Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium, Sodium, Potassium, Calcium, Magnesium, and Zinc Salts; Exemption from the Requirement of a Tolerance, 45079-45085 [2015-18610]

Download as PDF Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2014–0325; FRL–9930–22] Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium, Sodium, Potassium, Calcium, Magnesium, and Zinc Salts; Exemption from the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107–36– 8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No. 57267– 78–4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No. 1562–00–1); ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561–99– 5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550–47– 7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345– 56–1), and ethanesulfonic acid, 2hydroxy-, zinc salt (CAS Reg. No. 129756–32–7) when used as inert ingredients (chelator, sequestrant and conditioning agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and applied to animals. Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000 Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethanesulfonic acid, 2-hydroxy- and its corresponding ammonium, sodium, potassium, calcium, magnesium, and zinc salts. DATES: This regulation is effective July 29, 2015. Objections and requests for hearings must be received on or before September 28, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0325, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) ADDRESSES: VerDate Sep<11>2014 16:16 Jul 28, 2015 Jkt 235001 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 is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; 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 Government Printing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, 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 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 45079 provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2014–0325 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 28, 2015. 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– 2014–0325, 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. Petition for Exemption In the Federal Register of August 1, 2014 (79 FR 44729) (FRL–9911–67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10684) by Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000, Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381). The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of ethanesulfonic acid, 2hydroxy- (CAS Reg. No. 107–36–8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No. 57267– 78–4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No. 1562–00–1); E:\FR\FM\29JYR1.SGM 29JYR1 45080 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561–99– 5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550–47– 7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345– 56–1), and ethanesulfonic acid, 2hydroxy-, zinc salt (CAS Reg. No. 129756–32–7) when used as inert ingredients (chelator, sequestrant, and conditioning agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and applied to animals in accordance with 40 CFR 180.910 and 180.930, respectively. That document referenced a summary of the petition prepared by Technology Sciences Group Inc., the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. mstockstill on DSK4VPTVN1PROD with RULES 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(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 VerDate Sep<11>2014 16:16 Jul 28, 2015 Jkt 235001 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 . . . .’’ 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 appreciable risks 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 this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ethanesulfonic acid, 2-hydroxy and the corresponding ammonium, sodium, potassium, calcium, magnesium, and zinc salts (also referred to as isethionic acid and its salts) including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with isethionic acid and its 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 isethionic acid and its 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. PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 Isethionate salts are expected to metabolize and dissociate into isethionic acid in the body. Therefore, toxicity for each of the isethionate salt forms are expected to have equal toxicity and share similar physical and chemical characteristics. Studies on isethionic acid or any one of its salt can be considered relevant for the entire group. The acute oral toxicity of isethionic acid ammonium salt is low. The acute oral lethal dose (LD)50 in rats were > 1,000 milligram/kilogram/body weight (mg/kg-bw). The acute dermal toxicity in rats was > 1,000 mg/kg-bw. Ammonium isethionate is a minimal eye irritant based on a primary eye irritation study in rabbits. Ammonium isethionate is not dermally irritating based on a primary skin irritation study in rabbits. Ammonium isethionate has an acute inhalation lethal concentration (LC)50 > 6.295 milligram/liter (mg/L) and is not a dermal sensitizer. In a 90-day oral toxicity study on rats via gavage with sodium isethionate, decreased mean corpuscular hemoglobin concentration, increased mean absolute and relative reticulocyte counts, increased spleen weights and microscopic changes in the liver, bile duct, and spleen were observed at 1,000 milligram/kilogram/day (mg/kg/day) (LOAEL). Effects showed complete reversal after exposure was discontinued. The NOAEL for sodium isethionate was identified in this study as 200 mg/kg/day. In an OSCPP Harmonized Test Guideline 870.3650 