Etoxazole; Pesticide Tolerances, 51863-51867 [2018-22279]

Download as PDF Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations Parts per million Commodity * * * * * * * * * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0273; FRL–9983–96] Etoxazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of etoxazole in or on multiple commodities which are identified and discussed later in this document. In addition, it removes certain previously established tolerances that are superseded by this final rule. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 15, 2018. Objections and requests for hearings must be received on or before December 14, 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–2017–0273, is available at http://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 http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. 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. khammond on DSK30JT082PROD with RULES VerDate Sep<11>2014 16:29 Oct 12, 2018 Jkt 247001 I. General Information A. Does this action apply to me? [FR Doc. 2018–22282 Filed 10–12–18; 8:45 am] SUMMARY: SUPPLEMENTARY INFORMATION: 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 http://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– OPP–2017–0273 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 December 14, 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– 2017–0273, by one of the following methods: PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 51863 • Federal eRulemaking Portal: http:// 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 http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of October 23, 2017 (82 FR 49020) (FRL–9967–37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E8559) by IR–4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, New Jersey 08540. The petition requested that 40 CFR 180.593 be amended by establishing tolerances for residues of the miticide/insecticide etoxazole, (2(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole), in or on Corn, sweet, kernel plus cob with husks removed at 0.01 parts per million (ppm); Corn, sweet, forage at 1.5 ppm; Corn, sweet, stover at 5.0 ppm; Fruit, pome, group 11–10 at 0.20 ppm; Nut, tree, group 14– 12 at 0.01 ppm; Fruit, stone, group 12– 12 at 1.0 ppm; and Cottonseed subgroup 20C at 0.05 ppm. In addition, upon establishment of new tolerances referenced above, the petitioner requested the removal of existing tolerances in 40 CFR 180.593 for residues of etoxazole in or on Fruit, pome, group 11 at 0.20 ppm; Fruit, stone, group 12, except plum at 1.0 ppm; Nut, tree, group 14 at 0.01 ppm; Cotton, undelinted seed at 0.05 ppm; Pistachio at 0.01 ppm; Plum at 0.15 ppm; and Plum, prune, dried at 0.30 ppm. That document referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is issuing tolerances that vary from what the E:\FR\FM\15OCR1.SGM 15OCR1 51864 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations petitioner sought. The reasons for these changes are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for etoxazole including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with etoxazole follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The effects in the etoxazole database show liver toxicity in all species tested (enzyme release, hepatocellular swelling and histopathological indicators), and the severity does not appear to increase with time. In rats only, there were effects on incisors (elongation, whitening, and partial loss of upper and/or lower incisors). There is no evidence of neurotoxicity or immunotoxicity. No toxicity was seen at the limit dose in a 28-day dermal toxicity study in rats. Etoxazole was not mutagenic. No increased quantitative or qualitative susceptibilities were observed following in utero exposure to rats or rabbits in the developmental studies; however, offspring toxicity was more severe (increased pup mortality) than maternal toxicity (increased liver and adrenal weights) at the same dose (158.7 milligram/kilogram/day (mg/kg/ day)) in the rat reproduction study indicating increased qualitative susceptibility. Etoxazole is not likely to be carcinogenic. This decision was based on weight-of-evidence approach including the lack of carcinogenicity in two studies in mice, lack of carcinogenicity in one study in rats, and the lack of hormonal and reproductive effects in special studies. Etoxazole was categorized as having low acute toxicity via the oral, dermal, and inhalation routes. It is not an eye or dermal irritant or a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by etoxazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in document titled ‘‘Etoxazole: Human Health Risk Assessment in Support of Proposed Use a Sweet Corn, and Proposed Crop Group Updates for Pome Fruit 11–10, Tree Nut Group 14–12, Stone Fruit Group 12–12, and Cotton Subgroup 20C at pages 22– 27 in docket ID number EPA–HQ–OPP– 2017–0273. 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 http:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for etoxazole used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETOXAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/Scenario khammond on DSK30JT082PROD with RULES Chronic dietary (All populations) VerDate Sep<11>2014 16:29 Oct 12, 2018 POD and uncertainty/FQPA Safety factors NOAEL = 4.62 mg/ kg/day. UFA = 10x ................ UFH = 10x ................ FQPA SF = 1x ......... Jkt 247001 PO 00000 RfD, PAD, LOC for risk assessment cPAD = cRfD = 0.046 mg/kg/day. Frm 00050 Fmt 4700 Study and toxicological effects Chronic Oral Toxicity Study—Dog. LOAEL = 23.5 mg/kg/day based upon increased alkaline phosphatase activity, increased liver weights, liver enlargement (females), and incidences of centrilobular hepatocellular swelling in the liver. Sfmt 4700 E:\FR\FM\15OCR1.SGM 15OCR1 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations 51865 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETOXAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued Exposure/Scenario Cancer (Oral, dermal, inhalation). POD and uncertainty/FQPA Safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects EPA has classified etoxazole as ‘‘not likely to be carcinogenic to humans’’ according to EPA Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996). FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. 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). khammond on DSK30JT082PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to etoxazole, EPA considered exposure under the petitioned-for tolerances as well as all existing etoxazole tolerances in 40 CFR 180.593. EPA assessed dietary exposures from etoxazole in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for etoxazole; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2003–2008). As to residue levels in food, EPA assumed tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern, 100% crop treated (PCT), and in the absence of empirical data, default processing factors. iii. Cancer. Based on the data summarized in Unit III.A., EPA has classified etoxazole as ‘‘not likely’’ to be carcinogenic to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for etoxazole. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for etoxazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/ VerDate Sep<11>2014 16:29 Oct 12, 2018 Jkt 247001 transport characteristics of etoxazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. Based on the First Index Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) of etoxazole for chronic exposures are estimated to be 4.761 parts per billion (ppb) for surface water and <0.01 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 4.761 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Etoxazole is not registered for any specific use patterns that would result in residential exposure. 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 etoxazole to share a common mechanism of toxicity with any other substances, and etoxazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that etoxazole does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 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 Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data are available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. No increased quantitative or qualitative susceptibilities were observed following in utero exposure to rats or rabbits in the developmental studies. There is evidence of increased qualitative offspring susceptibility in the rat reproduction study, but the concern is low since: (1) The effects in pups are well-characterized with a clear NOAEL; (2) the selected endpoints are protective of the doses where the offspring toxicity is observed; and (3) offspring effects occur at the same doses as parental toxicity so protecting for parental effects is protective of offspring effects. There are no residual uncertainties for preand post-natal toxicity. 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 etoxazole is complete. E:\FR\FM\15OCR1.SGM 15OCR1 51866 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations khammond on DSK30JT082PROD with RULES ii. There is no indication that etoxazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. The observed qualitative postnatal susceptibility is protected for by the selected endpoints. iv. 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 etoxazole in drinking water. These assessments will not underestimate the exposure and risks posed by etoxazole. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the 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. 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, etoxazole is 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 etoxazole from food and water will utilize 15% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. There are no residential uses for etoxazole. 3. Short- and Intermediate-term risks. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short- and intermediate-term adverse effect was identified; however, etoxazole is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risks are assessed based on short- or intermediate-term residential exposure VerDate Sep<11>2014 16:29 Oct 12, 2018 Jkt 247001 plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- or intermediate-term risks), no further assessment of short- or intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risks for etoxazole. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, etoxazole is not expected to pose a cancer risk to humans. 