
chemistry findings, urinary urobilinogen, focal necrosis; proliferation 
of oval or bile duct cells, and fatty infiltration. Indications of 
kidney toxicity include increases in the following parameters: kidney 
weight; serum electrolytes, blood urea nitrogen (BUN), and creatinine; 
and urinary nitrate. There was quantitative fetal susceptibility 
demonstrated in the Sprague-Dawley rat developmental study, but no 
susceptibility in the Wistar rat or rabbit developmental studies, nor 
in the reproduction study. There are no genotoxicity, neurotoxicity or 
immunotoxicity concerns observed in the available toxicity studies. In 
the dermal toxicity test, skin irritation was observed at all doses, 
and systemic toxicity was noted at the limit dose.
    EPA has classified sodium salt of acifluorfen as ``likely to be 
carcinogenic to humans at high enough doses to cause the biochemical 
and histopathological changes in livers of rodents, but unlikely to be 
carcinogenic at doses below those causing these changes''. EPA 
determined that non-linear extrapolation is appropriate for risk 
assessment purposes. The non-linear reference dose (RfD) approach will 
be protective for chronic effects, including carcinogenicity.
    Sodium salt of acifluorfen has low acute toxicity by the oral and 
dermal exposure routes (Toxicity Category III). However, it is a severe 
eye irritant (Toxicity Category I) and moderate dermal irritant 
(Toxicity Category II). It is not considered a skin sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by sodium salt of acifluorfen 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 titled ``Sodium Acifluorfen. Human 
Health Risk Assessment of Proposed Tolerances and Uses on Edamame 
(Vegetable Soybean) and Crop Group Expansion and Use on Low-growing 
Berry Subgroup 13-07G'' (hereinafter ``Sodium Acifluorfen Human Health 
Risk Assessment'') on pages 24-32 in docket ID number EPA-HQ-OPP-2022-
0361.

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/cumulative-assessment-risk-pesticides.
    A summary of the toxicological endpoints for sodium salt of 
acifluorfen used for human risk assessment can be found in the Sodium 
Acifluorfen Human Health Risk Assessment on pages 12-15.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sodium salt of acifluorfen, EPA considered exposure under 
the petitioned-for tolerances as well as all existing sodium salt of 
acifluorfen tolerances in 40 CFR 180.383. EPA assessed dietary 
exposures from sodium salt of acifluorfen 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 sodium salt of acifluorfen.
    In estimating the acute dietary exposure, EPA used the Dietary 
Exposure Evaluation Model software using the Food Commodity Intake 
Database (DEEM-FCID) Version 4.02, which uses the 2005-2010 food 
consumption data from the United States Department of Agriculture's 
(USDA's) National Health and Nutrition Examination Survey, What We Eat 
in America (NHANES/WWEIA). The acute dietary exposure assessment 
assumes tolerance-level residues and 100% crop treated (PCT) for all 
commodities and incorporates default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the 2005-2010 food consumption data from the 
USDA's NHANES/WWEIA and DEEM-FCID; version 4.02. The chronic dietary 
exposure assessment assumes tolerance-level residues and 100 PCT for 
all commodities and incorporates default processing factors.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Based on the data summarized in Unit III.A., EPA has 
concluded that sodium salt of acifluorfen should be classified as 
``Likely to be Carcinogenic to Humans at high enough doses to cause the 
biochemical and histopathological changes in livers of rodents, but 
unlikely to be carcinogenic at doses below those causing these 
changes.'' The non-linear RfD approach will be protective for chronic 
effects, including carcinogenicity. Cancer risk was quantified using 
the same estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for sodium salt of acifluorfen. Tolerance level residues and/or 100 PCT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sodium salt of acifluorfen in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of sodium salt of acifluorfen. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at https://www.epa.gov/science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    Based on the groundwater modeling results from Pesticide Root Zone 
Model

[[Page 48386]]

for Ground Water (PRZM-GW), the estimated drinking water concentrations 
(EDWCs) of sodium salt of acifluorfen for acute and chronic exposures 
are estimated to be 146 parts per billion (ppb) for ground water. These 
modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    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). Sodium salt of 
acifluorfen is not registered for any specific use patterns that would 
result in residential exposure, and the new uses would not result in 
residential exposures; therefore, direct exposures in residential 
settings are not expected for adults and children.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide.
    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 sodium salt of acifluorfen 
and any other substances, and sodium salt of acifluorfen does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this action, therefore, EPA has not assumed that sodium 
salt of acifluorfen 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/cumulative-assessment-risk-pesticides.