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, ammonium isethionate was administered to rats by gavage. The parental systemic LOAEL for ammonium isethionate is 500 mg/kg/ day based on absolute and relative kidney weights and relative adrenal weights, and the parental systemic NOAEL is 250 mg/kg/day. The reproductive/developmental LOAEL for ammonium isethionate in rats was not identified, and the reproductive/ developmental NOAEL is greater than or equal to 500 mg/kg/day. Ammonium isethionate was negative for mutagenicity or chromosomal aberrations in a battery of tests of genotoxicity including a reverse gene mutation assay in bacteria, an in vitro mammalian cell gene mutation test using mouse lymphoma cells and an in vitro mammalian cell micronucleus test. The OncoLogicTM structure-activity model was used to evaluate the likelihood that isethionic acid and its salts may cause cancer. Structureactivity modeling using Oncologic E:\FR\FM\29JYR1.SGM 29JYR1 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations indicates that isethionic acid does not contain structural alerts of potential concern for carcinogenicity. Based on the negative results for genotoxicity as well as the structure-activity model for carcinogenicity there is a low concern for isethionic acid and its salts as potential carcinogens. No neurotoxicity studies were available in the database for isethionic acid and its salts. However, a functional observational battery (FOB) and locomotor activity patterns were evaluated in the combined reproduction/developmental toxicity screening test and 90-day oral toxicity study. No alterations in the FOB or locomotor activity patterns were observed. No Immunotoxicity studies on isethionic acid and its salts were available in the database. Increased spleen weights and microscopic changes in the spleen were observed in the 90- day toxicity study in rats; however, the chronic reference dose (cRfD) is based on this study and is protective of these effects. No metabolism studies were available in the database for isethionic acid and its salts. 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 the NOAEL and the 45081 LOAEL are identified. 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/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for isethionic acid and its salts used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISETHIONIC ACID AND ITS SALTS FOR USE IN HUMAN RISK ASSESSMENT Exposure/scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (Females 13–50 years of age). An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Acute dietary (General population including infants and children). An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Chronic dietary (All populations) Incidental oral short-term (1 to 30 days). Incidental oral intermediateterm (1 to 6 months). mstockstill on DSK4VPTVN1PROD with RULES Dermal short-term (1 to 30 days). Dermal intermediate-term (1 to 6 months). VerDate Sep<11>2014 16:16 Jul 28, 2015 NOAEL = 200 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x NOAEL = 200 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x NOAEL = 200 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Dermal (or oral) study NOAEL = 200 mg/kg/day (dermal absorption rate = 100%. UFA = 10x UFH = 10x FQPA SF = 1x Dermal (or oral) study NOAEL = 200 mg/kg/day (dermal absorption rate = 100%. UFA = 10x UFH = 10x FQPA SF = 1x Jkt 235001 PO 00000 Chronic RfD = 200 mg/kg/day. cPAD = 2.0 mg/kg/ day. 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\29JYR1.SGM 29JYR1 45082 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISETHIONIC ACID AND ITS SALTS FOR USE IN HUMAN RISK ASSESSMENT—Continued Exposure/scenario Inhalation short-term (1 to 30 days). Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver and microscopic changes in the liver, bile duct and spleen. Inhalation (1 to 6 months) ......... Inhalation (or oral) study NOAEL = 200 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x UFH = 10x FQPA SF = 1x Inhalation (or oral) study NOAEL = 200 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x UFH = 10x FQPA SF = 1x Cancer (Oral, dermal, inhalation). Based on structural activity analysis, lack of effects suggestive of potential carcinogenicity in subchronic studies and negative results for genotoxicity in bacterial and mammalian cell assays, there is a low concern for the salts of isethionate and isethionic acid as potential carcinogens. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). mstockstill on DSK4VPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isethionic acid and its salts, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from isethionic acid and its salts in food as follows: An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM–FCIDTM, Version 3.16 which includes food consumption information from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, ‘‘What We Eat In America’’, (NHANES/ WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model that assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading VerDate Sep<11>2014 16:16 Jul 28, 2015 Jkt 235001 to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled ‘‘Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts’’ (D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA–HQ–OPP–2008–0738. 2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for isethionic acid and its salts, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model. 3. 