Isoxaben; Pesticide Tolerances, 29340-29345 [2020-08962]

Download as PDF 29340 Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for acequinocyl in or on the bushberry subgroup 13–07B. jbell on DSKJLSW7X2PROD with RULES V. Conclusion Therefore, a tolerance is established for residues of acequinocyl, including its metabolites and degradates in or on the bushberry subgroup 13–07B at 3 ppm. VI. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under 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 VerDate Sep<11>2014 16:12 May 14, 2020 Jkt 250001 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: April 1, 2020. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.599, amend the table in paragraph (a) by adding in alphabetical order an entry for ‘‘Bushberry subgroup 13–07B’’ to read as follows: ■ § 180.599 Acequinocyl; tolerances for residues. * PO 00000 * * Frm 00018 * Fmt 4700 * Sfmt 4700 Parts per million Commodity * * * * Bushberry subgroup 13–07B .......... * * * * * * * * * 3 * * [FR Doc. 2020–09451 Filed 5–14–20; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2019–0070; FRL–10001–14] Isoxaben; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of isoxaben in or on the caneberry subgroup 13–07A and hop, dried cones. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 15, 2020. Objections and requests for hearings must be received on or before July 14, 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–2019–0070, 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 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: SUMMARY: E:\FR\FM\15MYR1.SGM 15MYR1 Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations 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). jbell on DSKJLSW7X2PROD with RULES 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 eCFR 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–2019–0070 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 14, 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– 2019–0070, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online VerDate Sep<11>2014 16:12 May 14, 2020 Jkt 250001 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 June 7, 2019 (84 FR 26630) (FRL–9993–93), 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 8E8731) by IR–4, IR–4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.650 be amended by establishing tolerances for residues of isoxaben, N-[3-(1-ethyl-1-methylpropyl)5-isoxazolyl]-2, 6-dimethoxybenzamide in or on the raw agricultural commodities Hop, dried cones at 0.01 parts per million (ppm) and Caneberry subgroup 13–07A at 0.01 ppm. That document referenced a summary of the petition prepared by the Dow Chemical Company, the registrant, which is available in the docket, http:// www.regulations.gov. A comment was received on the notice of filing. EPA’s response to this comment is discussed 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 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 29341 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 isoxaben including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with isoxaben 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. Isoxaben shows low acute toxicity by all routes. In chronic oral studies, the liver (mouse) and kidney (rat) were target organs, and decreased body weight was observed in the rat, mouse, and dog. There was no indication of neurotoxicity or immunotoxicity. There was no evidence of increased quantitative susceptibility for pre- and/ or post-natal effects in the rat and rabbit developmental toxicity studies, nor in the rat multigeneration reproductive toxicity study. Increased qualitative susceptibility was observed in the rat reproductive toxicity study; however, concern for qualitative susceptibility is low because these effects were only observed at the limit dose of 1,000 mg/ kg/day in the presence of maternal effects. Isoxaben is currently classified as having ‘‘suggestive evidence of carcinogenic potential,’’ based on the presence of liver tumors in male and female mice. Because the tumors were benign and observed at dose levels exceeding the limit dose of 1,000 mg/kg/ day and there was low concern for genotoxicity, the chronic reference dose is considered protective of potential carcinogenicity and a separate quantitative assessment of cancer risk was not conducted. Specific information on the studies received and the nature of the adverse effects caused by isoxaben as well as the no-observed-adverse-effect-level E:\FR\FM\15MYR1.SGM 15MYR1 29342 Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in the document titled ‘‘Isoxaben. Human Health Risk Assessment to Support Proposed New Uses on Caneberry Subgroup 13–07A and Hops’’ on page numbers 32–37 in docket ID number EPA–HQ–OPP–2019– 0070. jbell on DSKJLSW7X2PROD with RULES 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 isoxaben used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of February 7, 2018 (83 FR 5307) (FRL–9972–75). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isoxaben, EPA considered exposure under the petitioned-for tolerances as well as all existing isoxaben tolerances in 40 CFR 180.650. EPA assessed dietary exposures from isoxaben 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 VerDate Sep<11>2014 16:12 May 14, 2020 Jkt 250001 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 isoxaben; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used 2003–2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT). iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to isoxaben. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for isoxaben. 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 isoxaben in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of isoxaben. 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 Surface Water Concentration Calculator (SWCC v1.106) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of isoxaben for chronic exposures are estimated to be 43.6 parts per billion (ppb) for surface water and 909 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 value of 909 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). PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 Isoxaben is currently registered for the following uses that could result in residential exposures: Landscape ornamentals, lawns/turf, and trees. EPA assessed residential exposure using the following assumptions: Isoxaben residential uses constitute short- and intermediate-term exposure scenarios. For residential handlers, since a dermal endpoint was not selected, the only route of exposure quantitatively assessed for adult handlers is through inhalation. For post-application exposures, only intermediate-term incidental oral exposures for children were assessed due to the persistence of isoxaben residues in soil. Neither a short-term dermal nor short-term incidental oral endpoint was selected for children. Although there is potential for post-application inhalation exposure of both adults and children, the estimated exposure is anticipated to be negligible; therefore, a quantitative postapplication inhalation assessment was not required. For the purpose of performing an aggregate assessment, the Agency selected only the most conservative, or worst-case, residential adult and child scenarios to be included in the aggregate, based on the lowest overall MOE (highest exposure estimates). For adults, handler inhalation exposure resulting from applications of isoxabentreated mulch by hand has been used to estimate adult aggregate exposure. The inhalation exposure was added to background exposure from food and water and compared to the short-term inhalation POD. Post-application risks for adults in residential settings were not assessed due to the lack of a dermal endpoint. For children, an intermediate-term aggregate assessment was conducted by adding the incidental soil ingestion exposure, and average food and water exposure (chronic dietary exposure). The incidental oral residential exposure value selected for the aggregate analysis is based on children ingesting soil particles containing pesticide residues while playing on treated turf. Due to the persistence of isoxaben in the soil, the Agency used a conservative approach by using the maximum seasonal application rate for estimating soil ingestion by children rather than the standard maximum single application rate. This scenario resulted in the highest calculated exposure levels; therefore, it is protective for all other oral post-application exposure and risk for children in residential settings. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide- E:\FR\FM\15MYR1.SGM 15MYR1 Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations science-and-assessing-pesticide-risks/ standard-operating-proceduresresidential-pesticide. 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 isoxaben to share a common mechanism of toxicity with any other substances, and isoxaben does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isoxaben 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-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. jbell on DSKJLSW7X2PROD with RULES 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. There was no evidence of increased quantitative susceptibility for pre- and/ or post-natal effects in the rat and rabbit developmental toxicity studies, nor in the rat multigeneration reproductive toxicity study. Increased qualitative susceptibility was observed in the rat reproductive toxicity study, however, concern for qualitative susceptibility is low because these effects were only observed at the limit dose of 1,000 mg/ kg/day in the presence of maternal effects. The NOAEL/LOAEL for these effects is well-defined, and risk VerDate Sep<11>2014 16:12 May 14, 2020 Jkt 250001 assessment PODs were selected to be protective for these effects. 