Ethalfluralin; Pesticide Tolerances, 21107-21111 [2023-07456]

Download as PDF 21107 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations 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 tolerance 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). VIII. 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: March 31, 2023. Daniel Rosenblatt, Acting 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. In § 180.920, amend table 1 to 180.920, by revising the entry for ‘‘Acetophenone’’ to read as follows: ■ § 180.920 Inert ingredients used preharvest; exemptions from the requirement of a tolerance. * * * * * TABLE 1 TO 180.920 Inert ingredients Limits * * * * Acetophenone (CAS Reg. No. 98–86–2) ....................................................... ........................ * * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2021–0130 and EPA–HQ– OPP–2021–0555; FRL–10449–01–OCSPP] Ethalfluralin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. ddrumheller on DSK120RN23PROD with RULES1 AGENCY: Jkt 259001 * This regulation is effective April 10, 2023. Objections and requests for hearings must be received on or before June 9, 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 dockets for this action, identified by docket identification (ID) numbers EPA–HQ–OPP–2021–0130 and EPA–HQ–OPP–2021–0555, are available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency ADDRESSES: This regulation establishes tolerances for residues of ethalfluralin in or on multiple crops that are referenced later in this document. The Interregional Research Project Number 4 16:14 Apr 07, 2023 * * Attractant, solvent, co-solvent. DATES: 40 CFR Part 180 VerDate Sep<11>2014 * (IR–4) and Gowan Company LLC., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). [FR Doc. 2023–07459 Filed 4–7–23; 8:45 am] SUMMARY: Uses PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 * * * 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: Daniel Rosenblatt, Acting 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. E:\FR\FM\10APR1.SGM 10APR1 21108 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations 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/chapter-I/subchapter-E/ part-180?toc=1. 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(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2021–0130 and/or EPA–HQ–OPP– 2021–0555 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 June 9, 2023. At this time, the Office of Administrative Law Judges, in which the Hearing Clerk is located, encourages people to utilize the electronic system for filing. See Order Urging Electronic Service and Filing, https:// www.epa.gov/sites/default/files2020-05/ documents/2020-04-10_-_order_urging_ electronic_service_and_filing.pdf. The system for filing electronically can be found at this website, https:// www.epa.gov/alj. 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 16:14 Apr 07, 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– 2021–0130 and/or EPA–HQ–OPP–2021– 0555, 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//where-send-commentsepa-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 October 21, 2021 (86 FR 58239) (FRL–8792–04– 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 0E8876) in docket EPA–HQ–OPP–2021–0130, by IR–4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.416 be amended by adding tolerances for ethalfluralin, N-ethyl-N-(2-methyl-2propenyl)-2,6-dinitro-4-(trifluoromethyl) benzenamine in or on the raw agricultural commodities: Hemp, seed at 0.05 ppm; stevia, dried leaves at 0.05 ppm; vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; individual crops of Proposed Crop Subgroup 6– XXE: Dried shelled bean, except soybean, subgroup at 0.05 ppm; and individual crops of Proposed Crop Subgroup 6–XXF: Dried shelled pea subgroup at 0.05 ppm. Due to the length of the list of commodities, please refer to the document EPA issued in the Federal Register on October 21, 2021, for a complete list of commodities to be established. The petition also requested to remove established tolerances for residues of ethalfluralin in or on the raw agricultural commodities: Bean, dry, seed at 0.05 ppm; pea, dry, seed at 0.05 ppm; and potato at 0.05 ppm. That PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. No comments were received in response to the notice of filing. In the Federal Register of March 22, 2022 (87 FR 16133) (FRL–9410–11– 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 1F8929) in docket EPA–HQ–OPP–2021–0555 by Gowan Company LLC, 370 S Main Street, Yuma, AZ 85366. The petition requested that 40 CFR 180.416 be amended by adding a tolerance for residues of ethalfluralin in or on the onion, bulb crop subgroup 3–07A at 0.01 ppm. There was one comment received in response to the notice of filing. EPA’s response to this comment is addressed in section IV.C. 