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), PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Isethionic acid and its salts may be used as inert ingredients in pesticide products that are registered for specific uses that may result in indoor or outdoor residential inhalation and dermal exposures. A screening level residential exposure and risk assessment was completed utilizing conservative residential exposure assumptions. The Agency assessed short- and intermediate-term dermal and inhalation exposures for residential handlers that would result from low pressure hand wand, hose end sprayer and trigger sprayer for each pesticide type, herbicide, insecticide, and fungicide. The Agency assessed postapplication short-term dermal exposure for children short-term hand-to-mouth and dermal exposure for children and adults from contact with treated lawns. 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 isethionic acid and its salts to share a common mechanism E:\FR\FM\29JYR1.SGM 29JYR1 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES of toxicity with any other substances, and isethionic acid and its salts does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isethionic acid and its salts 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 Web site 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 tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Fetal susceptibility was not observed in the combined developmental/ reproduction toxicity screening test in rats. Neither offspring nor reproduction toxicity was observed in this study at dose levels up to 500 mg/kg/day in rats, the highest dose tested. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings: i. The toxicity database for isethionic acid and its salts contains the following acceptable studies: Subchronic, reproduction/developmental screening study, and a mutagenicity study. The database is considered to be adequate to assess prenatal and postnatal toxicity. ii. There is no indication that isethionic acid and its salts are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UF) to account for neurotoxicity. iii. There is no indication that isethionic acid and its salts are immunotoxic chemicals. Although increased spleen weights and VerDate Sep<11>2014 16:16 Jul 28, 2015 Jkt 235001 microscopic changes in the spleen were observed in the 90-day toxicity study in rats those effects were due to red blood cell destruction and therefore not considered an immuno toxic effect. In any event, the cRfD is based on this study and is protective of these effects. Therefore, there is no need for an Immunotoxicity study or additional UFs to account for Immunotoxicity. iv. There is no evidence that isethionic acid and its salts result in increased susceptibility for infants and children. v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isethionic acid and its salts in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isethionic acid and its salts. E. Aggregate Risks and Determination of Safety 1. Determination of safety section. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (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. 2. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, isethionic acid and its salts is not expected to pose an acute risk. 3. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isethionic acid and its salts from food and water will utilize 9.5% of the cPAD for the U.S. population and 35.3% of the cPAD for children 1–2 yrs. old, the population group receiving the greatest exposure. 4. Short-term risk. Short-term aggregate exposure takes into account PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 45083 short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isethionic acid and its salts may be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to isethionic acid and its salts. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 187 for adults and 123 for children. Because EPA’s level of concern for isethionic acid and its salts are MOEs of 100 or below, these MOEs are not of concern. 5. 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). Isethionic acid and its salts are currently used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure. The endpoint of concern selected for short- and intermediate-term exposure assessment is the same NOAEL, therefore intermediate term exposure is not expected to exceed short term aggregate exposure and therefore there are no concerns for intermediate-term aggregate exposure. 6. Aggregate cancer risk for U.S. population. The Agency has not identified any concerns for carcinogenicity relating to isethionic acid and its salts; therefore, a cancer dietary exposure assessment was not performed and an aggregate risk and aggregate cancer risk assessment is not a concern. 7. Determination of safety. Based on these risk assessments, 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 isethionic acid and its salt residues. V. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. VI. Conclusions Therefore, exemptions from the requirement of a tolerance are E:\FR\FM\29JYR1.SGM 29JYR1 45084 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 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). 