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 Environmental Protection Agency 40 CFR Part 180
[EPA-HQ-OPP-2021-0185; FRL-9925-01-OCSPP]
 AGENCY: Environmental Protection Agency (EPA).
 ACTION: Final rule.
 SUMMARY: This regulation amends tolerances for residues of benoxacor in or on field corn, popcorn, and sweet corn commodities when used as an inert ingredient (herbicide safener) in pesticide formulations. Management Contract Service, Inc., on behalf of Landis International, submitted a petition requesting this tolerance amendment under the Federal Food, Drug, and Cosmetic Act (FFDCA).
 DATES: This regulation is effective July 15, 2022. Objections and requests for hearings must be received on or before September 13, 2022 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-2021-0185, 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 OPP Docket is (202) 566-1744. Please review the visitor instructions and additional information about the docket available at 
                        *https://www.epa.gov/​dockets.*
 FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address: 
                        *RDFRNotices@epa.gov.*


SUPPLEMENTARY INFORMATION:  I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Crop production (NAICS code 111).
                Animal production (NAICS code 112).
                Food manufacturing (NAICS code 311).
                Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at 
                    *https://www.ecfr.gov/​current/​title-40.* C. 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-2021-0185 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before September 13, 2022. 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-2021-0185, 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/​contacts.html.* 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 June 1, 2021 (86 FR 29229), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11407) filed by Management Contract Services, Inc. on behalf of Landis International, Inc., P.O. Box 5126, Valdosta, GA 31603. The petition requested that EPA amend the tolerance in 40 CFR 180.460 for residues of benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2
                    *H*
                    -1,4-benzoxazine) (CAS Reg. No. 98730-04-2) as an inert safener in or on the raw agricultural commodity for which tolerances have been established for metolachlor or S-metolachlor at 0.01 ppm for all pesticide formulations. The published petition summary requested to amend benoxacor tolerances when used as a pesticide inert ingredient (safener) in pesticide formulations to include any herbicide in or on raw agricultural commodities for which tolerances have been established at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by the petitioner, 
                    ( print page 42328)
                    which is in the docket, and solicited comments on the petitioner's request. The Agency did not receive any significant public comments. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to benoxacor, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with benoxacor follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Benoxacor has low acute toxicity via the oral, dermal, and inhalation routes. It is not a skin irritant, but it is a moderate eye irritant and a skin sensitizer. In repeated-dose toxicity studies, the kidneys, liver, and stomach are the major target organs. There is no evidence of susceptibility in the available developmental and reproduction toxicity studies. No adverse maternal or developmental effects were found in the developmental toxicity study in rabbits and the offspring effects observed in the developmental and reproduction toxicity studies in rats occurred at the same doses at which maternal toxicity was observed. Negative results were observed in mutagenicity and genotoxicity studies with benoxacor. Although stomach tumors were observed in mice and rats, these results were considered equivocal and to be of little or no relevance to humans. Consequently, EPA described the carcinogenic potential of benoxacor as “cannot be determined but suggestive”, based on the 1996 Proposed Guidelines for Carcinogenic Risk Assessment, which can be found here 
                    *https://cfpub.epa.gov/​ncea/​risk/​recordisplay.cfm?​deid=​55868.*
                     Based on the cancer classification, the chronic reference dose is considered protective of the potential for cancer effects. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies points of departure (PODs) and levels of concern (LOCs) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see 
                    *https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​assessing-human-health-risk-pesticides.* A summary of the toxicological endpoints for benoxacor used for human risk assessment is shown in Table 1 of this unit. Table 1—Summary of Toxicological Doses and Endpoints for Benoxacor for Use in Human Health Risk Assessment
Exposure/scenario
Point of departure and uncertainty/safety factors
RfD, PAD, LOC for 
                             risk assessment
Study and toxicological effectsAcute Dietary (General Population including infants and Children)
NOAEL = 100 mg/kg/day
                             
                                UF
                                A
                                 = 10x
                             
                             
                                UF
                                H
                                 = 10x
                             
                             FQPA SF = 1x
Acute RfD = 1.0 mg/kg/day
                             aPAD = 1.0 mg/kg/day
Developmental (Rat): LOAEL = 400 mg/kg/day based on early resorptions.( print page 42329)Chronic Dietary (All Populations)
NOAEL= 0.4 mg/kg/day
                             
                                UF
                                A
                                 = 10x
                             
                             
                                UF
                                H
                                 = 10x
                             
                             FQPA SF = 1x
Chronic RfD = 0.004 mg/kg/day
                             cPAD = 0.004 mg/kg/day
Combined Chronic/Carcinogenicity (Rat): LOAEL = 2 mg/kg/day based on increased incidence of centro-lobular hepatic enlargement with or without hepatocyte vacuolation in the males.Incidental Oral Short-Term (1-30 days) and Intermediate-Term (1-6 months)
NOAEL = 50 ppm (4.6 mg/kg/day)
                             
