Ethoxylated Fatty Acid Methyl Esters; Exemption From the Requirement of a Tolerance, 25936-25941 [2018-12060]

Download as PDF 25936 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations [FR Doc. 2018–11597 Filed 6–4–18; 8:45 am] List of Subjects BILLING CODE 6560–50–P 40 CFR Part 60 Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements. ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 60, 61, and 63 [EPA–R06–OAR–2016–0091; FRL–9978–89– Region 6] New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to New Mexico Environmental Protection Agency (EPA). AGENCY: ACTION: Withdrawal of direct final rule. On April 13, 2018, the Environmental Protection Agency (EPA) published a direct final rule approving the updated delegation of EPA authority for implementation and enforcement of certain New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPs) for all sources (both part 70 and non-part 70 sources) to the New Mexico Environmental Department (NMED). EPA stated in the direct final rule that if EPA received relevant adverse comments by May 14, 2018, EPA would publish a timely withdrawal in the Federal Register. EPA received an adverse comment on May 14, 2018, and accordingly is withdrawing the direct final rule. SUMMARY: The direct final rule published on April 13, 2018 (83 FR 15964), is withdrawn effective June 5, 2018. DATES: FOR FURTHER INFORMATION CONTACT: amozie on DSK3GDR082PROD with RULES 16:50 Jun 04, 2018 Mr. Jkt 244001 Dated: May 30, 2018. Wren Stenger, Director, Multimedia Division, Region 6. Accordingly, the direct final rule published in the Federal Register on April 13, 2018 (83 FR 15964), amending 40 CFR 60.4, 40 CFR 61.04, and 40 CFR 63.99, which was to become effective on June 12, 2018, is withdrawn. ■ [FR Doc. 2018–12013 Filed 6–4–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2017–0666; FRL–9976–39] On April 13, 2018, EPA published a direct final rule approving the updated delegation of authority for implementation and enforcement of NSPS and NESHAPs for all sources (both part 70 and non-part 70 sources) to the NMED. The direct final rule was published without prior proposal because EPA anticipated no relevant adverse comments. EPA stated in the direct final rule that if relevant adverse comments were received by May 14, 2018, EPA would publish a timely withdrawal in the Federal Register. EPA received an adverse comment on May 14, 2018. Accordingly, EPA is withdrawing the direct final rule. In a separate subsequent final action EPA will address the comment received. The withdrawal is being taken pursuant to sections 111 and112 of the CAA. VerDate Sep<11>2014 40 CFR Part 63 Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements. 40 CFR Part 180 Rick Barrett, (214) 665–7227, barrett.richard@epa.gov. SUPPLEMENTARY INFORMATION: 40 CFR Part 61 Environmental protection, Administrative practice and procedure, Air pollution control, Arsenic, Benzene, Beryllium, Hazardous substances, Intergovernmental relations, Mercury, Reporting and recordkeeping requirements, Vinyl chloride. Ethoxylated Fatty Acid Methyl Esters; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. Corporation 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 ethoxylated fatty acid methyl esters when used in accordance with the terms of the exemption. DATES: This regulation is effective June 5, 2018. Objections and requests for hearings must be received on or before August 6, 2018, 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–2017–0666, 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: Michael Goodis, 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: AGENCY: I. General Information This regulation establishes an exemption from the requirement of a tolerance for residues of poly(oxy-1,2ethanediyl), a-(1-oxoalkyl)-w-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3–13 moles, when used as an inert ingredient (stabilizer and solubilizing agent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 25% by weight in the formulation. This related group of compounds are collectively known as the ethoxylated fatty acid methyl esters (EFAMEs). BASF 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). SUMMARY: PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations amozie on DSK3GDR082PROD with RULES 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. 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–2017–0666 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 August 6, 2018. 