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 contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). Inert ingredients Limits * * Ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107–36–8). Ethanesulfonic acid, 2-hydroxy-, ammonium salts (CAS Reg. No. 57267–78–4). Ethanesulfonic acid, 2-hydroxy-, calcium salts (CAS Reg. No. 10550–47–7). Ethanesulfonic acid, 2-hydroxy-, magnesium salts (CAS Reg. No. 17345–56–1). Ethanesulfonic acid, 2-hydroxy-, potassium salts (CAS Reg. No. 1561–99–5). Ethanesulfonic acid, 2-hydroxy-, sodium salts (CAS Reg. No. 1562–00–1). Ethanesulfonic acid, 2-hydroxy-, zinc salts (CAS Reg. No. 129756–32–7). * * * ........................................................................... * * Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. established under 40 CFR 180.910 and 40 CFR 180.930 for ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107–36–8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS Reg. No. 57267– 78–4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS Reg. No. 1562–00–1); ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561–99– 5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550–47– 7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345– 56–1), and ethanesulfonic acid, 2hydroxy-, zinc salt (CAS Reg. No. 129756–32–7) when used as inert ingredients (chelators, sequestrants, and conditioning agents) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest and applied to animals. mstockstill on DSK4VPTVN1PROD with RULES VII. Statutory and Executive Order Reviews * VerDate Sep<11>2014 * 16:16 Jul 28, 2015 * Jkt 235001 PO 00000 * Frm 00034 Fmt 4700 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 21, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 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, add alphabetically the inert ingredients to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * Uses * Sfmt 4700 * E:\FR\FM\29JYR1.SGM * 29JYR1 * 45085 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 3. In § 180.930, add alphabetically the inert ingredients to the table to read as follows: ■ § 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance. * * * * * Inert ingredients Limits * * Ethanesulfonic acid, 2-hydroxy- (CAS Reg. No. 107–36–8). Ethanesulfonic acid, 2-hydroxy-, ammonium salts (CAS Reg. No. 57267–78–4). Ethanesulfonic acid, 2-hydroxy-, calcium salts (CAS Reg. No. 10550–47–7). Ethanesulfonic acid, 2-hydroxy-, magnesium salts (CAS Reg. No. 17345–56–1). Ethanesulfonic acid, 2-hydroxy-, potassium salts (CAS Reg. No. 1561–99–5). Ethanesulfonic acid, 2-hydroxy-, sodium salts (CAS Reg. No. 1562–00–1). Ethanesulfonic acid, 2-hydroxy-, zinc salts (CAS Reg. No. 129756–32–7). * * * ........................................................................... * * Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. ........................................................................... Chelator, sequestrant, or conditioning agent. * * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA–HQ–SFUND–2005–0002; FRL–9931– 47–Region 2] National Oil and Hazardous Substance Pollution Contingency Plan National Priorities List: Deletion of the Crown Vantage Landfill Superfund Site Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) Region 2 announces the deletion of the Crown Vantage Landfill Superfund Site (Site), located in Alexandria Township, Hunterdon County, New Jersey, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of New Jersey, through the New Jersey Department of Environmental Protection, have determined that all appropriate response actions under CERCLA, other than long-term maintenance and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund. mstockstill on DSK4VPTVN1PROD with RULES VerDate Sep<11>2014 16:16 Jul 28, 2015 Jkt 235001 * This action is effective August 28, 2015. ADDRESSES: Docket: EPA has established a docket for this action under Docket Identification No. EPA–HQ–SFUND– 2005–0002. All documents in the docket are listed in the https:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in the hard copy. Publicly available docket materials are available either electronically in https:// www.regulations.gov or in hard copy at the Site Information repositories. Locations, contacts, telephone numbers and viewing hours are: U.S. Environmental Protection Agency, Region 2, Superfund Records Center, 290 Broadway, Room 1828, New York, NY 10007–1866, Telephone: 212– 637–4308, Hours: Monday through Friday from 9:00 a.m. to 5:00 p.m. and Milford Public Library, Crown Vantage Landfill Site Repository File, 40 Frenchtown Road, Milford, NJ 08848, Telephone: 908–995–4072, Hours: Monday 12:00 p.m. to 7:00 p.m., Tuesday 11 a.m. to 5:00 p.m., Wednesday 12 p.m. to 8:00 p.m., Thursday 11 a.m. to 8:00 p.m., Friday 10:00 a.m. to 1:00 p.m. and 5:00 p.m. to 8:00 p.m., and Saturday 10:00 a.m. to 1:00 p.m. FOR FURTHER INFORMATION CONTACT: Alison Hess, Remedial Project Manager, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 19th Floor, New York, NY 10007–1866; Telephone DATES: [FR Doc. 2015–18610 Filed 7–28–15; 8:45 am] SUMMARY: * Uses PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 * * 212–637–3959; or Email hess.alison@ epa.gov. The site to be deleted from the NPL is: Crown Vantage Landfill Superfund Site, Alexandria Township, New Jersey. A Notice of Intent to Delete for this Site was published in the Federal Register (80 FR 23757) on April 29, 2015. The closing date for comments on the Notice of Intent to Delete was May 29, 2015. No comments were received and therefore no response to comments was required. The deletion action is appropriate. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazards ranking system. Deletion of a site from the NPL does not affect the responsible party liability in the unlikely event that future conditions warrant further actions. SUPPLEMENTARY INFORMATION: List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply. Dated: July 6, 2015. Judith A. Enck, Regional Administrator, Region 2. For reasons set out in the preamble, 40 CFR part 300 is amended as follows: E:\FR\FM\29JYR1.SGM 29JYR1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Rules and Regulations]
[Pages 45079-45085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18610]

