Fomesafen; Pesticide Tolerances, 29835-29839 [2023-09819]

Download as PDF 29835 Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations State effective date Title * * 2008 Ozone Moderate Area Attainment Plan. Reasonably Available Control Technology for the 2008 8-Hour Ozone National Ambient Air Quality Standard (NAAQS) Moderate State Implementation Plan (RACT SIP). * 1/14/2017 8/2/2018 11/21/2017 6/8/2023 * * 2008 Ozone Serious Area Attainment Plan. * 2/14/2020 Reasonably Available Control Technology for the 2008 8-Hour Ozone National Ambient Air Quality Standard (NAAQS) Serious State Implementation Plan (RACT SIP). 2/14/2020 * * ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2019–0508; FRL–7261–05– OCSPP] RIN 2070–AK54 Notification of Submission to the Secretary of Agriculture; Pesticides; Exemptions of Certain PlantIncorporated Protectants (PIPs) Derived From Newer Technologies; Draft Final Rule This document notifies the public as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) a draft regulatory document entitled ‘‘Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies; Final Rule.’’ The draft regulatory document is not available to the public until after it has been signed and made available by EPA. DATES: Notification effective as of May 1, 2023. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2019–0508, is VerDate Sep<11>2014 17:00 May 08, 2023 * * [insert Federal Register citation], 5/9/2023. 6/8/2023 5/9/2023 ......................................... * * Except for contingency measures, RACM, enhanced monitoring, and attainment demonstration. Limited approval and limited disapproval. Jkt 259001 * * Amanda Pierce, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 566–1470; email address: pierce.amanda@epa.gov. I. What action is EPA taking? Environmental Protection Agency (EPA). ACTION: Notification of submission to the Secretary of Agriculture. FIFRA section 25(a)(2)(B) requires the EPA Administrator to provide the Secretary of USDA with a copy of any draft final rule at least 30 days before signing it in final form for publication in the Federal Register. The draft final rule is not available to the public until after it has been signed by EPA. If the Secretary of USDA comments in writing regarding the draft final rule within 15 days after receiving it, the EPA Administrator shall include the comments of the Secretary of USDA, if requested by the Secretary of USDA, and the EPA Administrator’s response to those comments with the final rule that publishes in the Federal Register. If the Secretary of USDA does not comment in writing within 15 days after receiving the draft final rule, then the EPA Administrator may sign the final rule for publication in the Federal Register any time after the 15-day period. PO 00000 * 6/8/2023 SUPPLEMENTARY INFORMATION: AGENCY: * Except major source NOX RACT. Previous SIP approvals 7/03/ 2018, 2/24/2021, and 11/05/ 2021. Limited approval/limited disapproval of RACT regulations 5/9/2023. FOR FURTHER INFORMATION CONTACT: 40 CFR Part 174 Comments * * 83 FR 31068, 7/3/2018 .................. available at https:// www.regulations.gov. That docket contains historical information and this Federal Register document; it does not contain the draft final rule. BILLING CODE 6560–50–P SUMMARY: Final rule citation/date [insert Federal Register citation], 5/9/2023. * [FR Doc. 2023–09229 Filed 5–8–23; 8:45 am] ddrumheller on DSK120RN23PROD with RULES1 EPA effective date Frm 00021 Fmt 4700 Sfmt 4700 * * II. Do any statutory and Executive Order reviews apply to this notification? No. This document is merely a notification of submission to the Secretary of USDA. As such, none of the regulatory assessment requirements apply to this document. List of Subjects in 40 CFR Part 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Plant-incorporated protectants, Reporting, and recordkeeping requirements. Dated: May 1, 2023. Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2023–09542 Filed 5–8–23; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2022–0005; FRL–10908–01– OCSPP] Fomesafen; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of fomesafen in or on Vegetable, bulb, group 3–07; Vegetable, cucurbit, group 9; Vegetable, fruiting, group 8–10; and Vegetable, legume, forage and hay, except soybean, SUMMARY: E:\FR\FM\09MYR1.SGM 09MYR1 29836 Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations subgroup 7–22A. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 9, 2023. Objections and requests for hearings must be received on or before July 10, 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). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2022–0005, 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. For the latest status information on EPA/DC services, docket access, visit https:// www.epa.gov/dockets. 