83 FR 22595 - Tebuconazole; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 95 (May 16, 2018)
Federal Register Volume 83, Issue 95 (May 16, 2018)
| Page Range | 22595-22601 | |
| FR Document | 2018-10345 |
[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)] [Rules and Regulations] [Pages 22595-22601] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10345] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0032; FRL-9976-62] Tebuconazole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of tebuconazole in or on ginseng, fresh at 0.15 parts per million (ppm) and ginseng, dried at 0.40 ppm. Bayer CropScience LP, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 16, 2018. Objections and requests for hearings must be received on or before July 16, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0032, 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, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460- 0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: 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-2017-0032 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 16, 2018. 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 [[Page 22596]] by docket ID number EPA-HQ-OPP-2017-0032, 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 April 10, 2017 (82 FR 17175) (FRL-9959- 61), 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 6E8534) by Bayer CropScience LP, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of tebuconazole, [alpha]-[2-(4-Chlorophenyl)ethyl]-[alpha]-(1,1- dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on ginseng, fresh at 0.15 ppm and ginseng, dried/red at 0.4 ppm. This document referenced a summary of the petition prepared by Bayer CropScience LP, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for tebuconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tebuconazole 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 toxicological profile remains unchanged from the discussion contained in the final rule published in the Federal Register on November 15, 2013 (78 FR 68741) (FRL-9392-1), which is hereby incorporated into this document. Specific information on the studies received and the nature of the adverse effects caused by tebuconazole 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 document Human Health Aggregate Risk Assessment for Establishment of a Permanent Tolerance Without U.S. Registration for Residues in/on Ginseng at pages 24-26 in docket ID number EPA-HQ- OPP-2017-0032. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for tebuconazole used for human risk assessment can be found in the preamble to the final rule published in the Federal Register on November 15, 2013. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tebuconazole, EPA considered exposure under the petitioned- for tolerances as well as all existing tebuconazole tolerances in 40 CFR 180.474. EPA assessed dietary exposures from tebuconazole 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. Such effects were identified for tebuconazole. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, a somewhat refined acute probalistic dietary exposure assessment was conducted for all existing and proposed food uses of tebuconazole. For the acute assessment, anticipated residues for grapes, grape juice, and peaches were derived using the latest USDA Pesticide Data Program (PDP) monitoring data. Anticipated residues for all other registered and proposed food commodities were based on field trial data. Anticipated residues for all current uses were further refined [[Page 22597]] using percent crop treated (%CT) data where available. Percentage of imported orange juice and oranges were also provided. Default DEEM (ver. 7.81) and empirical processing factors were assumed. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 (NHANES/WWEIA). As to residue levels in food, EPA used field trial data, USDA PDP data, assumed PCT data levels and used empirical DEEM (ver. 7.81) default processing factors as described in Unit III.C.iv. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to tebuconazole. The chronic risk assessment or RfD approach is considered to be protective of any cancer effects; therefore, a separate cancer assessment was not conducted. iv. Anticipated residue and percent crop treated (PCT) information. 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. For the acute assessment, the Agency estimated the PCT for existing uses as follows: Almonds 15%; apples 2.5%; apricots 20%; asparagus 30%; barley 2.5%; beans green 2.5%; cantaloupes 10%; cherries 45%; corn 2.5%; cotton 2.5%; cucumbers 2.5%; dry beans/peas 5%; garlic 95%; grapes 40%; nectarines 30%; oats 2.5%; onions 5%; peaches 25%; peanuts 65%; pears 5%; pecans 25%; plums/prunes 5%; soybeans 2.5%; squash 5%; sweet corn 5%; and wheat 25%. For the chronic assessment, the Agency estimated the PCT for existing uses as follows: Almonds 5%; apples 2.5%; apricots 10%; asparagus 5%; barley 2.5%; beans green 1%; cantaloupes 2.5%; cherries 25%; corn 1%; cotton 1%; cucumbers 1%; dry beans/peas 2.5%; garlic 65%; grapes 25%; nectarines 20%; oats 2.5%; onions 5%; peaches 10%; peanuts 45%; pears 5%; pecans 10%; pistachios 5%; plums/prunes 2.5%; pumpkins 2.5%; soybeans 1%; squash 2.5%; sweet corn 2.5%; walnuts 2.5%; watermelons 15%; and wheat 5%. The following estimated percent import estimates for the import oranges were used: Acute: Orange 16%; and orange juice 58%; Chronic: orange 12%; orange juice 46%. For all other crops not listed above, EPA assumed that 100% of the crop was treated. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis 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 2.5% or 1%. In those cases, EPA uses 2.5% or 1%, respectively, as the average PCT value. 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 in those situations in which the maximum PCT is less than 2.5%, in which case, the Agency uses 2.5% as the maximum PCT. 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 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 tebuconazole may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for tebuconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tebuconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI- GROW) models the estimated drinking water concentrations (EDWCs) of tebuconazole for acute exposures are estimated to be 87.7 parts per billion (ppb) for surface water and 1.56 ppb for ground water and for chronic exposures are estimated to be 68.8 ppb for surface water and 1.56 ppb for ground water. Modeled estimates of drinking water concentrations were previously entered into the dietary exposure model. For acute dietary risk assessment, a distribution of 30-year daily surface water concentration was estimated for the EDWCs of tebuconazole. For chronic dietary risk assessment, the water concentration of value 68.8 ppb was previously used to assess the [[Page 22598]] contribution to drinking water. Because the use of tebuconazole on ginseng is not associated with a U.S. registration, there is no impact on drinking water residues. As a result, the Agency is relying on the drinking water residues used in the dietary risk assessment previously provided, ``Drinking water and ecological risk for new use of tebuconazole/fluoxastrobin combination for turf and ornamental use'', which can be found at http://regulations.gov, under docket ID number EPA-HQ-OPP-2013-0653-0007. 