88 FR 96 pgs. 31625-31629 - 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
Type: RULEVolume: 88Number: 96Pages: 31625 - 31629
Pages: 31625, 31626, 31627, 31628, 31629Docket number: [EPA-HQ-OPP-2021-0612; FRL-10972-01-OCSPP]
FR document: [FR Doc. 2023-10349 Filed 5-17-23; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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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.
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: 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).
[top] • 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 Federal Register Office'se-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.
[top] 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
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 ß-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, LD 50 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
[top] 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
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.
[top] 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
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
1. The authority citation for part 180 continues to read as follows:
Authority:
21 U.S.C. 321(q), 346a and 371.
2. In §?180.910, 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:
§?180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.
| Inert ingredients | Limits | Uses |
|---|---|---|
| * * * * * * * | ||
| D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364-77-8) | Surfactant. | |
| D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577-37-4) | Surfactant. | |
| D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031-35-0) | Surfactant. | |
| * * * * * * * |
[FR Doc. 2023-10349 Filed 5-17-23; 8:45 am]
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