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– 2017–0666, 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 February 27, 2018 (83 FR 8408) (FRL–9972–17), VerDate Sep<11>2014 16:50 Jun 04, 2018 Jkt 244001 EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–11023) by BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), a-(1oxoalkyl)-w-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3–13 moles (CAS Reg. Nos. 53100–65–5, 194289–64–0, 34398–00–0, 9006–27–3, 32761–35–6, 53467–81–5, 518299–31–5, 34397–99–4) when used as an inert ingredient (stabilizer and solubilizing agent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 25% by weight in the formulation. That document referenced a summary of the petition prepared by BASF Corporation, the petitioner, which is available in the docket, https://www.regulations.gov. No comments were received in response to the notice of filing that are relevant to establishment of this exemption. 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 PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 25937 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 ethoxylated fatty acid methyl esters including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with ethoxylated fatty acid methyl esters 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. A series of acute toxicology studies have been conducted with representative EFAMEs. The acute E:\FR\FM\05JNR1.SGM 05JNR1 amozie on DSK3GDR082PROD with RULES 25938 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations toxicity study test substance was C6–10 ethoxylated fatty acid methyl ester (degree of ethoxylation is 10.6 EO). The studies show that the EFAMEs are practically non-toxic when ingested or inhaled via acute exposure. Skin and eye irritation studies indicate that the EFAMEs are slight skin and eye irritants. The skin sensitization potential of the EFAMEs could not be determined based on the ambiguous result in the Buehler assay. The genotoxicity studies conducted with representative EFAMEs including bacterial reverse mutation (Ames) test, mouse micronucleus assay and an in vitro mouse lymphoma assay were negative. Repeat dose data are not available for the EFAMEs; however, several repeat dose studies have been conducted with fatty acid methyl/alkyl esters and alcohol ethoxylates and these studies can be bridged to the EFAMEs based upon the structural similarities between EFAMEs and alcohol ethoxylates which are both nonionic surfactants in which the surfactant properties of each generally result in similar toxicological effects, at comparable dose levels) and the structural similarities of EFAMEs with fatty acid methyl/alkyl esters (both having terminal methoxy or alkoxy groups bound to a fatty acid or fatty acid derivative). The NOAEL of 50 mg/kg/ day from a chronic rat oral feeding study is the lowest NOAEL observed and is equal to the lowest NOAEL seen in the subchronic feeding studies. The lowest LOAEL in the subchronic studies, as well as the LOAEL in the chronic rat oral feeding study was established at 250 mg/kg/day based on reduced food consumption and body weight gain. In a dermal toxicity study no signs of tumors were observed and the dermal NOAEL was reported to be 300 mg/kg/day. Most of the 90-day studies reported NOAELs ranging from 50–200 mg/kg/day. The NOAELs for reproductive performance of males and females, as well as offspring toxicity are considered to range from >250 mg/kg/day to 1,000 mg/kg/day. None of the studies reported adverse reproductive, developmental, neurotoxic, or immunotoxic effects at dose levels below the range of >250 mg/ kg/day to 1,000 mg/kg/day. Specific information on the studies received and the nature of the adverse effects caused by ethoxylated fatty acid methyl esters as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in the document Ethoxylated Fatty Acid Methyl Esters VerDate Sep<11>2014 16:50 Jun 04, 2018 Jkt 244001 (CAS Reg. Nos. 53100–65–5, 194289– 64–0, 34398–00–0, 9006–27–3, 32761– 35–6, 53467–81–5, 518299–31–5, 34397–99–4); ‘‘Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient’’ in docket ID number EPA– HQ–OPP–2017–0666. increased prenatal or postnatal sensitivity as well as a lack of concern for neurotoxicity. A dermal absorption factor of 100% was used and a default value of 100% absorption was used for the inhalation absorption factor. The resultant chronic population adjusted dose (cPAD) is 0.5 mg/kg/day and acceptable MOEs for residential exposures are ≥100. 