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). Tebuconazole is currently registered for the following uses that could result in residential exposures: Turf, flower gardens, trees, ornamentals, and pressure-treated wood. EPA assessed residential exposure using the following assumptions: For residential handlers, exposure is expected to be short-term. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. For post-application exposures, the Agency assessed residential dermal and incidental oral post- application exposure for adults and children golfing, working in gardens, and performing physical activities on pressure-treated wood after application of tebuconazole may receive exposure to tebuconazole residues. Post-application exposure is expected to be short-term in duration. For assessment of both handler and post-application exposures, dermal and inhalation exposures were combined since the same endpoint and point of departure (POD) is used for both routes of exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. Because no new residential uses are being requested at this time, an updated residential exposure assessment would not normally be required. Each of the existing residential use patterns had been previously assessed and the resulting exposures and risk estimates did not exceed the agency's LOC. Since those assessments were conducted, however, a turf transferrable residue (TTR) study required by the Agency in 2013 was submitted to support a reevaluation of the aggregate exposures from the registered use on golf course turf. In addition, the agency updated the residential standard operating procedures and body weights to be used in all human health assessments. Therefore, the existing residential use patterns were reassessed using the updated procedures and data, since the residential exposures can impact the aggregate assessment for tebuconazole. The TTR study is reviewed in a separate HED memorandum available in the docket EPA-HQ-OPP-2017-0032. 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.'' Tebuconazole is a member of the conazole class of fungicides containing the 1,2,4-triazole moiety. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no conclusive data to indicate that conazoles share common mechanisms of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. 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 tebuconazole and any other substances. Although the conazoles 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 conazoles. The Agency has assessed the aggregate risks from the 1,2,4 triazole and its acid-conjugated metabolites (triazolylalanine and triazolylacetic acid) separately. Tebuconazole 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 tebuconazole 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. The toxicity database for tebuconazole includes prenatal developmental toxicity studies in three species (mouse, rat, and rabbit), a reproductive toxicity study in rats, and a developmental neurotoxicity study in rats. The data from prenatal developmental toxicity studies in mice and a developmental neurotoxicity study in rats indicated an increased quantitative and qualitative susceptibility following in utero exposure to tebuconazole. The NOAELs/LOAELs for developmental toxicity in these studies were found at dose levels less than those that induce maternal toxicity or in the presence of slight maternal toxicity. There was no indication of increased quantitative susceptibility in the rat and rabbit developmental toxicity studies, the NOAELs for developmental toxicity were comparable to or higher than the NOAELs for maternal toxicity. In all three species, however, there was indication of increased qualitative susceptibility. For most studies, minimal maternal toxicity was seen at the LOAEL (consisting of increases in [[Page 22599]] hematological findings in mice, increased liver weights in rabbits and rats, and decreased body weight gain/food consumption in rats) and did not increase substantially in severity at higher doses. However, there was more concern for the developmental effects at each LOAEL, which included increases in runts, increased fetal loss, and malformations in mice; increased skeletal variations in rats; and increased fetal loss and frank malformations in rabbits. Additionally, more severe developmental effects (including frank malformations) were seen at higher doses in mice, rats and rabbits. In the developmental neurotoxicity study, maternal toxicity was seen only at the high dose (decreased body weights, body weight gains, and food consumption, prolonged gestation and dystocia as well as decreased offspring survival). 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 3X. That decision is based on the following findings: i. The toxicity database for tebuconazole is complete. ii. Tebuconazole demonstrated neurotoxicity in the acute neurotoxicity study in rats; the lowest observable adverse effect level (LOAEL) of 100 mg/kg/day was based on increased motor activity in male and female rats and decreased footsplay in female rats. Although the subchronic neurotoxicity study was unacceptable since there was inadequate dosing, a new subchronic neurotoxicity study is not needed to evaluate levels at which subchronic neurotoxicity might occur; neurotoxicity was seen in other studies in the database at considerably lower doses than those tested in the subchronic neurotoxicity study. Malformations indicative of nervous system development disruption were seen in developmental toxicity studies in mice, rats, and rabbits. Neurotoxicity was also seen in the rat developmental neurotoxicity study as decreases in body weights, decreases in absolute brain weights, changes in brain morphometric parameters, and decreases in motor activity in offspring at the LOAEL of 8.8 mg/kg/day; a no observable adverse effect level (NOAEL) could not be established. The LOAEL (8.8 mg/kg/day) was employed as the point of departure (POD) for assessing risk for all exposure scenarios, and an FQPA SF of 3X has been retained as an uncertainty factor for use of a LOAEL to extrapolate a NOAEL (UFL). To determine whether the UFL is protective of any potential neurotoxicity, a Benchmark Dose (BMD) analysis of the datasets relevant to the adverse offspring effects (decreased body weight and brain weight) seen at the LOAEL in the developmental neurotoxicity (DNT) study was conducted. All of the BMDLs (benchmark dose lower limit) modeled successfully on statistically significant effects were 1-2X lower than the LOAEL. Therefore, an extrapolated NOAEL is not likely to be 10X lower than the LOAEL and that use of an UFL of 3X would not underestimate risk. Using an FQPA SF of 3X in risk assessment results in a NOAEL of 2.9 mg/kg/day (8.8 mg/kg/day / 3X = 2.9 mg/kg/day), which is further supported by other studies in the tebuconazole toxicity database, with the lowest NOAELs being 3 and 2.9 