Picarbutrazox; Pesticide Tolerances, 12829-12833 [2021-04251]

Download as PDF Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES purpose of this notice is to relieve a restriction (5 U.S.C. 553(d)(1)). III. Statutory and Executive Order Reviews This action defers sanctions and imposes no additional requirements. For that reason, this action: • Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994). • Is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). • Is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule VerDate Sep<11>2014 15:52 Mar 04, 2021 Jkt 253001 effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule as discussed in section II of this preamble, including the basis for that finding. Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 4, 2021. Filing a petition for reconsideration by the EPA Administrator of this final rule does not affect the finality of this rule for the purpose of judicial review nor does it extend the time within which petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see CAA section 307(b)(2)). 12829 Dated: February 23, 2021. Deborah Jordan, Acting Regional Administrator, Region IX. provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0653, 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, 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: [FR Doc. 2021–04388 Filed 3–4–21; 8:45 am] I. General Information List of Subjects in 40 CFR Part 52 Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Authority: 42 U.S.C. 7401 et seq. BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0653; FRL–10019–99] Picarbutrazox; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of picarbutrazox in or on multiple commodities which are identified and discussed later in this document. Nippon Soda Co., Ltd c/o Nisso America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 5, 2021. Objections and requests for hearings must be received on or before May 4, 2021, and must be filed in accordance with the instructions SUMMARY: PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 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 eCFR site at https://www.ecfr.gov/cgi-bin/ E:\FR\FM\05MRR1.SGM 05MRR1 12830 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations text-idx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl. jbell on DSKJLSW7X2PROD with RULES C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2017–0653 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 May 4, 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– 2017–0653, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of March 6, 2018 (83 FR 9471) (FRL–9973–27), 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 7F8623) by Nippon Soda Co., Ltd c/o Nisso America, Inc., 88 Pine VerDate Sep<11>2014 15:52 Mar 04, 2021 Jkt 253001 Street, 14th Floor, New York, NY 10005. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide picarbutrazox, 1,1-Dimethylethyl N-(6((((Z)-((1-methyl-1H-tetrazol-5-yl) phenylmethylene) amino)oxy)methyl)-2pyridinyl)carbamate, in or on corn, forage at 0.01 parts per million (ppm); corn, grain at 0.01 ppm; corn, stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; crop group 9, cucurbit vegetables at 0.20 ppm, crop subgroup 4–16A, leafy greens at 10 ppm; popcorn, grain at 0.01 ppm; soybean, forage at 0.01 ppm; soybean, hay at 0.01 ppm and soybean, seed at 0.01 ppm. That document referenced a summary of the petition prepared by Nippon Soda Co., Ltd c/o Nisso America, the registrant, which is available in the docket, https:// www.regulations.gov. Nine comments were received on the notice of filing. However, they were not germane to this submission. Based upon review of the data supporting the petition, EPA is establishing, in accordance with section 408(d)(4)(a)(i), tolerances that vary in some respects from what the petitioner requested. Also, EPA is not establishing tolerances for Crop Group 9, Cucurbit Vegetables and Crop Subgroup 4–16A, Leafy Greens, as the petitioner withdrew the request for those tolerances after submitting the petition. The Agency’s underlying rationale for those variations are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 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 picarbutrazox including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with picarbutrazox 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 primary target organs for picarbutrazox are the liver and the thyroid gland across species and durations (except acute). The rat was the most sensitive species, followed by the mouse and the dog. Both the liver and the thyroid showed increases in organ weights and histopathological changes. In the liver, changes included hepatocyte hypertrophy, periportal vacuolation, cytoplasmic inclusions, and portal inflammatory cell infiltration. In the thyroid, there were increased incidences of thyroid hypertrophy which corresponded with increased thyroid weights in both parental animals and neonates. Disruption of thyroid hormones was also observed across the guideline studies, for the short-term and long-term durations in rats (alterations in triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH)). Thyroid follicular tumors were observed in rats following 2 years of oral exposure. No treatment-related effects were observed in mice following 78 weeks of exposure. There is no evidence of genotoxicity or mutagenicity