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/pesticides/factsheets/ riskassess.htm. An effect attributed to a single dose was not identified in the toxicology database. The point of departure for chronic dietary exposures as well as dermal and inhalation exposures is based on a NOAEL of 50 mg/kg/day from a chronic oral feeding study in rats with the EFAMEs surrogate chemical, alcohol ethoxylate. In this study, the LOAEL was 250 mg/kg/day based upon reduced food consumption and body weight gain and elevated organ-to-body weight ratios. This represents the lowest NOAEL in the most sensitive species in the toxicity database. The standard uncertainty factors were applied to account for interspecies (10X) and intraspecies (10X) variations. The FQPA safety factor was reduced to 1X to account for completeness of the toxicity and exposure database and lack of C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ethoxylated fatty acid methyl esters, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from ethoxylated fatty acid methyl esters in food as follows. Dietary exposure (food and drinking water) to ethoxylated fatty acid methyl esters can occur following ingestion of foods with residues from treated crops. Because no adverse effects attributable to a single exposure of ethoxylated fatty acid methyl esters are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM– FCIDTM, Version 3.16, and food consumption information from the U.S. Department of Agriculture’s (USDA’s) 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for ethoxylated fatty acid methyl esters. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for all foods and use limitations of not more than 25% in pesticide formulations. 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. PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1 amozie on DSK3GDR082PROD with RULES Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations 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 ethoxylated fatty acid methyl esters, a conservative drinking water concentration value of 100 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), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Ethoxylated fatty acid methyl esters may be used as inert ingredients in products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. The Agency conducted a conservative assessment of potential residential exposure by assessing ethoxylated fatty acid methyl esters in pesticide formulations (outdoor scenarios) and in disinfectant-type uses (indoor scenarios). The Agency’s assessment of adult residential exposure combines high-end dermal and inhalation handler exposure from liquids/trigger sprayer/ home garden and indoor hard surface, wiping with a high-end post application dermal exposure from contact with treated lawns. The Agency’s assessment of children’s residential exposure includes total post-application exposures associated with total exposures associated with contact with treated lawns and surfaces (dermal and hand-to-mouth exposures). 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 ethoxylated fatty acid methyl esters to share a common mechanism of toxicity with any other substances, and ethoxylated fatty acid methyl esters does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ethoxylated fatty acid methyl esters does not have a common mechanism of toxicity with other VerDate Sep<11>2014 16:50 Jun 04, 2018 Jkt 244001 substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional 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 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. The toxicity database for ethoxylated fatty acid methyl esters contains subchronic and developmental toxicity studies conducted with surrogate chemicals. The NOAELs for reproductive performance of males and females, as well as offspring toxicity are considered to range from >250 mg/kg/ day to 1,000 mg/kg/day. None of the studies reported effects on the reproductive system or effects indicative of neurotoxicity. The established cRfD will be protective of the observed adverse effect, decreased body weight gain and food consumption, which was observed at dose levels much lower than potential adverse effects to infants or children. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated, tolerance-level residues, conservative drinking water modeling numbers, and a conservative assessment of potential residential exposure for infants and children. Based on the adequacy of the toxicity database, the conservative nature of the exposure assessment, and the lack of concern for prenatal and postnatal sensitivity as well as neurotoxicity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10X is reduced to 1X. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 25939 to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD by dividing the POD (i.e. toxicological endpoint) by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short, intermediate, and long term aggregate risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. Although there are no known current residential uses associated with EFAMEs, a residential exposure assessment was conducted. The level of concern for residential uses (i.e. nonoccupational, non-dietary exposure) associated with the EFAMEs is low. The level of MOEs for combined residential exposure is above 100. 1. 