mg/kg/day, from a developmental toxicity study in mice and a chronic toxicity study in dogs, respectively (respective LOAELs 10 and 4.5 mg/ kg/day). iii. There were increases in qualitative susceptibility in the prenatal developmental studies in rats, mice, and rabbits and in quantitative susceptibility in mice and developmental neurotoxicity in rats. However, the toxicity endpoint observed in developmental neurotoxicity study in rats was employed to establish the point of departure (POD) for risk assessment for all exposure scenarios. This toxicity endpoint was the most sensitive one, and the resulting POD was protective of all adverse effects found in the tebuconazole toxicity database. Therefore, the degree of concern for residual uncertainties for prenatal and/or postnatal toxicity was low. iv. There are no residual uncertainties identified in the exposure databases. EPA utilized a tiered approach in estimating exposure to tebuconazole. While some refinements were incorporated into dietary and residential exposure calculations, EPA is confident that the aggregate risk from exposure to tebuconazole in food, water and residential pathways will not be underestimated. The acute and chronic dietary exposure assessments incorporated somewhat refined estimates of residues in food commodities from reliable field trial data reflecting maximum use conditions, recent monitoring data from USDA's Pesticide Data Program (PDP), and relevant market survey data on the percentage of crops treated. Estimated concentrations of tebuconazole in drinking water were incorporated into the chronic dietary analysis as the upper bound point estimate and into the probabilistic acute dietary analysis as a distribution. For the residential exposure pathways (ornamentals, golf course turf, and treated wood products), potential exposure resulting from tebuconazole outdoor uses in the residential setting was assessed using screening-level inputs that assumes an adult or child will come in contact with turf and other surfaces immediately after application. 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 tebuconazole will occupy 77% of the aPAD for all infants (< 1 year old), the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tebuconazole from food and water will utilize 22% of the cPAD for all infants (< 1 year old) the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of tebuconazole is not expected. 3. Short-term risk and Intermediate-term risk. Short-term and intermediate-term risk aggregate exposure takes into account short-term residential exposure and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tebuconazole is currently registered for uses that could result in short-term residential exposure that could co-occur with background dietary exposure over the short-term (1-30 days), whereas co-occurring intermediate exposures (1-6 months) are less likely. However, since the POD employed for both durations are the same, the aggregate assessments address both exposure durations. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that residential exposures result in aggregate MOEs of 580 for adults, 600 for youths 11 to <16 years old, and children 6 to <11 years [[Page 22600]] 500 for the activity of golfing and 330 for children (1-2 years old) engaging in activities on pressure treated wood surfaces. Because EPA's level of concern (LOC) for tebuconazole is a MOE of 300 or below, these MOEs are not of concern. Therefore, aggregate risk estimates for all examined population subgroups were not of concern to the Agency. 4. Aggregate cancer risk for U.S. population. Based on the Agency's determination that the chronic risk assessment will be protective of any cancer effects, a separate quantitative cancer risk assessment was not conducted. Because there is no chronic risk of concern from aggregate exposure to tebuconazole, the Agency concludes that aggregate exposure to tebuconazole will not result in cancer risks of concern. 5. Aggregate Assessment for Free Triazole & its Conjugates. The conazole class of compounds, which includes tebuconazole, can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-containing pesticides, including tebucaonazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-containing fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). The Agency retained a 3X for the LOAEL to NOAEL safety factor when the reproduction study was used. In addition, the Agency retained a 10X for the lack of studies including a developmental neurotoxicity (DNT) study. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-0497. The Agency's latest updated aggregate risk assessment for the triazole-containing metabolites was finalized on July 18, 2017 and includes the proposed new uses of tebuconazole. That assessment concluded that aggregate exposure to the triazole metabolites does not exceed the Agency's level of concern. 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 tebuconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Gas Chromatography/Nitrogen Phosphorus Detector (GC/NPD) 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 established MRLs for tebuconazole in or on ginseng and ginseng, dried at 0.15 ppm and 0.40 ppm, respectively. These MRLs are the same as the tolerances established for tebuconazole in the United States. C. Revisions to Petitioned-For Tolerances For dried ginseng, the Agency is revising the commodity definition for the requested tolerance to reflect the correct commodity vocabulary currently used by the Agency. Specifically, ginseng dried/red was changed to ginseng, dried. Additionally, the Agency is revising the significant figures for the tolerance level based on current policy. V. Conclusion Therefore, tolerances are established for residues of tebuconazole, [alpha]-[2-(4-Chlorophenyl)ethyl]-[alpha]-(1,1-dimethylethyl)-1H-1,2,4- triazole-1-ethanol, in or on ginseng, dried at 0.40 ppm and ginseng, fresh at 0.15 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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, [[Page 22601]] 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 30, 2018. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Program. 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. 180.474, add alphabetically the entries ``Ginseng, dried'' and ``Ginseng, fresh'' to the table in paragraph (a)(1) to read as follows: Sec. 180.474 Tebuconazole; tolerances for residues. (a) * * * (1) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Ginseng, dried \1\...................................... 0.40 Ginseng, fresh \1\...................................... 0.15 * * * * * ------------------------------------------------------------------------ \1\ There are no U.S. registrations. * * * * * [FR Doc. 2018-10345 Filed 5-15-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Rules and Regulations 22595
Kentucky Area to remove the emissions Area of the Cincinnati-Hamilton, OH- Washington, DC 20460–0001; main
reductions associated with the use of KY-IN ozone maintenance area and is telephone number: (703) 305–7090;
RFG in this area and to demonstrate that thereby removing the prohibition on the email address: RDFRNotices@epa.gov.