in the picarbutrazox hazard database. There is no evidence of increased prenatal susceptibility in rats or rabbits or postnatal susceptibility in rats. There were no adverse fetal or maternal effects in the available developmental toxicity studies in rats or rabbits. Both studies tested up to the limit dose. In the multigeneration reproductive study, adverse thyroid effects were observed in the parental animals and occurred at doses lower than offspring effects. There were no adverse reproductive effects up to the highest dose tested (46/63 mg/kg/ day). E:\FR\FM\05MRR1.SGM 05MRR1 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES Subchronic studies in rats were performed for the numerous plant metabolites generated from parent picarbutrazox. All were less toxic than the parent molecule. No signs of neurotoxicity were observed in the acute neurotoxicity study up to the limit dose (2,000 mg/kg/day). No dermal toxicity was observed in rats up to the limit dose (1,000 mg/kg/day). Picarbutrazox is categorized as having low acute lethality through the oral, dermal, and inhalation routes. It is minimally irritating to the eye and is neither a dermal irritant nor sensitizer. In accordance with the EPA’s Final Guidelines for Carcinogen Risk Assessment (March 2005), the Agency classified picarbutrazox as ‘‘Suggestive Evidence of Carcinogenic Potential’’ based on an increase in the incidence of thyroid follicular cell tumors, driven by adenomas in male and female rats and combined thyroid follicular adenomas/ carcinomas in male rats. There is no concern for genotoxicity or mutagenicity and no treatment-related tumors were observed in mice. Based on its weightof-evidence analysis, the Agency has determined that quantification of risk using a non-linear approach (i.e., chronic reference dose (cRfD)) will adequately account for all chronic toxicity, including potential carcinogenicity, that could result from exposure to picarbutrazox. The chronic reference dose is several times lower than the dose at which tumors were observed. Specific information on the studies received and the nature of the adverse effects caused by picarbutrazox as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document ‘‘Picarbutrazox. Human Health Risk Assessment in Support of a New Active Ingredient for Use on Corn and Soybean Seed and Turf’’, dated December 18, 2020, hereinafter ‘‘Picarbutrazox Human Health Risk Assessment’’ in docket ID number EPA–HQ–OPP–2017–0653. 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 VerDate Sep<11>2014 15:52 Mar 04, 2021 Jkt 253001 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. A summary of the toxicological endpoints for picarbutrazox used for human risk assessment can be found on pages 19–20 in the Picarbutrazox Human Health Risk Assessment. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to picarbutrazox, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from picarbutrazox 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 picarbutrazox; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 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 data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to picarbutrazox. Quantification of risk using a non-linear approach (i.e., cRfD) will adequately PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 12831 account for all chronic toxicity, including potential carcinogenicity, that could result from exposure to picarbutrazox. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for picarbutrazox. 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 picarbutrazox in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of picarbutrazox. Further information regarding EPA drinking water models 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) ver. 1.52, EPA calculated the estimated drinking water concentrations (EDWCs) of picarbutrazox for chronic exposures in surface and ground water. The groundwater estimates were significantly lower. EPA used the modeled EDWC of 2.56 ppb directly in dietary exposure model to account for the contribution of picarbutrazox residues in drinking water for the 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). Picarbutrazox is currently proposed for turf uses that could result in residential exposures. EPA assessed residential exposure using the following assumptions: There is the potential for post-application exposure for adults and children following turf treatments made by professional applicators with picarbutrazox. A dermal exposure assessment was not quantitatively conducted because a dermal POD was not selected. The quantitative exposure/ risk assessment for residential postapplication exposures is based only on incidental oral scenarios for children 1 to <2 years old from hand to mouth activities on treated turf. Postapplication exposure and risk estimates indicate that the short-term incidental oral MOEs, ranging from 970 to 360,000, are not of concern (i.e., MOEs ≥30). Further information regarding EPA standard assumptions and generic E:\FR\FM\05MRR1.SGM 05MRR1 12832 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES inputs for residential exposures may be found at https://www.epa.gov/pesticidescience-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 picarbutrazox to share a common mechanism of toxicity with any other substances, and picarbutrazox does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that picarbutrazox 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 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 is no evidence of increased prenatal susceptibility in rats or rabbits or postnatal susceptibility in rats, with no adverse effects observed in the developmental toxicity studies. 