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 isoxaben is complete to allow the Agency to assess the toxicological profile of isoxaben. ii. There is no indication that isoxaben is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There was no evidence of increased quantitative susceptibility for pre- and/or post-natal effects in the rat and rabbit developmental toxicity studies, nor in the rat multigeneration reproductive toxicity study. Increased qualitative susceptibility was observed in the rat reproductive toxicity study, however, concern for qualitative susceptibility is low because these effects were only observed at the limit dose of 1,000 mg/kg/day in the presence of maternal effects. The regulatory endpoint is protective of the offspring effects. 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 isoxaben in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isoxaben. 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 29343 and no acute dietary endpoint was selected. Therefore, isoxaben 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 isoxaben from food and water will utilize 98% of the cPAD for all infants less than 1-year-old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of isoxaben is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isoxaben is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to isoxaben. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 10,500 for females 13 to 49 years old. Because EPA’s level of concern for isoxaben is a MOE of 100 or below, this MOE is not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isoxaben is currently registered for uses that could result in intermediateterm residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to isoxaben. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 7,200 for children 1 to 2 years old. Because EPA’s level of concern for isoxaben is a MOE of 100 or below, this MOE is not of concern. 5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., EPA considers the chronic aggregate risk assessment to be protective of any aggregate cancer risk. As there is no chronic risk of concern, EPA does not expect any cancer risk to E:\FR\FM\15MYR1.SGM 15MYR1 29344 Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations the U.S. population from aggregate exposure to isoxaben. 6. 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 isoxaben residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate analytical method utilizing liquid chromatography with tandem mass spectrometric detection (LC/MS/MS), GRM 02.26.S.1 (a revision of GRM 02.26), is available for enforcement of isoxaben residues in crop commodities. 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. The Codex has not established any MRLs for isoxaben. jbell on DSKJLSW7X2PROD with RULES C. Response to Comments One comment was received that stated in part that isoxaben ‘‘should (sic) not be allowed to be used on hop, etc.’’ Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the VerDate Sep<11>2014 16:12 May 14, 2020 Jkt 250001 available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that these isoxaben tolerances are safe. The commenter has provided no information supporting a contrary conclusion. V. Conclusion Therefore, tolerances are established for residues of isoxaben in or on the caneberry subgroup 13–07A at 0.01 ppm and hop, dried cones at 0.01 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); 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 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 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 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: April 3, 2020. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.650, add alphabetically the entries ‘‘Caneberry subgroup 13–07A’’ and ‘‘Hop, dried cones’’ to the table in paragraph (a) to read as follows: ■ § 180.650 Isoxaben; tolerances for residues. (a) * * * E:\FR\FM\15MYR1.SGM 15MYR1 Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations Commodity Parts per million * * * Caneberry subgroup 13– 0.01 07A. * * * * * Hop, dried cones ............ 0.01 * * * * * * * * * * * * [FR Doc. 2020–08962 Filed 5–14–20; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 200420–0118] RIN 0648–XH043 Fisheries of the Northeastern United States; Summer Flounder, Scup, and Black Sea Bass Fisheries; Revised 2020 and Projected 2021 Black Sea Bass and Scup Specifications National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. AGENCY: This action approves revised 2020 and projected 2021 specifications for the scup and black sea bass fisheries. Changes to the specifications are necessary to better achieve optimum yield within the fishery while controlling overfishing, consistent with recent stock assessment updates and the Magnuson-Stevens Fishery Conservation and Management Act. This rule informs the public of the changes to the specifications for the remainder of the 2020 fishing year and announces projected 2021 specifications. SUMMARY: Effective May 15, 2020, through December 31, 2020. ADDRESSES: Copies of the revised specifications, including the DATES: Environment Assessment, and other supporting documents for the action, are available upon request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 N State Street, Dover, DE 19901. These documents are also accessible via the internet at http://www.mafmc.org. FOR FURTHER INFORMATION