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: ADDRESSES: I. General Information ddrumheller on DSK120RN23PROD with RULES1 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- VerDate Sep<11>2014 17:00 May 08, 2023 Jkt 259001 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(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2022–0005 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 10, 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– 2022–0005, 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 April 28, 2022 (87 FR 25178) (FRL–9410–12– 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 1E8957) by PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 IR–4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.433 be amended by establishing tolerances for residues of fomesafen, 5-2-chloro-4(trifluoromethyl)phenoxy-N(methylsulfonyl)-2-nitrobenzamide in or on the raw agricultural commodities Vegetable, bulb, group 3–07 at 0.02 parts per million (ppm); Vegetable, cucurbit, group 9 at 0.025 ppm; Vegetable, foliage of legume, except soybean, subgroup 7A at 0.05 ppm; and Vegetable, fruiting, group 8–10 at 0.025 ppm. The petition also proposed to remove established tolerances for residues of fomesafen in or on the following: Cantaloupe at 0.025 ppm; Cucumber at 0.025 ppm; Pepper, bell at 0.025 ppm; Pepper, non-bell at 0.025 ppm; Pumpkin at 0.025 ppm; Squash, summer at 0.025 ppm; Squash, winter at 0.025 ppm; Tomato at 0.025 ppm; and Watermelon at 0.025 ppm. That document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. One comment was submitted in response to this petition. EPA’s response to this comment can be found in Unit VI.D. of this publication. Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is modifying some of the requested tolerances and one of the tolerance definitions. For details, see Unit VI.C. 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 E:\FR\FM\09MYR1.SGM 09MYR1 ddrumheller on DSK120RN23PROD with RULES1 Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations 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 fomesafen including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with fomesafen follows. In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking. EPA has previously published a tolerance rulemaking for fomesafen, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fomesafen and established tolerances for residues of that chemical. EPA is incorporating previously published sections of that rulemaking that remains unchanged, as described further in this rulemaking. Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by fomesafen, can be found in the document titled ‘‘Fomesafen. Human Health Risk Assessment for the Petition to Establish Permanent Tolerances and Associated Registrations for Bulb Vegetable (Group 3–07) and Vegetable, Foliage of Legume Except Soybean (Subgroup 7A) and for Proposed Crop Group Conversions and Expansions for Vegetable, Cucurbit (Group 9) and Vegetable, Fruiting (Group 8–10).’’ (hereafter, the Fomesafen Human Health Assessment) which is available in the docket for this action at https://www.regulations.gov. Toxicological profile. Fomesafen is an herbicide that is absorbed by leaves and roots and inhibits potato polyphenol oxidase (PPO), leading to irreversible cell membrane damage. PPO inhibits a step in the protoporphyrin synthesis pathway and is a precursor to both chlorophyll and hemoglobin synthesis. The toxicological database for fomesafen is complete. The primary target organ of fomesafen is the liver. Generally, in rats, after subchronic and chronic exposure, liver histopathology (hyalinization of hepatocytes, necrosis, etc.) provided the VerDate Sep<11>2014 17:00 May 08, 2023 Jkt 259001 most sensitive toxicological endpoint. In mice, liver tumors were observed after chronic exposure, and liver carcinogenicity has been established by a peroxisome proliferator-activated receptor (PPAR)-alpha mode of action. Decreased motor activity was observed at doses above those causing liver toxicity. Post-implantation loss was noted in the rat developmental study, but no quantitative or qualitative evidence of increased susceptibility was seen following in utero exposure to rats in developmental studies or in the 2generation reproduction study. Fomesafen can result in suppression of anti-sheep red blood cell (SRBC) immunoglobulin M response; however, this immunotoxic potential was noted only at high doses. In a metabolism study in rats, fomesafen was readily absorbed in male and female rats after oral dosing. The sex difference was not evident at higher doses, where urine was the main route of excretion after a single oral dose of 500 mg/kg. However, a marked sex difference in disposition was observed at low doses, with females excreting a higher percentage compared to males. Carcinogenicity was not observed in the rat chronic toxicity/carcinogenicity study. Liver tumors were produced in the mouse carcinogenicity study; however, the Agency determined that fomesafen should be classified as ‘‘Not Likely to be Carcinogenic to Humans.’’ This decision was based on the weightof-evidence (WOE) which supports activation of peroxisome proliferatoractivated receptor alpha (PPARa) as the mode of action for fomesafen-induced hepatocarcinogenesis in mice. Toxicological points of departure/ Levels of concern. The toxicological endpoints for fomesafen have changed since the last rulemaking and have been updated in accordance with current hazard evaluation practices. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment, see Section 4.5.3. of the Fomesafen Human Health Assessment. Exposure assessment. Much of the exposure assessment remains the same since the rulemaking that published on February 7, 2018 (83 FR 5312) (FRL– 9972–66), although the new exposure assessment incorporates additional dietary exposures from the petitionedfor tolerances. These updates are discussed in this section; for a description of the rest of EPA’s approach to and assumptions for the exposure assessment, see Unit III.C in the February 7, 2018, rulemaking. EPA conducted unrefined acute and chronic dietary (food and drinking PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 29837 water) exposure and risk assessments using the Dietary Exposure Evaluation Model with the Food Commodity Intake Database (DEEM–FCID, ver. 4.02) which incorporates food consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2005–2010). The acute and chronic dietary assessments used tolerance-level residues, 100 percent crop treated (PCT) and default processing factors. Drinking water and non-occupational exposures. The estimated drinking water concentrations (EDWCs) have been updated since the 2018 rulemaking. The Agency used EDWCs of 154 parts per billion for the acute assessment and 118 ppb for the chronic assessment. There are no proposed or registered residential uses of fomesafen at this time; therefore, a quantitative residential assessment was not conducted. Cumulative exposure. 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 fomesafen and any other substances. For the purposes of this action, therefore, EPA has not assumed that fomesafen has a common mechanism of toxicity with other substances. IV. 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 no evidence of increased E:\FR\FM\09MYR1.SGM 09MYR1 29838 Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES1 susceptibility of rat fetuses to in utero exposure to fomesafen. Postimplantation loss was noted in the rat developmental study, but no quantitative or qualitative evidence of increased susceptibility was seen following in utero exposure to rats in developmental studies or in the 2generation reproduction study. As the etiology of the post-implantation loss is unknown, it is considered to be both a maternal and fetal endpoint and not indicative of increased susceptibility. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the Food Quality Protection Act Safety Factor were reduced to 1X. That decision is based on the following findings: i. The toxicology database for fomesafen is complete and sufficient for assessing potential susceptibility to infants and children. ii. The potential of neurotoxicity (decreased motor activity) was observed in the acute neurotoxicity study in the rat. However, there is a low degree of concern for the potential neurotoxic effects of fomesafen since (1) clear no observed adverse effect levels (NOAELs) were identified for the neurotoxic effects; and (2) the endpoints chosen for risk assessment are protective of any potential neurotoxicity. iii. There is no evidence of increased susceptibility after exposure to fomesafen. Post-implantation loss was observed in the rat developmental toxicity study. However, as the etiology of the effect is unknown, it is considered to be both a maternal and fetal effect. iv. There are no residential uses for fomesafen, and the dietary assessment is based on high-end exposure assumptions including 100 PCT, tolerance level residues, and high-end estimates derived from ground drinking water modeling estimates. These exposure assessments are not likely to underestimate the resulting estimates of risk from exposure to fomesafen. V. 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 populationadjusted dose (aPAD) and 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 points of departure to ensure that an adequate margin of exposure (MOE) exists. VerDate Sep<11>2014 17:00 May 08, 2023 Jkt 259001 Acute dietary (food and drinking water) risks are below the Agency’s level of concern of 100% of the aPAD: they are 2.8% of the aPAD for all infants less than 1 year old, the population group with the highest exposure estimate. Chronic dietary (food and drinking water) risks are below the Agency’s level of concern of 100% of the cPAD: they are 18% of the cPAD for all infants less than 1 year old, which is the population subgroup with the highest exposure estimate. Because there are no proposed or registered residential uses of fomesafen, the acute and chronic aggregate risks are the same as the dietary (food and drinking water) risks and are not of concern. Finally, because fomesafen is classified as ‘‘Not Likely to be Carcinogenic to Humans’’ due to an absence of carcinogenicity in the available studies, EPA concludes that aggregate exposure to fomesafen will not pose a cancer risk. Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fomesafen residues. VI. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the February 7, 2018, rulemaking. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). There are currently no established Codex MRLs for the proposed new uses of fomesafen. C. Revisions to Tolerances The petitioner requested tolerances for the Vegetable, foliage of legume, except soybean, subgroup 7A, but EPA is establishing the tolerance for the new crop subgroup Vegetable, legume, forage and hay, except soybeans, subgroup 7– 22A. As noted in EPA’s regulations, once a revised crop group is established, EPA no longer establishes crop groups under the pre-existing crop group. See 40 CFR 180.40(j)(4). EPA updated subgroup 7A in its final rule dated PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 September 21, 2022. See Pesticides; Expansion of Crop Grouping Program VI (87 FR 57627) (FRL–5031–13–OCSPP). Additionally, the petitioned-for tolerances of 0.025 ppm for the Vegetable, cucurbit, group 9 and Vegetable, fruiting, group 8–10 are being established at 0.03 ppm to be consistent with Agency rounding practice. D. Response to Comments One comment was received in response to the Notice of Filing. The commenter stated in part that they were ‘‘against approval of any of the below applications for further pollution of the air water soil of this earth’’ and that the Agency should ‘‘shut down these dirty rotten businesses. now.’’ 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 tolerances are 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 the fomesafen tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported. VII. Conclusion Therefore, tolerances are established for residues of fomesafen in or on the Vegetable, bulb, group 3–07 at 0.02 ppm; Vegetable, cucurbit, group 9 at 0.03 ppm; Vegetable, fruiting, group 8– 10 at 0.03 ppm; and Vegetable, legume, forage and hay, except soybean, subgroup 7–22A at 0.05 ppm. Additionally, the established tolerances on Cantaloupe; Cucumber; Pepper, bell; Pepper, non-bell; Pumpkin; Squash, summer; Squash, winter; Tomato; and Watermelon are removed as unnecessary. VIII. 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 E:\FR\FM\09MYR1.SGM 09MYR1 29839 Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations FR 28355, May 22, 2001), or to 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). IX. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides, and pests, Reporting and recordkeeping requirements. Dated: May 4, 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. ■ 2. Revise § 180.433 to read as follows: § 180.433 Fomesafen; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide fomesafen, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels specified in the following table 1 to this paragraph (a) is to be determined by measuring only fomesafen, 5-[2-chloro-4(trifluoromethyl)phenoxy]-N(methylsulfonyl)-2-nitrobenzamide, in or on the commodity. TABLE 1 TO PARAGRAPH (a) Parts per million Commodity Berry, low growing, subgroup 13–07G, except cranberry ................................................................................................................... Cotton, gin byproducts ......................................................................................................................................................................... Cotton, undelinted seed ....................................................................................................................................................................... Vegetable, bulb, group 3–07 ............................................................................................................................................................... Vegetable, cucurbit, group 9 ............................................................................................................................................................... Vegetable, fruiting, group 8–10 ........................................................................................................................................................... Vegetable, legume, forage and hay, except soybean, subgroup 7–22A ............................................................................................ Vegetable, legume, group 6 ................................................................................................................................................................ Vegetable, tuberous and corm, subgroup 1C ..................................................................................................................................... (b)–(d) [Reserved] [FR Doc. 2023–09819 Filed 5–8–23; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 ddrumheller on DSK120RN23PROD with RULES1 [EPA–R04–RCRA–2023–0042; FRL–10671– 02–R4] South Carolina: Final Authorization of State Hazardous Waste Management Program Revisions Environmental Protection Agency (EPA). ACTION: Final action. AGENCY: VerDate Sep<11>2014 17:00 May 08, 2023 Jkt 259001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 0.02 0.025 0.025 0.02 0.03 0.03 0.05 0.05 0.025 The Environmental Protection Agency (EPA) is taking direct final action on the authorization of South Carolina’s changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA), as amended. These changes were outlined in a September 26, 2022, application to the EPA. We have determined that these changes satisfy all requirements needed for final authorization. DATES: This authorization is effective on July 10, 2023 without further notice SUMMARY: E:\FR\FM\09MYR1.SGM 09MYR1