                                UF
                                A
                                 = 10x
                             
                             
                                UF
                                H
                                 = 10x
                             
                             FQPA SF = 1x
LOC for MOE < 100
Reproduction toxicity study in rats MRID 42888703 LOAEL = 500 ppm (64 mg/kg/day for the F1 generation and 72.3 mg/kg/day for the F2 generation), based on decreased pup body weight on lactation day 21.Dermal Short-Term (1-30 days) and Intermediate-Term (1-6 months)
No dermal endpoint selected because no systemic effects were observed in the dermal study up to the limit dose and there is no evidence of increased susceptibility in the young.Inhalation Short-Term (1-30 days) and Intermediate-Term (1-6 months)
NOAEL = 50 ppm (4.6 mg/kg/day)
                             
                                UF
                                A
                                 = 10x
                             
                             
                                UF
                                H
                                 = 10x
                             
                             FQPA SF = 1x
LOC for MOE < 100
Reproduction toxicity study in rats MRID 42888703 LOAEL = 500 ppm (64 mg/kg/day for the F1 generation and 72.3 mg/kg/day for the F2 generation), based on decreased pup body weight on lactation day 21 and decreased parental weight.Cancer (Oral, Dermal, Inhalation)
The carcinogenic potential of benoxacor was described as “cannot be determined but suggestive”. The use of the RfD approach is protective of any potential carcinogenicityFQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. NOAEL = no observed adverse effect level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UF
                        A
                         = extrapolation from animal to human (interspecies). UF
                        H
                         = potential variation in sensitivity among members of the human population (intraspecies).
 C. Exposure Assessment 1. 
                    *Dietary exposure from food and feed uses.*
                     In evaluating dietary exposure to benoxacor, EPA considered exposure under the existing and petitioned-for tolerances. EPA assessed dietary exposures from benoxacor in food as follows: i. 
                    *Acute exposure.*
                     Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for benoxacor. Acute dietary (food only) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The current assessment includes every commodity available in DEEM. EPA conducted an unrefined acute dietary (food only) exposure assessment for the proposed uses of benoxacor. Food residues for all commodities were assumed to be at the tolerance level for 100% of crops treated; that is, a value of 0.01 ppm was assumed for all commodities upon which a tolerance has been established for metolachlor or S-metolachlor. Results of the acute dietary assessment indicate that the general U.S. population and all other population subgroups have exposure and risk estimates below EPA's level of concern (LOC). ii. 
                    *Chronic exposure.*
                     In conducting the chronic dietary (food only) exposure assessment, EPA used DEEM-FCID Version 4.02 with 2005-10 food consumption data from the USDA's NHANES/WWEIA. The current assessment includes every commodity available in DEEM. EPA conducted an unrefined chronic dietary (food only) exposure assessment for the proposed uses of benoxacor. Food residues for all commodities were assumed to be at the tolerance level for 100% of crops treated; that is, a value of 0.01 ppm was assumed for all commodities upon which a tolerance has been established for metolachlor or S-metolachlor. iii. 
                    *Cancer.*
                     Based on the data summarized in Unit IV.A., EPA has concluded that the chronic reference dose will be protective of the potential for cancer effects in humans. Therefore, a separate dietary exposure assessment for the purpose of assessing cancer risk was not performed. iv. 
                    *Anticipated residue and percent crop treated (PCT) information.*
                     EPA did not use anticipated residue and/or PCT information in the dietary assessment for benoxacor. Tolerance level residues and/or 100% CT were assumed for all food commodities. 2. 
                    *Dietary exposure from drinking water.*
                     A drinking water concentration of 0.025 ppm (24.8 ppb) was used for both acute and chronic exposure scenarios based on modeling using the US EPA Pesticide Water Calculator 
                    ( print page 42330)
                    (PWC) Version 1.52. Water modeling assumptions included 5% benoxacor in formulation and application rate of 0.5 lb/acre of benoxacor. 3. 
                    *From non-dietary exposure.*
                     The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (
                    *e.g.,*
                     for lawn and garden pest control, indoor pest control, termiticides, and fleas and tick control on pets). The proposed use of benoxacor in corn crops is not anticipated to result in residential exposure. Residential exposure (post-application only) to benoxacor may occur from existing pesticide uses in formulations with s-metolachlor (
                    *e.g.,*
                     uses on warm-season turf grasses, and other non-crop land including golf courses, sports fields, parks, lawns, and ornamental gardens that would result in residential post-application exposures). There are no current or proposed residential handler uses for benoxacor; therefore, a residential handler assessment was not conducted. For residential post-application exposure scenarios (short- and intermediate-term child hand to mouth) and dietary exposure were used for the aggregate exposure assessments. 4. 
                    *Cumulative effects from substances with a common mechanism of toxicity.*
                     Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found benoxacor to share a common mechanism of toxicity with any other substances, and benoxacor does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benoxacor does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at 
                    *https://www.epa.gov/​pesticides/​cumulative.* D. Safety Factor for Infants and Children 1. 
                    *In general.*