[[Page 45079]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0325; FRL-9930-22]

Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium,
Sodium, Potassium, Calcium, Magnesium, and Zinc Salts; Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ethanesulfonic acid, 2-hydroxy- (CAS
Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS
Reg. No. 57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS
Reg. No. 1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt
(CAS Reg. No. 1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt
(CAS Reg. No. 10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium
salt (CAS Reg. No. 17345-56-1), and ethanesulfonic acid, 2-hydroxy-,
zinc salt (CAS Reg. No. 129756-32-7) when used as inert ingredients
(chelator, sequestrant and conditioning agent) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest and applied to animals. Technology Sciences Group Inc.
(1150 18th St. NW., Suite 1000 Washington, DC 20036) on behalf of
Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of ethanesulfonic
acid, 2-hydroxy- and its corresponding ammonium, sodium, potassium,
calcium, magnesium, and zinc salts.

DATES: This regulation is effective July 29, 2015. Objections and
requests for hearings must be received on or before September 28, 2015,
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-2014-0325, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; 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 Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2014-0325 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 28, 2015. 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-2014-0325, 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. Petition for Exemption

In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10684) by
Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000,
Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling
Rd., The Woodlands, TX 77381). The petition requested that 40 CFR
180.910 and 40 CFR 180.930 be amended by establishing an exemption from
the requirement of a tolerance for residues of ethanesulfonic acid, 2-
hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-,
ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 2-
hydroxy-, sodium salt (CAS Reg. No. 1562-00-1);

[[Page 45080]]

ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-
5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-
47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No.
17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg.
No. 129756-32-7) when used as inert ingredients (chelator, sequestrant,
and conditioning agent) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest and applied to
animals in accordance with 40 CFR 180.910 and 180.930, respectively.
That document referenced a summary of the petition prepared by
Technology Sciences Group Inc., the petitioner, which is available in
the docket, 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(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 . . . .''
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 appreciable risks 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 this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for ethanesulfonic acid, 2-hydroxy
and the corresponding ammonium, sodium, potassium, calcium, magnesium,
and zinc salts (also referred to as isethionic acid and its salts)
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
isethionic acid and its 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 isethionic acid and its 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.
Isethionate salts are expected to metabolize and dissociate into
isethionic acid in the body. Therefore, toxicity for each of the
isethionate salt forms are expected to have equal toxicity and share
similar physical and chemical characteristics. Studies on isethionic
acid or any one of its salt can be considered relevant for the entire
group.
The acute oral toxicity of isethionic acid ammonium salt is low.
The acute oral lethal dose (LD)50 in rats were > 1,000
milligram/kilogram/body weight (mg/kg-bw). The acute dermal toxicity in
rats was > 1,000 mg/kg-bw. Ammonium isethionate is a minimal eye
irritant based on a primary eye irritation study in rabbits. Ammonium
isethionate is not dermally irritating based on a primary skin
irritation study in rabbits. Ammonium isethionate has an acute
inhalation lethal concentration (LC)50 > 6.295 milligram/
liter (mg/L) and is not a dermal sensitizer.
In a 90-day oral toxicity study on rats via gavage with sodium
isethionate, decreased mean corpuscular hemoglobin concentration,
increased mean absolute and relative reticulocyte counts, increased
spleen weights and microscopic changes in the liver, bile duct, and
spleen were observed at 1,000 milligram/kilogram/day (mg/kg/day)
(LOAEL). Effects showed complete reversal after exposure was
discontinued. The NOAEL for sodium isethionate was identified in this
study as 200 mg/kg/day.
In an OSCPP Harmonized Test Guideline 870.3650 combined repeated
dose toxicity study with the reproduction/developmental toxicity
screening test, ammonium isethionate was administered to rats by
gavage. The parental systemic LOAEL for ammonium isethionate is 500 mg/
kg/day based on absolute and relative kidney weights and relative
adrenal weights, and the parental systemic NOAEL is 250 mg/kg/day. The
reproductive/developmental LOAEL for ammonium isethionate in rats was
not identified, and the reproductive/developmental NOAEL is greater
than or equal to 500 mg/kg/day.
Ammonium isethionate was negative for mutagenicity or chromosomal
aberrations in a battery of tests of genotoxicity including a reverse
gene mutation assay in bacteria, an in vitro mammalian cell gene
mutation test using mouse lymphoma cells and an in vitro mammalian cell
micronucleus test.
The OncoLogic^TM structure-activity model was used to
evaluate the likelihood that isethionic acid and its salts may cause
cancer. Structure-activity modeling using Oncologic

