D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts; Exemptions From the Requirement of a Tolerance, 31625-31629 [2023-10349]

Download as PDF Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Rules and Regulations National Environmental Policy Act (NEPA) This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because this is a technical regulation. (For further information see 43 CFR 46.210(i).) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA. Effects on the Energy Supply (Executive Order 13211) This rulemaking is not a significant energy action under the definition in Executive Order 13211; the rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and the rule has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. A Statement of Energy Effects is not required. Determination To Issue Final Rule Without the Opportunity for Public Comment and With Immediate Effective Date The NPS recognizes that under 5 U.S.C. 553(b) and (c), notice of proposed rules ordinarily must be published in the Federal Register and the agency must give interested parties an opportunity to submit their views and comments. The NPS has determined under 5 U.S.C. 553(b) and 318 DM HB 5.3, however, that notice and public comment for this rule are not required. We find good cause to treat notice and comment as unnecessary because this rule simply updates the address of the Division of Permits Management that appears in NPS regulations to reflect the current address of the Division. List of Subjects in 36 CFR Part 7 lotter on DSK11XQN23PROD with RULES1 District of Columbia, National parks, Reporting and recordkeeping requirements. In consideration of the foregoing, the National Park Service amends 36 CFR part 7 as follows: PART 7—SPECIAL REGULATIONS, AREAS OF THE NATIONAL PARK SYSTEM 1. The authority for part 7 continues to read as follows: ■ Authority: 54 U.S.C. 100101, 100751, 320102; Sec. 7.96 also issued under DC Code 10–137 and DC Code 50–2201.07. VerDate Sep<11>2014 16:21 May 17, 2023 Jkt 259001 2. In § 7.96, amend paragraph (g)(3) by revising the first sentence to read as follows: ■ § 7.96 National Capital Region. * * * * * (g) * * * (3) Permit applications. Permit applications may be obtained at the Division of Permits Management, National Mall and Memorial Parks, 1100 Ohio Drive SW, Washington, DC 20024. * * * * * * * * Shannon Estenoz, Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. 2023–10377 Filed 5–17–23; 8:45 am] BILLING CODE 4312–52–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2021–0612; FRL–10972–01– OCSPP] D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; Dglucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts; Exemptions From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes exemptions from the requirement of a tolerance for residues of Dglucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts when used as inert ingredients (surfactants) pre- and post-harvest. Lamberti USA, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, SUMMARY: PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 31625 potassium salts; and D-glucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts, when used in accordance with the terms of these exemptions. This regulation is effective May 18, 2023. Objections and requests for hearings must be received on or before July 17, 2023 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The dockets for these actions, identified by docket identification (ID) number EPA–HQ– OPP–2021–0612, 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. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–1030; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). E:\FR\FM\18MYR1.SGM 18MYR1 31626 Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Rules and Regulations II. Petition for Exemption 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 Federal Register Office’s e-CFR site at https://www.ecfr.gov/ current/title-40/chapter-I/subchapter-E/ part-180?toc=1. lotter on DSK11XQN23PROD 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–2021–0612, in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 17, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2021–0612, by one of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/where-sendcomments-epa-dockets#express. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. VerDate Sep<11>2014 16:21 May 17, 2023 Jkt 259001 In the Federal Register of June 22, 2022 (87 FR 37287) (FRL–9410–02– OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–11613) by Spring Regulatory Sciences, on behalf of Lamberti-USA, Inc. (Lamberti), 161 Washington Street, Conshohocken, PA 19428. The petition requested that 40 CFR 180.910 be amended by establishing exemptions from the requirement of a tolerance for residues of D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031–35–0); D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364–77–8); and Dglucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No, 1228577–37–4) when used as inert ingredients (surfactants) in pesticide formulations pre- and postharvest. That document referenced a summary of the petition prepared by Lamberti, which is available in the docket at https://www.regulations.gov. There were no comments received in response to the notice of filing. 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(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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(c)(2)(A)(ii) of FFDCA PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 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. When making a safety determination for an exemption from the requirement of a tolerance, FFDCA section 408(c)(2)(B) directs EPA to take into account the considerations in section 408(b)(2)(C) and (D). 