Fenbuconazole; Pesticide Tolerances, 57331-57336 [2019-23380]

Download as PDF Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations Register regarding the pilot program’s termination. [FR Doc. 2019–23484 Filed 10–24–19; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2018–0300; FRL–9999–58] Fenbuconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: B. How can I get electronic access to other related information? This regulation establishes tolerances for residues of fenbuconazole in or on tea. Dow Agrosciences, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective October 25, 2019. Objections and requests for hearings must be received on or before December 24, 2019 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2018–0300, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: DATES: 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 VerDate Sep<11>2014 15:53 Oct 24, 2019 Jkt 250001 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). You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2018–0300 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 December 24, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2018–0300, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 57331 • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/ dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of July 24, 2018 (83 FR 34968) (FRL–9980–31), 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 8E8678) by Dow Agrosciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.480 be amended by establishing tolerances for residues of the fungicide fenbuconazole, in or on the raw agricultural commodities tea, dried at 10 parts per million (ppm); and tea, instant at 10 ppm. That document referenced a summary of the petition prepared by Dow Agrosciences, LLC, the registrant, which is available in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing. After the publication of the notice of filing in the Federal Register, Dow Agrosciences, LLC requested that its requested tolerance for residues on tea be established at 30 ppm in/on tea, dried and tea, instant based on additional magnitude of the residue studies conducted in 2016 and 2017. Based upon the data reviewed by the Food Safety Commission of Japan, EPA is establishing tolerances for tea, dried and tea, instant at 30 ppm. The reason for these changes are 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 E:\FR\FM\25OCR1.SGM 25OCR1 57332 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 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 fenbuconazole including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with fenbuconazole 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. Subchronic and chronic feeding studies were conducted in the rat, mouse, and dog. The liver was the main target of toxicity in all three species. At lower dose levels in the subchronic studies, there were changes in liver histopathology, predominantly hepatocellular hypertrophy, along with increased liver weight. In the absence of other findings, these effects appeared to be adaptive liver changes, but at higher dose levels, increased levels of enzymes indicative of liver damage were observed (alkaline phosphatase or ALK; serum glutamic-pyruvic transaminase or SGPT; and serum glutamic-oxaloacetic transaminase or SGOT). Increased hepatocellular vacuolization was observed at the higher dose levels as well, and in mice after subchronic exposure, hepatocellular necrosis was observed with a low incidence at the highest dose. In the rat after subchronic exposure, the thyroid was a secondary target organ with increased follicular cell size. In the chronic studies, liver effects were observed (including hepatocellular hypertrophy and vacuolization, changes in liver enzymes, and increased liver weights), as well as decreased body weight gains in all three species. Again, in the chronic rat study, the thyroid was a secondary target with increased thyroid and parathyroid weights and thyroid follicular cell hypertrophy. In addition, thyroid hormones were affected, with increased mean T4 (thyroxine) and decreased TSH (thyroid stimulating hormone) being observed in the high-dose rats near the end of the study. In the chronic dog study, kidney and adrenal weights were also increased. In the rat and rabbit developmental toxicity studies and the rat twogeneration study, all effects in the pups occurred in the presence of maternal toxicity, including changes in body weight in rats and decreased food consumption and clinical signs in rabbits. Developmental effects included increased post-implantation loss and decreased fetuses per dam in the rat developmental study; increased early resorptions in the rabbit developmental study; and decreased mean pup body weight, increased number of stillborn pups, decreased number of total offspring delivered, and decreased viability index of pups in the twogeneration study in rats. No increased qualitative or quantitative susceptibility was observed in any of the studies. There was no evidence of neurotoxicity in any of the studies available in the toxicology database. Fenbuconazole is classified as a ‘‘Group C,’’ or possible human carcinogen, based on an increased incidence of liver tumors in male and female mice and thyroid tumors in male rats. A cancer potency factor has been used to estimate potential cancer risk associated with fenbuconazole uses. Specific information on the studies received and referenced in this section and the nature of the adverse effects caused by fenbuconazole, 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 http:// www.regulations.gov in the document titled ‘‘Fenbuconazole: Human Health Risk Assessment for Proposed Use on Imported Tea,’’ on pages 23–30 in docket ID number EPA–HQ–OPP–2018– 0300. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL are observed, and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For nonthreshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for fenbuconazole used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (Females 13–49 years of age) ... NOAEL = 30 mg/kg/day ......... UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.3 mg/kg/day .... aPAD = 0.3 mg/kg/day Developmental Toxicity (Rat) Developmental LOAEL = 75 mg/kg/day based on increased resorption and decreased live fetuses per dam. VerDate Sep<11>2014 15:53 Oct 24, 2019 Jkt 250001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\25OCR1.SGM 25OCR1 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57333 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued Point of departure and uncertainty/safety factors Exposure/scenario RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (General population including infants and children). An endpoint for acute dietary (general population) exposures was not selected. An appropriate dose and endpoint were not identified for this population group. Chronic dietary (All populations) ...................... NOAEL = 3 mg/kg/day ........... UFA = 10x UFH = 10x FQPA SF = 1x Cancer (Oral, dermal, inhalation) ..................... Classification: Group C, possible human carcinogen. This classification is based on increased incidence of hepatocellular adenomas and carcinomas in male and female mice and thyroid follicular adenomas and combined adenomas/carcinomas in male rats. Quantification of risk was derived using combined hepatocellular adenomas/carcinomas in female mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)¥1 is 3.59 × 10¥3 in human equivalents. (TXR #0011894; CPRC; 4/15/1996) Chronic RfD = 0.03 mg/kg/day cPAD = 0.03 mg/kg/day Combined Chronic Toxicity/ Carcinogenicity (Rat) LOAEL = 30.6 mg/kg/day based on decreased body weight gain, increased thyroid weight, and histopathogical lesions in the liver and thyroid gland. FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. mg/kg/day = milligram/kilogram/day. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenbuconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing fenbuconazole tolerances in 40 CFR 180.480. EPA assessed dietary exposures from fenbuconazole 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. Although no endpoints of concern were identified for the general population including infants and children, such effects were identified for fenbuconazole for females 13–49 years old. In estimating acute dietary exposure, EPA used 2003–2008 food consumption information from the United States Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/ WWEIA). The acute dietary exposure analysis used tolerance-level residue estimates and assumed 100 percent crop treated (PCT). ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003–2008 food consumption data from the USDA’s NHANES/ WWEIA. As to residue estimates in food, EPA conducted a partially refined chronic dietary (food and drinking water) exposure assessment for all VerDate Sep<11>2014 15:53 Oct 24, 2019 Jkt 250001 established food uses of fenbuconazole. Average residues from field trials and 100 PCT were used. Empirical and default processing factors were used, as available. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenbuconazole should be classified as ‘‘a possible human carcinogen’’ and a linear approach has been used to quantify cancer risk. The cancer dietary exposure analysis used average field trial residue estimates and average PCT values. Empirical and default processing factors were used, as available. iv. Anticipated residue and PCT information. Average residue values were used in the Agency’s chronic and cancer assessment of fenbuconazole. Average percent crop treated estimates were used in the Agency’s cancer assessment of fenbuconazole. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: • Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. • Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. • Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used the following average PCT estimates for fenbuconazole for assessing cancer risk: Almonds: 5%; apples: 5%; apricots: 5%; blueberries: 55%; cherries: 15%; grapefruit: 40%; nectarines: 5%; oranges: 5%; peaches: 15%; pecans: 10%; plums/prunes: 1%; sugar beets: 1%; tangelos: 10%; tangerines: 1%. The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain E:\FR\FM\25OCR1.SGM 25OCR1 57334 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA’s computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fenbuconazole may be applied in a particular area. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic and cancer dietary risk analyses and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT. 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fenbuconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenbuconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment VerDate Sep<11>2014 15:53 Oct 24, 2019 Jkt 250001 can be found at http://www.epa.gov/ oppefed1/models/water/index.htm. Based on the (PRZM/EXAMS), the estimated drinking water concentrations (EDWCs) of fenbuconazole for acute exposures are estimated to be 24.1 parts per billion (ppb) for surface water and 0.031 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 16.5 ppb for surface water and 0.031 ppb for ground water. For chronic exposures for cancer assessments are estimated to be 11.7 ppb for surface water and 0.031 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The PRZM/EXAMS 1-in-10-year annual peak surface water value of 24.1 ppb for peppers is greater than the SCI–GROW groundwater value of 0.031 ppb. As a result, the surface water value was used in the acute dietary analysis. The 1-in10-year annual mean surface water value of 16.5 ppb for cherries is greater than the groundwater value of 0.031 ppb. As a result, the surface water value was used in the chronic dietary analysis. Finally, the 30-year annual mean surface water value of 11.7 ppb for cherries is greater than the groundwater value of 0.031 ppb. As a result, the surface water value was used in the cancer dietary analysis. 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). Fenbuconazole 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 fenbuconazole and any other substances. Although the conazole fungicides (triazoles) produce 1,2,4 triazole and its acid-conjugated metabolites (triazolylalanine and triazolylacetic acid), 1,2,4 triazole and its acid-conjugated metabolites do not contribute to the toxicity of the parent PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 conazole fungicides (triazoles). The Agency has assessed the aggregate risks from the 1,2,4 triazole and its acidconjugated metabolites (triazolylalanine and triazolylacetic acid) separately. The use of fenbuconazole on tea is not expected to quantitatively alter the dietary exposure estimates used in the most recent aggregate risk assessment for the common triazole metabolites because tea is not a significant consumption item and other conazoles are already registered for tea. The most recent triazole aggregate risk assessment (Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address New Section 3 Registrations For Use of Difenoconazole and Mefentrifluconazole; DP451447, dated May 15, 2019) can be found at https://www.regulations.gov at docket ID number EPA–HQ–OPP–2018–0002. Fenbuconazole does not appear to produce any other toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that fenbuconazole 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 is no indication of quantitative or qualitative susceptibility of rats or rabbits to in utero and/or postnatal exposure. 