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, the EFAMEs are not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to EFAMEs from food and water will utilize 70% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. Generally, a dietary risk estimate that is less than 100% of the cPAD does not exceed the Agency’s risk concerns. 3. Short- intermediate- and long-term risk. Short- intermediate- and long-term aggregate exposure takes into account short-, intermediate- and long- term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-, intermediate- and water with sort-, intermediate- and long-term residential exposures to EFAMEs. Using the exposure assumptions describe in this unit for short-term exposures, EPA has concluded the combined respective short-, intermediate- and long- term food water, and residential exposures resulted in aggregate margin of exposures (MOE) of 335 for adults and 122 for children. Because EPA’s level of E:\FR\FM\05JNR1.SGM 05JNR1 25940 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations concern for EFAMEs is a MOE of 100 or below, these MOEs are not of concern. 4. Aggregate cancer risk for U.S. population. Based on the discussion in Unit IV. A., EFAMEs is not expected to pose a cancer risk. 5. 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 ethoxylated fatty acid methyl esters 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. EPA is establishing limitations on the amount of EFAMEs that may be used in pesticide formulations applied to growing crops. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops or raw agricultural commodities after harvest for sale or distribution that exceeds 25% by weight of EFAMEs. VI. Conclusion Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for poly(oxy-1,2ethanediyl), a-(1-oxoalkyl)-w-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3–13 moles (CAS Reg. No. 53100–65–5, 194289–64–0, 4398–00–0, 9006–27–3, 32761–35–6, 53467–81–5, 518299–31–5, and 34397–99–4) when used as an inert ingredient (stabilizer and solubilizing agent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 25% by weight in the formulation. VII. Statutory and Executive Order Reviews amozie on DSK3GDR082PROD with RULES This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the VerDate Sep<11>2014 16:50 Jun 04, 2018 Jkt 244001 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); Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 ‘‘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: May 11, 2018. Donna Davis, Acting Director, Registration Division, Office of Pesticide Program. 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 ingredient to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * E:\FR\FM\05JNR1.SGM * * 05JNR1 * * 25941 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations Inert ingredients * Limits * * * Poly(oxy-1,2-ethanediyl), a-(1-oxoalkyl)-w-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3–13 moles (CAS Reg. No. 53100–65–5, 194289–64–0, 34398–00–0, 9006–27–3, 32761–35–6, 53467–81–5, 518299–31–5, and 34397–99–4). * * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2010–0234; FRL–9976–73] Alpha-cypermethrin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. This regulation amends existing tolerances for residues of alphacypermethrin in or on fruit, citrus group 10–10 and hog fat. EPA is modifying these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) to correct an error in a previous rulemaking that established these tolerances at an unintended level. DATES: This regulation is effective June 5, 2018. Objections and requests for hearings must be received on or before August 6, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2010–0234, 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. amozie on DSK3GDR082PROD with RULES VerDate Sep<11>2014 16:50 Jun 04, 2018 Jkt 244001 * A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. 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– Frm 00061 Fmt 4700 Sfmt 4700 * Stabilizer, solubilizing agent. * Michael L. Goodis, Director, 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: PO 00000 * Not to exceed 25% by weight in pesticide formulation. I. General Information AGENCY: ADDRESSES: * FOR FURTHER INFORMATION CONTACT: [FR Doc. 2018–12060 Filed 6–4–18; 8:45 am] Uses * * OPP–2010–0234 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 August 6, 2018. 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– 2010–0234, 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. Proposed Rule In the Federal Register of December 26, 2017 (82 FR 60940) (FRL–9969–97), EPA, pursuant to FFDCA section 408(e), 21 U.S.C. 346a(e), proposed revisions to existing tolerances for the insecticide alpha-cypermethrin to reduce the allowable levels of the pesticide in or on fruit, citrus, group 10–10 from 10 parts per million (ppm) to 0.35 ppm and in E:\FR\FM\05JNR1.SGM 05JNR1