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 0E8876) in docket EPA–HQ–OPP–2021–0130 by IR–4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.416 be amended by establishing a tolerance for residues of ethalfluralin in or on the raw agricultural commodity stevia, fresh leaves at 0.05 ppm. There was one comment received in response to the notice of filing. EPA’s response to this comment is addressed in section IV.C. Some of the commodity definitions have been modified to be consistent with Agency nomenclature and one requested tolerance is not being established, as explained in section IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a E:\FR\FM\10APR1.SGM 10APR1 ddrumheller on DSK120RN23PROD with RULES1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations 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 ethalfluralin including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with ethalfluralin 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 ethalfluralin in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to ethalfluralin and established tolerances for residues of that chemical. EPA is incorporating previously published sections from that rulemaking as described further in this rulemaking, as they remain unchanged. Toxicological profile. For a discussion of the Toxicological Profile of ethalfluralin, see Unit III.A. of the ethalfluralin tolerance rulemaking published in the Federal Register of July 28, 2020 (85 FR 45336) (FRL– 10008–20). Toxicological points of departure/ Levels of concern. For a summary of the Toxicological Points of Departure/ Levels of Concern for ethalfluralin used for human risk assessment, please reference Unit III.B. of the July 28, 2020, rulemaking. Exposure assessment from residues in or on food. EPA’s dietary exposure assessments have been updated to include the additional exposure from the petitioned-for tolerances as well as existing ethalfluralin tolerances in 40 CFR 180.416. The acute and chronic dietary (food and drinking water) assessments used tolerance-level residues and assumed 100 percent crop treated (PCT). The cancer dietary (food VerDate Sep<11>2014 16:14 Apr 07, 2023 Jkt 259001 and drinking water) analysis was refined and used half the field trial limit of detection value for all potato commodities; data from the United States Department of Agriculture (USDA’s) Pesticide Data Program (PDP) for dried bean/pea, soybean grain, soy infant formula, cucurbit vegetables, and peanut butter; tolerance-level residues for the remaining commodities, as well as average PCT data for canola/rapeseed, cantaloupe, cucumber, peanut, pumpkin, summer/winter squash, sunflower, and watermelon and 100 PCT for the remaining commodities. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: • Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. • Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. • Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The cancer assessment incorporated average PCT data for the following commodities: canola/rapeseed (2.5%); cantaloupe (5%); cucumber (55%); peanut (25%); pumpkin (20%); summer/winter squash (35%); sunflower (5%); and watermelon (25%). In most cases, EPA uses available data from United States Department of PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 21109 Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT. The Agency believes that Conditions a, b, and c discussed above have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA’s computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which ethalfluralin may be applied in a particular area. Drinking water and non-occupational exposures. An updated drinking water assessment for all proposed and registered uses was conducted. The acute, chronic, and cancer assessments incorporated modeled surface water E:\FR\FM\10APR1.SGM 10APR1 ddrumheller on DSK120RN23PROD with RULES1 21110 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations estimated drinking water concentrations of 26.1 ppb, 0.57 ppb, and 0.41 ppb, respectively. 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.’’ The Agency has determined that although ethalfluralin shares some chemical and/or toxicological characteristics (e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. See: Dinitroanilines: Screening Analysis of Toxicological Profiles to Consider Whether a Candidate Common Mechanism Group Can Be Established. Consequently, no further review of cumulative effects is required for ethalfluralin at this time. Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the July 28, 2020, rulemaking for a discussion of the Agency’s rationale for that determination. Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Acute dietary risks are below the Agency’s level of concern of 100% of the aPAD; they are less than 1% of the aPAD for females 13 to 49 years old, the only population group of concern. Chronic dietary risks are below the Agency’s level of concern of 100% of the cPAD; they are less than 1% of the cPAD for children 1 to 2 years old, the group with the highest exposure. Because there are no proposed or previously registered residential uses of ethalfluralin, short- and intermediateterm residential exposure is not expected; therefore, aggregate risk is equal to the chronic dietary risk, which VerDate Sep<11>2014 16:14 Apr 07, 2023 Jkt 259001 is below the Agency’s level of concern. A refined cancer dietary assessment was conducted, using the Q1* for ethalfluralin of 0.089 (mg/kg/day)¥1, resulting in a cancer risk estimate for adults of 1 × 10¥6, which the Agency considers to be a negligible 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 ethalfluralin residues. More detailed information on this action can be found in the document titled ‘‘Ethalfluralin. Human Health Risk Assessment for Proposed Section 3 Registration for the New Uses on Hemp, Bulb Onion, and Stevia plus Crop Group Expansions’’ in docket ID EPA–HQ– OPP–2021–0130. IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the July 28, 2020, 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). Codex has not established ethalfluralin MRLs in/on any of the commodities for which tolerances were requested. Therefore, harmonization is not an issue. C. Response to Comments One comment was received in response to the March 22, 2022, Notice of Filing. The comment reads in part ‘‘deny application for fluoride use on onions by gowan profiteering co. the detriment to healthy life on earth [sic].’’ It is unclear whether the commenter intended to submit a comment on the present action, which includes a request for a tolerance for residues of ethalfluralin, not fluoride, on onions, among many other commodities. To the extent the comment is about fluoride residues, this comment is irrelevant to the present action. To the extent the comment is about ethalfluralin, the commenter has provided no information to support a conclusion that the tolerances requested would not meet the FFDCA safety standard. The existing legal framework provided by section PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. One comment was received in response to the April 28, 2022, Notice of Filing. The commenter opposed EPA approving the requested tolerances, stating that doing so would poison the food and feed in the U.S. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that the trinexapacethyl tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported. D. Revisions to Petitioned-For Tolerances Several of the commodity definitions have been modified to conform to Agency nomenclature. Additionally, although the petitioner requested that EPA establish individual tolerances for the commodities contained in the proposed crop subgroups 6–XXE (Dried shelled bean, except soybean) and 6– XXF (Dried shelled pea subgroup), EPA is establishing tolerances for the corresponding subgroups that have recently been established by EPA in a final rule. See the Federal Register of September 21, 2022 (87 FR 57627) (FRL–5031–13–OCSPP). The corresponding subgroups that are being established are ‘‘Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E’’ and ‘‘Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F’’. The commodities in the established subgroups are the same as the individual commodities for which the petitioner sought tolerances. EPA is not establishing a tolerance for Soybean, vegetable, dry seed because it is not a commodity that requires a tolerance. Edamame (vegetable soybean) exists only in the succulent seed and edible podded forms. V. Conclusion Therefore, tolerances are established for residues of ethalfluralin in or on Hemp, seed at 0.05 ppm; Onion, bulb, subgroup 3–07A at 0.01 ppm; Stevia, E:\FR\FM\10APR1.SGM 10APR1 21111 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES1 dried leaves at 0.05 ppm; Stevia, fresh leaves at 0.05 ppm; Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E at 0.05 ppm; Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F at 0.05 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm. Additionally, the following tolerances are removed as unnecessary: Bean, dry, seed at 0.05 ppm; pea, dry, seed at 0.05 ppm; and potato at 0.01 ppm. Finally, EPA is removing the tolerance on potato at 0.05 ppm as a housecleaning measure, since that tolerance expired on January 28, 2021. 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 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 VerDate Sep<11>2014 16:14 Apr 07, 2023 Jkt 259001 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: March 31, 2023. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter 1 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. In § 180.416, amend paragraph (a) by revising the table to read as follows: ■ § 180.416 Ethalfluralin; tolerances for residues. PO 00000 (a) * * * Frm 00053 Fmt 4700 Sfmt 4700 TABLE 1 TO PARAGRAPH (a) Parts per million Commodity Dill, dried leaves ................... Dill, fresh leaves ................... Hemp, seed .......................... Onion, bulb, subgroup 3–07A Peanut .................................. Rapeseed subgroup 20A ...... Soybean ................................ Stevia, dried leaves .............. Stevia, fresh leaves .............. Sunflower subgroup 20B ...... Vegetable, cucurbit, group 9 Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6–22E Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F ...................... Vegetable, tuberous and corm, subgroup 1C ........... * * * * 0.05 0.05 0.05 0.01 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.01 * [FR Doc. 2023–07456 Filed 4–7–23; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket No. 17–310; FCC 23–6; FR ID 135131] Promoting Telehealth in Rural America; Correction Federal Communications Commission. ACTION: Final rule; correction. AGENCY: The Federal Communications Commission (Commission) is correcting a final rule that appeared in the Federal Register on March 23, 2023. In the document, amendatory instruction 4 of the rules incorrectly removed the subparagraphs to paragraph (a) when paragraph (a) was revised. This correction is made to amend instruction 4 so that only paragraph (a) introductory text be revised and the subparagraphs remain in place. DATES: Effective April 10, 2023. FOR FURTHER INFORMATION CONTACT: Bryan P. Boyle, Bryan.Boyle@fcc.gov, Telecommunications Access Policy Division, Wireline Competition Bureau, (202) 418–7400 or TTY: (202) 418–0484. SUPPLEMENTARY INFORMATION: In FR Doc. 2023–04991, appearing on page 17379 in the Federal Register of Thursday, March 23, 2023, the following correction is made: SUMMARY: § 54.619 [Corrected] 1. On page 17396, in the first column, in part 54, in amendment 4, the ■ E:\FR\FM\10APR1.SGM 10APR1

