Benzpyrimoxan; Pesticide Tolerances, 43442-43446 [2023-14404]

Download as PDF 43442 Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2021–0646; FRL–11057–01– OCSPP] Benzpyrimoxan; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of benzpyrimoxan in or on rice, husked; rice, polished rice; and rice, bran. Nichino America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 10, 2023. Objections and requests for hearings must be received on or before September 8, 2023 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–2021–0646, 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 and the OPP docket is (202) 566–1744. For the latest status information on EPA/DC services, docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–1030; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: lotter on DSK11XQN23PROD with RULES1 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 VerDate Sep<11>2014 15:54 Jul 07, 2023 Jkt 259001 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 Federal Register Office’s e-CFR site at https://www.ecfr.gov/current/title-40. 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–2021–0646 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 September 8, 2023. 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– 2021–0646, 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. PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 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 February 25, 2022 (87 FR 10760) (FRL–9410–01– OCSPP), 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 1E8949) by Nichino America, Inc. 4550 Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide benzpyrimoxan, including its metabolites and degradates, in or on the raw agricultural commodity rice, grain at 0.9 parts per million (ppm). The requested tolerance is for food imported into the U.S. and it is not registered for use in the U.S. That document referenced a summary of the petition prepared by Nichino America, Inc., 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 the comment is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA is revising the tolerance commodity definition for the requested tolerance in/on rice, grain and is also establishing tolerances for rice, polished rice and rice, bran. The reason for these changes is explained in Unit IV.D. 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. . . .’’ E:\FR\FM\10JYR1.SGM 10JYR1 Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 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 benzpyrimoxan including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with benzpyrimoxan 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 toxicology database for benzpyrimoxan is complete for the establishment of a tolerance without U.S. registration. The affected target organs following the administration of benzpyrimoxan are the kidney and urinary tract. Crystals were observed in the kidneys and urinary tract along with tissue damage in both mice and rats following subchronic and chronic oral administration. The rat appeared to be the most sensitive species tested, with mouse and dog having similar toxicity. There did not appear to be a difference in toxicity by sex in any species. Increased quantitative susceptibility was seen in the rabbit preliminary developmental study where decreases in fetal body weight were observed in the absence of adverse maternal toxicity. There was no evidence of increased quantitative or qualitative lifestage susceptibility in the definitive rat or rabbit developmental toxicity or in the preliminary rat developmental toxicity. Increased qualitative susceptibility in the form of mortality (post-implantation loss and decreased viability index) was seen in the reproductive toxicity study in rats. The concern for increased susceptibility is low as there were clear lowest-observed-adverse-effect-levels (LOAELs) and no-observed-adverseeffect-levels (NOAELs) in the developmental and reproductive toxicity studies and the points of departure (PODs) are protective of the increased susceptibility. There was no evidence of treatment-related tumors in the rat or mouse carcinogenicity studies and all of the mutagenicity studies were negative. Benzpyrimoxan is classified as: ‘‘Not likely to be carcinogenic to humans’’ VerDate Sep<11>2014 15:54 Jul 07, 2023 Jkt 259001 based on lack of treatment-related tumors in long-term dietary studies in the rat and mouse and low concern for genotoxicity. No treatment-related increase in the incidence of tumors was observed in carcinogenicity studies in rats or mice. Additionally, there is no evidence of mutagenicity in vivo or in vitro. Toxicity data were submitted for the benzpyrimoxan metabolite DH–04 in the form of a 90-day oral toxicity study in rats. In this study, kidney effects and urine effects were observed in males and females at 65 and 78 mg/kg/day, respectively. Mortality was observed at the highest dose tested (168/181 mg/kg/ day [M/F]), and histopathological evaluation revealed various cardiovascular and/or renal lesions. By comparing the effects at the LOAEL for this study to the parent 90-day oral rat study, it is estimated that DH–04 is approximately 3X more toxic than the parent compound. Consequently, a 3X potency factor for DH–04 will be used when conducting the dietary exposure assessment. Specific information on the studies received and the nature of the adverse effects caused by benzpyrimoxan 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 document ‘‘Benzpyrimoxan: First Food Use; Human Health Risk Assessment to Support the Establishment of a Tolerance without U.S. Registration in/ on Rice’’ hereinafter ‘‘Benzpyrimoxan Human Health Risk Assessment’’ at page 24 in docket ID number EPA–HQ– OPP–2021–0646. 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 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 43443 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:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for benzpyrimoxan used for human risk assessment can be found in the Benzpyrimoxan Human Health Risk Assessment on pages 15–16. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to benzpyrimoxan, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from benzpyrimoxan 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 benzpyrimoxan; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used 2005–2010 food consumption data from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues (or higher to account for additional residues of concern), default processing factors, and 100 percent crop treated (PCT) assumptions. iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a fooduse pesticide based on the weight of the evidence from cancer studies and other relevant data. Based on the data summarized in Unit III.A., EPA has concluded that benzpyrimoxan does not pose a cancer risk to humans due to absence of treatment-related tumors or evidence of mutagenicity in the available studies. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT E:\FR\FM\10JYR1.SGM 10JYR1 43444 Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Rules and Regulations information in the dietary assessment for benzpyrimoxan. Tolerance level residues (or higher to account for additional residues of concern), default processing factors, and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. EPA assumes that there is no exposure through drinking water because benzpyrimoxan is not registered for use in the United States. Because residues are not expected in drinking water, dietary risk estimates include exposures from food only. 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). Benzpyrimoxan is not registered for any specific use patterns that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to benzpyrimoxan and any other substances. In addition, benzpyrimoxan does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that benzpyrimoxan has a common mechanism of toxicity with other substances. lotter on DSK11XQN23PROD with RULES1 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 VerDate Sep<11>2014 15:54 Jul 07, 2023 Jkt 259001 data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no evidence of increased quantitative or qualitative lifestage susceptibility in the definitive rat or rabbit developmental toxicity or in the preliminary rat developmental toxicity. However, in the preliminary rabbit developmental study, which tested up to a higher dose than the definitive study (30 mg/kg/day), decreased fetal body weights were observed at 60 mg/ kg/day in the absence of adverse maternal effects. Marginal body-weight decreases associated with marked food consumption decreases were observed in the maternal animals in this study, but they did not reach adversity. In the two-generation reproduction study, the parental animals had gross (depressed areas) and histopathological (pelvic crystals and obstructive nephropathy) effects in the kidneys of P and F1 generation males. Degenerative necrosis and hepatocyte centrilobular hypertrophy associated with increased liver weights were also observed in the parental generation. In the offspring F1 and F2 generations, increased incidences of mortality and decreases in pup body weight were observed. Increased incidence of postimplantation loss and decreased viability indices early during lactation at the same dose as that eliciting parental effects were considered to be both offspring and reproductive effects and indicated increased qualitative 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 from 10X to 1X. That decision is based on the following findings: i. The toxicity database for benzpyrimoxan is complete for evaluating and characterizing toxicity, assessing pre- and postnatal susceptibility under FQPA, and selecting endpoints for the anticipated exposure pathways. Developmental toxicity studies in the rat and rabbit and a two-generation reproductive toxicity study in the rat are available, in addition to an acute neurotoxicity study. ii. There is no evidence of neurotoxicity in the benzpyrimoxan database including an acute neurotoxicity study which tested up to the limit dose and functional observation batteries and motor activity observations performed in the 90-day and combined chronic/carcinogenicity rat studies. EPA has waived both the PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 subchronic neurotoxicity and immunotoxicity studies at this time. iii. As stated above, no evidence of increased quantitative or qualitative lifestage susceptibility was seen in the definitive rat and rabbit developmental studies, as there were no maternal or developmental adverse effects in those studies. In the preliminary rabbit developmental study, which tested up to a higher dose (60 mg/kg/day) than the definitive study (30 mg/kg/day), adverse fetal body weights were observed in the absence of adverse maternal effects, suggesting quantitative susceptibility at ≥60 mg/kg/day. Transient body-weight decreases and marked decreases in food consumption during treatment were observed in maternal animals at this dose but were not considered to reach adversity; however, based on the findings at the highest dose tested (60 mg/kg/day) it is unlikely that the maternal animals could have tolerated much higher dosing given those observations. In the two-generation reproduction toxicity study, parental toxicity (kidney and liver effects) was observed at the same dose as offspring (mortality, decreases in body weight, post-implantation loss, and decreased viability indices) and reproductive (post-implantation loss and decreased viability indices) effects. The concern for susceptibility observed in the preliminary developmental study in rabbits is low as the effects in the maternal animals approached adversity. Additionally, there is a clear NOAEL established for developmental effects in that study and the offspring and reproductive effects in the twogeneration reproduction study, and the PODs selected for risk assessment are protective of the observed quantitative and qualitative susceptibility in those two studies. iv. There are no residual uncertainties identified in the exposure databases. An unrefined dietary exposure assessment was completed (tolerance level residues (or higher to account for additional residues of concern), default processing factors, and 100 PCT were assumed). In addition, there are no proposed or registered uses that would result to residential exposures. These assessments will not underestimate the exposure and risks posed by benzpyrimoxan. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term E:\FR\FM\10JYR1.SGM 10JYR1 Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 aggregate risks are evaluated by comparing the estimated total 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, benzpyrimoxan 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 benzpyrimoxan from food only will utilize less than (<) 1% of the cPAD for all infants (<1 year old), the subpopulation with the highest risk estimate. There are no residential uses for benzpyrimoxan. 3. Short- and intermediate- term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because benzpyrimoxan is not registered in the United States, the only exposures will be dietary from residues in or on imported rice; therefore, no short-term or intermediate-term residential exposure is expected. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for benzpyrimoxan. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, benzpyrimoxan is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to benzpyrimoxan residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Smithers Method 14078.6140, a QuEChERS based liquid chromatography with tandem mass VerDate Sep<11>2014 15:54 Jul 07, 2023 Jkt 259001 spectrometry (LC–MS/MS) multiresidue method) 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. The Codex has not established a MRL for benzpyrimoxan. C. Response to Comments One comment was received in response to the Notice of Filing. The comment stated that ‘‘there is still a lot we do not know about many of the chemicals we utilize and ingestion of these chemicals is not likely beneficial. Gathering that we should limit potential exposure to these by consumers as much as possible, why was the petition made to grant an exemption or tolerance? What is the user’s or manufacturer’s reasoning to request the allowance of more of these chemicals to remain on produce and potentially be ingested, and should more long-term information be acquired on the chemicals before allowing such a decision to be made?’’ Although the Agency recognizes that some individuals believe pesticides should be more restricted on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 43445 benzpyrimoxan tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported. D. Revisions to Petitioned-For Tolerances Although the petitioner requested a tolerance for ‘‘rice, grain’’, EPA is establishing tolerances for ‘‘rice, husked’’, ‘‘rice, polished rice’’, and ‘‘rice, bran’’. Each of these commodities is a processed form of the ‘‘rice, grain’’ raw agricultural commodity that was requested. Consistent with its authority to establish tolerances that vary from what was requested under section 408(d)(4)(A)(i) of the FFDCA, EPA is establishing tolerances that align better with the Agency’s current preferred commodity vocabulary and with the actual form of the commodities that may be imported into the United States. In addition, the available residue data indicate that separate tolerances are needed for the processed commodities of ‘‘rice, polished rice’’ and ‘‘rice, bran’’ due to the concentration of residues. V. Conclusion Therefore, tolerances are established for residues of benzpyrimoxan, including its metabolites and degradates, in or on rice, husked at 0.9 ppm; rice, polished rice at 0.15 ppm; and rice, bran at 3 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). 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 E:\FR\FM\10JYR1.SGM 10JYR1 43446 Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Rules and Regulations 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 lotter on DSK11XQN23PROD with RULES1 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 15:54 Jul 07, 2023 Jkt 259001 Therefore, 40 CFR chapter I is amended 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 § 180.724 to subpart C to read as follows: ■ § 180.724 Benzpyrimoxan; tolerances for residues. (a) General. Tolerances are established for residues of benzpyrimoxan, including its metabolites and degradates, in or on the commodities in Table 1 to this paragraph (a). Compliance with the tolerance levels specified in Table 1 to this paragraph (a) is to be determined by measuring residues of benzpyrimoxan (5-(1,3-dioxan-2-yl)-4-[[4(trifluoromethyl)phenyl] methoxy]pyrimidine) in or on the following commodities: TABLE 1 TO PARAGRAPH (a) Parts per million Commodity Rice, husked 1 ....................... Rice, polished rice 1 .............. Rice, bran 1 ........................... 0.9 0.15 3 1 There are no U.S. registrations as of July 10, 2023. (b)–(d) [Reserved] [FR Doc. 2023–14404 Filed 7–7–23; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 0 and 64 [CG Docket No. 17–59; WC Docket 17–97; FCC 23–37; FR ID 148396] Advanced Methods To Target and Eliminate Unlawful Robocalls, Call Authentication Trust Anchor Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Federal Communications Commission (Commission) expands several rules previously adopted for gateway providers to other categories of voice service providers and modifies or SUMMARY: Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. VerDate Sep<11>2014 Dated: June 30, 2023. Daniel Rosenblatt, Acting Director, Office of Pesticide Programs. PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 removes existing rules consistent with these changes. Specifically, the Commission requires all domestic voice service providers to respond to traceback requests from the Commission, civil and criminal law enforcement, and the industry traceback consortium within 24 hours of the receipt of the request. Second, it requires originating providers to block substantially similar traffic when the Commission notifies the provider of illegal traffic or risk the Commission requiring all providers immediately downstream to block all of that provider’s traffic. This rule is consistent with the rule for gateway providers, and requires non-gateway intermediate or terminating providers that receive such a notice to promptly inform the Commission that it is not the originating or gateway provider for the identified traffic, identify the upstream provider(s) from which it received the traffic, and, if possible, take lawful step to mitigate the traffic. Third it requires all voice service providers to take reasonable and effective steps to ensure that the immediate upstream provider is not using it to carry or process a high volume of illegal traffic. Finally, it updates the Commission’s Robocall Mitigation Database certification requirements to reflect the 24-hour traceback requirement. DATES: Effective January 8, 2024, except for the amendments to 47 CFR 64.6305(d)(2)(ii) and (iii), (e)(2)(ii), and (f)(2)(iii) (amendatory instruction 5), which are delayed indefinitely. The amendments to 47 CFR 64.6305(d)(2)(ii) and (iii), (e)(2)(ii), and (f)(2)(iii) will become effective following publication of a document in the Federal Register announcing approval of the information collection and the relevant effective date. FOR FURTHER INFORMATION CONTACT: Jerusha Burnett, Consumer Policy Division, Consumer and Governmental Affairs Bureau, email at jerusha.burnett@fcc.gov or by phone at (202) 418–0526. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Report and Order, in CG Docket No. 17–59 and WC Docket 17–97, FCC 23–37, adopted on May 18, 2023, and released on May 19, 2023. The Further Notice of Proposed Rulemaking and Notice of Inquiry that was adopted concurrently with the Report and Order is published elsewhere in this issue of the Federal Register. The document is available for download at https://docs.fcc.gov/public/ attachments/FCC-23-37A1.pdf. To request this document in accessible formats for people with E:\FR\FM\10JYR1.SGM 10JYR1