CONTACT: Emily Keiley, Fishery Policy Analyst, (978) 281–9116. SUPPLEMENTARY INFORMATION: Background The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission jointly manage the scup and black sea bass fisheries as part of the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP). Scup and black sea bass annual catch and landings limits do not roll over from one year to the next. To meet the FMP objectives and requirements of the Magnuson-Stevens Act, commercial quotas and recreational harvest limits (RHL) must be in place by January 1 of each year. At a joint meeting in October 2019, the Council and the Commission’s Summer Flounder, Scup, and Black Sea Bass Board adopted interim 2020 catch and landings limits for scup and black sea bass in late 2019 (84 FR 54041, October 9, 2019). The interim limits were identical to 2019 limits and intended to be replaced as soon as possible following operational stock assessments for both species conducted in the fall of 2019. Interim 2020 specifications were necessary because there was not sufficient time to complete the specification development and rulemaking between the stock assessment peer review and January 1, 2020. This action implements the updated 2020 specifications replacing the interim measures and announces projected 2021 specifications for scup and black sea bass. The Council’s Scientific and Statistical Committee (SSC) and the Summer Flounder, Scup, and Black Sea Bass Monitoring Committee (MC) met in October 2019 to review the operational 29345 stock assessment results and make recommendations to the Council for revised catch and landings limits. The SSC applied the Council’s risk policy and acceptable biological catch (ABC) control rule to derive recommended overfishing limits (OFL) and ABC values for fishing years 2020 and 2021. The Council and Board reviewed the new operational stock assessment information and the SSC and MCrecommended specifications at their joint meeting in October 2019, and took final action on revised 2020 and projected 2021 specifications. This action implements the Council and Board’s preferred alternatives. This action is being published without prior notice and a formal public comment period. The revised 2020 scup and black sea bass specifications included in this action were anticipated during development of the interim specifications, which were the subject of a notice and comment rulemaking process. Prior to our rulemaking, the Council and Board discussed that the interim measures would be replaced as quickly as possible once the operational stock assessment process was complete. The public was also notified of our intent to publish revised specifications in the proposed and final rules of the interim scup and black sea bass specifications action (84 FR 54041, October 9, 2019). Revised Specifications Black Sea Bass Specifications The Council and Board recommended 2020–2021 black sea bass catch and landings limits are shown in Table 1. The recommendations are based on the averaged 2020–2021 ABCs recommended by the SSC. This approach allows for constant catch and landings limits across both years. The ABCs are based on an SSC-modified OFL and the Council’s risk policy for a species with a typical life history and biomass level above BMSY, resulting in a 40-percent probability of overfishing. The final 2020 commercial quota and RHL are 59 percent higher than the interim 2020 limits. TABLE 1—2020–2021 BLACK SEA BASS CATCH AND LANDINGS LIMITS * Measure Mil lb. jbell on DSKJLSW7X2PROD with RULES OFL .......................................................................................................................................................................... ABC .......................................................................................................................................................................... ABC Landings Portion ............................................................................................................................................. ABC Discards Portion .............................................................................................................................................. Expected Commercial Discards .............................................................................................................................. Expected Recreational Discards ............................................................................................................................. Commercial ACL = ACT .......................................................................................................................................... Commercial Quota ................................................................................................................................................... VerDate Sep<11>2014 16:12 May 14, 2020 Jkt 250001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\15MYR1.SGM 15MYR1 2020: 19.39 2021: 17.68 15.07 11.39 3.68 1.4 2.28 6.98 5.58 Metric ton 2020: 8,795 2021: 8,021 6,835 5,164 1,671 637 1,034 3,167 2,530