Agencies

[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25936-25941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12060]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0666; FRL-9976-39]


Ethoxylated Fatty Acid Methyl Esters; 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 poly(oxy-1,2-ethanediyl), [alpha]-(1-
oxoalkyl)-[omega]-methoxy-, where the alkyl chain contains a minimum of 
6 and a maximum of 18 carbons and the oxyethylene content is 3-13 
moles, when used as an inert ingredient (stabilizer and solubilizing 
agent) in pesticide formulations applied to growing crops or raw 
agricultural commodities after harvest at a concentration not to exceed 
25% by weight in the formulation. This related group of compounds are 
collectively known as the ethoxylated fatty acid methyl esters 
(EFAMEs). BASF Corporation 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 ethoxylated fatty acid methyl esters when used in 
accordance with the terms of the exemption.

DATES: This regulation is effective June 5, 2018. Objections and 
requests for hearings must be received on or before August 6, 2018, 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-2017-0666, 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: Michael Goodis, 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

[[Page 25937]]

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.

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-2017-0666 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 
August 6, 2018. 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-2017-0666, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11023) by BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932. 
The petition requested that 40 CFR 180.910 be amended by establishing 
an exemption from the requirement of a tolerance for residues of 
poly(oxy-1,2-ethanediyl), [alpha]-(1-oxoalkyl)-[omega]-methoxy-, where 
the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and 
the oxyethylene content is 3-13 moles (CAS Reg. Nos. 53100-65-5, 
194289-64-0, 34398-00-0, 9006-27-3, 32761-35-6, 53467-81-5, 518299-31-
5, 34397-99-4) when used as an inert ingredient (stabilizer and 
solubilizing agent) in pesticide formulations applied to growing crops 
or raw agricultural commodities after harvest at a concentration not to 
exceed 25% by weight in the formulation. That document referenced a 
summary of the petition prepared by BASF Corporation, the petitioner, 
which is available in the docket, https://www.regulations.gov. No 
comments were received in response to the notice of filing that are 
relevant to establishment of this exemption.

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 ethoxylated fatty acid methyl 
esters including exposure resulting from the exemption established by 
this action. EPA's assessment of exposures and risks associated with 
ethoxylated fatty acid methyl esters 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. A series of acute toxicology studies have been conducted with 
representative EFAMEs. The acute

[[Page 25938]]

toxicity study test substance was C6-10 ethoxylated fatty acid methyl 
ester (degree of ethoxylation is 10.6 EO). The studies show that the 
EFAMEs are practically non-toxic when ingested or inhaled via acute 
exposure. Skin and eye irritation studies indicate that the EFAMEs are 
slight skin and eye irritants. The skin sensitization potential of the 
EFAMEs could not be determined based on the ambiguous result in the 
Buehler assay.
    The genotoxicity studies conducted with representative EFAMEs 
including bacterial reverse mutation (Ames) test, mouse micronucleus 
assay and an in vitro mouse lymphoma assay were negative.
    Repeat dose data are not available for the EFAMEs; however, several 
repeat dose studies have been conducted with fatty acid methyl/alkyl 
esters and alcohol ethoxylates and these studies can be bridged to the 
EFAMEs based upon the structural similarities between EFAMEs and 
alcohol ethoxylates which are both nonionic surfactants in which the 
surfactant properties of each generally result in similar toxicological 
effects, at comparable dose levels) and the structural similarities of 
EFAMEs with fatty acid methyl/alkyl esters (both having terminal 
methoxy or alkoxy groups bound to a fatty acid or fatty acid 
derivative). The NOAEL of 50 mg/kg/day from a chronic rat oral feeding 
study is the lowest NOAEL observed and is equal to the lowest NOAEL 
seen in the subchronic feeding studies. The lowest LOAEL in the 
subchronic studies, as well as the LOAEL in the chronic rat oral 
feeding study was established at 250 mg/kg/day based on reduced food 
consumption and body weight gain. In a dermal toxicity study no signs 
of tumors were observed and the dermal NOAEL was reported to be 300 mg/
kg/day. Most of the 90-day studies reported NOAELs ranging from 50-200 
mg/kg/day.
    The NOAELs for reproductive performance of males and females, as 
well as offspring toxicity are considered to range from >250 mg/kg/day 
to 1,000 mg/kg/day. None of the studies reported adverse reproductive, 
developmental, neurotoxic, or immunotoxic effects at dose levels below 
the range of >250 mg/kg/day to 1,000 mg/kg/day.
    Specific information on the studies received and the nature of the 
adverse effects caused by ethoxylated fatty acid methyl esters as well 
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at https://www.regulations.gov in the document Ethoxylated Fatty 
Acid Methyl Esters (CAS Reg. Nos. 53100-65-5, 194289-64-0, 34398-00-0, 
9006-27-3, 32761-35-6, 53467-81-5, 518299-31-5, 34397-99-4); ``Human 
Health Risk Assessment and Ecological Effects Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as an 
Inert Ingredient'' in docket ID number EPA-HQ-OPP-2017-0666.