the RFG opt-out would not interfere sale of conventional gasoline in that SUPPLEMENTARY INFORMATION:
with the area’s ability to attain or area as of July 1, 2018. (See 40 CFR
maintain the 2008 ozone NAAQS and 80.72). This opt-out effective date I. General Information
any other NAAQS as required by CAA applies to retailers, wholesale A. Does this action apply to me?
section 110(l). (See 40 CFR 80.72(b)). purchasers, consumers, refiners,
EPA published a proposed approval of importers, and distributors. You may be potentially affected by
the SIP revision on February 14, 2018 this action if you are an agricultural
Dated: May 9, 2018. producer, food manufacturer, or
(83 FR 6496) and a final approval of the E. Scott Pruitt,
SIP revision on April 2, 2018 (83 FR pesticide manufacturer. The following
Administrator. list of North American Industrial
13872). The final approval of the
maintenance plan revision was effective [FR Doc. 2018–10456 Filed 5–15–18; 8:45 am] Classification System (NAICS) codes is
upon publication, April 2, 2018. The BILLING CODE 6560–50–P not intended to be exhaustive, but rather
RFG opt-out regulations provide that the provides a guide to help readers
opt-out effective date shall be no less determine whether this document
ENVIRONMENTAL PROTECTION applies to them. Potentially affected
than 90 days from the EPA SIP approval
AGENCY entities may include:
effective date. (See 40 CFR 80.72(c)(7)).
EPA is unaware of any reason that the • Crop production (NAICS code 111).
40 CFR Part 180 • Animal production (NAICS code
effective date should be postponed, and
therefore, is establishing an opt-out [EPA–HQ–OPP–2017–0032; FRL–9976–62] 112).
effective date of July 1, 2018 for the • Food manufacturing (NAICS code
Northern Kentucky Area. Tebuconazole; Pesticide Tolerances 311).
As provided by the RFG Opt-out Rule AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
and the opt-out regulations, EPA will Agency (EPA). code 32532).
publish a final rule at a later date to ACTION: Final rule. B. How can I get electronic access to
remove the three counties in the other related information?
Northern Kentucky Area from the list of SUMMARY: This regulation establishes
RFG covered areas in 40 CFR 80.70 after tolerances for residues of tebuconazole You may access a frequently updated
the effective date of the opt-out. EPA in or on ginseng, fresh at 0.15 parts per electronic version of EPA’s tolerance
believes that it is prudent to complete million (ppm) and ginseng, dried at 0.40 regulations at 40 CFR part 180 through
this ministerial exercise to revise the list ppm. Bayer CropScience LP, requested the Government Printing Office’s e-CFR
of covered areas in the Code of Federal these tolerances under the Federal Food, site at http://www.ecfr.gov/cgi-bin/text-
Regulations after the effective date of Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
the opt-out. DATES: This regulation is effective May
40tab_02.tpl.
III. Action 16, 2018. Objections and requests for C. How can I file an objection or hearing
hearings must be received on or before request?
EPA is approving Kentucky’s petition July 16, 2018, and must be filed in
because it contained the information Under FFDCA section 408(g), 21
accordance with the instructions
required by 40 CFR 80.72, including U.S.C. 346a, any person may file an
provided in 40 CFR part 178 (see also
that Kentucky revised the approved objection to any aspect of this regulation
Unit I.C. of the SUPPLEMENTARY
maintenance plan for the 2008 ozone and may also request a hearing on those
INFORMATION).
NAAQS for the Northern Kentucky Area objections. You must file your objection
to remove the emissions reductions ADDRESSES: The docket for this action, or request a hearing on this regulation
associated with RFG. EPA is also identified by docket identification (ID) in accordance with the instructions
determining the opt-out effective date number EPA–HQ–OPP–2017–0032, is provided in 40 CFR part 178. To ensure
by applying the criteria in 40 CFR available at http://www.regulations.gov proper receipt by EPA, you must
80.72(c)(7). As discussed in Section II.A. or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
of this document, the opt-out Regulatory Public Docket (OPP Docket) OPP–2017–0032 in the subject line on
regulations require that if a state in the Environmental Protection Agency the first page of your submission. All
included RFG as a control measure in an Docket Center (EPA/DC), West William objections and requests for a hearing
approved SIP, the state must revise the Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
SIP, reflecting the removal of RFG as a Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or
control measure before an opt-out can 20460–0001. The Public Reading Room before July 16, 2018. Addresses for mail
be effective and the opt-out cannot be is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and
effective less than 90 days after the Monday through Friday, excluding legal hearing requests are provided in 40 CFR
effective date of the approval of the SIP holidays. The telephone number for the 178.25(b).