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 or exemption 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 . . . .’’ Section 408(b)(2)(D) lists other factors for EPA’s consideration in making safety determinations, e.g., the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances, among other factors. EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of these actions. EPA has sufficient data to assess the hazards of and to make a determination on E:\FR\FM\18MYR1.SGM 18MYR1 Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 aggregate exposure for D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts, including exposure resulting from the exemptions established by this action. These three chemicals are potassium salts of alkyl (C8–C20) polyglucoside esters (AGEs) and are herein referred to as the AGE potassium salts. EPA’s assessment of exposures and risks associated with the AGE potassium salts follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their 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. Specific information on the studies received and the nature of the adverse effects caused by the AGE potassium salts as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit. The toxicological database of the AGE potassium salts is supported by data used for the Agency’s 2015 evaluation of two AGE sodium salts and one AGE lactate (80 FR 31481, June 3, 2015). When EPA previously reviewed those AGEs, limited data were available, and the Agency determined that it would be appropriate to bridge to data for similar chemicals. EPA has determined that a similar approach is appropriate for the three AGE potassium salts because of the similarities in the manufacturing processes, functional groups/structure, composition, physical/chemical properties, and expected toxicity of these chemicals to those previously reviewed. The AGEs are reaction products of glucose and fatty acids in which the alcohol moiety is attached to the polyglucoside by a b-glucosides linkage. Alkyl polyglucoside is the first degradation product in the biodegradation pathway of the AGEs, and toxicity data for alkyl polyglucoside are very similar for the different alcohol chain lengths in the range C8–C20. The toxicity profile of the AGE potassium salts is therefore based upon data considered in the previous risk assessment for AGE sodium salts and VerDate Sep<11>2014 16:21 May 17, 2023 Jkt 259001 AGE lactate where the alcohol component of the AGE substances is in the same C8–C20 range and is considered appropriate for read across purposes. Specifically, EPA considered data for D-glucopyranose, oligomeric, 6(dihydrogen 2-hydroxy-1,2,3propanetricarboxylate), 1-(coco alky) ethers, sodium salts (CAS No. 151911– 51–2); D-glucopyranose, oligomeric, 6(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911–53–4); D-glucopyranose, oligomeric, 6-[hydrogen (2R, 3R)-2,3dihydroxybutanedioate], 1-(coco alkyl) ethers, sodium salts (CAS No. 151911– 52–3); and D-Glucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, sodium salts (CAS No. 1228577–41–0), as well as the metabolites disodium sulfosuccinate and other sulfosuccinates. In acute studies, the oral lethal dose, LD50 for the AGEs was >5,000 milligrams/kilogram (mg/kg). There is no available data regarding acute exposure via the dermal, eye or inhalation routes. Repeat dose studies were conducted with alkyl polyglucosides and organic acids (metabolites) in which no toxicity was seen at doses as high as 1,000 mg/kg/ day. No fetal, parental, or reproductive toxicity was seen in a reproduction/ developmental toxicity screening test up to 1,000 mg/kg/day. In addition, no evidence of neurotoxicity was seen in the database. Ames studies conducted with various AGE sodium salts were negative for mutagenicity, and there was no indication of carcinogenicity when the Agency evaluated the carcinogenic potential of AGEs by conducting a qualitative structure activity relationship (SAR) using the database, DEREK Nexus Version 2.0. No structural alerts were identified for carcinogenicity. Specific information on the studies reviewed and the nature of the adverse effects caused by the AGEs can be found at https://www.regulations.gov in the documents ‘‘IN–11613; Alkyl (C8–C20) polyglucoside esters (AGEs) potassium salts. Human Health Risk Assessment and Ecological Effects Assessment to Support Inert Ingredient Approval for use in Pesticide Formulations’’ in docket ID number EPA–HQ–OPP–2021– 0612, and ‘‘PC Codes 911028, 911029, 911030: Alkyl (C8–C20) polyglucoside Esters (AGEs); Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations’’ PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 31627 in docket ID number EPA–HQ–OPP– 2014–0678. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-pesticide-program. The hazard profile of the AGE potassium salts is adequately defined. These salts are rapidly hydrolyzed in intestine and liver. The cleavage products, sugars, and long-chain alcohols enter the pathways of lipid and carbohydrate metabolism. Based on the low acute, subchronic, and developmental toxicity of AGEs, the body’s ability to rapidly metabolize these substances, the expected metabolites being fatty acids and carbohydrates (which are normal constituents of the body), and the lack of observed adverse effects for repeat dose studies at the limit dose (1,000 mg/ kg/day), no toxicological endpoint of concern or PODs were identified. Therefore, a qualitative risk assessment for the AGE potassium salts can be performed. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to the AGE potassium salts, EPA considered exposure under the proposed exemptions from the E:\FR\FM\18MYR1.SGM 18MYR1 lotter on DSK11XQN23PROD with RULES1 31628 Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Rules and Regulations requirement of a tolerance. There are no other known food uses for these chemicals; therefore, EPA assessed the proposed dietary exposures from the AGE potassium salts in food as follows: Dietary exposure (food and drinking water) to the AGE potassium salts may occur following ingestion of foods with residues from their use in accordance with these exemptions. However, a quantitative dietary exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified. 2. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). AGE potassium salts may be present in pesticide and non-pesticide products that may be used in and around the home, including personal care products such as antiperspirants, shampoos, conditioners, and moisturizers. However, a quantitative residential exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified. 3. 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.’’ Based on the lack of toxicity in the available database, EPA has not found the AGE potassium salts to share a common mechanism of toxicity with any other substances, and the AGE potassium salts do not appear to produce a toxic metabolite produced by other substances. For the purposes of these tolerance exemptions, therefore, EPA has assumed that AGE potassium salts do 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/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. D. Additional Safety Factor for the Protection of Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety VerDate Sep<11>2014 16:21 May 17, 2023 Jkt 259001 for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act safety factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. Based on an assessment of surrogate data for the AGE potassium salts, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. Because there are no threshold effects associated with the AGE potassium salts, EPA conducted a qualitative assessment. As part of that assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. E. Aggregate Risks and Determination of Safety Because no toxicological endpoints of concern were identified, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to the AGE potassium salt residues. V. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing exemptions from the requirement of a tolerance without any numerical limitation. VI. Conclusions Therefore, exemptions from the requirement of a tolerance are established for residues of Dglucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031– 35–0); D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364–77–8); and Dglucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577–37–4) when used as inert ingredients (surfactants) in pesticide formulations applied pre- and post-harvest under 40 CFR 180.910. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 VII. Statutory and Executive Order Reviews This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions 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 E:\FR\FM\18MYR1.SGM 18MYR1 31629 Federal Register / Vol. 88, No. 96 / Thursday, May 18, 2023 / Rules and Regulations 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 Therefore, for the reasons stated in the preamble, the EPA amends 40 CFR chapter I as follows: 2. In § 180.910, amend Table 1 to 180.910 by adding, in alphabetical order, entries for ‘‘D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364–77–8)’’, ‘‘Dglucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577–37–4)’’, and ‘‘Dglucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031– 35–0)’’ to read as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. ■ Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 10, 2023. Charles Smith, Director, Registration Division, Office of Pesticide Programs. * * * * * 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. TABLE 1 TO 180.910 Inert ingredients Limits * * * * * D-glucopyranose, oligomeric, maleates, C10–16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364–77–8). D-glucopyranose, oligomeric, maleates, C9–11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577–37–4). D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031–35–0). * ........................ * Surfactant. ........................ Surfactant. ........................ Surfactant. * * * [FR Doc. 2023–10349 Filed 5–17–23; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2022–0942; FRL–10868–01– OCSPP] Erucamide in Pesticide Formulations; Tolerance Exemption This regulation establishes an exemption from the requirement of a tolerance for residues of erucamide (CAS Reg. No. 112–84–5) when used as an inert ingredient (lubricant) in pesticide formulations when applied on the raw agricultural commodities honey and honeycomb. Veto-Pharma SAS submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a lotter on DSK11XQN23PROD with RULES1 VerDate Sep<11>2014 16:21 May 17, 2023 Jkt 259001 * tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of erucamide, when used in accordance with the terms of this exemption. DATES: This regulation is effective May 18, 2023. Objections and requests for hearings must be received on or before July 17, 2023 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2022–0942, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP docket is (202) 566–1744. For the latest ADDRESSES: Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: * PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 * Uses * status information on EPA/DC services, docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–2427; 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). E:\FR\FM\18MYR1.SGM 18MYR1