Agencies

[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Rules and Regulations]
[Pages 21107-21111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07456]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0130 and EPA-HQ-OPP-2021-0555; FRL-10449-01-OCSPP]


Ethalfluralin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
ethalfluralin in or on multiple crops that are referenced later in this 
document. The Interregional Research Project Number 4 (IR-4) and Gowan 
Company LLC., requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 10, 2023. Objections and 
requests for hearings must be received on or before June 9, 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 dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2021-0130 and EPA-HQ-OPP-2021-
0555, are 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: Daniel Rosenblatt, Acting 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].

[[Page 21108]]


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/chapter-I/subchapter-E/part-180?toc=1.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2021-0130 and/or EPA-HQ-OPP-2021-0555 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 June 9, 2023. At this time, the Office 
of Administrative Law Judges, in which the Hearing Clerk is located, 
encourages people to utilize the electronic system for filing. See 
Order Urging Electronic Service and Filing, https://www.epa.gov/sites/default/files2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. The system for filing 
electronically can be found at this website, https://www.epa.gov/alj.
    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-2021-0130 and/or 
EPA-HQ-OPP-2021-0555, 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//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 October 21, 2021 (86 FR 58239) (FRL-
8792-04-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 0E8876) in docket EPA-HQ-OPP-2021-0130, by IR-4, North 
Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, 
Raleigh, NC 27606. The petition requested that 40 CFR 180.416 be 
amended by adding tolerances for ethalfluralin, N-ethyl-N-(2-methyl-2-
propenyl)-2,6-dinitro-4-(trifluoromethyl) benzenamine in or on the raw 
agricultural commodities: Hemp, seed at 0.05 ppm; stevia, dried leaves 
at 0.05 ppm; vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; 
individual crops of Proposed Crop Subgroup 6-XXE: Dried shelled bean, 
except soybean, subgroup at 0.05 ppm; and individual crops of Proposed 
Crop Subgroup 6-XXF: Dried shelled pea subgroup at 0.05 ppm. Due to the 
length of the list of commodities, please refer to the document EPA 
issued in the Federal Register on October 21, 2021, for a complete list 
of commodities to be established. The petition also requested to remove 
established tolerances for residues of ethalfluralin in or on the raw 
agricultural commodities: Bean, dry, seed at 0.05 ppm; pea, dry, seed 
at 0.05 ppm; and potato at 0.05 ppm. That document referenced a summary 
of the petition, which is available in the docket, https://www.regulations.gov. No comments were received in response to the 
notice of filing.
    In the Federal Register of March 22, 2022 (87 FR 16133) (FRL-9410-
11-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 
1F8929) in docket EPA-HQ-OPP-2021-0555 by Gowan Company LLC, 370 S Main 
Street, Yuma, AZ 85366. The petition requested that 40 CFR 180.416 be 
amended by adding a tolerance for residues of ethalfluralin in or on 
the onion, bulb crop subgroup 3-07A at 0.01 ppm. There was one comment 
received in response to the notice of filing. EPA's response to this 
comment is addressed in section IV.C.
    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 
0E8876) in docket EPA-HQ-OPP-2021-0130 by IR-4, North Carolina State 
University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 
27606. The petition requested that 40 CFR 180.416 be amended by 
establishing a tolerance for residues of ethalfluralin in or on the raw 
agricultural commodity stevia, fresh leaves at 0.05 ppm. There was one 
comment received in response to the notice of filing. EPA's response to 
this comment is addressed in section IV.C.
    Some of the commodity definitions have been modified to be 
consistent with Agency nomenclature and one requested tolerance is not 
being established, as explained in section IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a