[[Page 45081]]

indicates that isethionic acid does not contain structural alerts of
potential concern for carcinogenicity. Based on the negative results
for genotoxicity as well as the structure-activity model for
carcinogenicity there is a low concern for isethionic acid and its
salts as potential carcinogens.
No neurotoxicity studies were available in the database for
isethionic acid and its salts. However, a functional observational
battery (FOB) and locomotor activity patterns were evaluated in the
combined reproduction/developmental toxicity screening test and 90-day
oral toxicity study. No alterations in the FOB or locomotor activity
patterns were observed.
No Immunotoxicity studies on isethionic acid and its salts were
available in the database. Increased spleen weights and microscopic
changes in the spleen were observed in the 90-day toxicity study in
rats; however, the chronic reference dose (cRfD) is based on this study
and is protective of these effects.
No metabolism studies were available in the database for isethionic
acid and its salts.

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 the NOAEL and the LOAEL are identified.
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/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for isethionic acid and
its salts used for human risk assessment is shown in Table 1 of this
unit.

Table 1--Summary of Toxicological Doses and Endpoints for Isethionic Acid and Its Salts for Use in Human Risk
Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 An acute effect was not found in the database therefore an acute dietary
years of age). assessment is not necessary.
------------------------------------------------------------------------------
Acute dietary (General population An acute effect was not found in the database therefore an acute dietary
including infants and children). assessment is not necessary.
------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 200 mg/kg/ Chronic RfD = 200 90-day oral toxicity-rat LOAEL =
day. mg/kg/day. 1,000 mg/kg/day based on
UFA = 10x........... cPAD = 2.0 mg/kg/ decreased body weight, changes in
UFH = 10x........... day. hematology parameters, increased
FQPA SF = 1x........ spleen weights, macroscopic
changes in the liver and
microscopic changes in the liver,
bile duct and spleen.
Incidental oral short-term (1 to NOAEL = 200 mg/kg/ LOC for MOE = 100.. 90-day oral toxicity-rat LOAEL =
30 days). day. 1,000 mg/kg/day based on
UFA = 10x........... decreased body weight, changes in
UFH = 10x........... hematology parameters, increased
FQPA SF = 1x........ spleen weights, macroscopic
changes in the liver and
microscopic changes in the liver,
bile duct and spleen.
Incidental oral intermediate-term NOAEL = 200 mg/kg/ LOC for MOE = 100.. 90-day oral toxicity-rat LOAEL =
(1 to 6 months). day. 1,000 mg/kg/day based on
UFA = 10x........... decreased body weight, changes in
UFH = 10x........... hematology parameters, increased
FQPA SF = 1x........ spleen weights, macroscopic
changes in the liver and
microscopic changes in the liver,
bile duct and spleen.
Dermal short-term (1 to 30 days). Dermal (or oral) LOC for MOE = 100.. 90-day oral toxicity-rat LOAEL =
study NOAEL = 200 1,000 mg/kg/day based on
mg/kg/day (dermal decreased body weight, changes in
absorption rate = hematology parameters, increased
100%. spleen weights, macroscopic
UFA = 10x........... changes in the liver and
UFH = 10x........... microscopic changes in the liver,
FQPA SF = 1x........ bile duct and spleen.
Dermal intermediate-term (1 to 6 Dermal (or oral) LOC for MOE = 100.. 90-day oral toxicity-rat LOAEL =
months). study NOAEL = 200 1,000 mg/kg/day based on
mg/kg/day (dermal decreased body weight, changes in
absorption rate = hematology parameters, increased
100%. spleen weights, macroscopic
UFA = 10x........... changes in the liver and
UFH = 10x........... microscopic changes in the liver,
FQPA SF = 1x........ bile duct and spleen.

