Trifludimoxazin; Pesticide Tolerances, 26672-26677 [2021-10286]

Download as PDF 26672 Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Rules and Regulations may cause damage to the national security. Public Law 96–511, ‘‘Paperwork Reduction Act’’ (44 U.S.C. Chapter 35) ENVIRONMENTAL PROTECTION AGENCY Regulatory Procedures It has been determined that this rule does not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 40 CFR Part 180 Executive Order 13132, ‘‘Federalism’’ AGENCY: Executive Order 12866, ‘‘Regulatory Planning and Review,’’ Executive Order 13563, ‘‘Improving Regulation and Regulatory Review’’ Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 also emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this rule is not a significant regulatory action under these Executive Orders. The Congressional Review Act, title 5, U.S.C. 801 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The DoD 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). 2 U.S.C. Ch. 25, ‘‘Unfunded Mandates Reform Act’’ khammond on DSKJM1Z7X2PROD with RULES9 This final rule is not subject to the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1532) because it does not contain a federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100M or more in any one year. Public Law 96–354, ‘‘Regulatory Flexibility Act’’ (5 U.S.C. Chapter 6) It has been certified that this rule does not have a significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within DoD. A Regulatory Flexibility Analysis is not required. 21:39 May 14, 2021 List of Subjects in 32 CFR Part 310 Privacy. Accordingly, 32 CFR part 310 is amended as follows: Congressional Review Act VerDate Sep<11>2014 Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial effect on State and local governments. Jkt 253001 PART 310—[AMENDED] 1. The authority citation for 32 CFR part 310 continues to read as follows: ■ Authority: 5 U.S.C. 552a. 2. Section 310.29 is amended by adding paragraph (c)(28) to read as follows: ■ § 310.29 Procedures for exemptions. * * * * * (c) * * * (28) System identifier and name. DMDC 18 DoD, Synchronized Predeployment and Operational Tracker Enterprise Suite (SPOT–ES) Records. (i) Exemption. Information classified under E.O. 13526, as implemented by DoD Instruction (DoDI) 5200.01 and DoD Manual (DoDM) 5200.01, Volumes 1 and 3, may be exempt pursuant to 5 U.S.C. 552a(k)(1). (ii) Authority. 5 U.S.C. 552a(k)(1). (iii) Reasons. From subsection 5 U.S.C. 552a(d) because granting access to information that is properly classified pursuant to E.O. 13526, as implemented by DoD Instruction 5200.01 and DoD Manual 5200.01, Volumes 1 and 3, may cause damage to the national security. [EPA–HQ–OPP–2018–0762; FRL–10019–62] Trifludimoxazin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. This regulation establishes tolerances for residues of trifludimoxazin in or on multiple commodities which are identified and discussed later in this document. BASF corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective May 17, 2021. Objections and requests for hearings must be received on or before July 16, 2021 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2018–0762, 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. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. ADDRESSES: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2021–10313 Filed 5–14–21; 8:45 am] Marietta Echeverria, Acting Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305– 7090; email address: RDFRNotices@epa. gov. BILLING CODE 5001–06–P SUPPLEMENTARY INFORMATION: Dated: May 12, 2021. Aaron T. Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 U:\17MYR1.SGM 17MYR1 Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / 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). khammond on DSKJM1Z7X2PROD with RULES9 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 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–2018–0762 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 16, 2021. 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– 2018–0762, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online VerDate Sep<11>2014 21:39 May 14, 2021 Jkt 253001 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 April 19, 2019 (84 FR 16430) (FRL–9991–14), 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 8F8709) by BASF corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide trifludimoxazin, in or on almond, hulls at 0.15 parts per million (ppm); fruit, citrus, group 10–10 at 0.01 ppm; fruit, pome, group 11–10 at 0.01 ppm; grain, cereal, forage, fodder and straw, group 16 (except rice) at 0.01 ppm; grain, cereal, group 15 at 0.01 ppm; nut, tree, group 14–12 at 0.01 ppm; peanut at 0.01 ppm; peanut, hay at 0.01 ppm; vegetable, foliage of legume, group 07 at 0.01 