Etoxazole; Pesticide Tolerances, 66626-66630 [2019-26158]

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General Information 0.4 0.4 * [FR Doc. 2019–26131 Filed 12–4–19; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2018–0644; FRL–10000–97] Etoxazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: jbell on DSKJLSW7X2PROD with RULES VerDate Sep<11>2014 16:17 Dec 04, 2019 Jkt 250001 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? This regulation establishes tolerances for residues of etoxazole in or on beet, sugar, roots and beet, sugar, leaves. The Interregional Research Project Number 4 (IR–4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 5, 2019. Objections and requests for hearings must be received on or before February 3, 2020 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–2018–0644, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency SUMMARY: 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: You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Publishing Office’s eCFR 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–2018–0644 in the subject line on the first page of your submission. All PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before February 3, 2020. 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– 2018–0644, 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. Summary of Petitioned-For Tolerance In the Federal Register of March 18, 2018 (84 FR 9737) (FRL–9989–71), 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 8E8701) by IR–4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W. Princeton, NJ 08540. The petition requested that 40 CFR part 180.593 be amended by establishing tolerances for residues of the insecticide etoxazole, (2(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole), in or on the following sugar beet commodities: Roots at 0.02 parts per million (ppm); dried pulp at 0.04 ppm; and leaves at 1 ppm. In addition, the petition requested tolerances for etoxazole residues in or on the leaves of many other commodities at 1 ppm. That document referenced a summary of the petition prepared by Valent U.S.A. Corporation, E:\FR\FM\05DER1.SGM 05DER1 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Rules and Regulations the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from what the petitioner requested, in accordance with section 408(d)(4)(A)(i). 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 database 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. 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 mutagenic and not likely to be carcinogenic based on the lack of carcinogenicity effects in the database. 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 66627 toxicity studies can be found at https:// www.regulations.gov in document, ‘‘Etoxazole: Human Health Risk Assessment for Registration Review and a Proposed Section 3 Use on Sugar Beets’’ at pages 33–37 in docket ID number EPA–HQ–OPP–2018–0644. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// 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. jbell on DSKJLSW7X2PROD with RULES TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETOXAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario POD and uncertainty/FQPA safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Chronic dietary (All populations) ...................... NOAEL= 4.62 mg/kg/day ....... UFA = 10X UFH = 10X FQPA SF = 1X cPAD = cRfD = 0.046 mg/kg/ day. 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. VerDate Sep<11>2014 16:17 Dec 04, 2019 Jkt 250001 PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 E:\FR\FM\05DER1.SGM 05DER1 66628 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETOXAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued POD and uncertainty/FQPA safety factors Exposure/scenario Cancer (Oral, dermal, inhalation) ..................... RfD, PAD, LOC for risk assessment Study and toxicological effects EPA has classified etoxazole as ‘‘not likely to be carcinogenic to humans.’’ jbell on DSKJLSW7X2PROD with RULES FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to 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 Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCID), Version 3.16. This software uses 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 tolerancelevel residues and 100% crop treated (PCT) for all food commodities. EPA’s 2018 default processing factors were used except in cases where adequate processing data were available. In the cases where there was no significant concentration, the default processing factors were set to 1. 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 VerDate Sep<11>2014 16:17 Dec 04, 2019 Jkt 250001 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 https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. Etoxazole residues of concern in drinking water, which were used in the dietary exposure assessment for this new use, include the parent and two major metabolites, R–8 and R–13. 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 exposure and 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.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 toxicity, EPA has not made a common mechanism of toxicity finding as to etoxazole and any other substances and etoxazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that etoxazole has 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:// 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 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. 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 in the presence of parental toxicity. 3. Conclusion. Based on the available hazard and exposure database for E:\FR\FM\05DER1.SGM 05DER1 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES etoxazole, EPA recommends that the FQPA SF be reduced to 1X for all exposure scenarios relevant to the current safety assessment. 