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/pesticides/factsheets/riskassess.htm.
    An effect attributed to a single dose was not identified in the 
toxicology database. The point of departure for chronic dietary 
exposures as well as dermal and inhalation exposures is based on a 
NOAEL of 50 mg/kg/day from a chronic oral feeding study in rats with 
the EFAMEs surrogate chemical, alcohol ethoxylate. In this study, the 
LOAEL was 250 mg/kg/day based upon reduced food consumption and body 
weight gain and elevated organ-to-body weight ratios. This represents 
the lowest NOAEL in the most sensitive species in the toxicity 
database. The standard uncertainty factors were applied to account for 
interspecies (10X) and intraspecies (10X) variations. The FQPA safety 
factor was reduced to 1X to account for completeness of the toxicity 
and exposure database and lack of increased prenatal or postnatal 
sensitivity as well as a lack of concern for neurotoxicity. A dermal 
absorption factor of 100% was used and a default value of 100% 
absorption was used for the inhalation absorption factor. The resultant 
chronic population adjusted dose (cPAD) is 0.5 mg/kg/day and acceptable 
MOEs for residential exposures are >=100.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ethoxylated fatty acid methyl esters, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance. EPA assessed dietary exposures from ethoxylated fatty acid 
methyl esters in food as follows.
    Dietary exposure (food and drinking water) to ethoxylated fatty 
acid methyl esters can occur following ingestion of foods with residues 
from treated crops. Because no adverse effects attributable to a single 
exposure of ethoxylated fatty acid methyl esters are seen in the 
toxicity databases, an acute dietary risk assessment is not necessary. 
For the chronic dietary risk assessment, EPA used the Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCIDTM, Version 3.16, and food consumption information 
from the U.S. Department of Agriculture's (USDA's) 2003-2008 National 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA). As to residue levels in food, no residue data were 
submitted for ethoxylated fatty acid methyl esters. In the absence of 
specific residue data, EPA has developed an approach which uses 
surrogate information to derive upper bound exposure estimates for the 
subject inert ingredient. Upper bound exposure estimates are based on 
the highest tolerance for a given commodity from a list of high use 
insecticides, herbicides, and fungicides. One hundred percent crop 
treated was assumed, default processing factors, and tolerance-level 
residues for all foods and use limitations of not more than 25% in 
pesticide formulations. 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.

[[Page 25939]]