ppm; vegetable, legume, group 06 at 0.01 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, https:// www.regulations.gov. One 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 26673 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 trifludimoxazin including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with trifludimoxazin follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The available database of guideline studies for trifludimoxazin indicates that the primary target organs are the thyroid and liver. Trifludimoxazin is a protoporphyrinogen oxidase (PPO)inhibitor. PPO is a key enzyme in chlorophyll and cytochrome pigments, as well as in heme. Although hematological effects associated with this class were observed, they are not considered adverse at the selected lowest-observable adverse-effects levels (LOAELs). Effects on the thyroid occurred in rats and consisted primarily of follicular cell hypertrophy/ hyperplasia and altered colloid of the thyroid after subchronic and chronic exposure durations. Increased relative thyroid weights were also observed in male rats; however, thyroid hormones were not adversely affected after subchronic exposure for males and females. Liver effects (increased alanine aminotransferase (ALT) and alkaline phosphatase (ALP), organ weight, and histopathology) were also observed at the same dose as thyroid effects in male rats after subchronic exposure. In mice, increased liver weight, increased gglutamyl transferase (GGT), and hypertrophy were observed after subchronic exposures. Increased liver U:\17MYR1.SGM 17MYR1 khammond on DSKJM1Z7X2PROD with RULES9 26674 Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Rules and Regulations weight, foci of (eosinophilic) cellular alteration, centrilobular hypertrophy, macrovesicular fatty change and centrilobular pigment storage was observed in male mice and oval cell hyperplasia and (multi)focal necrosis was observed in female mice after chronic exposure. After chronic exposure to the rat, increased pigment, multinucleated hepatocytes, and bile duct hyperplasia in the liver was observed at the same dose as thyroid effects. Effects on the reproductive system were observed as evidence of increased abnormal sperm in male rats in the extended one generation reproductive toxicity study (EOGRTS), and as effects to the epididymis in rats after subchronic and chronic exposure. Trifludimoxazin did not demonstrate neurotoxic potential in either acute or subchronic neurotoxicity studies in rats. Observations suggestive of neurotoxicity were seen in the 90-day subchronic study in dogs (e.g., functional observational battery (FOB) deficits, histopathological findings in the spinal cord and medulla oblongata (degeneration of fasciculus gracilis and white matter)), but no neurotoxicity effects were seen in either the 28-day dog study, which tested lower doses, or the chronic dog study, which tested higher doses relative to the 90-day study. There were no adverse maternal or developmental effects observed in the rat developmental toxicity study at the limit dose. However, in the rabbit developmental study, decreased fetal body weight was observed at a lower dose than maternal toxicity (increased incidence of late abortions); thus, increased quantitative susceptibility was observed. The Extended OneGeneration Reproductive Toxicity Study (EOGRTS) in rats demonstrated no increase in susceptibility as no effects were observed in the offspring while increased incidence and severity of follicular cell hypertrophy/hyperplasia and altered colloid in the thyroid was observed in the parental animals. Immunotoxicity was not observed throughout the toxicity database. Additionally, there were no effects in the dermal toxicity study, including any effects to the thyroid. The Agency has classified trifludimoxazin as ‘‘suggestive evidence of carcinogenic potential’’ based on thyroid tumors, driven by adenomas, observed in male rats at 750 ppm (33 mg/kg/day); an absence of treatmentrelated tumors in female rats and in male and female mice, and a lack of concern for mutagenicity. The Agency has concluded that quantification of cancer risk using a non-linear approach VerDate Sep<11>2014 21:39 May 14, 2021 Jkt 253001 (i.e., reference dose (RfD)) will adequately account for all chronic toxicity, including potential carcinogenicity, that could result from exposure to trifludimoxazin. The chronic reference dose (0.11 mg/kg/day) is several times lower than the level at which tumors were observed. Specific information on the studies received and the nature of the adverse effects caused by trifludimoxazin as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in pages 13–19 of document Trifludimoxazin: New Active Ingredient Human Health Risk Assessment for Registrations on Legume Vegetable Group 6, Foliage of Legume Vegetable Group 7, Citrus Fruit Group 10–10, Pome Fruit Group 11–10, Tree Nut Group 14–12, Cereal Grain Group 15 (except rice), Forage Fodder and Straw of Cereal Grain Group 16 (except rice), Peanut and Peanut Hay (hereinafter ‘‘Trifludimoxazin Human Health Risk Assessment’’) in docket ID number EPA–HQ–OPP–2018–0762. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 A summary of the toxicological endpoints for trifludimoxazin used for human risk assessment can be found in the Trifludimoxazin Human Health Risk Assessment. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to trifludimoxazin, EPA considered exposure under the petitioned-for trifludimoxazin tolerances in 40 CFR part 180. EPA assessed dietary exposures from trifludimoxazin 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 trifludimoxazin; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the 2003–2008 food consumption data from the United States 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 conducted an unrefined chronic dietary exposure assessment using tolerance-level residues, 100 percent crop treated (PCT), and default processing factors. iii. Cancer. Based on the Agency’s analysis of the available data, EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to trifludimoxazin. Quantification of cancer risk using a non-linear RfD approach will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to trifludimoxazin; therefore, a separate cancer dietary assessment was not conducted. iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for trifludimoxazin. Tolerance level residues and/or 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 trifludimoxazin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of trifludimoxazin. Further information regarding EPA drinking water models U:\17MYR1.SGM 17MYR1 Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES9 used in pesticide exposure assessment can be found at https://www2.epa.gov/ pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. Using the Pesticides in Water Calculator (PWC), Pesticide Root Zone Model and the Varying Volume Water Model (PRZM/VVWM), EPA calculated the estimated drinking water concentrations (EDWCs) of trifludimoxazin for acute and chronic exposures in surface and ground water. EPA used the modeled EDWCs directly in dietary exposure model to account for the contribution of trifludimoxazin residues in drinking water as follows: 5.0 ppb was used in acute dietary assessment and 3.6 ppb was used in chronic dietary risk assessment. 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). Trifludimoxazin 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.’’ The Agency has not found trifludimoxazin to share a common mechanism of toxicity with any other substances, and trifludimoxazin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that trifludimoxazin does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// 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 VerDate Sep<11>2014 21:39 May 14, 2021 Jkt 253001 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 evidence of quantitative prenatal susceptibility in the rabbit developmental toxicity study. However, the degree of concern is low because clear NOAELs were identified for the effects, and the selected endpoints and doses are protective of the observed developmental effects and observed susceptibility. 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 trifludimoxazin is complete. ii. Although there was evidence for neurotoxicity in the 90-day subchronic dog study, the degree of concern for the toxicity is low because this study is used as the basis for the risk assessment PODs and is protective of any potential neurotoxicity. iii. Clear NOAELs were identified for the developmental/offspring effects observed in the rat and rabbit prenatal developmental studies, and endpoints selected for risk assessment are protective of these effects and the quantitative susceptibility observed in the rabbit developmental study and rat EOGRTS. iv. There is no concern due to any residual uncertainties in the exposure database. No data gaps were identified, and exposure estimates are based upon conservative default assumptions. Tolerance-level residues and 100PCT are used in dietary exposure assessments, and residential exposures are not anticipated from the proposed use pattern. As such, residual uncertainty is negligible and does not impact considerations for the FQPA Safety Factor. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to trifludimoxazin in drinking water. These assessments will not underestimate the exposure and risks posed by trifludimoxazin. PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 26675 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, trifludimoxazin 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 the chronic risk estimates of food and drinking water for trifludimoxazin are below the Agency’s LOC at <1% of the cPAD for the United States population and all population subgroups. There are no residential uses for trifludimoxazin. 3. Short-term risk and Intermediateterm risk. Short-term and intermediateterm aggregate exposure takes into account short-term and intermediateterm residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term and intermediate-term adverse effect was identified; however, trifludimoxazin is not registered for any use patterns that would result in shortterm or intermediate-term residential exposure. Short-term and intermediateterm risk is assessed based on shortterm or intermediate-term residential exposure plus chronic dietary exposure. Because there is no short-term 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-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term and intermediateterm risk for trifludimoxazin. 4. Aggregate cancer risk for U.S. population. As indicated above, the Agency has determined that the noncancer chronic dietary assessment would account for any dietary cancer U:\17MYR1.SGM 17MYR1 26676 Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Rules and Regulations risks. Based on the level of chronic risk being below the Agency’s level of concern, EPA concludes aggregate exposure to trifludimoxazin will not pose a cancer risk. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to trifludimoxazin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (High-Performance Liquid Chromatography with tandem Mass Spectroscopy (HPLC–MS/MS) method (Method D147/02 in plant matrices)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. Trifludimoxazin is a new active ingredient, and no maximum residue limits (MRLs) have yet been established by Codex. khammond on DSKJM1Z7X2PROD with RULES9 C. Response to Comments One commenter expressed concern about the release of pesticide chemicals to the environment. The FFDCA does not authorize EPA to consider risks to the environment, per se; rather, the FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when VerDate Sep<11>2014 21:39 May 14, 2021 Jkt 253001 the Agency can determine that such tolerances are safe. Taking into consideration the factors required in the FFDCA, EPA has made that safety determination for the tolerances subject to this action; the commenter provided no information relevant to that conclusion. D. Revisions to Petitioned-For Tolerances Based upon review of submitted data, the Agency is establishing tolerances that vary from what the petitioner requested. The petitioner had requested to establish tolerance on the entire cereal crop groups 15 and 16; however, the Agency has determined that the petitioned tolerance for cereal crop groups 15 and 16 must be revised to exclude rice commodities. While there are no data gaps for human health, the Agency has insufficient environmental fate data to support a tolerance on rice; therefore, the request to allow use on rice on the trifludimoxazin label will not be granted at this time. Because the product will not be used on rice, tolerances are not needed for residues in or on rice. Consequently, EPA is excluding rice from the tolerances being set on cereal crop groups 15 and 16. V. Conclusion Therefore, tolerances are established for residues of trifludimoxazin in or on almond, hulls; fruit, citrus, group 10–10; fruit, pome, group 11–10; grain, cereal, forage, fodder and straw, group 16 (except rice); grain, cereal, group 15 (except rice); nut, tree, group 14–12; peanut; peanut, hay; vegetable, foliage of legume, group 07 and vegetable, legume, group 06. 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 13771, entitled ‘‘Reducing Regulations PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 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 U:\17MYR1.SGM 17MYR1 Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Rules and Regulations Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). FEDERAL COMMUNICATIONS COMMISSION List of Subjects in 40 CFR Part 180 47 CFR Part 1 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 5, 2021. Edward Messina, Acting Director, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 2. Add § 180.717 to subpart C to read as follows: ■ § 180.717 Trifludimoxazin; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide trifludimoxazin, including its metabolites and degradates, in or on the commodities to Table 1 of this section. Compliance with the tolerance levels specified in Table 1 is to be determined by measuring only trifludimoxazin, dihydro-1,5-dimethyl-6-thioxo-3-[2,2,7trifluoro-3,4-dihydro-3-oxo-4-(2-propyn1-yl)-2H-1,4-benzoxazin-6-yl]-1,3,5triazine-2,4(1H,3H)-dione, in or on the commodity. TABLE 1 TO PARAGRAPH (a) Parts per million Almond, hulls ........................................... Fruit, citrus, group 10–10 ........................ Fruit, pome, group 11–10 ........................ Grain, cereal, forage, fodder, and straw, Group 16, except rice .......................... Grain, cereal, group 15, except rice ....... Nut, tree, group 14–12 ............................ Peanut ..................................................... Peanut, hay ............................................. Vegetable, legume, group 6 .................... Vegetable, foliage of legume, group 7 .... khammond on DSKJM1Z7X2PROD with RULES9 ACTION: (b)–(d) [Reserved] [FR Doc. 2021–10286 Filed 5–14–21; 8:45 am] BILLING CODE 6560–50–P Jkt 253001 0.15 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 In this document, the Federal Communications Commission (Commission) acts on several proposals that will impact FY 2021 regulatory fees. SUMMARY: This is a summary of the Commission’s Report and Order, FCC 21–49, MD Docket No. 21–190, and MD Docket No. 20–105, adopted on May 3, 2021 and released on May 4, 2021. The full text of this document is available for public inspection and copying during normal business hours in the FCC Reference Center (Room CY–A257), 445 12th Street SW, Washington, DC 20554, or by downloading the text from the Commission’s website at https:// transition.fcc.gov/Daily_Releases/Daily_ Business/2017/db0906/FCC-17111A1.pdf.a. FOR FURTHER INFORMATION CONTACT: Roland Helvajian, Office of Managing Director at (202) 418–0444. SUPPLEMENTARY INFORMATION: I. Administrative Matters A. Final Regulatory Flexibility Analysis 1. As required by the Regulatory Flexibility Act of 1980 (RFA), the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) relating to this Report and Order. The FRFA is located towards the end of this document. B. Final Paperwork Reduction Act of 1995 Analysis 2. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104–13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107–198, see 44 U.S.C. 3506(c)(4). PO 00000 Frm 00029 Fmt 4700 C. Congressional Review Act 3. The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs that these rules are non-major under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of this Report & Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A). II. Introduction Final action. ADDRESSES: Authority: 21 U.S.C. 321(q), 346a and 371. 21:39 May 14, 2021 Federal Communications Commission. AGENCY: This final action is effective June 16, 2021. 1. The authority citation for part 180 continues to read as follows: VerDate Sep<11>2014 Assessment and Collection of Regulatory Fees for Fiscal Year 2021 DATES: ■ Commodity [MD Docket Nos. 20–105; MD Docket Nos. 21–190; FCC 21–49; FRS 26030] 26677 Sfmt 4700 1. In this Report and Order, we adopt a new distinction between nongeostationary orbit (NGSO) satellite systems, as further described below, by creating two new fee subcategories, one for ‘‘less complex’’ NGSO systems and a second for all other NGSO systems identified as ‘‘other’’ NGSO systems, both under the broader category of ‘‘Space Stations (Non-Geostationary Orbit)’’. III. Report and Order—New Regulatory Fee Categories for Certain NGSO Space Stations 2. We first address the recent modifications in methodology for International Bureau licensee fees to more closely reflect the statutory requirement. After previously increasing the allocation of indirect full time equivalents (FTEs) in the International Bureau, in FY 2020 the Commission adopted a regulatory fee for foreign licensed space stations with U.S. market access, recharacterizing and thereby increasing the total number of direct FTEs for the International Bureau to 28. The Commission also adjusted the FTE allocation for the international bearer circuit (IBC) category to eight FTEs, from 6.9 FTEs, to better reflect the direct FTE work in the International Bureau for that fee category, resulting in 20 FTEs assigned to the satellite and earth station regulatory fee category. The Commission also adjusted the allocation of FTEs among geostationary orbit (GSO) and NGSO space station and earth station operators. The Commission noted the disparity in number of units between GSO space stations (98) and NGSO space stations (seven), and noted that under a single NGSO license, many satellites can be operated while counting as a single unit for regulatory fee purposes, but only one satellite can be operated per GSO space station regulatory fee unit. To ensure that regulatory fees more closely reflect the work of processing applications and rulemaking for each category, the Commission allocated 80% of space station regulatory fees to GSOs and 20% U:\17MYR1.SGM 17MYR1