Agencies

[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Rules and Regulations]
[Pages 43442-43446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14404]



[[Page 43442]]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0646; FRL-11057-01-OCSPP]


Benzpyrimoxan; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
benzpyrimoxan in or on rice, husked; rice, polished rice; and rice, 
bran. Nichino America, Inc. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2023. Objections and 
requests for hearings must be received on or before September 8, 2023 
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-2021-0646, 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 and the OPP docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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 Federal Register 
Office's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2021-0646 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 
September 8, 2023. 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-2021-0646, 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 February 25, 2022 (87 FR 10760) (FRL-
9410-01-OCSPP), 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 1E8949) by Nichino America, Inc. 4550 Linden Hill Road, 
Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 
part 180 be amended by establishing tolerances for residues of the 
insecticide benzpyrimoxan, including its metabolites and degradates, in 
or on the raw agricultural commodity rice, grain at 0.9 parts per 
million (ppm). The requested tolerance is for food imported into the 
U.S. and it is not registered for use in the U.S. That document 
referenced a summary of the petition prepared by Nichino America, Inc., 
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 the comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
revising the tolerance commodity definition for the requested tolerance 
in/on rice, grain and is also establishing tolerances for rice, 
polished rice and rice, bran. The reason for these changes is explained 
in Unit IV.D.