[[Page 21109]]

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 ethalfluralin including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with ethalfluralin 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 
ethalfluralin in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to ethalfluralin and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from that rulemaking as described further 
in this rulemaking, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of ethalfluralin, see Unit III.A. of the ethalfluralin 
tolerance rulemaking published in the Federal Register of July 28, 2020 
(85 FR 45336) (FRL-10008-20).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
ethalfluralin used for human risk assessment, please reference Unit 
III.B. of the July 28, 2020, rulemaking.
    Exposure assessment from residues in or on food. EPA's dietary 
exposure assessments have been updated to include the additional 
exposure from the petitioned-for tolerances as well as existing 
ethalfluralin tolerances in 40 CFR 180.416. The acute and chronic 
dietary (food and drinking water) assessments used tolerance-level 
residues and assumed 100 percent crop treated (PCT). The cancer dietary 
(food and drinking water) analysis was refined and used half the field 
trial limit of detection value for all potato commodities; data from 
the United States Department of Agriculture (USDA's) Pesticide Data 
Program (PDP) for dried bean/pea, soybean grain, soy infant formula, 
cucurbit vegetables, and peanut butter; tolerance-level residues for 
the remaining commodities, as well as average PCT data for canola/
rapeseed, cantaloupe, cucumber, peanut, pumpkin, summer/winter squash, 
sunflower, and watermelon and 100 PCT for the remaining commodities.
    Anticipated residue and PCT information. Section 408(b)(2)(E) of 
FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The cancer assessment incorporated average PCT data for the 
following commodities: canola/rapeseed (2.5%); cantaloupe (5%); 
cucumber (55%); peanut (25%); pumpkin (20%); summer/winter squash 
(35%); sunflower (5%); and watermelon (25%).
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that Conditions a, b, and c discussed above 
have been met. With respect to Condition a, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions b and c, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
reliable information on the regional consumption of food to which 
ethalfluralin may be applied in a particular area.
    Drinking water and non-occupational exposures. An updated drinking 
water assessment for all proposed and registered uses was conducted. 
The acute, chronic, and cancer assessments incorporated modeled surface 
water

[[Page 21110]]

estimated drinking water concentrations of 26.1 ppb, 0.57 ppb, and 0.41 
ppb, respectively.
    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.'' The Agency has 
determined that although ethalfluralin shares some chemical and/or 
toxicological characteristics (e.g., chemical structure or apical 
endpoint) with other pesticides, the toxicological database does not 
support a testable hypothesis for a common mechanism of action. See: 
Dinitroanilines: Screening Analysis of Toxicological Profiles to 
Consider Whether a Candidate Common Mechanism Group Can Be Established. 
Consequently, no further review of cumulative effects is required for 
ethalfluralin at this time.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit 
III.D. of the July 28, 2020, rulemaking for a discussion of the 
Agency's rationale for that determination.
    Aggregate risks and determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
aggregate exposure estimates to the acute population adjusted dose 
(aPAD) and chronic population adjusted dose (cPAD). Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate points of departure to ensure that an adequate margin of 
exposure (MOE) exists. For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
exposure.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are less than 1% of the aPAD for females 13 to 49 
years old, the only population group of concern. Chronic dietary risks 
are below the Agency's level of concern of 100% of the cPAD; they are 
less than 1% of the cPAD for children 1 to 2 years old, the group with 
the highest exposure. Because there are no proposed or previously 
registered residential uses of ethalfluralin, short- and intermediate-
term residential exposure is not expected; therefore, aggregate risk is 
equal to the chronic dietary risk, which is below the Agency's level of 
concern. A refined cancer dietary assessment was conducted, using the 
Q1* for ethalfluralin of 0.089 (mg/kg/day)-\1\, 
resulting in a cancer risk estimate for adults of 1 x 
10-\6\, which the Agency considers to be a negligible 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 ethalfluralin residues. More detailed information 
on this action can be found in the document titled ``Ethalfluralin. 
Human Health Risk Assessment for Proposed Section 3 Registration for 
the New Uses on Hemp, Bulb Onion, and Stevia plus Crop Group 
Expansions'' in docket ID EPA-HQ-OPP-2021-0130.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the July 28, 2020, 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).
    Codex has not established ethalfluralin MRLs in/on any of the 
commodities for which tolerances were requested. Therefore, 
harmonization is not an issue.