Agencies

[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Rules and Regulations]
[Pages 31625-31629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10349]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0612; FRL-10972-01-OCSPP]


D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides, 
sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, 
C10-16-alkyl glycosides, sulfonated, potassium salts; and D-
glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl 
glycosides, sulfonated, potassium salts; Exemptions From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of D-glucopyranose, oligomeric, maleates, 
decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, 
oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium 
salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and 
linear alkyl glycosides, sulfonated, potassium salts when used as inert 
ingredients (surfactants) pre- and post-harvest. Lamberti USA, Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting establishment of exemptions from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of D-glucopyranose, 
oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium 
salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, 
sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, 
C9-11-branched and linear alkyl glycosides, sulfonated, potassium 
salts, when used in accordance with the terms of these exemptions.

DATES: This regulation is effective May 18, 2023. Objections and 
requests for hearings must be received on or before July 17, 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 these actions, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0612, 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. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

 Crop production (NAICS code 111).
 Animal production (NAICS code 112).
 Food manufacturing (NAICS code 311).
 Pesticide manufacturing (NAICS code 32532).

[[Page 31626]]

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 Federal Register Office'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-2021-0612, in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 17, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2021-0612, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 22, 2022 (87 FR 37287) (FRL-9410-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11613) by Spring Regulatory Sciences, on behalf of Lamberti-USA, Inc. 
(Lamberti), 161 Washington Street, Conshohocken, PA 19428. The petition 
requested that 40 CFR 180.910 be amended by establishing exemptions 
from the requirement of a tolerance for residues of D-glucopyranose, 
oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium 
salts (CAS Reg. No. 2585031-35-0); D-glucopyranose, oligomeric, 
maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS 
Reg. No. 2587364-77-8); and D-glucopyranose, oligomeric, maleates, C9-
11-branched and linear alkyl glycosides, sulfonated, potassium salts 
(CAS Reg. No, 1228577-37-4) when used as inert ingredients 
(surfactants) in pesticide formulations pre- and post-harvest. That 
document referenced a summary of the petition prepared by Lamberti, 
which is available in the docket at https://www.regulations.gov. There 
were no comments received in response to the notice of filing.

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(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for 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(c)(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. When making a safety determination for an 
exemption from the requirement of a tolerance, FFDCA section 
408(c)(2)(B) directs EPA to take into account the considerations in 
section 408(b)(2)(C) and (D). 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 or 
exemption 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 . . . .'' Section 408(b)(2)(D) lists other 
factors for EPA's consideration in making safety determinations, e.g., 
the validity, completeness, and reliability of available data, nature 
of toxic effects, available information concerning the cumulative 
effects of the pesticide chemical and other substances with a common 
mechanism of toxicity, and available information concerning aggregate 
exposure levels to the pesticide chemical and other related substances, 
among other factors.
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no harm to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of these 
actions. EPA has sufficient data to assess the hazards of and to make a 
determination on