Agencies

[Federal Register Volume 86, Number 93 (Monday, May 17, 2021)]
[Rules and Regulations]
[Pages 26672-26677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10286]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0762; FRL-10019-62]


Trifludimoxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
trifludimoxazin in or on multiple commodities which are identified and 
discussed later in this document. BASF corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 17, 2021. Objections and 
requests for hearings must be received on or before July 16, 2021 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-2018-0762, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 26673]]

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-2018-0762 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 16, 2021. 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-2018-0762, 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 April 19, 2019 (84 FR 16430) (FRL-9991-
14), 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 
8F8709) by BASF corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide 
trifludimoxazin, in or on almond, hulls at 0.15 parts per million 
(ppm); fruit, citrus, group 10-10 at 0.01 ppm; fruit, pome, group 11-10 
at 0.01 ppm; grain, cereal, forage, fodder and straw, group 16 (except 
rice) at 0.01 ppm; grain, cereal, group 15 at 0.01 ppm; nut, tree, 
group 14-12 at 0.01 ppm; peanut at 0.01 ppm; peanut, hay at 0.01 ppm; 
vegetable, foliage of legume, group 07 at 0.01 ppm; vegetable, legume, 
group 06 at 0.01 ppm. That document referenced a summary of the 
petition prepared by BASF Corporation, the registrant, which is 
available in the docket, https://www.regulations.gov. One 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 trifludimoxazin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with trifludimoxazin 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The available database of guideline studies for trifludimoxazin 
indicates that the primary target organs are the thyroid and liver. 
Trifludimoxazin is a protoporphyrinogen oxidase (PPO)-inhibitor. PPO is 
a key enzyme in chlorophyll and cytochrome pigments, as well as in 
heme. Although hematological effects associated with this class were 
observed, they are not considered adverse at the selected lowest-
observable adverse-effects levels (LOAELs). Effects on the thyroid 
occurred in rats and consisted primarily of follicular cell 
hypertrophy/hyperplasia and altered colloid of the thyroid after 
subchronic and chronic exposure durations. Increased relative thyroid 
weights were also observed in male rats; however, thyroid hormones were 
not adversely affected after subchronic exposure for males and females. 
Liver effects (increased alanine aminotransferase (ALT) and alkaline 
phosphatase (ALP), organ weight, and histopathology) were also observed 
at the same dose as thyroid effects in male rats after subchronic 
exposure. In mice, increased liver weight, increased [gamma]-glutamyl 
transferase (GGT), and hypertrophy were observed after subchronic 
exposures. Increased liver

[[Page 26674]]

weight, foci of (eosinophilic) cellular alteration, centrilobular 
hypertrophy, macrovesicular fatty change and centrilobular pigment 
storage was observed in male mice and oval cell hyperplasia and 
(multi)focal necrosis was observed in female mice after chronic 
exposure. After chronic exposure to the rat, increased pigment, 
multinucleated hepatocytes, and bile duct hyperplasia in the liver was 
observed at the same dose as thyroid effects. Effects on the 
reproductive system were observed as evidence of increased abnormal 
sperm in male rats in the extended one generation reproductive toxicity 
study (EOGRTS), and as effects to the epididymis in rats after 
subchronic and chronic exposure.
    Trifludimoxazin did not demonstrate neurotoxic potential in either 
acute or subchronic neurotoxicity studies in rats. Observations 
suggestive of neurotoxicity were seen in the 90-day subchronic study in 
dogs (e.g., functional observational battery (FOB) deficits, 
histopathological findings in the spinal cord and medulla oblongata 
(degeneration of fasciculus gracilis and white matter)), but no 
neurotoxicity effects were seen in either the 28-day dog study, which 
tested lower doses, or the chronic dog study, which tested higher doses 
relative to the 90-day study.
    There were no adverse maternal or developmental effects observed in 
the rat developmental toxicity study at the limit dose. However, in the 
rabbit developmental study, decreased fetal body weight was observed at 
a lower dose than maternal toxicity (increased incidence of late 
abortions); thus, increased quantitative susceptibility was observed. 
The Extended One-Generation Reproductive Toxicity Study (EOGRTS) in 
rats demonstrated no increase in susceptibility as no effects were 
observed in the offspring while increased incidence and severity of 
follicular cell hypertrophy/hyperplasia and altered colloid in the 
thyroid was observed in the parental animals.
    Immunotoxicity was not observed throughout the toxicity database. 
Additionally, there were no effects in the dermal toxicity study, 
including any effects to the thyroid.
    The Agency has classified trifludimoxazin as ``suggestive evidence 
of carcinogenic potential'' based on thyroid tumors, driven by 
adenomas, observed in male rats at 750 ppm (33 mg/kg/day); an absence 
of treatment-related tumors in female rats and in male and female mice, 
and a lack of concern for mutagenicity. The Agency has concluded that 
quantification of cancer risk using a non-linear approach (i.e., 
reference dose (RfD)) will adequately account for all chronic toxicity, 
including potential carcinogenicity, that could result from exposure to 
trifludimoxazin. The chronic reference dose (0.11 mg/kg/day) is several 
times lower than the level at which tumors were observed.
    Specific information on the studies received and the nature of the 
adverse effects caused by trifludimoxazin 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 pages 13-19 of document Trifludimoxazin: New 
Active Ingredient Human Health Risk Assessment for Registrations on 
Legume Vegetable Group 6, Foliage of Legume Vegetable Group 7, Citrus 
Fruit Group 10-10, Pome Fruit Group 11-10, Tree Nut Group 14-12, Cereal 
Grain Group 15 (except rice), Forage Fodder and Straw of Cereal Grain 
Group 16 (except rice), Peanut and Peanut Hay (hereinafter 
``Trifludimoxazin Human Health Risk Assessment'') in docket ID number 
EPA-HQ-OPP-2018-0762.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for trifludimoxazin used 
for human risk assessment can be found in the Trifludimoxazin Human 
Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to trifludimoxazin, EPA considered exposure under the 
petitioned-for trifludimoxazin tolerances in 40 CFR part 180. EPA 
assessed dietary exposures from trifludimoxazin 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 trifludimoxazin; therefore, 
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 food consumption data from the United 
States 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 conducted an unrefined chronic 
dietary exposure assessment using tolerance-level residues, 100 percent 
crop treated (PCT), and default processing factors.
    iii. Cancer. Based on the Agency's analysis of the available data, 
EPA has concluded that a nonlinear RfD approach is appropriate for 
assessing cancer risk to trifludimoxazin. Quantification of cancer risk 
using a non-linear RfD approach will adequately account for all chronic 
toxicity, including carcinogenicity that could result from exposure to 
trifludimoxazin; therefore, a separate cancer dietary assessment was 
not conducted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for trifludimoxazin. Tolerance level residues and/or 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 trifludimoxazin in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of trifludimoxazin. Further information 
regarding EPA drinking water models