revision. EPA published a final approval Public Reading Room is (202) 566–1744, In addition to filing an objection or
of Kentucky’s maintenance plan and the telephone number for the OPP hearing request with the Hearing Clerk
revision and noninterference Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
demonstration on April 2, 2018 (83 FR the visitor instructions and additional submit a copy of the filing (excluding
nshattuck on DSK9F9SC42PROD with RULES
13872). The final approval was effective information about the docket available any Confidential Business Information
upon publication. at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
In summary, EPA is today notifying FOR FURTHER INFORMATION CONTACT: Information not marked confidential
the public that it has applied its Michael Goodis, Director, Registration pursuant to 40 CFR part 2 may be
regulatory criteria to approve the Division (7505P), Office of Pesticide disclosed publicly by EPA without prior
petition by Kentucky to opt-out of the Programs, Environmental Protection notice. Submit the non-CBI copy of your
RFG program for the Northern Kentucky Agency, 1200 Pennsylvania Ave. NW, objection or hearing request, identified
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![22596 Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Rules and Regulations
by docket ID number EPA–HQ–OPP– 408(b)(2)(C) of FFDCA requires EPA to analysis of the doses in each
2017–0032, by one of the following give special consideration to exposure toxicological study to determine the
methods: of infants and children to the pesticide dose at which no adverse effects are
• Federal eRulemaking Portal: http:// chemical residue in establishing a observed (the NOAEL) and the lowest
www.regulations.gov. Follow the online tolerance and to ‘‘ensure that there is a dose at which adverse effects of concern
instructions for submitting comments. reasonable certainty that no harm will are identified (the LOAEL). Uncertainty/
Do not submit electronically any result to infants and children from safety factors are used in conjunction
information you consider to be CBI or aggregate exposure to the pesticide with the POD to calculate a safe
other information whose disclosure is chemical residue. . . .’’ exposure level—generally referred to as
restricted by statute. Consistent with FFDCA section a population-adjusted dose (PAD) or a
• Mail: OPP Docket, Environmental 408(b)(2)(D), and the factors specified in reference dose (RfD)—and a safe margin
Protection Agency Docket Center (EPA/ FFDCA section 408(b)(2)(D), EPA has of exposure (MOE). For non-threshold
DC), (28221T), 1200 Pennsylvania Ave. reviewed the available scientific data risks, the Agency assumes that any
NW, Washington, DC 20460–0001. and other relevant information in amount of exposure will lead to some
• Hand Delivery: To make special support of this action. EPA has degree of risk. Thus, the Agency
arrangements for hand delivery or sufficient data to assess the hazards of estimates risk in terms of the probability
delivery of boxed information, please and to make a determination on of an occurrence of the adverse effect
follow the instructions at http:// aggregate exposure for tebuconazole expected in a lifetime. For more
www.epa.gov/dockets/contacts.html. including exposure resulting from the information on the general principles
Additional instructions on commenting tolerances established by this action. EPA uses in risk characterization and a
or visiting the docket, along with more EPA’s assessment of exposures and risks complete description of the risk
information about dockets generally, is associated with tebuconazole follows. assessment process, see http://
available at http://www.epa.gov/ www2.epa.gov/pesticide-science-and-
dockets. A. Toxicological Profile
assessing-pesticide-risks/assessing-
EPA has evaluated the available human-health-risk-pesticides.
II. Summary of Petitioned-For
toxicity data and considered its validity, A summary of the toxicological
Tolerance
completeness, and reliability as well as endpoints for tebuconazole used for
In the Federal Register of April 10, the relationship of the results of the human risk assessment can be found in
2017 (82 FR 17175) (FRL–9959–61), studies to human risk. EPA has also the preamble to the final rule published
EPA issued a document pursuant to considered available information in the Federal Register on November 15,
FFDCA section 408(d)(3), 21 U.S.C. concerning the variability of the 2013.
346a(d)(3), announcing the filing of a sensitivities of major identifiable
pesticide petition (PP 6E8534) by Bayer C. Exposure Assessment
subgroups of consumers, including
CropScience LP, 2 T.W. Alexander infants and children. 1. Dietary exposure from food and
Drive, P.O. Box 12014, Research The toxicological profile remains feed uses. In evaluating dietary
Triangle Park, NC 27709. The petition unchanged from the discussion exposure to tebuconazole, EPA
requested that 40 CFR part 180 be contained in the final rule published in considered exposure under the
amended by establishing tolerances for the Federal Register on November 15, petitioned-for tolerances as well as all
residues of tebuconazole, a-[2-(4- 2013 (78 FR 68741) (FRL–9392–1), existing tebuconazole tolerances in 40
Chlorophenyl)ethyl]-a-(1,1- which is hereby incorporated into this CFR 180.474. EPA assessed dietary
dimethylethyl)-1H-1,2,4-triazole-1- document. exposures from tebuconazole in food as
ethanol, in or on ginseng, fresh at 0.15 Specific information on the studies follows:
ppm and ginseng, dried/red at 0.4 ppm. received and the nature of the adverse i. Acute exposure. Quantitative acute
This document referenced a summary of effects caused by tebuconazole as well dietary exposure and risk assessments
the petition prepared by Bayer as the no-observed-adverse-effect-level are performed for a food-use pesticide,
CropScience LP, the registrant, which is (NOAEL) and the lowest-observed- if a toxicological study has indicated the
available in the docket, http:// adverse-effect-level (LOAEL) from the possibility of an effect of concern
www.regulations.gov. No comments toxicity studies can be found at http:// occurring as a result of a 1-day or single
were received in response to the notice www.regulations.gov in document exposure. Such effects were identified
of filing. Human Health Aggregate Risk for tebuconazole. In estimating acute
Assessment for Establishment of a dietary exposure, EPA used food
III. Aggregate Risk Assessment and consumption information from the
Permanent Tolerance Without U.S.