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 for current exposure scenarios. That decision is based on the following findings: i. The toxicity database for etoxazole is complete including acceptable developmental toxicity studies in rats and rabbits, a two-generation reproduction study in rats, and acute and subchronic neurotoxicity studies in rats. ii. There is no evidence of neurotoxicity in the etoxazole database including guideline acute and subchronic neurotoxicity studies. iii. There are no residual uncertainties for pre- and/or post-natal toxicity. The observed qualitative postnatal susceptibility is protected for by the selected endpoints. iv. There are no residual uncertainties identified in the exposure databases. Adequate data are available to determine the nature and magnitude of the residue in all proposed/registered crops and in livestock. The current dietary exposure analysis assumed 100 PCT, tolerance-level residues, modeled drinking water estimates, and in the absence of empirical data, default processing factors. Therefore, the dietary exposure analysis is conservative and unlikely to underestimate exposure. There are no registered residential uses for 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 VerDate Sep<11>2014 16:17 Dec 04, 2019 Jkt 250001 chronic exposure, EPA has concluded that chronic exposure to etoxazole from food and water will utilize 3.6% of the cPAD for the U.S. population and 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 exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Short- and intermediate-term risk is 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. EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk 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 enforcement methodology, Valent Method RM–37, gas chromatography/mass-selective detector (GC/MSD) or GC/nitrogen-phosphorus detector (NPD), is available for enforcing the current plant and livestock tolerances. 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 PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 66629 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. There are no Codex MRLs for residues of etoxazole in/on sugar beet commodities. C. Revisions to Petitioned-for Tolerances EPA concluded that a separate tolerance for etoxazole residues in or on Beet, sugar, dried pulp is not needed because available processing data indicate that quantifiable residues of etoxazole are unlikely to occur in sugar beet processed commodities following an application at the maximum use rate. In addition, EPA is not establishing any tolerances for residues on plant leaves (other than the tolerance on beet, sugar, leaves) because the petitioner withdrew its request for those tolerances. At this time, those tolerances are not necessary. V. Conclusion Therefore, a tolerance is established for residues of etoxazole, (2-(2,6difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole), in or on Beet, sugar, leaves at 1 ppm and Beet, sugar, roots at 0.02 ppm. 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 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), nor is it considered a regulatory action under Executive Order E:\FR\FM\05DER1.SGM 05DER1 66630 Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES 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 tolerances 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 VerDate Sep<11>2014 16:17 Dec 04, 2019 Jkt 250001 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: November 21, 2019. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. with the Atlantic Bluefish Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial bluefish quotas for North Carolina and Rhode Island. Effective December 4, 2019, through December 31, 2019. DATES: FOR FURTHER INFORMATION CONTACT: Cynthia Ferrio, Fishery Management Specialist, (978) 281–9180. SUPPLEMENTARY INFORMATION: Regulations governing the Atlantic bluefish fishery are found in 50 CFR 648.160 through 648.167. These PART 180—[AMENDED] regulations require annual specification of a commercial quota that is ■ 1. The authority citation for part 180 apportioned among the coastal states continues to read as follows: from Maine through Florida. The Authority: 21 U.S.C. 321(q), 346a and 371. process to set the annual commercial ■ 2. In the table in paragraph (a) of quota and the percent allocated to each § 180.593, add alphabetically the state is described in § 648.162 and the commodities ‘‘Beet, sugar, leaves’’ and initial 2019 allocations were published ‘‘Beet, sugar, roots’’ to read as follows: on March 12, 2019 (84 FR 8826). § 180.593 Etoxazole; tolerances for The final rule implementing residues. Amendment 1 to the Bluefish Fishery (a) * * * Management Plan published in the Federal Register on July 26, 2000 (65 FR Parts per 45844), and provided a mechanism for Commodity million transferring bluefish quota from one state to another. Two or more states, under mutual agreement and with the * * * * * Beet, sugar, leaves ..................... 1 concurrence of the NMFS Greater Beet, sugar, roots ....................... 0.02 Atlantic Regional Administrator, can request approval to transfer or combine * * * * * bluefish commercial quota under § 648.162(e)(1)(i) through (iii). The * * * * * Regional Administrator must first [FR Doc. 2019–26158 Filed 12–4–19; 8:45 am] approve any such transfer based on the BILLING CODE 6560–50–P criteria in § 648.162(e). North Carolina is transferring 150,000 lb (63 mt) of bluefish commercial quota DEPARTMENT OF COMMERCE to Rhode Island through mutual National Oceanic and Atmospheric agreement of the states. This transfer Administration was requested to ensure that Rhode Island would not exceed its allocated 50 CFR Part 648 2019 state quota. The revised bluefish quotas for 2019 are: North Carolina, [Docket No. 181010932–9124–02; RTID 0648–XX028] 2,321,746 lb (1,053 mt); and Rhode Island, 674,874 lb (306 mt). Fisheries of the Northeastern United Classification States; Atlantic Bluefish Fishery; Quota Transfer From NC to RI This action is taken under 50 CFR AGENCY: National Marine Fisheries part 648 and is exempt from review Service (NMFS), National Oceanic and under Executive Order 12866. Atmospheric Administration (NOAA), Authority: 16 U.S.C. 1801 et seq. Commerce. Dated: December 2, 2019. ACTION: Notification of quota transfer. Therefore, 40 CFR chapter I is amended as follows: NMFS announces that the State of North Carolina is transferring a portion of its 2019 commercial bluefish quota to the State of Rhode Island. This quota adjustment is necessary to comply SUMMARY: PO 00000 Frm 00070 Fmt 4700 Sfmt 9990 Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2019–26291 Filed 12–4–19; 8:45 am] BILLING CODE 3510–22–P E:\FR\FM\05DER1.SGM 05DER1