[[Page 26675]]

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.
    Using the Pesticides in Water Calculator (PWC), Pesticide Root Zone 
Model and the Varying Volume Water Model (PRZM/VVWM), EPA calculated 
the estimated drinking water concentrations (EDWCs) of trifludimoxazin 
for acute and chronic exposures in surface and ground water. EPA used 
the modeled EDWCs directly in dietary exposure model to account for the 
contribution of trifludimoxazin residues in drinking water as follows: 
5.0 ppb was used in acute dietary assessment and 3.6 ppb was used in 
chronic dietary risk assessment.
    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).
    Trifludimoxazin 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.''
    The Agency has not found trifludimoxazin to share a common 
mechanism of toxicity with any other substances, and trifludimoxazin 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that trifludimoxazin does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
https://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 evidence of 
quantitative pre-natal susceptibility in the rabbit developmental 
toxicity study. However, the degree of concern is low because clear 
NOAELs were identified for the effects, and the selected endpoints and 
doses are protective of the observed developmental effects and observed 
susceptibility.
    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 trifludimoxazin is complete.
    ii. Although there was evidence for neurotoxicity in the 90-day 
subchronic dog study, the degree of concern for the toxicity is low 
because this study is used as the basis for the risk assessment PODs 
and is protective of any potential neurotoxicity.
    iii. Clear NOAELs were identified for the developmental/offspring 
effects observed in the rat and rabbit prenatal developmental studies, 
and endpoints selected for risk assessment are protective of these 
effects and the quantitative susceptibility observed in the rabbit 
developmental study and rat EOGRTS.
    iv. There is no concern due to any residual uncertainties in the 
exposure database. No data gaps were identified, and exposure estimates 
are based upon conservative default assumptions. Tolerance-level 
residues and 100PCT are used in dietary exposure assessments, and 
residential exposures are not anticipated from the proposed use 
pattern. As such, residual uncertainty is negligible and does not 
impact considerations for the FQPA Safety Factor. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to trifludimoxazin in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
trifludimoxazin.