Agencies

[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Rules and Regulations]
[Pages 29340-29345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08962]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0070; FRL-10001-14]


Isoxaben; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isoxaben in or on the caneberry subgroup 13-07A and hop, dried cones. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 15, 2020. Objections and 
requests for hearings must be received on or before July 14, 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-2019-0070, 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 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: 

[[Page 29341]]

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 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-2019-0070 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
July 14, 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-2019-0070, 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 June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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 
8E8731) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.650 be 
amended by establishing tolerances for residues of isoxaben, N-[3-(1-
ethyl-1-methylpropyl)-5-isoxazolyl]-2, 6-dimethoxybenzamide in or on 
the raw agricultural commodities Hop, dried cones at 0.01 parts per 
million (ppm) and Caneberry subgroup 13-07A at 0.01 ppm. That document 
referenced a summary of the petition prepared by the Dow Chemical 
Company, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. 
EPA's response to this comment is discussed 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 isoxaben including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with isoxaben 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.
    Isoxaben shows low acute toxicity by all routes. In chronic oral 
studies, the liver (mouse) and kidney (rat) were target organs, and 
decreased body weight was observed in the rat, mouse, and dog. There 
was no indication of neurotoxicity or immunotoxicity. There was no 
evidence of increased quantitative susceptibility for pre- and/or post-
natal effects in the rat and rabbit developmental toxicity studies, nor 
in the rat multigeneration reproductive toxicity study. Increased 
qualitative susceptibility was observed in the rat reproductive 
toxicity study; however, concern for qualitative susceptibility is low 
because these effects were only observed at the limit dose of 1,000 mg/
kg/day in the presence of maternal effects.
    Isoxaben is currently classified as having ``suggestive evidence of 
carcinogenic potential,'' based on the presence of liver tumors in male 
and female mice. Because the tumors were benign and observed at dose 
levels exceeding the limit dose of 1,000 mg/kg/day and there was low 
concern for genotoxicity, the chronic reference dose is considered 
protective of potential carcinogenicity and a separate quantitative 
assessment of cancer risk was not conducted.
    Specific information on the studies received and the nature of the 
adverse effects caused by isoxaben as well as the no-observed-adverse-
effect-level

[[Page 29342]]

(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the 
toxicity studies can be found at http://www.regulations.gov in the 
document titled ``Isoxaben. Human Health Risk Assessment to Support 
Proposed New Uses on Caneberry Subgroup 13-07A and Hops'' on page 
numbers 32-37 in docket ID number EPA-HQ-OPP-2019-0070.

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 isoxaben used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of February 7, 2018 (83 FR 5307) 
(FRL-9972-75).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isoxaben, EPA considered exposure under the petitioned-for 
tolerances as well as all existing isoxaben tolerances in 40 CFR 
180.650. EPA assessed dietary exposures from isoxaben 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 
isoxaben; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed tolerance-level residues and 100 
percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to isoxaben. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
isoxaben. 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 isoxaben in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of isoxaben. 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 Surface Water Concentration Calculator (SWCC v1.106) 
and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of isoxaben for chronic exposures 
are estimated to be 43.6 parts per billion (ppb) for surface water and 
909 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 value of 909 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).
    Isoxaben is currently registered for the following uses that could 
result in residential exposures: Landscape ornamentals, lawns/turf, and 
trees. EPA assessed residential exposure using the following 
assumptions: Isoxaben residential uses constitute short- and 
intermediate-term exposure scenarios. For residential handlers, since a 
dermal endpoint was not selected, the only route of exposure 
quantitatively assessed for adult handlers is through inhalation. For 
post-application exposures, only intermediate-term incidental oral 
exposures for children were assessed due to the persistence of isoxaben 
residues in soil. Neither a short-term dermal nor short-term incidental 
oral endpoint was selected for children. Although there is potential 
for post-application inhalation exposure of both adults and children, 
the estimated exposure is anticipated to be negligible; therefore, a 
quantitative post-application inhalation assessment was not required.
    For the purpose of performing an aggregate assessment, the Agency 
selected only the most conservative, or worst-case, residential adult 
and child scenarios to be included in the aggregate, based on the 
lowest overall MOE (highest exposure estimates). For adults, handler 
inhalation exposure resulting from applications of isoxaben-treated 
mulch by hand has been used to estimate adult aggregate exposure. The 
inhalation exposure was added to background exposure from food and 
water and compared to the short-term inhalation POD. Post-application 
risks for adults in residential settings were not assessed due to the 
lack of a dermal endpoint.
    For children, an intermediate-term aggregate assessment was 
conducted by adding the incidental soil ingestion exposure, and average 
food and water exposure (chronic dietary exposure). The incidental oral 
residential exposure value selected for the aggregate analysis is based 
on children ingesting soil particles containing pesticide residues 
while playing on treated turf. Due to the persistence of isoxaben in 
the soil, the Agency used a conservative approach by using the maximum 
seasonal application rate for estimating soil ingestion by children 
rather than the standard maximum single application rate. This scenario 
resulted in the highest calculated exposure levels; therefore, it is 
protective for all other oral post-application exposure and risk for 
children in residential settings.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/
pesticide-