[[Page 31627]]

aggregate exposure for D-glucopyranose, oligomeric, maleates, decyl 
octyl glycosides, sulfonated, potassium salts; D-glucopyranose, 
oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium 
salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and 
linear alkyl glycosides, sulfonated, potassium salts, including 
exposure resulting from the exemptions established by this action. 
These three chemicals are potassium salts of alkyl (C8-C20) 
polyglucoside esters (AGEs) and are herein referred to as the AGE 
potassium salts. EPA's assessment of exposures and risks associated 
with the AGE potassium salts follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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. Specific information on the studies received and the nature 
of the adverse effects caused by the AGE potassium salts as well as the 
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in 
this unit.
    The toxicological database of the AGE potassium salts is supported 
by data used for the Agency's 2015 evaluation of two AGE sodium salts 
and one AGE lactate (80 FR 31481, June 3, 2015). When EPA previously 
reviewed those AGEs, limited data were available, and the Agency 
determined that it would be appropriate to bridge to data for similar 
chemicals. EPA has determined that a similar approach is appropriate 
for the three AGE potassium salts because of the similarities in the 
manufacturing processes, functional groups/structure, composition, 
physical/chemical properties, and expected toxicity of these chemicals 
to those previously reviewed.
    The AGEs are reaction products of glucose and fatty acids in which 
the alcohol moiety is attached to the polyglucoside by a [beta]-
glucosides linkage. Alkyl polyglucoside is the first degradation 
product in the biodegradation pathway of the AGEs, and toxicity data 
for alkyl polyglucoside are very similar for the different alcohol 
chain lengths in the range C8-C20. The toxicity profile of the AGE 
potassium salts is therefore based upon data considered in the previous 
risk assessment for AGE sodium salts and AGE lactate where the alcohol 
component of the AGE substances is in the same C8-C20 range and is 
considered appropriate for read across purposes.
    Specifically, EPA considered data for D-glucopyranose, oligomeric, 
6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alky) 
ethers, sodium salts (CAS No. 151911-51-2); D-glucopyranose, 
oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethers, 
sodium salts (CAS No. 151911-53-4); D-glucopyranose, oligomeric, 6-
[hydrogen (2R, 3R)-2,3-dihydroxybutanedioate], 1-(coco alkyl) ethers, 
sodium salts (CAS No. 151911-52-3); and D-Glucopyranose, oligomeric, 
maleates, C9-11-branched and linear alkyl glycosides, sulfonated, 
sodium salts (CAS No. 1228577-41-0), as well as the metabolites 
disodium sulfosuccinate and other sulfosuccinates.
    In acute studies, the oral lethal dose, LD50 for the 
AGEs was >5,000 milligrams/kilogram (mg/kg). There is no available data 
regarding acute exposure via the dermal, eye or inhalation routes. 
Repeat dose studies were conducted with alkyl polyglucosides and 
organic acids (metabolites) in which no toxicity was seen at doses as 
high as 1,000 mg/kg/day. No fetal, parental, or reproductive toxicity 
was seen in a reproduction/developmental toxicity screening test up to 
1,000 mg/kg/day. In addition, no evidence of neurotoxicity was seen in 
the database. Ames studies conducted with various AGE sodium salts were 
negative for mutagenicity, and there was no indication of 
carcinogenicity when the Agency evaluated the carcinogenic potential of 
AGEs by conducting a qualitative structure activity relationship (SAR) 
using the database, DEREK Nexus Version 2.0. No structural alerts were 
identified for carcinogenicity.
    Specific information on the studies reviewed and the nature of the 
adverse effects caused by the AGEs can be found at https://www.regulations.gov in the documents ``IN-11613; Alkyl (C8-C20) 
polyglucoside esters (AGEs) potassium salts. Human Health Risk 
Assessment and Ecological Effects Assessment to Support Inert 
Ingredient Approval for use in Pesticide Formulations'' in docket ID 
number EPA-HQ-OPP-2021-0612, and ``PC Codes 911028, 911029, 911030: 
Alkyl (C8-C20) polyglucoside Esters (AGEs); Human Health Risk 
Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2014-0678.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The hazard profile of the AGE potassium salts is adequately 
defined. These salts are rapidly hydrolyzed in intestine and liver. The 
cleavage products, sugars, and long-chain alcohols enter the pathways 
of lipid and carbohydrate metabolism. Based on the low acute, 
subchronic, and developmental toxicity of AGEs, the body's ability to 
rapidly metabolize these substances, the expected metabolites being 
fatty acids and carbohydrates (which are normal constituents of the 
body), and the lack of observed adverse effects for repeat dose studies 
at the limit dose (1,000 mg/kg/day), no toxicological endpoint of 
concern or PODs were identified. Therefore, a qualitative risk 
assessment for the AGE potassium salts can be performed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to the AGE potassium salts, EPA considered exposure under the 
proposed exemptions from the