[[Page 45082]]

Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100.. 90-day oral toxicity-rat LOAEL =
days). study NOAEL = 200 1,000 mg/kg/day based on
mg/kg/day decreased body weight, changes in
(inhalation hematology parameters, increased
absorption rate = spleen weights, macroscopic
100%). changes in the liver and
UFA = 10x........... microscopic changes in the liver,
UFH = 10x........... bile duct and spleen.
FQPA SF = 1x........
Inhalation (1 to 6 months)....... Inhalation (or oral) LOC for MOE = 100.. 90-day oral toxicity-rat LOAEL =
study NOAEL = 200 1,000 mg/kg/day based on
mg/kg/day decreased body weight, changes in
(inhalation hematology parameters, increased
absorption rate = spleen weights, macroscopic
100%). changes in the liver and
UFA = 10x........... microscopic changes in the liver,
UFH = 10x........... bile duct and spleen.
FQPA SF = 1x........
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Based on structural activity analysis, lack of effects suggestive of
potential carcinogenicity in subchronic studies and negative results for
genotoxicity in bacterial and mammalian cell assays, there is a low concern
for the salts of isethionate and isethionic acid as potential carcinogens.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = 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 isethionic acid and its salts, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from isethionic acid and its salts in food
as follows:
An acute dietary risk assessment was not conducted because no
endpoint of concern following a single exposure was identified in the
available studies. A chronic dietary exposure assessment was completed
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, Version 3.16 which includes food consumption information from
the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, ``What We Eat In America'', (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. In the absence of
actual residue data, the inert ingredient evaluation is based on a
highly conservative model that assumes that the residue level of the
inert ingredient would be no higher than the highest established
tolerance for an active ingredient on a given commodity. Implicit in
this assumption is that there would be similar rates of degradation
between the active and inert ingredient (if any) and that the
concentration of inert ingredient in the scenarios leading to these
highest of tolerances would be no higher than the concentration of the
active ingredient. The model assumes 100 percent crop treated (PCT) for
all crops and that every food eaten by a person each day has tolerance-
level residues. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts'' (D361707, S.
Piper, 2/25/09) and can be found at https://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for isethionic acid and
its salts, a conservative drinking water concentration value of 100
parts per billion (ppb) based on screening level modeling was used to
assess the contribution to drinking water for the chronic dietary risk
assessments for parent compound. These values were directly entered
into the dietary exposure model.
3. 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).
Isethionic acid and its salts may be used as inert ingredients in
pesticide products that are registered for specific uses that may
result in indoor or outdoor residential inhalation and dermal
exposures. A screening level residential exposure and risk assessment
was completed utilizing conservative residential exposure assumptions.
The Agency assessed short- and intermediate-term dermal and inhalation
exposures for residential handlers that would result from low pressure
hand wand, hose end sprayer and trigger sprayer for each pesticide
type, herbicide, insecticide, and fungicide. The Agency assessed post-
application short-term dermal exposure for children short-term hand-to-
mouth and dermal exposure for children and adults from contact with
treated lawns.
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 isethionic acid and its salts to share a common
mechanism