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 etoxazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate methodologies (Valent Method RM–37, gas chromatography/ mass-selective detector (GC/MSD) or GC/nitrogen-phosphorus detector (NPD)) are available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. Codex has established maximum residue limits (MRLs) for residues of PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 etoxazole in or on pome fruit (0.07 ppm) and tree nut (0.01 ppm). The relevant U.S. tolerances are harmonized with the tree nut MRL but cannot be harmonized with the pome fruit MRL because doing so could result in exceedances for application consistent with the domestic registration. C. Revisions to Petitioned-for Tolerances Instead of the petitioned-for tolerance on Fruit, stone, group 12–12 at 1.0 ppm, EPA is establishing separate subgroup tolerances for this crop group including Cherry subgroup 12–12A at 1.0 ppm, Peach subgroup 12–12B at 1.0 ppm, and Plum subgroup 12–12C at 0.15 ppm; and is retaining the existing separate, lower tolerance on Plum, prune, dried at 0.30 ppm as that remains necessary to cover the processed commodity. Separate subgroup tolerances are being established because there is more than a factor of five between the residue levels for the cherry and peach subgroups and the residues levels for commodities in the plum subgroup. V. Conclusion Therefore, tolerances are established for residues of etoxazole, (2-(2,6difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole, in or on Cherry subgroup 12–12A at 1.0 ppm; Corn, sweet, forage at 1.5 ppm; Corn, sweet, kernel plus cob with husks removed at 0.01 ppm; Corn, sweet, stover at 5.0 ppm; Cottonseed subgroup 20C at 0.05 ppm; Fruit, pome, group 11–10 at 0.20 ppm; Nut, tree group 14–12 at 0.01 ppm, Peach subgroup 12–12B at 1.0 ppm and Plum subgroup 12–12C at 0.15 ppm. In addition, this regulation removes existing tolerances in 40 CFR 180.593 for residues of etoxazole in or on Fruit, pome, group 11 at 0.20 ppm; Fruit, stone, group 12, except plum at 1.0 ppm; Nut, tree, group 14 at 0.01 ppm; Cotton, undelinted seed at 0.05 ppm; Pistachio at 0.01 ppm; and Plum at 0.15 ppm that are superseded by this action. VI. Statutory and Executive Order Reviews This action establishes tolerances 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 E:\FR\FM\15OCR1.SGM 15OCR1 51867 khammond on DSK30JT082PROD with RULES Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations 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); 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). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will VerDate Sep<11>2014 16:29 Oct 12, 2018 Jkt 247001 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). Parts per million Commodity * * * * Plum subgroup 12–12C .............. * * * * * * * * * 0.15 * * List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. [FR Doc. 2018–22279 Filed 10–12–18; 8:45 am] Dated: October 2, 2018. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs. 47 CFR Part 1 Therefore, 40 CFR chapter I is amended as follows: Accelerating Wireless and Wireline Broadband Deployment by Removing Barriers to Infrastructure Investment Federal Communications Commission. ACTION: Final rule. AGENCY: 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Amend the table in § 180.593(a) as follows: ■ a. Add alphabetically the entries for ‘‘Cherry subgroup 12–12A’’; ‘‘Corn, sweet, forage’’; ‘‘Corn, sweet, kernel plus cob with husks removed’’; ‘‘Corn, sweet, stover’’; ‘‘Cottonseed subgroup 20C’’; ‘‘Fruit, pome, group 11–10’’; ‘‘Nut, tree group 14–12’’; Peach subgroup 12–12B’’; and ‘‘Plum subgroup 12–12C’’. ■ b. Remove the entries for ‘‘Cotton, undelinted seed’’; ‘‘Fruit, pome, group 11’’; ‘‘Fruit, stone, group 12, except plum’’; ‘‘Nut, tree, group 14’’; ‘‘Pistachio’’; and ‘‘Plum.’’ ■ § 180.593 Etoxazole; tolerances for residues. (a) * * * Parts per million * * * * Cherry subgroup 12–12A ........... * * * * * Corn, sweet, forage .................... Corn, sweet, kernel plus cob with husks removed ................ Corn, sweet, stover ..................... * 0.01 5.0 * * * * Cottonseed subgroup 20C ......... Fruit, pome, group 11–10 ........... * 0.05 0.20 * * * * Nut, tree group 14–12 ................ * 0.01 * * * * Peach subgroup 12–12B ............ * PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 FEDERAL COMMUNICATIONS COMMISSION [WT Docket No. 17–79, WC Docket No. 17– 84; FCC 18–133] PART 180—[AMENDED] Commodity BILLING CODE 6560–50–P 1.0 1.5 1.0 In this document, the Federal Communications Commission (‘‘Commission’’ or ‘‘FCC’’) issues guidance and adopts rules to streamline the wireless infrastructure siting review process to facilitate the deployment of next-generation wireless facilities. Specifically, in the Declaratory Ruling, the Commission identifies specific fee levels for the deployment of Small Wireless Facilities, and it addresses state and local consideration of aesthetic concerns that effect the deployment of Small Wireless Facilities. In the Order, the Commission addresses the ‘‘shot clocks’’ governing the review of wireless infrastructure deployments and establishes two new shot clocks for Small Wireless Facilities. DATES: Effective January 14, 2019. FOR FURTHER INFORMATION CONTACT: Jiaming Shang, Deputy Chief (Acting) Competition and Infrastructure Policy Division, Wireless Telecommunications Bureau, (202) 418–1303, email Jiaming.shang@fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Declaratory Ruling and Third Report and Order (Declaratory Ruling and Order), WT Docket No. 17–79 and WC Docket No. 17–84; FCC 18–133, adopted September 26, 2018 and released September 27, 2018. The full text of this document is available for inspection and copying during business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY–A257, Washington, DC 20554. Also, it may be purchased from the Commission’s duplicating contractor at SUMMARY: E:\FR\FM\15OCR1.SGM 15OCR1