Determination of Safety United States Department of Agriculture
Registration for Residues in/on Ginseng
Section 408(b)(2)(A)(i) of FFDCA at pages 24–26 in docket ID number (USDA) 2003–2008 National Health and
allows EPA to establish a tolerance (the EPA–HQ–OPP–2017–0032. Nutrition Examination Survey, What We
legal limit for a pesticide chemical Eat in America, (NHANES/WWEIA). As
residue in or on a food) only if EPA B. Toxicological Points of Departure/ to residue levels in food, a somewhat
determines that the tolerance is ‘‘safe.’’ Levels of Concern refined acute probalistic dietary
Section 408(b)(2)(A)(ii) of FFDCA Once a pesticide’s toxicological exposure assessment was conducted for
defines ‘‘safe’’ to mean that ‘‘there is a profile is determined, EPA identifies all existing and proposed food uses of
reasonable certainty that no harm will toxicological points of departure (POD) tebuconazole. For the acute assessment,
result from aggregate exposure to the and levels of concern to use in anticipated residues for grapes, grape
nshattuck on DSK9F9SC42PROD with RULES
pesticide chemical residue, including evaluating the risk posed by human juice, and peaches were derived using
all anticipated dietary exposures and all exposure to the pesticide. For hazards the latest USDA Pesticide Data Program
other exposures for which there is that have a threshold below which there (PDP) monitoring data. Anticipated
reliable information.’’ This includes is no appreciable risk, the toxicological residues for all other registered and
exposure through drinking water and in POD is used as the basis for derivation proposed food commodities were based
residential settings, but does not include of reference values for risk assessment. on field trial data. Anticipated residues
occupational exposure. Section PODs are developed based on a careful for all current uses were further refined
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![22600 Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Rules and Regulations
500 for the activity of golfing and 330 6. Determination of safety. Based on Chlorophenyl)ethyl]-a-(1,1-
for children (1–2 years old) engaging in these risk assessments, EPA concludes dimethylethyl)-1H-1,2,4-triazole-1-
activities on pressure treated wood that there is a reasonable certainty that ethanol, in or on ginseng, dried at 0.40
surfaces. Because EPA’s level of concern no harm will result to the general ppm and ginseng, fresh at 0.15 ppm.
(LOC) for tebuconazole is a MOE of 300 population, or to infants and children
VI. Statutory and Executive Order
or below, these MOEs are not of from aggregate exposure to tebuconazole
Reviews
concern. Therefore, aggregate risk residues.
estimates for all examined population This action establishes tolerances
IV. Other Considerations under FFDCA section 408(d) in
subgroups were not of concern to the
Agency. A. Analytical Enforcement Methodology response to a petition submitted to the
4. Aggregate cancer risk for U.S. Agency. The Office of Management and
Adequate enforcement methodology
population. Based on the Agency’s Budget (OMB) has exempted these types
(Gas Chromatography/Nitrogen
determination that the chronic risk of actions from review under Executive
Phosphorus Detector (GC/NPD) is
assessment will be protective of any Order 12866, entitled ‘‘Regulatory
available to enforce the tolerance
cancer effects, a separate quantitative Planning and Review’’ (58 FR 51735,
expression.
cancer risk assessment was not The method may be requested from: October 4, 1993). Because this action
conducted. Because there is no chronic Chief, Analytical Chemistry Branch, has been exempted from review under
risk of concern from aggregate exposure Environmental Science Center, 701 Executive Order 12866, this action is
to tebuconazole, the Agency concludes Mapes Rd., Ft. Meade, MD 20755–5350; not subject to Executive Order 13211,
that aggregate exposure to tebuconazole telephone number: (410) 305–2905; entitled ‘‘Actions Concerning
will not result in cancer risks of email address: residuemethods@ Regulations That Significantly Affect
concern. epa.gov. Energy Supply, Distribution, or Use’’ (66
5. Aggregate Assessment for Free FR 28355, May 22, 2001); Executive
Triazole & its Conjugates. The conazole B. International Residue Limits Order 13045, entitled ‘‘Protection of
class of compounds, which includes In making its tolerance decisions, EPA Children from Environmental Health
tebuconazole, can form the common seeks to harmonize U.S. tolerances with Risks and Safety Risks’’ (62 FR 19885,
metabolite 1,2,4-triazole and two international standards whenever April 23, 1997); or Executive Order
triazole conjugates (triazolylalanine and possible, consistent with U.S. food 13771, entitled ‘‘Reducing Regulations
triazolylacetic acid). To support existing safety standards and agricultural and Controlling Regulatory Costs’’ (82
tolerances and to establish new practices. EPA considers the FR 9339, February 3, 2017). This action
tolerances for triazole-containing international maximum residue limits does not contain any information
pesticides, including tebucaonazole, (MRLs) established by the Codex collections subject to OMB approval
EPA conducted a human health risk Alimentarius Commission (Codex), as under the Paperwork Reduction Act
assessment for exposure to 1,2,4- required by FFDCA section 408(b)(4). (PRA) (44 U.S.C. 3501 et seq.), nor does
triazole, triazolylalanine, and The Codex Alimentarius is a joint it require any special considerations
triazolylacetic acid resulting from the United Nations Food and Agriculture under Executive Order 12898, entitled
use of all current and pending uses of Organization/World Health ‘‘Federal Actions to Address
any triazole-containing fungicide. The Organization food standards program, Environmental Justice in Minority
risk assessment is a highly conservative, and it is recognized as an international Populations and Low-Income
screening-level evaluation in terms of food safety standards-setting Populations’’ (59 FR 7629, February 16,
hazards associated with common organization in trade agreements to 1994).