[[Page 31628]]

requirement of a tolerance. There are no other known food uses for 
these chemicals; therefore, EPA assessed the proposed dietary exposures 
from the AGE potassium salts in food as follows:
    Dietary exposure (food and drinking water) to the AGE potassium 
salts may occur following ingestion of foods with residues from their 
use in accordance with these exemptions. However, a quantitative 
dietary exposure assessment was not conducted since a toxicological 
endpoint for risk assessment was not identified.
    2. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables). AGE 
potassium salts may be present in pesticide and non-pesticide products 
that may be used in and around the home, including personal care 
products such as antiperspirants, shampoos, conditioners, and 
moisturizers. However, a quantitative residential exposure assessment 
was not conducted since a toxicological endpoint for risk assessment 
was not identified.
    3. 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.''
    Based on the lack of toxicity in the available database, EPA has 
not found the AGE potassium salts to share a common mechanism of 
toxicity with any other substances, and the AGE potassium salts do not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of these tolerance exemptions, therefore, EPA has assumed 
that AGE potassium salts do 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
safety factor. In applying this provision, EPA either retains the 
default value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    Based on an assessment of surrogate data for the AGE potassium 
salts, EPA has concluded that there are no toxicological endpoints of 
concern for the U.S. population, including infants and children. 
Because there are no threshold effects associated with the AGE 
potassium salts, EPA conducted a qualitative assessment. As part of 
that assessment, the Agency did not use safety factors for assessing 
risk, and no additional safety factor is needed for assessing risk to 
infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to the AGE potassium salt residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing exemptions from the requirement of a 
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of D-glucopyranose, oligomeric, maleates, 
decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 
2585031-35-0); D-glucopyranose, oligomeric, maleates, C10-16-alkyl 
glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364-77-8); 
and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear 
alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577-37-
4) when used as inert ingredients (surfactants) in pesticide 
formulations applied pre- and post-harvest under 40 CFR 180.910.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001), or Executive Order 13045, entitled ``Protection 
of Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemptions 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

[[Page 31629]]

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: May 10, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

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

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

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

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

0
2. In Sec.  180.910, amend Table 1 to 180.910 by adding, in 
alphabetical order, entries for ``D-glucopyranose, oligomeric, 
maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS 
Reg. No. 2587364-77-8)'', ``D-glucopyranose, oligomeric, maleates, C9-
11-branched and linear alkyl glycosides, sulfonated, potassium salts 
(CAS Reg. No. 1228577-37-4)'', and ``D-glucopyranose, oligomeric, 
maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. 
No. 2585031-35-0)'' to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
       Inert ingredients             Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
D-glucopyranose, oligomeric,     ..............  Surfactant.
 maleates, C10-16-alkyl
 glycosides, sulfonated,
 potassium salts (CAS Reg. No.
 2587364-77-8).
D-glucopyranose, oligomeric,     ..............  Surfactant.
 maleates, C9-11-branched and
 linear alkyl glycosides,
 sulfonated, potassium salts
 (CAS Reg. No. 1228577-37-4).
D-glucopyranose, oligomeric,     ..............  Surfactant.
 maleates, decyl octyl
 glycosides, sulfonated,
 potassium salts (CAS Reg. No.
 2585031-35-0).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2023-10349 Filed 5-17-23; 8:45 am]
BILLING CODE 6560-50-P
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