Agencies

[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Rules and Regulations]
[Pages 51863-51867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22279]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0273; FRL-9983-96]


Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on multiple commodities which are identified and 
discussed later in this document. In addition, it removes certain 
previously established tolerances that are superseded by this final 
rule. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 15, 2018. Objections and 
requests for hearings must be received on or before December 14, 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-2017-0273, is available at http://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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. 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).

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 http://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-2017-0273 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 
December 14, 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-2017-0273, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E8559) by IR-4 Project Headquarters, 500 College Road East, Suite 201 
W, Princeton, New Jersey 08540. The petition requested that 40 CFR 
180.593 be amended by establishing tolerances for residues of the 
miticide/insecticide etoxazole, (2-(2,6-difluorophenyl)-4-[4-(1,1-
dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole), in or on Corn, 
sweet, kernel plus cob with husks removed at 0.01 parts per million 
(ppm); Corn, sweet, forage at 1.5 ppm; Corn, sweet, stover at 5.0 ppm; 
Fruit, pome, group 11-10 at 0.20 ppm; Nut, tree, group 14-12 at 0.01 
ppm; Fruit, stone, group 12-12 at 1.0 ppm; and Cottonseed subgroup 20C 
at 0.05 ppm. In addition, upon establishment of new tolerances 
referenced above, the petitioner requested the removal of existing 
tolerances in 40 CFR 180.593 for residues of etoxazole in or on Fruit, 
pome, group 11 at 0.20 ppm; Fruit, stone, group 12, except plum at 1.0 
ppm; Nut, tree, group 14 at 0.01 ppm; Cotton, undelinted seed at 0.05 
ppm; Pistachio at 0.01 ppm; Plum at 0.15 ppm; and Plum, prune, dried at 
0.30 ppm. That document referenced a summary of the petition prepared 
by Valent U.S.A. Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is 
issuing tolerances that vary from what the

[[Page 51864]]