metabolites (e.g., use of a maximum which the United States is a party. EPA Since tolerances and exemptions that
combination of uncertainty factors) and may establish a tolerance that is are established on the basis of a petition
potential dietary and non-dietary different from a Codex MRL; however, under FFDCA section 408(d), such as
exposures (i.e., high end estimates of FFDCA section 408(b)(4) requires that the tolerance in this final rule, do not
both dietary and non-dietary exposures). EPA explain the reasons for departing require the issuance of a proposed rule,
The Agency retained a 3X for the from the Codex level. the requirements of the Regulatory
LOAEL to NOAEL safety factor when The Codex has established MRLs for Flexibility Act (RFA) (5 U.S.C. 601 et
the reproduction study was used. In tebuconazole in or on ginseng and seq.), do not apply.
addition, the Agency retained a 10X for ginseng, dried at 0.15 ppm and 0.40 This action directly regulates growers,
the lack of studies including a ppm, respectively. These MRLs are the food processors, food handlers, and food
developmental neurotoxicity (DNT) same as the tolerances established for retailers, not States or tribes, nor does
study. The assessment includes tebuconazole in the United States. this action alter the relationships or
evaluations of risks for various distribution of power and
subgroups, including those comprised C. Revisions to Petitioned-For responsibilities established by Congress
of infants and children. The Agency’s Tolerances in the preemption provisions of FFDCA
complete risk assessment is found in the For dried ginseng, the Agency is section 408(n)(4). As such, the Agency
propiconazole reregistration docket at revising the commodity definition for has determined that this action will not
http://www.regulations.gov, Docket the requested tolerance to reflect the have a substantial direct effect on States
Identification (ID) Number EPA–HQ– correct commodity vocabulary currently or tribal governments, on the
OPP–2005–0497. The Agency’s latest used by the Agency. Specifically, relationship between the national
updated aggregate risk assessment for ginseng dried/red was changed to government and the States or tribal
nshattuck on DSK9F9SC42PROD with RULES
the triazole-containing metabolites was ginseng, dried. Additionally, the Agency governments, or on the distribution of
finalized on July 18, 2017 and includes is revising the significant figures for the power and responsibilities among the
the proposed new uses of tebuconazole. tolerance level based on current policy. various levels of government or between
That assessment concluded that the Federal Government and Indian
aggregate exposure to the triazole V. Conclusion tribes. Thus, the Agency has determined
metabolites does not exceed the Therefore, tolerances are established that Executive Order 13132, entitled
Agency’s level of concern. for residues of tebuconazole, a-[2-(4- ‘‘Federalism’’ (64 FR 43255, August 10,
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![Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Rules and Regulations 22601
1999) and Executive Order 13175, * * * * * 26 to the FMP in the Federal Register
entitled ‘‘Consultation and Coordination [FR Doc. 2018–10345 Filed 5–15–18; 8:45 am] (82 FR 17387). That final rule adjusted
with Indian Tribal Governments’’ (65 FR BILLING CODE 6560–50–P the management boundaries, zones, and
67249, November 9, 2000) do not apply annual catch limits for Gulf migratory
to this action. In addition, this action group king mackerel (Gulf king
does not impose any enforceable duty or DEPARTMENT OF COMMERCE mackerel). The commercial quota for the
contain any unfunded mandate as Gulf king mackerel in the Gulf northern
described under Title II of the Unfunded National Oceanic and Atmospheric zone is 511,200 lb (231,876 kg) for the
Mandates Reform Act (UMRA) (2 U.S.C. Administration current fishing year, October 1, 2017,
1501 et seq.). through September 30, 2018 (50 CFR
This action does not involve any 50 CFR Part 622 622.384(b)(1)(ii)).
technical standards that would require [Docket No. 160426363–7275–02]
The Gulf king mackerel northern zone
Agency consideration of voluntary is located in the EEZ between a line at
consensus standards pursuant to section RIN 0648–XF920 87°31.6′ W long., which is a line
12(d) of the National Technology extending due south of the state
Coastal Migratory Pelagic Resources boundary of Alabama and Florida, and
Transfer and Advancement Act of the Gulf of Mexico and Atlantic
(NTTAA) (15 U.S.C. 272 note). a line at 26°19.48′ N lat., which is a line
Region; 2017–2018 Commercial extending west from the boundary of
VII. Congressional Review Act Closure for King Mackerel in the Gulf Lee and Collier Counties in southwest
of Mexico Northern Zone Florida.