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 fenbuconazole is complete. ii. There is no indication that fenbuconazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. E:\FR\FM\25OCR1.SGM 25OCR1 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations iii. There is no evidence that fenbuconazole results in increased susceptibility 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 exposure assessment was based on field-trial residues and modeled drinking water estimates that will not underestimate dietary exposure and risk. The acute dietary exposure analysis used tolerance-level residues and assumed 100 PCT. The chronic and cancer dietary exposure analyses used average field-trial residue estimates. The chronic (non-cancer) assessment assumed 100 PCT, and the cancer analysis made use of average PCT estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fenbuconazole in drinking water. These assessments will not underestimate the exposure and risks posed by fenbuconazole. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenbuconazole will occupy 3.0% of the aPAD at the 95th percentile of exposure for females 13–49 years old, the only population subgroup with a relevant endpoint. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fenbuconazole from food and water uses 6.8% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. The chronic risk estimate for the general U.S. population uses 2.5% of the cPAD. There are no residential uses for fenbuconazole. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background VerDate Sep<11>2014 15:53 Oct 24, 2019 Jkt 250001 exposure level). There are no registered residential uses for fenbuconazole, and therefore aggregate exposure and risk are equivalent to dietary exposure and risk, and these risk estimates are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). There are no registered residential uses for fenbuconazole, and therefore aggregate exposure and risk are equivalent to dietary exposure and risk, and these risk estimates are not of concern. 5. Aggregate cancer risk for U.S. population. Cancer risk was estimated at 1.8 x 10¥6. The Agency generally considers risks up to 3 x 10¥6 to be within the negligible risk range and below the Agency’s LOC. In addition, actual cancer risk is likely to be much lower, since the residue inputs were based on field trial data (as opposed to monitoring data) and used upper-bound PCT estimates. 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 fenbuconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Tolerance enforcement method 34– 90–47R is available for determining residues of fenbuconazole, RH–9129, and RH–9130 in plant commodities through gas chromatography with a nitrogen phosphorous detector (GC– NPD). The method has undergone successful independent laboratory validation. The GC–NPD method TR 34– 94–142 is adequate for collecting data on residues of fenbuconazole, RH–9129, and RH–9130 in livestock commodities. These methods 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 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 57335 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 an MRL for fenbuconazole in tea. C. Revisions to Petitioned-For Tolerances The petitioner initially proposed a tolerance level of 10 ppm for residues in/on tea, dried and tea, instant, based on 1995 magnitude of the residue data reviewed by the Food Safety Commission of Japan. However, based on additional magnitude of the residue studies conducted in 2016 and 2017, the petitioner updated the proposed tolerance to 30 ppm in/on tea, dried and tea, instant. The proposed 30 ppm tolerance is in accordance with the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedure. Based on the residue data reviewed by the Food Safety Commission of Japan, the Agency concluded that the proposed tolerances of 30 ppm in/on tea, dried and tea, instant are appropriate. V. Conclusion Therefore, tolerances are established for residues of fenbuconazole and its lactone metabolites (trans- or cis-5-(4chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazol-1-ylmethyl)-2(3H)furanone), in or on tea, dried and tea, instant at 30 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 E:\FR\FM\25OCR1.SGM 25OCR1 57336 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the 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 VerDate Sep<11>2014 17:20 Oct 24, 2019 Jkt 250001 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: September 30, 2019. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.480, add alphabetically entries for ‘‘tea, dried’’ and ‘‘tea, instant’’ to the table in paragraph (a) to read as follows: ■ § 180.480 Fenbuconazole; tolerances for residues. (a) * * * tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is effective October 25, 2019. Objections and requests for hearings must be received on or before December 24, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2018–0619, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: * 30 (703) 305–7090; email address: 30 RDFRNotices@epa.gov. Parts per million Commodity * * * Tea, dried 2 ........................... Tea, instant 2 ......................... * * * * * * * * * * * SUPPLEMENTARY INFORMATION: I. General Information 2 There are no U.S. registrations for use of fenbuconazole on tea. * * * * * [FR Doc. 2019–23380 Filed 10–24–19; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2018–0619; FRL–10000–06] Pendimethalin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of pendimethalin in or on the leaf petiole vegetable subgroup 22B, monarda oil, monarda fresh leaves, rosemary oil, and rosemary fresh leaves. Interregional Research Project Number 4 (IR–4) requested these SUMMARY: PO 00000 Frm 00024 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 E:\FR\FM\25OCR1.SGM 25OCR1