petitioner sought. The reasons for these changes are explained in Unit 
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for etoxazole including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with etoxazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The effects in the etoxazole database show liver toxicity in all 
species tested (enzyme release, hepatocellular swelling and 
histopathological indicators), and the severity does not appear to 
increase with time. In rats only, there were effects on incisors 
(elongation, whitening, and partial loss of upper and/or lower 
incisors). There is no evidence of neurotoxicity or immunotoxicity. No 
toxicity was seen at the limit dose in a 28-day dermal toxicity study 
in rats. Etoxazole was not mutagenic.
    No increased quantitative or qualitative susceptibilities were 
observed following in utero exposure to rats or rabbits in the 
developmental studies; however, offspring toxicity was more severe 
(increased pup mortality) than maternal toxicity (increased liver and 
adrenal weights) at the same dose (158.7 milligram/kilogram/day (mg/kg/
day)) in the rat reproduction study indicating increased qualitative 
susceptibility. Etoxazole is not likely to be carcinogenic. This 
decision was based on weight-of-evidence approach including the lack of 
carcinogenicity in two studies in mice, lack of carcinogenicity in one 
study in rats, and the lack of hormonal and reproductive effects in 
special studies. Etoxazole was categorized as having low acute toxicity 
via the oral, dermal, and inhalation routes. It is not an eye or dermal 
irritant or a dermal sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by etoxazole 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 http://www.regulations.gov in document titled ``Etoxazole: Human Health Risk 
Assessment in Support of Proposed Use a Sweet Corn, and Proposed Crop 
Group Updates for Pome Fruit 11-10, Tree Nut Group 14-12, Stone Fruit 
Group 12-12, and Cotton Subgroup 20C at pages 22-27 in docket ID number 
EPA-HQ-OPP-2017-0273.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for etoxazole used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                   POD and uncertainty/   RfD, PAD, LOC for
        Exposure/Scenario           FQPA Safety factors    risk assessment      Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 4.62 mg/kg/   cPAD = cRfD = 0.046  Chronic Oral Toxicity Study--Dog.
                                    day.                  mg/kg/day.          LOAEL = 23.5 mg/kg/day based upon
                                   UFA = 10x...........                        increased alkaline phosphatase
                                   UFH = 10x...........                        activity, increased liver
                                   FQPA SF = 1x........                        weights, liver enlargement
                                                                               (females), and incidences of
                                                                               centrilobular hepatocellular
                                                                               swelling in the liver.
                                  ------------------------------------------------------------------------------

[[Page 51865]]

 
Cancer (Oral, dermal, inhalation)   EPA has classified etoxazole as ``not likely to be carcinogenic to humans''
                                     according to EPA Proposed Guidelines for Carcinogen Risk Assessment (April
                                                                     10, 1996).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. 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 etoxazole, EPA considered exposure under the petitioned-for 
tolerances as well as all existing etoxazole tolerances in 40 CFR 
180.593. EPA assessed dietary exposures from etoxazole in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
etoxazole; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA National 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed 
tolerance-level residues or tolerance-level residues adjusted to 
account for the residues of concern, 100% crop treated (PCT), and in 
the absence of empirical data, default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
classified etoxazole as ``not likely'' to be carcinogenic to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for etoxazole. Tolerance level residues and 100 PCT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for etoxazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of etoxazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST), and 
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated 
drinking water concentrations (EDWCs) of etoxazole for chronic 
exposures are estimated to be 4.761 parts per billion (ppb) for surface 
water and <0.01 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration of value 4.761 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Etoxazole is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 etoxazole to share a common mechanism of toxicity 
with any other substances, and etoxazole does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that etoxazole 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data are available to EPA support the 
choice of a different factor.
    2. Prenatal and postnatal sensitivity. No increased quantitative or 
qualitative susceptibilities were observed following in utero exposure 
to rats or rabbits in the developmental studies. There is evidence of 
increased qualitative offspring susceptibility in the rat reproduction 
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the selected endpoints are 
protective of the doses where the offspring toxicity is observed; and 
(3) offspring effects occur at the same doses as parental toxicity so 
protecting for parental effects is protective of offspring effects. 
There are no residual uncertainties for pre- and post-natal toxicity.
    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 etoxazole is complete.

[[Page 51866]]