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will AGENCY: National Marine Fisheries Regulations at 50 CFR 622.388(a)(1)(i)
submit a report containing this rule and Service (NMFS), National Oceanic and require NMFS to close the commercial
other required information to the U.S. Atmospheric Administration (NOAA), sector for Gulf king mackerel in the
Senate, the U.S. House of Commerce. northern zone when the commercial
Representatives, and the Comptroller ACTION: Temporary rule; closure.
quota is reached, or is projected to be
General of the United States prior to reached, by filing a notification to that
publication of the rule in the Federal SUMMARY: NMFS implements an effect with the Office of the Federal
Register. This action is not a ‘‘major accountability measure (AM) for Register. NMFS has determined the
rule’’ as defined by 5 U.S.C. 804(2). commercial king mackerel in the commercial quota of 511,200 lb (231,876
northern zone of the Gulf of Mexico kg) for Gulf king mackerel in the
List of Subjects in 40 CFR Part 180 (Gulf) exclusive economic zone (EEZ) northern zone will be reached by May
Environmental protection, through this temporary rule. NMFS has 15, 2018. Accordingly, the northern
Administrative practice and procedure, determined that the commercial quota zone is closed to commercial fishing for
Agricultural commodities, Pesticides for king mackerel in the northern zone Gulf king mackerel effective from 12:01
and pests, Reporting and recordkeeping of the Gulf EEZ will be reached by May a.m., local time, on May 15, 2018,
requirements. 15, 2018. Therefore, NMFS closes the through September 30, 2018, the end of
northern zone of the Gulf EEZ to the current fishing year.
Dated: April 30, 2018. commercial king mackerel fishing on During the closure, a person on board
Daniel Rosenblatt, May 15, 2018. This closure is necessary a vessel that has been issued a valid
Acting Director, Registration Division, Office to protect the Gulf king mackerel Federal commercial or charter vessel/
of Pesticide Program. resource. headboat permit for coastal migratory
Therefore, 40 CFR chapter I is DATES: The closure is effective at 12:01 pelagic fish may continue to retain the
amended as follows: a.m., local time, May 15, 2018, until king mackerel in the northern zone
12:01 a.m., local time, on October 1, under the recreational bag and
PART 180—[AMENDED] possession limits specified in 50 CFR
2018.
622.382(a)(1)(ii) and (a)(2), as long as
■ 1. The authority citation for part 180 FOR FURTHER INFORMATION CONTACT: the recreational sector for Gulf king
continues to read as follows: Kelli O’Donnell, NMFS Southeast mackerel in the northern zone is open
Authority: 21 U.S.C. 321(q), 346a and 371. Regional Office, telephone: 727–824– (50 CFR 622.384(e)(1)).
5305, email: kelli.odonnell@noaa.gov. Also during the closure, king
■ 2. In § 180.474, add alphabetically the SUPPLEMENTARY INFORMATION: The mackerel from the closed zone,
entries ‘‘Ginseng, dried’’ and ‘‘Ginseng, fishery for coastal migratory pelagic fish including those harvested under the bag
fresh’’ to the table in paragraph (a)(1) to includes king mackerel, Spanish and possession limits, may not be
read as follows: mackerel, and cobia, and is managed purchased or sold. This prohibition
§ 180.474 Tebuconazole; tolerances for under the Fishery Management Plan for does not apply to king mackerel from
residues. the Coastal Migratory Pelagic Resources the closed zone that were harvested,
(a) * * * of the Gulf of Mexico and Atlantic landed ashore, and sold prior to the
Region (FMP). The FMP was prepared closure and were held in cold storage by
(1) * * *
by the Gulf of Mexico and South a dealer or processor (50 CFR
Parts per Atlantic Fishery Management Councils 622.384(e)(2)).
Commodity and is implemented by NMFS under the
million
authority of the Magnuson-Stevens Classification
nshattuck on DSK9F9SC42PROD with RULES
Fishery Conservation and Management The Regional Administrator for the
* * * * * Act (Magnuson-Stevens Act) by NMFS Southeast Region has determined
Ginseng, dried 1 .................... 0.40 regulations at 50 CFR part 622. All this temporary rule is necessary for the
1
Ginseng, fresh .................... 0.15 weights for Gulf king mackerel below conservation and management of Gulf
apply as either round or gutted weight. king mackerel and is consistent with the
* * * * *
On April 11, 2017, NMFS published Magnuson-Stevens Act and other
1 There are no U.S. registrations. a final rule to implement Amendment applicable laws.
VerDate Sep<11>2014 13:12 May 15, 2018 Jkt 244001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\16MYR1.SGM 16MYR1](https://thefederalregister.org/doc/83_FR_22690/page/7.svg)
Document Created: 2018-11-02 09:13:20
Document Modified: 2018-11-02 09:13:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective May 16, 2018. Objections and requests for hearings must be received on or before July 16, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460- | |
| FR Citation | 83 FR 22595 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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