Agencies

[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57331-57336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23380]


=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0300; FRL-9999-58]


Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
fenbuconazole in or on tea. Dow Agrosciences, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 25, 2019. Objections and 
requests for hearings must be received on or before December 24, 2019 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2018-0300, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

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 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0300 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 
December 24, 2019. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2018-0300, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
8E8678) by Dow Agrosciences, LLC, 9330 Zionsville Road, Indianapolis, 
IN 46268. The petition requested that 40 CFR 180.480 be amended by 
establishing tolerances for residues of the fungicide fenbuconazole, in 
or on the raw agricultural commodities tea, dried at 10 parts per 
million (ppm); and tea, instant at 10 ppm. That document referenced a 
summary of the petition prepared by Dow Agrosciences, LLC, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    After the publication of the notice of filing in the Federal 
Register, Dow Agrosciences, LLC requested that its requested tolerance 
for residues on tea be established at 30 ppm in/on tea, dried and tea, 
instant based on additional magnitude of the residue studies conducted 
in 2016 and 2017.
    Based upon the data reviewed by the Food Safety Commission of 
Japan, EPA is establishing tolerances for tea, dried and tea, instant 
at 30 ppm. The reason for these changes are 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

[[Page 57332]]

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 fenbuconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenbuconazole 
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.
    Subchronic and chronic feeding studies were conducted in the rat, 
mouse, and dog. The liver was the main target of toxicity in all three 
species. At lower dose levels in the subchronic studies, there were 
changes in liver histopathology, predominantly hepatocellular 
hypertrophy, along with increased liver weight. In the absence of other 
findings, these effects appeared to be adaptive liver changes, but at 
higher dose levels, increased levels of enzymes indicative of liver 
damage were observed (alkaline phosphatase or ALK; serum glutamic-
pyruvic transaminase or SGPT; and serum glutamic-oxaloacetic 
transaminase or SGOT). Increased hepatocellular vacuolization was 
observed at the higher dose levels as well, and in mice after 
subchronic exposure, hepatocellular necrosis was observed with a low 
incidence at the highest dose. In the rat after subchronic exposure, 
the thyroid was a secondary target organ with increased follicular cell 
size. In the chronic studies, liver effects were observed (including 
hepatocellular hypertrophy and vacuolization, changes in liver enzymes, 
and increased liver weights), as well as decreased body weight gains in 
all three species. Again, in the chronic rat study, the thyroid was a 
secondary target with increased thyroid and parathyroid weights and 
thyroid follicular cell hypertrophy. In addition, thyroid hormones were 
affected, with increased mean T4 (thyroxine) and decreased TSH (thyroid 
stimulating hormone) being observed in the high-dose rats near the end 
of the study. In the chronic dog study, kidney and adrenal weights were 
also increased.
    In the rat and rabbit developmental toxicity studies and the rat 
two-generation study, all effects in the pups occurred in the presence 
of maternal toxicity, including changes in body weight in rats and 
decreased food consumption and clinical signs in rabbits. Developmental 
effects included increased post-implantation loss and decreased fetuses 
per dam in the rat developmental study; increased early resorptions in 
the rabbit developmental study; and decreased mean pup body weight, 
increased number of stillborn pups, decreased number of total offspring 
delivered, and decreased viability index of pups in the two-generation 
study in rats. No increased qualitative or quantitative susceptibility 
was observed in any of the studies. There was no evidence of 
neurotoxicity in any of the studies available in the toxicology 
database.
    Fenbuconazole is classified as a ``Group C,'' or possible human 
carcinogen, based on an increased incidence of liver tumors in male and 
female mice and thyroid tumors in male rats. A cancer potency factor 
has been used to estimate potential cancer risk associated with 
fenbuconazole uses.
    Specific information on the studies received and referenced in this 
section and the nature of the adverse effects caused by fenbuconazole, 
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 http://www.regulations.gov in the document titled 
``Fenbuconazole: Human Health Risk Assessment for Proposed Use on 
Imported Tea,'' on pages 23-30 in docket ID number EPA-HQ-OPP-2018-
0300.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL are observed, and the LOAEL are 
identified. Uncertainty/safety factors are used in conjunction with the 
POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenbuconazole used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fenbuconazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 30 mg/kg/day...  Acute RfD = 0.3 mg/kg/   Developmental Toxicity
 age).                                 UFA = 10x..............   day.                     (Rat)
                                       UFH = 10x..............  aPAD = 0.3 mg/kg/day...  Developmental
                                       FQPA SF = 1x...........                           LOAEL = 75 mg/kg/day
                                                                                          based on increased
                                                                                          resorption and
                                                                                          decreased live fetuses
                                                                                          per dam.
----------------------------------------------------------------------------------------------------------------

[[Page 57333]]

 
Acute dietary (General population      An endpoint for acute dietary (general population) exposures was not
 including infants and children).       selected. An appropriate dose and endpoint were not identified for this
                                        population group.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL = 3 mg/kg/day....  Chronic RfD = 0.03 mg/   Combined Chronic
                                       UFA = 10x..............   kg/day.                  Toxicity/
                                       UFH = 10x..............  cPAD = 0.03 mg/kg/day..   Carcinogenicity (Rat)
                                       FQPA SF = 1x...........                           LOAEL = 30.6 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain,
                                                                                          increased thyroid
                                                                                          weight, and
                                                                                          histopathogical
                                                                                          lesions in the liver
                                                                                          and thyroid gland.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: Group C, possible human carcinogen. This classification
                                        is based on increased incidence of hepatocellular adenomas and
                                        carcinomas in male and female mice and thyroid follicular adenomas and
                                        combined adenomas/carcinomas in male rats. Quantification of risk was
                                        derived using combined hepatocellular adenomas/carcinomas in female
                                        mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-\1\ is 3.59
                                        x 10-\3\ in human equivalents. (TXR #0011894; CPRC; 4/15/1996)
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. mg/kg/day = milligram/kilogram/day.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
  extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
  the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenbuconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenbuconazole 
tolerances in 40 CFR 180.480. EPA assessed dietary exposures from 
fenbuconazole 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.
    Although no endpoints of concern were identified for the general 
population including infants and children, such effects were identified 
for fenbuconazole for females 13-49 years old. In estimating acute 
dietary exposure, EPA used 2003-2008 food consumption information from 
the United States Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). The acute dietary exposure analysis used tolerance-level 
residue estimates and assumed 100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue estimates in food, EPA conducted a 
partially refined chronic dietary (food and drinking water) exposure 
assessment for all established food uses of fenbuconazole. Average 
residues from field trials and 100 PCT were used. Empirical and default 
processing factors were used, as available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenbuconazole should be classified as ``a possible human 
carcinogen'' and a linear approach has been used to quantify cancer 
risk. The cancer dietary exposure analysis used average field trial 
residue estimates and average PCT values. Empirical and default 
processing factors were used, as available.
    iv. Anticipated residue and PCT information. Average residue values 
were used in the Agency's chronic and cancer assessment of 
fenbuconazole. Average percent crop treated estimates were used in the 
Agency's cancer assessment of fenbuconazole.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used the following average PCT estimates for 
fenbuconazole for assessing cancer risk: Almonds: 5%; apples: 5%; 
apricots: 5%; blueberries: 55%; cherries: 15%; grapefruit: 40%; 
nectarines: 5%; oranges: 5%; peaches: 15%; pecans: 10%; plums/prunes: 
1%; sugar beets: 1%; tangelos: 10%; tangerines: 1%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain

[[Page 57334]]

that the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which fenbuconazole may be applied in a particular area.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the California Department 
of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic and cancer dietary risk analyses and a maximum 
PCT for acute dietary risk analysis. The average PCT figure for each 
existing use is derived by combining available public and private 
market survey data for that use, averaging across all observations, and 
rounding to the nearest 5%, except for those situations in which the 
average PCT is less than 1% or less than 2.5%. In those cases, the 
Agency would use less than 1% or less than 2.5% as the average PCT 
value, respectively. The maximum PCT figure is the highest observed 
maximum value reported within the recent 10 years of available public 
and private market survey data for the existing use and rounded up to 
the nearest multiple of 5%, except where the maximum PCT is less than 
2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for fenbuconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenbuconazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the (PRZM/EXAMS), the estimated drinking water 
concentrations (EDWCs) of fenbuconazole for acute exposures are 
estimated to be 24.1 parts per billion (ppb) for surface water and 
0.031 ppb for ground water. For chronic exposures for non-cancer 
assessments are estimated to be 16.5 ppb for surface water and 0.031 
ppb for ground water. For chronic exposures for cancer assessments are 
estimated to be 11.7 ppb for surface water and 0.031 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The PRZM/EXAMS 1-in-10-year 
annual peak surface water value of 24.1 ppb for peppers is greater than 
the SCI-GROW groundwater value of 0.031 ppb. As a result, the surface 
water value was used in the acute dietary analysis. The 1-in-10-year 
annual mean surface water value of 16.5 ppb for cherries is greater 
than the groundwater value of 0.031 ppb. As a result, the surface water 
value was used in the chronic dietary analysis. Finally, the 30-year 
annual mean surface water value of 11.7 ppb for cherries is greater 
than the groundwater value of 0.031 ppb. As a result, the surface water 
value was used in the cancer dietary analysis.
    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). Fenbuconazole 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 fenbuconazole and any 
other substances. Although the conazole fungicides (triazoles) produce 
1,2,4 triazole and its acid-conjugated metabolites (triazolylalanine 
and triazolylacetic acid), 1,2,4 triazole and its acid-conjugated 
metabolites do not contribute to the toxicity of the parent conazole 
fungicides (triazoles). The Agency has assessed the aggregate risks 
from the 1,2,4 triazole and its acid-conjugated metabolites 
(triazolylalanine and triazolylacetic acid) separately. The use of 
fenbuconazole on tea is not expected to quantitatively alter the 
dietary exposure estimates used in the most recent aggregate risk 
assessment for the common triazole metabolites because tea is not a 
significant consumption item and other conazoles are already registered 
for tea. The most recent triazole aggregate risk assessment (Common 
Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to 
Address New Section 3 Registrations For Use of Difenoconazole and 
Mefentrifluconazole; DP451447, dated May 15, 2019) can be found at 
https://www.regulations.gov at docket ID number EPA-HQ-OPP-2018-0002. 
Fenbuconazole does not appear to produce any other toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has not assumed that fenbuconazole 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 is no indication of 
quantitative or qualitative susceptibility of rats or rabbits to in 
utero and/or postnatal exposure.
    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 fenbuconazole is complete.
    ii. There is no indication that fenbuconazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.