                     Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional ten-fold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety factor (SF). in applying this provision, the 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 susceptibility in the available developmental and reproduction toxicity studies. No adverse maternal or developmental effects were found in the developmental toxicity study in rabbits and the offspring effects observed in the developmental and reproduction toxicity studies in rats occurred at the same doses at which maternal toxicity was observed. There are no residual uncertainties identified in the exposure databases. An unrefined dietary exposure assessment was completed, and tolerance level residues and 100% CT were assumed. EPA used similarly conservative assumptions to assess post-application exposures of children. Thus, these assessments will not underestimate the exposure and risks posed by benoxacor. 3. 
                    *Conclusion.*
                     EPA has determined that reliable data show the safety of infants and children is adequately protected when reducing the FQPA SF from 10x to 1x. The FQPA safety factor has been reduced to 1x because: (1) the toxicity database is adequate to characterize potential pre- and postnatal risk for infants and children; (2) no reproductive effects were observed in rats; (3) although there were slight developmental/offspring effects in the reproductive and developmental studies in rats, these were seen in the presence of comparable parental toxicity, thus, there is no evidence of increase susceptibility in the young; (4) the endpoints selected are protective of any potential neurotoxic effects; (5) the PODs selected for risk assessment purposes are protective of the offspring effects seen in the database; and (6) the exposure assumptions are unlikely to underestimate risk. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. 
                    *Acute risk.*
                     An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption from food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to benoxacor will occupy 0.17% of the aPAD for the general U.S. population, and 0.50% of the aPAD for the highest exposed population subgroup, non-nursing infants. 2. 
                    *Chronic risk.*
                     Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to benoxacor from food and water will utilize 18.0% of the cPAD for the general U.S. population, and 75.5% of the cPAD for the highest exposed population subgroup, non-nursing infants. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of benoxacor is not expected. 3. 
                    *Short-term risk.*
                     Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The short-term aggregate MOE is 550 for adults and 125 for children. As the level of concern is for MOEs that are lower than 100, these MOEs are not of concern. 4. 
                    *Intermediate-term risk.*
                     Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The intermediate-term aggregate MOE is 550 for adults and 127 for children. As the level of concern is for MOEs that are lower than 100, there are no concerns for intermediate-term aggregate risk. 5. 
                    *Aggregate cancer risk for U.S. population.*
                     The RfD methodology is considered protective of any potential carcinogenicity. Because the aggregate chronic risk is not of concern, EPA concludes that there is not a cancer risk from aggregate exposure to benoxacor. 6. 
                    *Determination of safety.*
                     Based on its risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general U.S. population, or to infants and children from aggregate exposure to benoxacor residues.
                    ( print page 42331) V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography with nitrogen phosphorous detection (GC/NPD)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
                    *residuemethods@epa.gov.* B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for benoxacor. C. Revisions to Petitioned-For Tolerances After submitting its original petition seeking tolerances of 0.01 ppm on all commodities on which any herbicidal formulations may be used, the petitioner revised its request to tolerances for residues of benoxacor on only field corn, popcorn, and sweet corn commodities when benoxacor is used in any herbicidal formulation. The available residue data was limited to corn commodities, and because residues may differ between commodities, there was not sufficient data to support extending the benoxacor tolerances beyond corn commodities. VI. Conclusion Taking into consideration all available information on benoxacor, EPA has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to benoxacor residues. Therefore, tolerances are established for residues of benoxacor, including its metabolites and degradates, in or on corn, field, forage; corn, field, grain; corn, field, stover; corn, pop, grain; corn, pop, stover; corn, sweet, forage; corn, sweet, kernel plus cob with husks removed; and corn, sweet, stover at 0.01 ppm. Compliance with the tolerances is to be determined by measuring only benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2
                    *H*
                    -1,4-benzoxazine). VII. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule 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 section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (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: July 8, 2022. Marietta Echeverria 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 § 180.460, paragraph (a) is revised to read as follows: § 180.460
  (a) 
                            *General.*
                             (1) Tolerances are established for residues of the inert ingredient (safener) benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2H-1, 4-benzoxazine) at 0.01 parts per million (ppm) when used in pesticide formulations containing metolachlor or S-metolachlor in or on raw agricultural commodities for which tolerances have 
                            ( print page 42332)
                            been established for metolachlor orS-metolachlor. (2) Tolerances are established for residues of benoxacor, including its metabolites and degradates, in or on the commodities in the following table, when used as an inert ingredient (herbicide safener) in pesticide formulations. Compliance with the tolerance levels specified in the following table is to be determined by measuring only benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-2
                            *H*
                            -1,4-benzoxazine). Table 1 to Paragraph 
                                (a)
Commodity
Parts per 
                                     millionCorn, field forage
0.01Corn, field, grain
0.01Corn, field, stover
0.01Corn, pop, grain
0.01Corn, pop, stover
0.01Corn, sweet, forage
0.01Corn, sweet, kernel plus cob with husks removed
0.01Corn, sweet, stover
0.01


[FR Doc. 2022-15018 Filed 7-14-22; 8:45 am] BILLING CODE 6560-50-P