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. . . 
.''

[[Page 43443]]

    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 benzpyrimoxan including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with benzpyrimoxan 
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 toxicology database for benzpyrimoxan is complete for the 
establishment of a tolerance without U.S. registration. The affected 
target organs following the administration of benzpyrimoxan are the 
kidney and urinary tract. Crystals were observed in the kidneys and 
urinary tract along with tissue damage in both mice and rats following 
subchronic and chronic oral administration. The rat appeared to be the 
most sensitive species tested, with mouse and dog having similar 
toxicity. There did not appear to be a difference in toxicity by sex in 
any species.
    Increased quantitative susceptibility was seen in the rabbit 
preliminary developmental study where decreases in fetal body weight 
were observed in the absence of adverse maternal toxicity. There was no 
evidence of increased quantitative or qualitative lifestage 
susceptibility in the definitive rat or rabbit developmental toxicity 
or in the preliminary rat developmental toxicity. Increased qualitative 
susceptibility in the form of mortality (post-implantation loss and 
decreased viability index) was seen in the reproductive toxicity study 
in rats. The concern for increased susceptibility is low as there were 
clear lowest-observed-adverse-effect-levels (LOAELs) and no-observed-
adverse-effect-levels (NOAELs) in the developmental and reproductive 
toxicity studies and the points of departure (PODs) are protective of 
the increased susceptibility. There was no evidence of treatment-
related tumors in the rat or mouse carcinogenicity studies and all of 
the mutagenicity studies were negative.
    Benzpyrimoxan is classified as: ``Not likely to be carcinogenic to 
humans'' based on lack of treatment-related tumors in long-term dietary 
studies in the rat and mouse and low concern for genotoxicity. No 
treatment-related increase in the incidence of tumors was observed in 
carcinogenicity studies in rats or mice. Additionally, there is no 
evidence of mutagenicity in vivo or in vitro.
    Toxicity data were submitted for the benzpyrimoxan metabolite DH-04 
in the form of a 90-day oral toxicity study in rats. In this study, 
kidney effects and urine effects were observed in males and females at 
65 and 78 mg/kg/day, respectively. Mortality was observed at the 
highest dose tested (168/181 mg/kg/day [M/F]), and histopathological 
evaluation revealed various cardiovascular and/or renal lesions. By 
comparing the effects at the LOAEL for this study to the parent 90-day 
oral rat study, it is estimated that DH-04 is approximately 3X more 
toxic than the parent compound. Consequently, a 3X potency factor for 
DH-04 will be used when conducting the dietary exposure assessment.
    Specific information on the studies received and the nature of the 
adverse effects caused by benzpyrimoxan 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 ``Benzpyrimoxan: First Food Use; Human 
Health Risk Assessment to Support the Establishment of a Tolerance 
without U.S. Registration in/on Rice'' hereinafter ``Benzpyrimoxan 
Human Health Risk Assessment'' at page 24 in docket ID number EPA-HQ-
OPP-2021-0646.

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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for benzpyrimoxan used for 
human risk assessment can be found in the Benzpyrimoxan Human Health 
Risk Assessment on pages 15-16.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to benzpyrimoxan, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
benzpyrimoxan 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 benzpyrimoxan; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used 2005-2010 food consumption data from the U.S. 
Department of Agriculture's National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance-level residues (or higher to account for 
additional residues of concern), default processing factors, and 100 
percent crop treated (PCT) assumptions.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Based on the data summarized in Unit III.A., EPA has concluded that 
benzpyrimoxan does not pose a cancer risk to humans due to absence of 
treatment-related tumors or evidence of mutagenicity in the available 
studies. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT

[[Page 43444]]

information in the dietary assessment for benzpyrimoxan. Tolerance 
level residues (or higher to account for additional residues of 
concern), default processing factors, and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. EPA assumes that there is 
no exposure through drinking water because benzpyrimoxan is not 
registered for use in the United States. Because residues are not 
expected in drinking water, dietary risk estimates include exposures 
from food only.
    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). Benzpyrimoxan is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to benzpyrimoxan and any 
other substances. In addition, benzpyrimoxan does not appear to produce 
a toxic metabolite produced by other substances. For the purposes of 
this action, therefore, EPA has not assumed that benzpyrimoxan has a 
common mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased quantitative or qualitative lifestage susceptibility in the 
definitive rat or rabbit developmental toxicity or in the preliminary 
rat developmental toxicity. However, in the preliminary rabbit 
developmental study, which tested up to a higher dose than the 
definitive study (30 mg/kg/day), decreased fetal body weights were 
observed at 60 mg/kg/day in the absence of adverse maternal effects. 
Marginal body-weight decreases associated with marked food consumption 
decreases were observed in the maternal animals in this study, but they 
did not reach adversity.
    In the two-generation reproduction study, the parental animals had 
gross (depressed areas) and histopathological (pelvic crystals and 
obstructive nephropathy) effects in the kidneys of P and F1 generation 
males. Degenerative necrosis and hepatocyte centrilobular hypertrophy 
associated with increased liver weights were also observed in the 
parental generation. In the offspring F1 and F2 generations, increased 
incidences of mortality and decreases in pup body weight were observed. 
Increased incidence of post-implantation loss and decreased viability 
indices early during lactation at the same dose as that eliciting 
parental effects were considered to be both offspring and reproductive 
effects and indicated increased qualitative 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 from 10X to 1X. That decision is based on the 
following findings:
    i. The toxicity database for benzpyrimoxan is complete for 
evaluating and characterizing toxicity, assessing pre- and postnatal 
susceptibility under FQPA, and selecting endpoints for the anticipated 
exposure pathways. Developmental toxicity studies in the rat and rabbit 
and a two-generation reproductive toxicity study in the rat are 
available, in addition to an acute neurotoxicity study.
    ii. There is no evidence of neurotoxicity in the benzpyrimoxan 
database including an acute neurotoxicity study which tested up to the 
limit dose and functional observation batteries and motor activity 
observations performed in the 90-day and combined chronic/
carcinogenicity rat studies. EPA has waived both the subchronic 
neurotoxicity and immunotoxicity studies at this time.
    iii. As stated above, no evidence of increased quantitative or 
qualitative lifestage susceptibility was seen in the definitive rat and 
rabbit developmental studies, as there were no maternal or 
developmental adverse effects in those studies. In the preliminary 
rabbit developmental study, which tested up to a higher dose (60 mg/kg/
day) than the definitive study (30 mg/kg/day), adverse fetal body 
weights were observed in the absence of adverse maternal effects, 
suggesting quantitative susceptibility at >=60 mg/kg/day. Transient 
body-weight decreases and marked decreases in food consumption during 
treatment were observed in maternal animals at this dose but were not 
considered to reach adversity; however, based on the findings at the 
highest dose tested (60 mg/kg/day) it is unlikely that the maternal 
animals could have tolerated much higher dosing given those 
observations. In the two-generation reproduction toxicity study, 
parental toxicity (kidney and liver effects) was observed at the same 
dose as offspring (mortality, decreases in body weight, post-
implantation loss, and decreased viability indices) and reproductive 
(post-implantation loss and decreased viability indices) effects. The 
concern for susceptibility observed in the preliminary developmental 
study in rabbits is low as the effects in the maternal animals 
approached adversity. Additionally, there is a clear NOAEL established 
for developmental effects in that study and the offspring and 
reproductive effects in the two-generation reproduction study, and the 
PODs selected for risk assessment are protective of the observed 
quantitative and qualitative susceptibility in those two studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. An unrefined dietary exposure assessment was completed 
(tolerance level residues (or higher to account for additional residues 
of concern), default processing factors, and 100 PCT were assumed). In 
addition, there are no proposed or registered uses that would result to 
residential exposures. These assessments will not underestimate the 
exposure and risks posed by benzpyrimoxan.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing dietary exposure estimates to the acute 
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term