Agencies

[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Rules and Regulations]
[Pages 66626-66630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26158]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0644; FRL-10000-97]


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 beet, sugar, roots and beet, sugar, leaves. The 
Interregional Research Project Number 4 (IR-4) requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2019. Objections and 
requests for hearings must be received on or before February 3, 2020 
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-2018-0644, 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).

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 
Publishing 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-2018-0644 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 
February 3, 2020. 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-2018-0644, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of March 18, 2018 (84 FR 9737) (FRL-9989-
71), 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 
8E8701) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W. Princeton, NJ 08540. The petition 
requested that 40 CFR part 180.593 be amended by establishing 
tolerances for residues of the insecticide etoxazole, (2-(2,6-
difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on the following sugar beet commodities: Roots 
at 0.02 parts per million (ppm); dried pulp at 0.04 ppm; and leaves at 
1 ppm. In addition, the petition requested tolerances for etoxazole 
residues in or on the leaves of many other commodities at 1 ppm. That 
document referenced a summary of the petition prepared by Valent U.S.A. 
Corporation,

[[Page 66627]]

the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what the petitioner requested, 
in accordance with section 408(d)(4)(A)(i). 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 database 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.
    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 mutagenic and not likely to be 
carcinogenic based on the lack of carcinogenicity effects in the 
database.
    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 https://www.regulations.gov in document, ``Etoxazole: Human Health Risk 
Assessment for Registration Review and a Proposed Section 3 Use on 
Sugar Beets'' at pages 33-37 in docket ID number EPA-HQ-OPP-2018-0644.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://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 risk  Study and toxicological
          Exposure/scenario              FQPA safety factors           assessment                effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL= 4.62 mg/kg/day..  cPAD = cRfD = 0.046 mg/  Chronic Oral Toxicity
                                       UFA = 10X..............   kg/day.                  Study--Dog.
                                       UFH = 10X..............                           LOAEL = 23.5 mg/kg/day
                                       FQPA SF = 1X...........                            based upon increased
                                                                                          alkaline phosphatase
                                                                                          activity, increased
                                                                                          liver weights, liver
                                                                                          enlargement (females),
                                                                                          and incidences of
                                                                                          centrilobular
                                                                                          hepatocellular
                                                                                          swelling in the liver.
                                      --------------------------------------------------------------------------