    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 ethoxylated fatty 
acid methyl esters, a conservative drinking water concentration value 
of 100 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). 
Ethoxylated fatty acid methyl esters may be used as inert ingredients 
in products that are registered for specific uses that may result in 
residential exposure, such as pesticides used in and around the home. 
The Agency conducted a conservative assessment of potential residential 
exposure by assessing ethoxylated fatty acid methyl esters in pesticide 
formulations (outdoor scenarios) and in disinfectant-type uses (indoor 
scenarios). The Agency's assessment of adult residential exposure 
combines high-end dermal and inhalation handler exposure from liquids/
trigger sprayer/home garden and indoor hard surface, wiping with a 
high-end post application dermal exposure from contact with treated 
lawns. The Agency's assessment of children's residential exposure 
includes total post-application exposures associated with total 
exposures associated with contact with treated lawns and surfaces 
(dermal and hand-to-mouth exposures).
    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 ethoxylated fatty acid methyl esters to share a 
common mechanism of toxicity with any other substances, and ethoxylated 
fatty acid methyl esters does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that ethoxylated fatty acid methyl 
esters does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional 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 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. The toxicity database for 
ethoxylated fatty acid methyl esters contains subchronic and 
developmental toxicity studies conducted with surrogate chemicals. The 
NOAELs for reproductive performance of males and females, as well as 
offspring toxicity are considered to range from >250 mg/kg/day to 1,000 
mg/kg/day. None of the studies reported effects on the reproductive 
system or effects indicative of neurotoxicity.
    The established cRfD will be protective of the observed adverse 
effect, decreased body weight gain and food consumption, which was 
observed at dose levels much lower than potential adverse effects to 
infants or children. In addition, the Agency used conservative exposure 
estimates, with 100 percent crop treated, tolerance-level residues, 
conservative drinking water modeling numbers, and a conservative 
assessment of potential residential exposure for infants and children. 
Based on the adequacy of the toxicity database, the conservative nature 
of the exposure assessment, and the lack of concern for prenatal and 
postnatal sensitivity as well as neurotoxicity, the Agency has 
concluded that there is reliable data to determine that infants and 
children will be safe if the FQPA SF of 10X is reduced to 1X.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD represent the highest safe exposures, taking into account 
all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD 
by dividing the POD (i.e. toxicological endpoint) by all applicable 
UFs. For linear cancer risks, EPA calculates the probability of 
additional cancer cases given the estimated aggregate exposure. Short, 
intermediate, and long term aggregate risks are evaluated by comparing 
the estimated aggregate food, water, and residential exposure to the 
POD to ensure that the MOE called for by the product of all applicable 
UFs is not exceeded.
    Although there are no known current residential uses associated 
with EFAMEs, a residential exposure assessment was conducted. The level 
of concern for residential uses (i.e. non-occupational, non-dietary 
exposure) associated with the EFAMEs is low. The level of MOEs for 
combined residential exposure is above 100.
    1. 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, 
the EFAMEs are not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
EFAMEs from food and water will utilize 70% of the cPAD for children 1-
2 years old, the population group receiving the greatest exposure. 
Generally, a dietary risk estimate that is less than 100% of the cPAD 
does not exceed the Agency's risk concerns.
    3. Short- intermediate- and long-term risk. Short- intermediate- 
and long-term aggregate exposure takes into account short-, 
intermediate- and long- term residential exposure plus chronic exposure 
to food and water (considered to be a background exposure level). The 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short-, intermediate- and water 
with sort-, intermediate- and long-term residential exposures to 
EFAMEs. Using the exposure assumptions describe in this unit for short-
term exposures, EPA has concluded the combined respective short-, 
intermediate- and long- term food water, and residential exposures 
resulted in aggregate margin of exposures (MOE) of 335 for adults and 
122 for children. Because EPA's level of

[[Page 25940]]

concern for EFAMEs is a MOE of 100 or below, these MOEs are not of 
concern.
    4. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit IV. A., EFAMEs is not expected to pose a cancer 
risk.
    5. 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 ethoxylated fatty acid methyl esters 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. EPA is establishing 
limitations on the amount of EFAMEs that may be used in pesticide 
formulations applied to growing crops. These limitations will be 
enforced through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq. EPA will not register any pesticide formulation for use on 
growing crops or raw agricultural commodities after harvest for sale or 
distribution that exceeds 25% by weight of EFAMEs.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for poly(oxy-1,2-ethanediyl), [alpha]-
(1-oxoalkyl)-[omega]-methoxy-, where the alkyl chain contains a minimum 
of 6 and a maximum of 18 carbons and the oxyethylene content is 3-13 
moles (CAS Reg. No. 53100-65-5, 194289-64-0, 4398-00-0, 9006-27-3, 
32761-35-6, 53467-81-5, 518299-31-5, and 34397-99-4) when used as an 
inert ingredient (stabilizer and solubilizing agent) in pesticide 
formulations applied to growing crops or raw agricultural commodities 
after harvest at a concentration not to exceed 25% by weight in the 
formulation.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption 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); Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 11, 2018.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Program.
    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 ingredient to the 
table to read as follows:


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

* * * * *

[[Page 25941]]



------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
Poly(oxy-1,2-ethanediyl),         Not to exceed 25%   Stabilizer,
 [alpha]-(1-oxoalkyl)-[omega]-     by weight in        solubilizing
 methoxy-, where the alkyl chain   pesticide           agent.
 contains a minimum of 6 and a     formulation.
 maximum of 18 carbons and the
 oxyethylene content is 3-13
 moles (CAS Reg. No. 53100-65-5,
 194289-64-0, 34398-00-0, 9006-
 27-3, 32761-35-6, 53467-81-5,
 518299-31-5, and 34397-99-4).
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. 2018-12060 Filed 6-4-18; 8:45 am]
BILLING CODE 6560-50-P
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