[[Page 57335]]

    iii. There is no evidence that fenbuconazole results in increased 
susceptibility 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 exposure assessment was based on field-trial residues 
and modeled drinking water estimates that will not underestimate 
dietary exposure and risk. The acute dietary exposure analysis used 
tolerance-level residues and assumed 100 PCT. The chronic and cancer 
dietary exposure analyses used average field-trial residue estimates. 
The chronic (non-cancer) assessment assumed 100 PCT, and the cancer 
analysis made use of average PCT estimates. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to fenbuconazole in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
fenbuconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fenbuconazole will occupy 3.0% of the aPAD at the 95th percentile of 
exposure for females 13-49 years old, the only population subgroup with 
a relevant endpoint.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenbuconazole from food and water uses 6.8% of the cPAD for children 1-
2 years old, the population group receiving the greatest exposure. The 
chronic risk estimate for the general U.S. population uses 2.5% of the 
cPAD. There are no residential uses for fenbuconazole.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). There are no 
registered residential uses for fenbuconazole, and therefore aggregate 
exposure and risk are equivalent to dietary exposure and risk, and 
these risk estimates are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). There are no registered residential uses for fenbuconazole, and 
therefore aggregate exposure and risk are equivalent to dietary 
exposure and risk, and these risk estimates are not of concern.
    5. Aggregate cancer risk for U.S. population. Cancer risk was 
estimated at 1.8 x 10-\6\. The Agency generally considers 
risks up to 3 x 10-\6\ to be within the negligible risk 
range and below the Agency's LOC. In addition, actual cancer risk is 
likely to be much lower, since the residue inputs were based on field 
trial data (as opposed to monitoring data) and used upper-bound PCT 
estimates.
    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 fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Tolerance enforcement method 34-90-47R is available for determining 
residues of fenbuconazole, RH-9129, and RH-9130 in plant commodities 
through gas chromatography with a nitrogen phosphorous detector (GC-
NPD). The method has undergone successful independent laboratory 
validation. The GC-NPD method TR 34-94-142 is adequate for collecting 
data on residues of fenbuconazole, RH-9129, and RH-9130 in livestock 
commodities.
    These methods 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 an MRL for fenbuconazole in tea.

C. Revisions to Petitioned-For Tolerances

    The petitioner initially proposed a tolerance level of 10 ppm for 
residues in/on tea, dried and tea, instant, based on 1995 magnitude of 
the residue data reviewed by the Food Safety Commission of Japan. 
However, based on additional magnitude of the residue studies conducted 
in 2016 and 2017, the petitioner updated the proposed tolerance to 30 
ppm in/on tea, dried and tea, instant. The proposed 30 ppm tolerance is 
in accordance with the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedure. Based on the 
residue data reviewed by the Food Safety Commission of Japan, the 
Agency concluded that the proposed tolerances of 30 ppm in/on tea, 
dried and tea, instant are appropriate.

V. Conclusion

    Therefore, tolerances are established for residues of fenbuconazole 
and its lactone metabolites (trans- or cis-5-(4-chlorophenyl)dihydro-3-
phenyl-3-(1H-1,2,4-triazol-1-ylmethyl)-2(3H)-furanone), in or on tea, 
dried and tea, instant at 30 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

[[Page 57336]]

Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 
require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the 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: September 30, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.480, add alphabetically entries for ``tea, dried'' and 
``tea, instant'' to the table in paragraph (a) to read as follows:


Sec.  180.480  Fenbuconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea, dried \2\..........................................              30
Tea, instant \2\........................................              30
 
                                * * * * *
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
\2\ There are no U.S. registrations for use of fenbuconazole on tea.

* * * * *
[FR Doc. 2019-23380 Filed 10-24-19; 8:45 am]
 BILLING CODE 6560-50-P