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 picarbutrazox is complete. VerDate Sep<11>2014 15:52 Mar 04, 2021 Jkt 253001 ii. There is no indication that picarbutrazox is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that picarbutrazox results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT, tolerance-level residues, default processing factors, and modeled drinking water estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to picarbutrazox 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 picarbutrazox. 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). 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, picarbutrazox 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 picarbutrazox from food and water will utilize <1% of the cPAD for all infants (<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 picarbutrazox is not expected. 3. Short-term and Intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term or intermediate-term residential exposure plus chronic PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 exposure to food and water (considered to be a background exposure level). Picarbutrazox is currently proposed for uses that could result in short-term and intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term or intermediate-term residential exposures to picarbutrazox. Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded the combined short-term or intermediate-term food, water, and residential exposures result in aggregate MOE of 950 for children 1 to <2 years old from dietary (food and drinking water) and incidental oral exposure from hand-to-mouth activities from post-application exposure to turf applications. Because EPA’s level of concern for picarbutrazox is an MOE of 30 or below, these MOEs are not of concern. 4. Aggregate cancer risk for U.S. population. As stated in Unit III.A., a separate cancer analysis was not conducted as the chronic assessment adequately accounts for all chronic toxicity, including potential carcinogenicity. Based on the lack of chronic risk, EPA concludes that aggregate exposure to picarbutrazox 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 picarbutrazox residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (liquid chromatography with tandem mass spectroscopy (LC/MS/MS) and high-performance liquid chromatography (HPLC/MS/MS)) is available to enforce the tolerance expression. 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, E:\FR\FM\05MRR1.SGM 05MRR1 12833 Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations 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. Picarbutrazox is a new active ingredient, and no maximum residue limits (MRLs) have yet been established by Codex. C. Revisions to Petitioned-For Tolerances The Agency is establishing tolerances for picarbutrazox using tolerance expression and commodity definitions that conform to current practices. Additionally, the Agency is establishing a tolerance on corn, pop, stover and corn, field, stover; the petitioner requested a tolerance on ‘‘corn, stover’’, but the correct terminology is ‘‘corn, pop, stover’’ and ‘‘corn, field, stover’’. jbell on DSKJLSW7X2PROD with RULES V. Conclusion Therefore, tolerances are established for residues of picarbutrazox, 1,1Dimethylethyl N-(6-((((Z)-((1-methyl-1Htetrazol-5-yl) phenylmethylene) amino)oxy)methyl)-2pyridinyl)carbamate, in or on corn, field, forage at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; soybean, forage at 0.01 ppm; soybean, hay at 0.01 ppm and soybean, seed 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) 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 VerDate Sep<11>2014 15:52 Mar 04, 2021 Jkt 253001 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 PO 00000 Frm 00035 Fmt 4700 Sfmt 9990 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. 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 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Add § 180.718 to subpart C to read as follows: ■ § 180.718 Picarbutrazox; tolerances for residues. (a) General. Tolerances are established for residues of the fungicide picarbutrazox, 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 picarbutrazox (1,1dimethylethyl N-[6-[[[(Z)-[(1-methyl-1Htetrazol-5-yl)phenylmethylene] amino]oxy]methyl]-2-pyridinyl] carbamate in or on the commodity. TABLE 1 TO PARAGRAPH (a) Commodity Parts per million Corn, field, forage ....................... Corn, field, grain ......................... Corn, field, stover ....................... Corn, pop, grain .......................... Corn, pop, stover ........................ Corn, sweet, forage .................... Corn, sweet, kernel plus cob with husks removed ................ Corn, sweet, stover .................... Soybean, forage ......................... Soybean, hay .............................. Soybean, seed ............................ (b)–(d) [Reserved] [FR Doc. 2021–04251 Filed 3–4–21; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\05MRR1.SGM 05MRR1 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01