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 Food Quality 
Protection Act (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. There is evidence of 
increased susceptibility following in utero exposure to sodium salt of 
acifluorfen in the Sprague Dawley rat developmental toxicity study. 
However, there is low concern for developmental toxicity because the 
effects are well characterized with clear NOAEL/LOAEL values and the 
chosen points of departure for risk assessment for each scenario are 
protective of these effects.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced from 10X to 1X. That decision is based on the 
following findings:
    i. The toxicity database for sodium salt of acifluorfen is 
complete.
    ii. The weight of evidence (WOE) suggests that sodium salt of 
acifluorfen is not neurotoxic. This conclusion is based on the 
following: (1) indications of treatment-related toxicity in the acute 
neurotoxicity study (ACN) are well-characterized, and the decreased 
motor activity observed could be an indication of systemic toxicity 
from the bolus dose; (2) the slight effect observed in fetuses in a 
developmental toxicity study with Sprague-Dawley rats (dilated brain 
ventricles) were not reproduced in another developmental toxicity study 
with Wistar rats nor in developmental toxicity studies with rabbits; 
and (3) there was no indication of treatment-related neurotoxicity 
observed in any studies for structurally-related chemicals (fomesafen, 
lactofen, and oxyfluorfen), except for decreased motor activity in an 
acute neurotoxicity study with fomesafen at the same dose where general 
systemic toxicity (body weight loss) was observed. No immunotoxicity 
was observed. In the dermal toxicity test, skin irritation was observed 
at all doses, and systemic toxicity was noted at the limit dose.
    iii. There is evidence that sodium salt of acifluorfen results in 
increased susceptibility following exposure in utero rats in the 
Sprague Dawley rat prenatal developmental study. However, there is low 
concern because effects are well characterized with clear NOAEL/LOAEL 
values and the chosen points of departure for risk assessment for each 
scenario are protective of these effects.
    iv. There are no residual uncertainties identified in the exposure 
database. The dietary food exposure assessments were performed based on 
100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sodium salt of acifluorfen in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by sodium salt of acifluorfen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing dietary exposure estimates to the acute 
population adjusted dose (aPAD) and the chronic population adjusted 
dose (cPAD). Short-, intermediate-, and chronic term aggregate risks 
are evaluated by comparing the estimated total food, water, and 
residential exposure to the appropriate PODs to ensure that an adequate 
MOE exists.
    1. Acute risk. An acute aggregate risk takes into account exposure 
estimated from dietary consumption of food and drinking water. Using 
the exposure assumptions described in this unit for acute exposure, EPA 
has concluded that acute exposure to sodium salt of acifluorfen will 
occupy less than 1% of the aPAD for all infants less than 1 year old, 
the population group receiving the greatest exposure. There are no 
registered residential uses of sodium salt of acifluorfen so acute 
aggregate risk is equivalent to acute dietary risk, which is not of 
concern. A separate, lower POD was selected for females 13 to 49 years 
old for which the estimated risk was 3.9% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sodium salt of acifluorfen from food and water will utilize 87% of the 
cPAD for all infants less than 1 year old, the population group 
receiving the greatest exposure. There are no registered residential 
uses of sodium salt of acifluorfen, so chronic aggregate risk is 
equivalent to chronic dietary risk, which is not of concern.
    3. Short-term/Intermediate-term risk. Short- and intermediate-term 
aggregate exposure take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water

[[Page 48387]]

(considered to be a background exposure level). A short-term and an 
intermediate-term adverse effect were identified; however, sodium salt 
of acifluorfen is not registered for any use patterns that would result 
in short- or intermediate-term residential exposure. Short- and 
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there 
is no short- or intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess short- or intermediate-term risk), no further assessment of 
short- or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for sodium salt of acifluorfen
    4. Aggregate cancer risk for U.S. population. As explained in Unit 
III.A., sodium salt of acifluorfen is classified as ``likely to be 
carcinogenic to humans at doses high enough to cause the biochemical 
and histopathological changes in livers of rodents, but unlikely to be 
carcinogenic at doses below those causing these changes.'' EPA 
determined that the non-linear RfD approach will be protective for 
chronic effects, including carcinogenicity. Because the chronic risks 
are below EPA's level of concern, sodium salt of acifluorfen is not 
expected to pose a cancer risk to humans.
    5. 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 sodium salt of acifluorfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for enforcement of tolerances of 
sodium salt of acifluorfen in the Pesticide Analytical Manual (PAM) 
Volume II. PAM Volume II lists a gas chromatography/electron capture 
detector (GC/ECD) method, (Method I), for the determination of sodium 
salt of acifluorfen in/on plant commodities. Identifications are 
confirmed by gas chromatograph equipped with a mass spectroscopy (GC/
MS), Method A in PAM II.

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).
    Codex has not established any MRLs for sodium salt of acifluorfen; 
thus, harmonization is not an issue.

V. Conclusion

    Therefore, tolerances are established for residues of sodium salt 
of acifluorfen, including its metabolites and degradates, in or on the 
following commodities: berry, low growing, subgroup 13-07G at 0.1 ppm; 
soybean, vegetable, edible podded at 0.09 ppm and soybean, vegetable, 
succulent shelled at 0.09 ppm. Additionally, EPA is removing the 
established tolerance for residues of sodium salt of acifluorfen in or 
on strawberry at 0.05 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: July 19, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

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

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

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

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


[[Page 48388]]



0
2. In Sec.  180.383, amend paragraph (a) by:
0
a. Designating the table to paragraph (a); and
0
b. In newly designated table 1 to paragraph (a):
0
i. Adding in alphabetical order the entries ``Berry, low growing, 
subgroup 13-07G''; ``Soybean, vegetable, edible podded''; and 
``Soybean, vegetable, succulent shelled''; and
0
ii. Removing the entry for ``Strawberry''.
    The additions read as follows:


Sec.  180.383  Sodium salt of acifluorfen; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G.........................         0.1
 
                                * * * * *
Soybean, vegetable, edible podded...........................        0.09
Soybean, vegetable, succulent shelled.......................        0.09
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-15900 Filed 7-26-23; 8:45 am]
BILLING CODE 6560-50-P
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