[[Page 66628]]

 
Cancer (Oral, dermal, inhalation)....  EPA has classified etoxazole as ``not likely to be carcinogenic to
                                        humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 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 Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCID), Version 3.16. This 
software uses 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 and 100% crop treated (PCT) for all food commodities. EPA's 
2018 default processing factors were used except in cases where 
adequate processing data were available. In the cases where there was 
no significant concentration, the default processing factors were set 
to 1.
    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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Etoxazole residues of concern in drinking water, which were used in 
the dietary exposure assessment for this new use, include the parent 
and two major metabolites, R-8 and R-13. 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 
exposure and 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to etoxazole and any other 
substances and etoxazole does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has not assumed that etoxazole has 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://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 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. 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 in the presence of parental toxicity.
    3. Conclusion. Based on the available hazard and exposure database 
for

[[Page 66629]]

etoxazole, EPA recommends that the FQPA SF be reduced to 1X for all 
exposure scenarios relevant to the current safety assessment.
    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 for current exposure scenarios. That decision is based on the 
following findings:
    i. The toxicity database for etoxazole is complete including 
acceptable developmental toxicity studies in rats and rabbits, a two-
generation reproduction study in rats, and acute and subchronic 
neurotoxicity studies in rats.
    ii. There is no evidence of neurotoxicity in the etoxazole database 
including guideline acute and subchronic neurotoxicity studies.
    iii. There are no residual uncertainties for pre- and/or post-natal 
toxicity. The observed qualitative postnatal susceptibility is 
protected for by the selected endpoints.
    iv. There are no residual uncertainties identified in the exposure 
databases. Adequate data are available to determine the nature and 
magnitude of the residue in all proposed/registered crops and in 
livestock. The current dietary exposure analysis assumed 100 PCT, 
tolerance-level residues, modeled drinking water estimates, and in the 
absence of empirical data, default processing factors. Therefore, the 
dietary exposure analysis is conservative and unlikely to underestimate 
exposure. There are no registered residential uses for 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 3.6% of the cPAD for the 
U.S. population and 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 exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term risk is 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. EPA relies on the chronic dietary 
risk assessment for evaluating short- and intermediate-term risk 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 enforcement methodology, Valent Method RM-37, gas 
chromatography/mass-selective detector (GC/MSD) or GC/nitrogen-
phosphorus detector (NPD), is available for enforcing the current plant 
and livestock tolerances.
    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.
    There are no Codex MRLs for residues of etoxazole in/on sugar beet 
commodities.

C. Revisions to Petitioned-for Tolerances

    EPA concluded that a separate tolerance for etoxazole residues in 
or on Beet, sugar, dried pulp is not needed because available 
processing data indicate that quantifiable residues of etoxazole are 
unlikely to occur in sugar beet processed commodities following an 
application at the maximum use rate. In addition, EPA is not 
establishing any tolerances for residues on plant leaves (other than 
the tolerance on beet, sugar, leaves) because the petitioner withdrew 
its request for those tolerances. At this time, those tolerances are 
not necessary.

V. Conclusion

    Therefore, a tolerance is established for residues of etoxazole, 
(2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on Beet, sugar, leaves at 1 ppm and Beet, sugar, 
roots at 0.02 ppm.

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 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), nor is it considered a 
regulatory action under Executive Order

[[Page 66630]]

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 tolerances 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: November 21, 2019.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In the table in paragraph (a) of Sec.  180.593, add alphabetically 
the commodities ``Beet, sugar, leaves'' and ``Beet, sugar, roots'' to 
read as follows:


Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, leaves.........................................           1
Beet, sugar, roots..........................................        0.02
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-26158 Filed 12-4-19; 8:45 am]
 BILLING CODE 6560-50-P
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