    ii. There is no indication that etoxazole is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. The observed qualitative postnatal susceptibility is protected 
for by the selected endpoints.
    iv. 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 etoxazole in drinking water. These assessments 
will not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
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.
    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, 
etoxazole is 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 
etoxazole from food and water will utilize 15% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for etoxazole.
    3. Short- and Intermediate-term risks. Short- and intermediate-term 
aggregate exposures take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    A short- and intermediate-term adverse effect was identified; 
however, etoxazole is not registered for any use patterns that would 
result in either short- or intermediate-term residential exposure. 
Short- and intermediate-term risks are assessed based on short- or 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or intermediate-term residential exposure 
and chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
POD used to assess short- or intermediate-term risks), no further 
assessment of short- or intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risks for etoxazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, etoxazole is not expected to pose a cancer risk to humans.
    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 etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methodologies (Valent Method RM-37, gas chromatography/
mass-selective detector (GC/MSD) or GC/nitrogen-phosphorus detector 
(NPD)) are available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex has established maximum residue limits (MRLs) for residues of 
etoxazole in or on pome fruit (0.07 ppm) and tree nut (0.01 ppm). The 
relevant U.S. tolerances are harmonized with the tree nut MRL but 
cannot be harmonized with the pome fruit MRL because doing so could 
result in exceedances for application consistent with the domestic 
registration.

C. Revisions to Petitioned-for Tolerances

    Instead of the petitioned-for tolerance on Fruit, stone, group 12-
12 at 1.0 ppm, EPA is establishing separate subgroup tolerances for 
this crop group including Cherry subgroup 12-12A at 1.0 ppm, Peach 
subgroup 12-12B at 1.0 ppm, and Plum subgroup 12-12C at 0.15 ppm; and 
is retaining the existing separate, lower tolerance on Plum, prune, 
dried at 0.30 ppm as that remains necessary to cover the processed 
commodity. Separate subgroup tolerances are being established because 
there is more than a factor of five between the residue levels for the 
cherry and peach subgroups and the residues levels for commodities in 
the plum subgroup.

V. Conclusion

    Therefore, tolerances are established for residues of etoxazole, 
(2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on Cherry subgroup 12-12A at 1.0 ppm; Corn, 
sweet, forage at 1.5 ppm; Corn, sweet, kernel plus cob with husks 
removed at 0.01 ppm; Corn, sweet, stover at 5.0 ppm; Cottonseed 
subgroup 20C at 0.05 ppm; Fruit, pome, group 11-10 at 0.20 ppm; Nut, 
tree group 14-12 at 0.01 ppm, Peach subgroup 12-12B at 1.0 ppm and Plum 
subgroup 12-12C at 0.15 ppm. In addition, this regulation removes 
existing tolerances in 40 CFR 180.593 for residues of etoxazole in or 
on Fruit, pome, group 11 at 0.20 ppm; Fruit, stone, group 12, except 
plum at 1.0 ppm; Nut, tree, group 14 at 0.01 ppm; Cotton, undelinted 
seed at 0.05 ppm; Pistachio at 0.01 ppm; and Plum at 0.15 ppm that are 
superseded by this action.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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

[[Page 51867]]

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); 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).

VII. 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: October 2, 2018.
Michael L. Goodis,
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. Amend the table in Sec.  180.593(a) as follows:
0
a. Add alphabetically the entries for ``Cherry subgroup 12-12A''; 
``Corn, sweet, forage''; ``Corn, sweet, kernel plus cob with husks 
removed''; ``Corn, sweet, stover''; ``Cottonseed subgroup 20C''; 
``Fruit, pome, group 11-10''; ``Nut, tree group 14-12''; Peach subgroup 
12-12B''; and ``Plum subgroup 12-12C''.
0
b. Remove the entries for ``Cotton, undelinted seed''; ``Fruit, pome, 
group 11''; ``Fruit, stone, group 12, except plum''; ``Nut, tree, group 
14''; ``Pistachio''; and ``Plum.''


Sec.  180.593   Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cherry subgroup 12-12A......................................         1.0
 
                                * * * * *
Corn, sweet, forage.........................................         1.5
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................         5.0
 
                                * * * * *
Cottonseed subgroup 20C.....................................        0.05
Fruit, pome, group 11-10....................................        0.20
 
                                * * * * *
Nut, tree group 14-12.......................................        0.01
 
                                * * * * *
Peach subgroup 12-12B.......................................         1.0
 
                                * * * * *
Plum subgroup 12-12C........................................        0.15
 
                                * * * * *
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[FR Doc. 2018-22279 Filed 10-12-18; 8:45 am]
 BILLING CODE 6560-50-P