Agencies

[Federal Register Volume 88, Number 89 (Tuesday, May 9, 2023)]
[Rules and Regulations]
[Pages 29835-29839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09819]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0005; FRL-10908-01-OCSPP]


Fomesafen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fomesafen in or on Vegetable, bulb, group 3-07; Vegetable, cucurbit, 
group 9; Vegetable, fruiting, group 8-10; and Vegetable, legume, forage 
and hay, except soybean,

[[Page 29836]]

subgroup 7-22A. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective May 9, 2023. Objections and 
requests for hearings must be received on or before July 10, 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-2022-0005, 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. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

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(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2022-0005 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
July 10, 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-2022-0005, 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 April 28, 2022 (87 FR 25178) (FRL-9410-
12-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 
1E8957) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 
40 CFR 180.433 be amended by establishing tolerances for residues of 
fomesafen, 5-2-chloro-4-(trifluoromethyl)phenoxy-N-(methylsulfonyl)-2-
nitrobenzamide in or on the raw agricultural commodities Vegetable, 
bulb, group 3-07 at 0.02 parts per million (ppm); Vegetable, cucurbit, 
group 9 at 0.025 ppm; Vegetable, foliage of legume, except soybean, 
subgroup 7A at 0.05 ppm; and Vegetable, fruiting, group 8-10 at 0.025 
ppm.
    The petition also proposed to remove established tolerances for 
residues of fomesafen in or on the following: Cantaloupe at 0.025 ppm; 
Cucumber at 0.025 ppm; Pepper, bell at 0.025 ppm; Pepper, non-bell at 
0.025 ppm; Pumpkin at 0.025 ppm; Squash, summer at 0.025 ppm; Squash, 
winter at 0.025 ppm; Tomato at 0.025 ppm; and Watermelon at 0.025 ppm.
    That document referenced a summary of the petition, which is 
available in the docket, https://www.regulations.gov. One comment was 
submitted in response to this petition. EPA's response to this comment 
can be found in Unit VI.D. of this publication.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is modifying some of the requested tolerances and one of the tolerance 
definitions. For details, see Unit VI.C.

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

[[Page 29837]]