[[Page 43445]]

aggregate risks are evaluated by comparing the estimated total 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, 
benzpyrimoxan 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 
benzpyrimoxan from food only will utilize less than (<) 1% of the cPAD 
for all infants (<1 year old), the subpopulation with the highest risk 
estimate. There are no residential uses for benzpyrimoxan.
    3. Short- and intermediate- term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because benzpyrimoxan 
is not registered in the United States, the only exposures will be 
dietary from residues in or on imported rice; therefore, no short-term 
or intermediate-term residential exposure is expected. Because there is 
no short- or intermediate-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short- or intermediate-term risk 
is necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and intermediate-term risk for benzpyrimoxan.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, benzpyrimoxan is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to benzpyrimoxan residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Smithers Method 14078.6140, a 
QuEChERS based liquid chromatography with tandem mass spectrometry (LC-
MS/MS) multi-residue method) 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.
    The Codex has not established a MRL for benzpyrimoxan.

C. Response to Comments

    One comment was received in response to the Notice of Filing. The 
comment stated that ``there is still a lot we do not know about many of 
the chemicals we utilize and ingestion of these chemicals is not likely 
beneficial. Gathering that we should limit potential exposure to these 
by consumers as much as possible, why was the petition made to grant an 
exemption or tolerance? What is the user's or manufacturer's reasoning 
to request the allowance of more of these chemicals to remain on 
produce and potentially be ingested, and should more long-term 
information be acquired on the chemicals before allowing such a 
decision to be made?''
    Although the Agency recognizes that some individuals believe 
pesticides should be more restricted on agricultural crops, the 
existing legal framework provided by section 408 of the FFDCA 
authorizes EPA to establish tolerances when it determines that the 
tolerance is safe. Upon consideration of the validity, completeness, 
and reliability of the available data as well as other factors the 
FFDCA requires EPA to consider, EPA has determined that benzpyrimoxan 
tolerances are safe. The commenter has provided no information 
indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    Although the petitioner requested a tolerance for ``rice, grain'', 
EPA is establishing tolerances for ``rice, husked'', ``rice, polished 
rice'', and ``rice, bran''. Each of these commodities is a processed 
form of the ``rice, grain'' raw agricultural commodity that was 
requested. Consistent with its authority to establish tolerances that 
vary from what was requested under section 408(d)(4)(A)(i) of the 
FFDCA, EPA is establishing tolerances that align better with the 
Agency's current preferred commodity vocabulary and with the actual 
form of the commodities that may be imported into the United States. In 
addition, the available residue data indicate that separate tolerances 
are needed for the processed commodities of ``rice, polished rice'' and 
``rice, bran'' due to the concentration of residues.

V. Conclusion

    Therefore, tolerances are established for residues of 
benzpyrimoxan, including its metabolites and degradates, in or on rice, 
husked at 0.9 ppm; rice, polished rice at 0.15 ppm; and rice, bran at 3 
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). 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

[[Page 43446]]

Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 30, 2023.
Daniel Rosenblatt,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.724 to subpart C to read as follows:


Sec.  180.724  Benzpyrimoxan; tolerances for residues.

    (a) General. Tolerances are established for residues of 
benzpyrimoxan, including its metabolites and degradates, in or on the 
commodities in Table 1 to this paragraph (a). Compliance with the 
tolerance levels specified in Table 1 to this paragraph (a) is to be 
determined by measuring residues of benzpyrimoxan (5-(1,3-dioxan-2-yl)-
4-[[4-(trifluoromethyl)phenyl]methoxy]pyrimidine) in or on the 
following commodities:

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Rice, husked \1\........................................             0.9
Rice, polished rice \1\.................................            0.15
Rice, bran \1\..........................................               3
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 10, 2023.

    (b)-(d) [Reserved]

[FR Doc. 2023-14404 Filed 7-7-23; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.