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, 
trifludimoxazin 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 the chronic risk 
estimates of food and drinking water for trifludimoxazin are below the 
Agency's LOC at <1% of the cPAD for the United States population and 
all population subgroups. There are no residential uses for 
trifludimoxazin.
    3. Short-term risk and Intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    A short-term and intermediate-term adverse effect was identified; 
however, trifludimoxazin is not registered for any use patterns that 
would result in short-term or intermediate-term residential exposure. 
Short-term and intermediate-term risk is assessed based on short-term 
or intermediate-term residential exposure plus chronic dietary 
exposure. Because there is no short-term 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-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term and 
intermediate-term risk for trifludimoxazin.
    4. Aggregate cancer risk for U.S. population. As indicated above, 
the Agency has determined that the non-cancer chronic dietary 
assessment would account for any dietary cancer

[[Page 26676]]

risks. Based on the level of chronic risk being below the Agency's 
level of concern, EPA concludes aggregate exposure to trifludimoxazin 
will not pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to trifludimoxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High-Performance Liquid 
Chromatography with tandem Mass Spectroscopy (HPLC-MS/MS) method 
(Method D147/02 in plant matrices)) is available to enforce the 
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Trifludimoxazin is a new active ingredient, and no maximum residue 
limits (MRLs) have yet been established by Codex.

C. Response to Comments

    One commenter expressed concern about the release of pesticide 
chemicals to the environment. The FFDCA does not authorize EPA to 
consider risks to the environment, per se; rather, the FFDCA authorizes 
EPA to establish tolerances that permit certain levels of pesticide 
residues in or on food when the Agency can determine that such 
tolerances are safe. Taking into consideration the factors required in 
the FFDCA, EPA has made that safety determination for the tolerances 
subject to this action; the commenter provided no information relevant 
to that conclusion.

D. Revisions to Petitioned-For Tolerances

    Based upon review of submitted data, the Agency is establishing 
tolerances that vary from what the petitioner requested. The petitioner 
had requested to establish tolerance on the entire cereal crop groups 
15 and 16; however, the Agency has determined that the petitioned 
tolerance for cereal crop groups 15 and 16 must be revised to exclude 
rice commodities. While there are no data gaps for human health, the 
Agency has insufficient environmental fate data to support a tolerance 
on rice; therefore, the request to allow use on rice on the 
trifludimoxazin label will not be granted at this time. Because the 
product will not be used on rice, tolerances are not needed for 
residues in or on rice. Consequently, EPA is excluding rice from the 
tolerances being set on cereal crop groups 15 and 16.

V. Conclusion

    Therefore, tolerances are established for residues of 
trifludimoxazin in or on almond, hulls; fruit, citrus, group 10-10; 
fruit, pome, group 11-10; grain, cereal, forage, fodder and straw, 
group 16 (except rice); grain, cereal, group 15 (except rice); nut, 
tree, group 14-12; peanut; peanut, hay; vegetable, foliage of legume, 
group 07 and vegetable, legume, group 06.

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 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

[[Page 26677]]

Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 5, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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. Add Sec.  180.717 to subpart C to read as follows:


Sec.  180.717  Trifludimoxazin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide trifludimoxazin, including its metabolites and degradates, in 
or on the commodities to Table 1 of this section. Compliance with the 
tolerance levels specified in Table 1 is to be determined by measuring 
only trifludimoxazin, dihydro-1,5-dimethyl-6-thioxo-3-[2,2,7-trifluoro-
3,4-dihydro-3-oxo-4-(2-propyn-1-yl)-2H-1,4-benzoxazin-6-yl]-1,3,5-
triazine-2,4(1H,3H)-dione, in or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls................................................       0.15
Fruit, citrus, group 10-10...................................       0.01
Fruit, pome, group 11-10.....................................       0.01
Grain, cereal, forage, fodder, and straw, Group 16, except          0.01
 rice........................................................
Grain, cereal, group 15, except rice.........................       0.01
Nut, tree, group 14-12.......................................       0.01
Peanut.......................................................       0.01
Peanut, hay..................................................       0.01
Vegetable, legume, group 6...................................       0.01
Vegetable, foliage of legume, group 7........................       0.01
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2021-10286 Filed 5-14-21; 8:45 am]
BILLING CODE 6560-50-P
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