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 fomesafen including exposure resulting from the tolerances 
established by this action. EPA's assessment of exposures and risks 
associated with fomesafen follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemaking of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking, and EPA considers referral back to those sections 
as sufficient to provide an explanation of the information EPA 
considered in making its safety determination for the new rulemaking.
    EPA has previously published a tolerance rulemaking for fomesafen, 
in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to fomesafen and established tolerances for residues of that 
chemical. EPA is incorporating previously published sections of that 
rulemaking that remains unchanged, as described further in this 
rulemaking. Specific information on the risk assessment conducted in 
support of this action, including on the studies received and the 
nature of the adverse effects caused by fomesafen, can be found in the 
document titled ``Fomesafen. Human Health Risk Assessment for the 
Petition to Establish Permanent Tolerances and Associated Registrations 
for Bulb Vegetable (Group 3-07) and Vegetable, Foliage of Legume Except 
Soybean (Subgroup 7A) and for Proposed Crop Group Conversions and 
Expansions for Vegetable, Cucurbit (Group 9) and Vegetable, Fruiting 
(Group 8-10).'' (hereafter, the Fomesafen Human Health Assessment) 
which is available in the docket for this action at https://www.regulations.gov.
    Toxicological profile. Fomesafen is an herbicide that is absorbed 
by leaves and roots and inhibits potato polyphenol oxidase (PPO), 
leading to irreversible cell membrane damage. PPO inhibits a step in 
the protoporphyrin synthesis pathway and is a precursor to both 
chlorophyll and hemoglobin synthesis. The toxicological database for 
fomesafen is complete. The primary target organ of fomesafen is the 
liver. Generally, in rats, after subchronic and chronic exposure, liver 
histopathology (hyalinization of hepatocytes, necrosis, etc.) provided 
the most sensitive toxicological endpoint. In mice, liver tumors were 
observed after chronic exposure, and liver carcinogenicity has been 
established by a peroxisome proliferator-activated receptor (PPAR)-
alpha mode of action. Decreased motor activity was observed at doses 
above those causing liver toxicity. Post-implantation loss was noted in 
the rat developmental study, but no quantitative or qualitative 
evidence of increased susceptibility was seen following in utero 
exposure to rats in developmental studies or in the 2-generation 
reproduction study. Fomesafen can result in suppression of anti-sheep 
red blood cell (SRBC) immunoglobulin M response; however, this 
immunotoxic potential was noted only at high doses. In a metabolism 
study in rats, fomesafen was readily absorbed in male and female rats 
after oral dosing. The sex difference was not evident at higher doses, 
where urine was the main route of excretion after a single oral dose of 
500 mg/kg. However, a marked sex difference in disposition was observed 
at low doses, with females excreting a higher percentage compared to 
males.
    Carcinogenicity was not observed in the rat chronic toxicity/
carcinogenicity study. Liver tumors were produced in the mouse 
carcinogenicity study; however, the Agency determined that fomesafen 
should be classified as ``Not Likely to be Carcinogenic to Humans.'' 
This decision was based on the weight-of-evidence (WOE) which supports 
activation of peroxisome proliferator-activated receptor alpha 
(PPAR[alpha]) as the mode of action for fomesafen-induced 
hepatocarcinogenesis in mice.
    Toxicological points of departure/Levels of concern. The 
toxicological endpoints for fomesafen have changed since the last 
rulemaking and have been updated in accordance with current hazard 
evaluation practices. For a summary of the Toxicological Points of 
Departure/Levels of Concern used for the safety assessment, see Section 
4.5.3. of the Fomesafen Human Health Assessment.
    Exposure assessment. Much of the exposure assessment remains the 
same since the rulemaking that published on February 7, 2018 (83 FR 
5312) (FRL-9972-66), although the new exposure assessment incorporates 
additional dietary exposures from the petitioned-for tolerances. These 
updates are discussed in this section; for a description of the rest of 
EPA's approach to and assumptions for the exposure assessment, see Unit 
III.C in the February 7, 2018, rulemaking.
    EPA conducted unrefined acute and chronic dietary (food and 
drinking water) exposure and risk assessments using the Dietary 
Exposure Evaluation Model with the Food Commodity Intake Database 
(DEEM-FCID, ver. 4.02) which incorporates food consumption data from 
the United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 
2005-2010). The acute and chronic dietary assessments used tolerance-
level residues, 100 percent crop treated (PCT) and default processing 
factors.
    Drinking water and non-occupational exposures. The estimated 
drinking water concentrations (EDWCs) have been updated since the 2018 
rulemaking. The Agency used EDWCs of 154 parts per billion for the 
acute assessment and 118 ppb for the chronic assessment.
    There are no proposed or registered residential uses of fomesafen 
at this time; therefore, a quantitative residential assessment was not 
conducted.
    Cumulative exposure. 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 fomesafen and any other substances. For the 
purposes of this action, therefore, EPA has not assumed that fomesafen 
has a common mechanism of toxicity with other substances.

IV. 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 no evidence of 
increased

[[Page 29838]]

susceptibility of rat fetuses to in utero exposure to fomesafen. Post-
implantation loss was noted in the rat developmental study, but no 
quantitative or qualitative evidence of increased susceptibility was 
seen following in utero exposure to rats in developmental studies or in 
the 2-generation reproduction study. As the etiology of the post-
implantation loss is unknown, it is considered to be both a maternal 
and fetal endpoint and not indicative of increased susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
Food Quality Protection Act Safety Factor were reduced to 1X. That 
decision is based on the following findings:
    i. The toxicology database for fomesafen is complete and sufficient 
for assessing potential susceptibility to infants and children.
    ii. The potential of neurotoxicity (decreased motor activity) was 
observed in the acute neurotoxicity study in the rat. However, there is 
a low degree of concern for the potential neurotoxic effects of 
fomesafen since (1) clear no observed adverse effect levels (NOAELs) 
were identified for the neurotoxic effects; and (2) the endpoints 
chosen for risk assessment are protective of any potential 
neurotoxicity.
    iii. There is no evidence of increased susceptibility after 
exposure to fomesafen. Post-implantation loss was observed in the rat 
developmental toxicity study. However, as the etiology of the effect is 
unknown, it is considered to be both a maternal and fetal effect.
    iv. There are no residential uses for fomesafen, and the dietary 
assessment is based on high-end exposure assumptions including 100 PCT, 
tolerance level residues, and high-end estimates derived from ground 
drinking water modeling estimates. These exposure assessments are not 
likely to underestimate the resulting estimates of risk from exposure 
to fomesafen.