[[Page 45083]]

of toxicity with any other substances, and isethionic acid and its
salts does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that isethionic acid and its salts 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 Web site 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 tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. Fetal susceptibility was not
observed in the combined developmental/reproduction toxicity screening
test in rats. Neither offspring nor reproduction toxicity was observed
in this study at dose levels up to 500 mg/kg/day in rats, the highest
dose tested.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for isethionic acid and its salts contains
the following acceptable studies: Subchronic, reproduction/
developmental screening study, and a mutagenicity study. The database
is considered to be adequate to assess prenatal and postnatal toxicity.
ii. There is no indication that isethionic acid and its salts are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors (UF) to account
for neurotoxicity.
iii. There is no indication that isethionic acid and its salts are
immunotoxic chemicals. Although increased spleen weights and
microscopic changes in the spleen were observed in the 90-day toxicity
study in rats those effects were due to red blood cell destruction and
therefore not considered an immuno toxic effect. In any event, the cRfD
is based on this study and is protective of these effects. Therefore,
there is no need for an Immunotoxicity study or additional UFs to
account for Immunotoxicity.
iv. There is no evidence that isethionic acid and its salts result
in increased susceptibility for infants and children.
v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to isethionic acid and its salts in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by isethionic acid and its salts.

E. Aggregate Risks and Determination of Safety

1. Determination of safety section. EPA determines whether acute
and chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute PAD (aPAD) and chronic PAD (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.
2. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
isethionic acid and its salts is not expected to pose an acute risk.
3. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
isethionic acid and its salts from food and water will utilize 9.5% of
the cPAD for the U.S. population and 35.3% of the cPAD for children 1-2
yrs. old, the population group receiving the greatest exposure.
4. 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). Isethionic
acid and its salts may be used as an inert ingredient in pesticide
products that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to isethionic acid and its salts.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 187 for adults
and 123 for children. Because EPA's level of concern for isethionic
acid and its salts are MOEs of 100 or below, these MOEs are not of
concern.
5. 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). Isethionic acid and its salts are currently used as an inert
ingredient in pesticide products that are registered for uses that
could result in intermediate-term residential exposure. The endpoint of
concern selected for short- and intermediate-term exposure assessment
is the same NOAEL, therefore intermediate term exposure is not expected
to exceed short term aggregate exposure and therefore there are no
concerns for intermediate-term aggregate exposure.
6. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to isethionic acid
and its salts; therefore, a cancer dietary exposure assessment was not
performed and an aggregate risk and aggregate cancer risk assessment is
not a concern.
7. Determination of safety. Based on these risk assessments, 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 isethionic acid and its salt residues.

V. Analytical Enforcement Methodology

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

VI. Conclusions

Therefore, exemptions from the requirement of a tolerance are

[[Page 45084]]

established under 40 CFR 180.910 and 40 CFR 180.930 for ethanesulfonic
acid, 2-hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-
hydroxy-, ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid,
2-hydroxy-, sodium salt (CAS Reg. No. 1562-00-1); ethanesulfonic acid,
2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-5); ethanesulfonic
acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-47-7);
ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345-56-
1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No.
129756-32-7) when used as inert ingredients (chelators, sequestrants,
and conditioning agents) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest and applied to
animals.

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 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: July 21, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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, add alphabetically the inert ingredients to the
table to read as follows:

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

* * * * *

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------

* * * * * * *
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy- (CAS Reg. No. 107- sequestrant, or
36-8). conditioning agent.
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy-, ammonium salts sequestrant, or
(CAS Reg. No. 57267-78-4). conditioning agent.
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy-, calcium salts sequestrant, or
(CAS Reg. No. 10550-47-7). conditioning agent.
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy-, magnesium salts sequestrant, or
(CAS Reg. No. 17345-56-1). conditioning agent.
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy-, potassium salts sequestrant, or
(CAS Reg. No. 1561-99-5). conditioning agent.
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy-, sodium salts (CAS sequestrant, or
Reg. No. 1562-00-1). conditioning agent.
Ethanesulfonic acid, 2- .................... Chelator,
hydroxy-, zinc salts (CAS sequestrant, or
Reg. No. 129756-32-7). conditioning agent.

* * * * * * *
------------------------------------------------------------------------

[[Page 45085]]

0
3. In Sec. 180.930, add alphabetically the inert ingredients to the
table to read as follows:

Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------

* * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-18610 Filed 7-28-15; 8:45 am]
BILLING CODE 6560-50-P

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