Agencies

[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Rules and Regulations]
[Pages 12829-12833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04251]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0653; FRL-10019-99]


Picarbutrazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
picarbutrazox in or on multiple commodities which are identified and 
discussed later in this document. Nippon Soda Co., Ltd c/o Nisso 
America, Inc. requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 5, 2021. Objections and 
requests for hearings must be received on or before May 4, 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-2017-0653, 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, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/

[[Page 12830]]

text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0653 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 
May 4, 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-2017-0653, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), 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 
7F8623) by Nippon Soda Co., Ltd c/o Nisso America, Inc., 88 Pine 
Street, 14th Floor, New York, NY 10005. The petition requested that 40 
CFR part 180 be amended by establishing tolerances for residues of the 
fungicide picarbutrazox, 1,1-Dimethylethyl N-(6-((((Z)-((1-methyl-1H-
tetrazol-5-yl) phenylmethylene) amino)oxy)methyl)-2-
pyridinyl)carbamate, in or on corn, forage at 0.01 parts per million 
(ppm); corn, grain at 0.01 ppm; corn, stover at 0.01 ppm; corn, sweet, 
forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 
0.01 ppm; corn, sweet, stover at 0.01 ppm; crop group 9, cucurbit 
vegetables at 0.20 ppm, crop subgroup 4-16A, leafy greens at 10 ppm; 
popcorn, grain at 0.01 ppm; soybean, forage at 0.01 ppm; soybean, hay 
at 0.01 ppm and soybean, seed at 0.01 ppm. That document referenced a 
summary of the petition prepared by Nippon Soda Co., Ltd c/o Nisso 
America, the registrant, which is available in the docket, https://www.regulations.gov. Nine comments were received on the notice of 
filing. However, they were not germane to this submission.
    Based upon review of the data supporting the petition, EPA is 
establishing, in accordance with section 408(d)(4)(a)(i), tolerances 
that vary in some respects from what the petitioner requested. Also, 
EPA is not establishing tolerances for Crop Group 9, Cucurbit 
Vegetables and Crop Subgroup 4-16A, Leafy Greens, as the petitioner 
withdrew the request for those tolerances after submitting the 
petition. The Agency's underlying rationale for those variations are 
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for picarbutrazox including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with picarbutrazox 
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 primary target organs for picarbutrazox are the liver and the 
thyroid gland across species and durations (except acute). The rat was 
the most sensitive species, followed by the mouse and the dog. Both the 
liver and the thyroid showed increases in organ weights and 
histopathological changes. In the liver, changes included hepatocyte 
hypertrophy, periportal vacuolation, cytoplasmic inclusions, and portal 
inflammatory cell infiltration. In the thyroid, there were increased 
incidences of thyroid hypertrophy which corresponded with increased 
thyroid weights in both parental animals and neonates. Disruption of 
thyroid hormones was also observed across the guideline studies, for 
the short-term and long-term durations in rats (alterations in 
triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone 
(TSH)). Thyroid follicular tumors were observed in rats following 2 
years of oral exposure. No treatment-related effects were observed in 
mice following 78 weeks of exposure. There is no evidence of 
genotoxicity or mutagenicity in the picarbutrazox hazard database.
    There is no evidence of increased prenatal susceptibility in rats 
or rabbits or postnatal susceptibility in rats. There were no adverse 
fetal or maternal effects in the available developmental toxicity 
studies in rats or rabbits. Both studies tested up to the limit dose. 
In the multi-generation reproductive study, adverse thyroid effects 
were observed in the parental animals and occurred at doses lower than 
offspring effects. There were no adverse reproductive effects up to the 
highest dose tested (46/63 mg/kg/day).

[[Page 12831]]

    Subchronic studies in rats were performed for the numerous plant 
metabolites generated from parent picarbutrazox. All were less toxic 
than the parent molecule. No signs of neurotoxicity were observed in 
the acute neurotoxicity study up to the limit dose (2,000 mg/kg/day). 
No dermal toxicity was observed in rats up to the limit dose (1,000 mg/
kg/day). Picarbutrazox is categorized as having low acute lethality 
through the oral, dermal, and inhalation routes. It is minimally 
irritating to the eye and is neither a dermal irritant nor sensitizer.
    In accordance with the EPA's Final Guidelines for Carcinogen Risk 
Assessment (March 2005), the Agency classified picarbutrazox as 
``Suggestive Evidence of Carcinogenic Potential'' based on an increase 
in the incidence of thyroid follicular cell tumors, driven by adenomas 
in male and female rats and combined thyroid follicular adenomas/
carcinomas in male rats. There is no concern for genotoxicity or 
mutagenicity and no treatment-related tumors were observed in mice. 
Based on its weight-of-evidence analysis, the Agency has determined 
that quantification of risk using a non-linear approach (i.e., chronic 
reference dose (cRfD)) will adequately account for all chronic 
toxicity, including potential carcinogenicity, that could result from 
exposure to picarbutrazox. The chronic reference dose is several times 
lower than the dose at which tumors were observed.
    Specific information on the studies received and the nature of the 
adverse effects caused by picarbutrazox as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Picarbutrazox. Human Health Risk 
Assessment in Support of a New Active Ingredient for Use on Corn and 
Soybean Seed and Turf'', dated December 18, 2020, hereinafter 
``Picarbutrazox Human Health Risk Assessment'' in docket ID number EPA-
HQ-OPP-2017-0653.