V. 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 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 points of departure to ensure that an 
adequate margin of exposure (MOE) exists.
    Acute dietary (food and drinking water) risks are below the 
Agency's level of concern of 100% of the aPAD: they are 2.8% of the 
aPAD for all infants less than 1 year old, the population group with 
the highest exposure estimate. Chronic dietary (food and drinking 
water) risks are below the Agency's level of concern of 100% of the 
cPAD: they are 18% of the cPAD for all infants less than 1 year old, 
which is the population subgroup with the highest exposure estimate.
    Because there are no proposed or registered residential uses of 
fomesafen, the acute and chronic aggregate risks are the same as the 
dietary (food and drinking water) risks and are not of concern. 
Finally, because fomesafen is classified as ``Not Likely to be 
Carcinogenic to Humans'' due to an absence of carcinogenicity in the 
available studies, EPA concludes that aggregate exposure to fomesafen 
will not pose a cancer risk.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to fomesafen residues.

VI. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the February 7, 2018, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).
    There are currently no established Codex MRLs for the proposed new 
uses of fomesafen.

C. Revisions to Tolerances

    The petitioner requested tolerances for the Vegetable, foliage of 
legume, except soybean, subgroup 7A, but EPA is establishing the 
tolerance for the new crop subgroup Vegetable, legume, forage and hay, 
except soybeans, subgroup 7-22A. As noted in EPA's regulations, once a 
revised crop group is established, EPA no longer establishes crop 
groups under the pre-existing crop group. See 40 CFR 180.40(j)(4). EPA 
updated subgroup 7A in its final rule dated September 21, 2022. See 
Pesticides; Expansion of Crop Grouping Program VI (87 FR 57627) (FRL-
5031-13-OCSPP). Additionally, the petitioned-for tolerances of 0.025 
ppm for the Vegetable, cucurbit, group 9 and Vegetable, fruiting, group 
8-10 are being established at 0.03 ppm to be consistent with Agency 
rounding practice.

D. Response to Comments

    One comment was received in response to the Notice of Filing. The 
commenter stated in part that they were ``against approval of any of 
the below applications for further pollution of the air water soil of 
this earth'' and that the Agency should ``shut down these dirty rotten 
businesses. now.'' 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 
tolerances are 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 the fomesafen 
tolerances are safe. The commenter has provided no information 
indicating that a safety determination cannot be supported.

VII. Conclusion

    Therefore, tolerances are established for residues of fomesafen in 
or on the Vegetable, bulb, group 3-07 at 0.02 ppm; Vegetable, cucurbit, 
group 9 at 0.03 ppm; Vegetable, fruiting, group 8-10 at 0.03 ppm; and 
Vegetable, legume, forage and hay, except soybean, subgroup 7-22A at 
0.05 ppm.
    Additionally, the established tolerances on Cantaloupe; Cucumber; 
Pepper, bell; Pepper, non-bell; Pumpkin; Squash, summer; Squash, 
winter; Tomato; and Watermelon are removed as unnecessary.

VIII. 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

[[Page 29839]]

FR 28355, May 22, 2001), or to 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).

IX. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 4, 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.


0
2. Revise Sec.  180.433 to read as follows:


Sec.  180.433  Fomesafen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide fomesafen, including its metabolites and degradates, in or on 
the following commodities. Compliance with the tolerance levels 
specified in the following table 1 to this paragraph (a) is to be 
determined by measuring only fomesafen, 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide, in or on 
the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G, except cranberry...            0.02
Cotton, gin byproducts..................................           0.025
Cotton, undelinted seed.................................           0.025
Vegetable, bulb, group 3-07.............................            0.02
Vegetable, cucurbit, group 9............................            0.03
Vegetable, fruiting, group 8-10.........................            0.03
Vegetable, legume, forage and hay, except soybean,                  0.05
 subgroup 7-22A.........................................
Vegetable, legume, group 6..............................            0.05
Vegetable, tuberous and corm, subgroup 1C...............           0.025
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2023-09819 Filed 5-8-23; 8:45 am]
BILLING CODE 6560-50-P


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