[[Page 29343]]

science-and-assessing-pesticide-risks/standard-operating-procedures-
residential-pesticide.
    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 isoxaben to share a common mechanism of toxicity 
with any other substances, and isoxaben does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that isoxaben 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 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. There was no evidence of 
increased quantitative susceptibility for pre- and/or post-natal 
effects in the rat and rabbit developmental toxicity studies, nor in 
the rat multigeneration reproductive toxicity study. Increased 
qualitative susceptibility was observed in the rat reproductive 
toxicity study, however, concern for qualitative susceptibility is low 
because these effects were only observed at the limit dose of 1,000 mg/
kg/day in the presence of maternal effects. The NOAEL/LOAEL for these 
effects is well-defined, and risk assessment PODs were selected to be 
protective for these effects.
    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 isoxaben is complete to allow the 
Agency to assess the toxicological profile of isoxaben.
    ii. There is no indication that isoxaben is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There was no evidence of increased quantitative susceptibility 
for pre- and/or post-natal effects in the rat and rabbit developmental 
toxicity studies, nor in the rat multigeneration reproductive toxicity 
study. Increased qualitative susceptibility was observed in the rat 
reproductive toxicity study, however, concern for qualitative 
susceptibility is low because these effects were only observed at the 
limit dose of 1,000 mg/kg/day in the presence of maternal effects. The 
regulatory endpoint is protective of the offspring effects.
    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 isoxaben in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
isoxaben.

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, 
isoxaben 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 
isoxaben from food and water will utilize 98% of the cPAD for all 
infants less than 1-year-old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
isoxaben is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Isoxaben is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to isoxaben.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 10,500 for 
females 13 to 49 years old. Because EPA's level of concern for isoxaben 
is a MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Isoxaben is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to isoxaben.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in an 
aggregate MOE of 7,200 for children 1 to 2 years old. Because EPA's 
level of concern for isoxaben is a MOE of 100 or below, this MOE is not 
of concern.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA considers the chronic aggregate risk 
assessment to be protective of any aggregate cancer risk. As there is 
no chronic risk of concern, EPA does not expect any cancer risk to

[[Page 29344]]

the U.S. population from aggregate exposure to isoxaben.
    6. 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 isoxaben residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method utilizing liquid chromatography with 
tandem mass spectrometric detection (LC/MS/MS), GRM 02.26.S.1 (a 
revision of GRM 02.26), is available for enforcement of isoxaben 
residues in crop commodities.
    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]ov.

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.
    The Codex has not established any MRLs for isoxaben.

C. Response to Comments

    One comment was received that stated in part that isoxaben ``should 
(sic) not be allowed to be used on hop, etc.'' Although the Agency 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
authorizes EPA to establish tolerances when it determines that the 
tolerance is safe. Upon consideration of the validity, completeness, 
and reliability of the available data as well as other factors the 
FFDCA requires EPA to consider, EPA has determined that these isoxaben 
tolerances are safe. The commenter has provided no information 
supporting a contrary conclusion.

V. Conclusion

    Therefore, tolerances are established for residues of isoxaben in 
or on the caneberry subgroup 13-07A at 0.01 ppm and hop, dried cones at 
0.01 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); 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 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: April 3, 2020.
Michael 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. In Sec.  180.650, add alphabetically the entries ``Caneberry 
subgroup 13-07A'' and ``Hop, dried cones'' to the table in paragraph 
(a) to read as follows:


Sec.  180.650   Isoxaben; tolerances for residues.

    (a) * * *

[[Page 29345]]



------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
 
                                * * * * *
Caneberry subgroup 13-07A.................  0.01
 
                                * * * * *
Hop, dried cones..........................  0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-08962 Filed 5-14-20; 8:45 am]
 BILLING CODE 6560-50-P