C. Response to Comments

    One comment was received in response to the March 22, 2022, Notice 
of Filing. The comment reads in part ``deny application for fluoride 
use on onions by gowan profiteering co. the detriment to healthy life 
on earth [sic].'' It is unclear whether the commenter intended to 
submit a comment on the present action, which includes a request for a 
tolerance for residues of ethalfluralin, not fluoride, on onions, among 
many other commodities. To the extent the comment is about fluoride 
residues, this comment is irrelevant to the present action. To the 
extent the comment is about ethalfluralin, the commenter has provided 
no information to support a conclusion that the tolerances requested 
would not meet the FFDCA safety standard. The existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute.
    One comment was received in response to the April 28, 2022, Notice 
of Filing. The commenter opposed EPA approving the requested 
tolerances, stating that doing so would poison the food and feed in the 
U.S. Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the FFDCA authorizes EPA to 
establish tolerances when it determines that the tolerance is safe. 
Upon consideration of the validity, completeness, and reliability of 
the available data as well as other factors the FFDCA requires EPA to 
consider, EPA has determined that the trinexapac-ethyl tolerances are 
safe. The commenter has provided no information indicating that a 
safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    Several of the commodity definitions have been modified to conform 
to Agency nomenclature. Additionally, although the petitioner requested 
that EPA establish individual tolerances for the commodities contained 
in the proposed crop subgroups 6-XXE (Dried shelled bean, except 
soybean) and 6-XXF (Dried shelled pea subgroup), EPA is establishing 
tolerances for the corresponding subgroups that have recently been 
established by EPA in a final rule. See the Federal Register of 
September 21, 2022 (87 FR 57627) (FRL-5031-13-OCSPP). The corresponding 
subgroups that are being established are ``Vegetable, legume, pulse, 
bean, dried shelled, except soybean, subgroup 6-22E'' and ``Vegetable, 
legume, pulse, pea, dried shelled, subgroup 6-22F''. The commodities in 
the established subgroups are the same as the individual commodities 
for which the petitioner sought tolerances.
    EPA is not establishing a tolerance for Soybean, vegetable, dry 
seed because it is not a commodity that requires a tolerance. Edamame 
(vegetable soybean) exists only in the succulent seed and edible podded 
forms.

V. Conclusion

    Therefore, tolerances are established for residues of ethalfluralin 
in or on Hemp, seed at 0.05 ppm; Onion, bulb, subgroup 3-07A at 0.01 
ppm; Stevia,

[[Page 21111]]

dried leaves at 0.05 ppm; Stevia, fresh leaves at 0.05 ppm; Vegetable, 
legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 
0.05 ppm; Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F 
at 0.05 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm.
    Additionally, the following tolerances are removed as unnecessary: 
Bean, dry, seed at 0.05 ppm; pea, dry, seed at 0.05 ppm; and potato at 
0.01 ppm. Finally, EPA is removing the tolerance on potato at 0.05 ppm 
as a housecleaning measure, since that tolerance expired on January 28, 
2021.

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 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).

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: March 31, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 as follows:

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

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

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

0
2. In Sec.  180.416, amend paragraph (a) by revising the table to read 
as follows:


Sec.  180.416  Ethalfluralin; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Dill, dried leaves......................................            0.05
Dill, fresh leaves......................................            0.05
Hemp, seed..............................................            0.05
Onion, bulb, subgroup 3-07A.............................            0.01
Peanut..................................................            0.05
Rapeseed subgroup 20A...................................            0.05
Soybean.................................................            0.05
Stevia, dried leaves....................................            0.05
Stevia, fresh leaves....................................            0.05
Sunflower subgroup 20B..................................            0.05
Vegetable, cucurbit, group 9............................            0.05
Vegetable, legume, pulse, bean, dried shelled, except               0.05
 soybean, subgroup 6-22E................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-           0.05
 22F....................................................
Vegetable, tuberous and corm, subgroup 1C...............            0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-07456 Filed 4-7-23; 8:45 am]
BILLING CODE 6560-50-P


This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.