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 picarbutrazox used for 
human risk assessment can be found on pages 19-20 in the Picarbutrazox 
Human Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to picarbutrazox, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
picarbutrazox 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 picarbutrazox; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 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 data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to picarbutrazox. Quantification of risk using a non-linear 
approach (i.e., cRfD) will adequately account for all chronic toxicity, 
including potential carcinogenicity, that could result from exposure to 
picarbutrazox.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for picarbutrazox. 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 picarbutrazox in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of picarbutrazox. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Using the Pesticides in Water Calculator (PWC) ver. 1.52, EPA 
calculated the estimated drinking water concentrations (EDWCs) of 
picarbutrazox for chronic exposures in surface and ground water. The 
groundwater estimates were significantly lower. EPA used the modeled 
EDWC of 2.56 ppb directly in dietary exposure model to account for the 
contribution of picarbutrazox residues in drinking water for the 
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). Picarbutrazox is 
currently proposed for turf uses that could result in residential 
exposures. EPA assessed residential exposure using the following 
assumptions: There is the potential for post-application exposure for 
adults and children following turf treatments made by professional 
applicators with picarbutrazox. A dermal exposure assessment was not 
quantitatively conducted because a dermal POD was not selected. The 
quantitative exposure/risk assessment for residential post-application 
exposures is based only on incidental oral scenarios for children 1 to 
<2 years old from hand to mouth activities on treated turf. Post-
application exposure and risk estimates indicate that the short-term 
incidental oral MOEs, ranging from 970 to 360,000, are not of concern 
(i.e., MOEs >=30). Further information regarding EPA standard 
assumptions and generic

[[Page 12832]]

inputs for residential exposures may be found at https://www.epa.gov/pesticide-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 picarbutrazox to share a common mechanism of 
toxicity with any other substances, and picarbutrazox does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
picarbutrazox 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 is no evidence of 
increased prenatal susceptibility in rats or rabbits or postnatal 
susceptibility in rats, with no adverse effects observed in the 
developmental toxicity studies.
    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 picarbutrazox is complete.
    ii. There is no indication that picarbutrazox is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that picarbutrazox results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, tolerance-level residues, default processing factors, and 
modeled drinking water estimates. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to picarbutrazox 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 
picarbutrazox.

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). 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, 
picarbutrazox 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 
picarbutrazox from food and water will utilize <1% of the cPAD for all 
infants (<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 
picarbutrazox is not expected.
    3. Short-term and Intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term or 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Picarbutrazox 
is currently proposed for uses that could result in short-term and 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short-term or intermediate-term residential exposures to 
picarbutrazox.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined 
short-term or intermediate-term food, water, and residential exposures 
result in aggregate MOE of 950 for children 1 to <2 years old from 
dietary (food and drinking water) and incidental oral exposure from 
hand-to-mouth activities from post-application exposure to turf 
applications. Because EPA's level of concern for picarbutrazox is an 
MOE of 30 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. As stated in Unit 
III.A., a separate cancer analysis was not conducted as the chronic 
assessment adequately accounts for all chronic toxicity, including 
potential carcinogenicity. Based on the lack of chronic risk, EPA 
concludes that aggregate exposure to picarbutrazox 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 picarbutrazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectroscopy (LC/MS/MS) and high-performance liquid chromatography 
(HPLC/MS/MS)) is available to enforce the tolerance expression.

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,

[[Page 12833]]

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.
    Picarbutrazox is a new active ingredient, and no maximum residue 
limits (MRLs) have yet been established by Codex.

C. Revisions to Petitioned-For Tolerances

    The Agency is establishing tolerances for picarbutrazox using 
tolerance expression and commodity definitions that conform to current 
practices. Additionally, the Agency is establishing a tolerance on 
corn, pop, stover and corn, field, stover; the petitioner requested a 
tolerance on ``corn, stover'', but the correct terminology is ``corn, 
pop, stover'' and ``corn, field, stover''.

V. Conclusion

    Therefore, tolerances are established for residues of 
picarbutrazox, 1,1-Dimethylethyl N-(6-((((Z)-((1-methyl-1H-tetrazol-5-
yl) phenylmethylene) amino)oxy)methyl)-2-pyridinyl)carbamate, in or on 
corn, field, forage at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, 
field, stover at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, pop, 
stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, 
kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 
0.01 ppm; soybean, forage at 0.01 ppm; soybean, hay at 0.01 ppm and 
soybean, seed 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) 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 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.

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.  180.718 to subpart C to read as follows:


Sec.  180.718  Picarbutrazox; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide picarbutrazox, 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 picarbutrazox (1,1-dimethylethyl N-[6-[[[(Z)-[(1-methyl-1H-
tetrazol-5-yl)phenylmethylene]amino]oxy]methyl]-2-pyridinyl]carbamate 
in or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.01
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.01
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.01
Corn, sweet, forage.........................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.01
Soybean, forage.............................................        0.01
Soybean, hay................................................        0.01
Soybean, seed...............................................        0.01
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2021-04251 Filed 3-4-21; 8:45 am]
BILLING CODE 6560-50-P
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