83 FR 51857 - Pyraclostrobin; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 199 (October 15, 2018)
Federal Register Volume 83, Issue 199 (October 15, 2018)
| Page Range | 51857-51863 | |
| FR Document | 2018-22282 |
[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)] [Rules and Regulations] [Pages 51857-51863] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22282] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0311; FRL-9980-56] Pyraclostrobin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of pyraclostrobin in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 15, 2018. Objections and requests for hearings must be received on or before December 14, 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-2017-0311, 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 [[Page 51858]] 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-2017-0311 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 14, 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 by docket ID number EPA-HQ-OPP-2017-0311, 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 October 23, 2017 (82 FR 49020) (FRL- 9967-37), 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 7E8569) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide pyraclostrobin, carbamic acid, [2-[[[ 1- (4-chlorophenyl)-1H-pyrazol-3-yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite, methyl-N-[[[1-(4-chlorophenyl)- 1H-pyrazol-3-yl]oxy]methyl] phenylcarbamate expressed as parent compound in or on Brassica, leafy greens, subgroup 4-16B at 16.0 ppm, celtuce at 29.0 ppm, Florence, fennel at 29.0 ppm, kohlrabi at 5.0 ppm, leaf petiole vegetable subgroup 22B at 29.0 ppm, leafy greens subgroup 4-16A at 40 ppm, tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B at 0.6 ppm, and vegetable, Brassica, head and stem, group 5-16 at 5.0 ppm. The petition also requested that the following established tolerances be removed: Avocado at 0.6 ppm, banana at 0.04 ppm, Brassica, head and stem, subgroup 5A at 5.0 ppm, Brassica leafy greens, subgroup 5B, at 16.0 ppm, and vegetable, leafy, except Brassica, group 4 at 29 ppm. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments 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 pyraclostrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraclostrobin 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 most consistently observed effects of pyraclostrobin exposure across species, genders, and treatment durations were diarrhea, decreased body weight, and decreased food consumption. Pyraclostrobin also causes intestinal disturbance as indicated by increased incidence of diarrhea or duodenum mucosal thickening. These intestinal effects appeared to be related to the irritating action on the mucus membranes as demonstrated by redness and chemosis (i.e., swelling of the conjunctiva) seen in the primary eye irritation study. In the rat acute and subchronic neurotoxicity studies, neuropathology and behavior changes were not observed. In the rat and rabbit developmental toxicity studies, developmental toxicity (i.e. skeletal variations, post-implantation loss, and fetal resorption) was observed, as well as maternal toxicity (i.e. diarrhea, decreased body weight, food consumption, and clinical signs of toxicity). In the reproduction study, systemic toxicity manifested as decreased body weight in both the parents and offspring; no reproductive toxicity was observed. In the rat subchronic inhalation toxicity studies, inhalation toxicity [[Page 51859]] consisted of both portal of entry effects (i.e., olfactory atrophy/ necrosis and histiocytosis in the lungs) and systemic effects (i.e., hyperplasia in the duodenum). Pyraclostrobin was classified by the Agency as ``Not Likely to be Carcinogenic to Humans'' based on the lack of treatment-related increase in tumor incidence in adequately conducted carcinogenicity studies in rats and mice. Pyraclostrobin did not cause mutagenicity or genotoxicity in the in vivo and in vitro assays. Pyraclostrobin did not cause immunotoxicity in mice assays. Specific information on the studies received and the nature of the adverse effects caused by pyraclostrobin 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 on pages 34-39 in the document titled ``Pyraclostrobin. Human Health Risk Assessment for a Petition for the Establishment of Use on Greenhouse-Grown Leafy Greens, Except Head Lettuce, Subgroup 4-16A; Cucurbit Vegetables, Group 9; and Fruiting Vegetables, Group 8-10 and Crop Group Conversions and Expansion of Tolerances for Brassica, Leafy Greens, Subgroup 4-16B; Celtuce; Florence Fennel; Kohlrabi; Leaf Petiole Vegetables, Subgroup 22B; Tropical and Subtropical, Medium to Large Fruit, Inedible Peel, Subgroup 23B; and Brassica Head and Stem, Group 5-16 and a Revised Tolerance Level for Leafy Greens, Subgroup 4-16A'' in docket ID number EPA-HQ-OPP-2017-0311. 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 pyraclostrobin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 10, 2015 (80 FR 19231) (FRL- 9925-02). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraclostrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing pyraclostrobin tolerances in 40 CFR 180.582. EPA assessed dietary exposures from pyraclostrobin 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 pyraclostrobin. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, the acute dietary exposure assessments were performed assuming 100 percent crop treated (PCT) and incorporating tolerance-level or highest field-trial residues. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's NHANES/ WWEIA. As to residue levels in food, the chronic dietary exposure assessments were performed using average percent crop treated estimates and tolerance-level or average field-trial residues. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that pyraclostrobin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and 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, and 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 estimated the PCT for existing uses in the chronic dietary assessment as follows: Almonds 45%; apples 20%; apricots 30%; barley 10%; green beans 5%; blueberries 40%; broccoli 5%; Brussels sprouts 15%; cabbage 10%; caneberries 50%; cantaloupes 15%; carrots 35%; cauliflower 5%; celery <2.5%; cherries 55%; chicory 5%; corn 10%; cotton (seed treatment) 10%; cucumber 5%; dry beans/peas 10%; garlic 10%; grapefruit 35%; grapes 30%; hazelnuts 20%; lemons 5%; lettuce 5%; nectarines 15%; oats 5%; onions 30%; oranges 5%; peaches 25%; peanuts 20%; pears 20%; green peas 5%; pecans 5%; peppers 15%; pistachios 30%; potatoes 20%; pumpkins 15%; soybeans (seed treatment) 10%; spinach 5%; squash 15%; strawberries 65%; sugar beets 50%; sugarcane 5%; sweet corn 5%; tangerines 10%; tomatoes 25%; walnuts 10%; watermelons 25%; wheat 5%. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), [[Page 51860]] proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic 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%, in which case 2.5% is used as the average PCT, or less than 1%, in which case 1% is used as the average PCT. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for pyraclostrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of pyraclostrobin. 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 and Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of pyraclostrobin for acute exposures are estimated to be 35.6 parts per billion (ppb) for surface water and 0.02 ppb for ground water and for chronic exposures are estimated to be 2.3 ppb for surface water and 0.02 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 35.6 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 2.3 ppb was used to assess the contribution to drinking water. 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). Pyraclostrobin is currently registered for the following uses that could result in residential handler and post-application exposures: Treated gardens, fruit or nut trees, tomato transplants, and turf. EPA assessed residential exposure using the following assumptions: Short- term adult handler exposures via the dermal and inhalation routes resulting from application of pyraclostrobin to gardens, trees, and turf. Short-term dermal post-application exposures were assessed for adults, youth 11 to 16 years old, and children 6 to 11 years old. Short-term dermal and incidental oral exposures were assessed for children 1 to less than 2 years old. Intermediate-term exposures are not likely because of the intermittent nature of applications in residential settings. For the aggregate assessment, inhalation and dermal exposures were not aggregated together because the toxicity effect from the inhalation route of exposure was different than the effect from the dermal route of exposure. The scenarios with the highest residential exposures that were used in the short-term aggregate assessment for pyraclostrobin are as follows: Adult short-term aggregate assessment--residential dermal post-application exposure via activities on treated turf. Youth (11 to 16 years old) short-term aggregate assessment--residential dermal exposure from post-application golfing on treated turf. Children (6 to 11 years old) short-term aggregate assessment--residential dermal exposures from post-application activities in treated gardens. Children (1 to less than 2 years old) short-term aggregate assessment--residential dermal and hand-to-mouth exposures from post- application exposure to treated turf. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found pyraclostrobin to share a common mechanism of toxicity with any other substances, and pyraclostrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyraclostrobin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence that pyraclostrobin results in increased quantitative susceptibility in rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. Although there is evidence of increased qualitative susceptibility in the prenatal development study in rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The degree of concern for prenatal and/or postnatal toxicity is low. 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 pyraclostrobin is complete. ii. There is no indication that pyraclostrobin is a neurotoxic chemical. Effects seen in the acute and subchronic neurotoxicity studies in rats are considered to reflect perturbations in mitochondrial respiration leading to effects on energy production rather than signs of neurotoxicity; therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that pyraclostrobin results in increased quantitative susceptibility in rats in the prenatal developmental study or in young rats in the 2-generation reproduction study. The prenatal rabbit developmental toxicity study showed [[Page 51861]] evidence of increased qualitative susceptibility to prenatal rabbits; however, this study was chosen for endpoint selection for the acute dietary (females 13-49) and short-term dermal exposure scenarios. This study has a clearly defined NOAEL of 5.0 mg/kg/day. EPA did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The degree of concern for prenatal and/or postnatal toxicity is low. iv. There are no residual uncertainties identified in the exposure databases. The acute dietary exposure assessments were performed assuming 100 PCT and tolerance-level or highest field trial residues. The chronic dietary exposure assessments were performed using average PCT estimates, when available, and tolerance-level or average field trial residues. These data are reliable and are not expected to underestimate risks to adults or children. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pyraclostrobin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyraclostrobin. 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 pyraclostrobin will occupy 88% of the aPAD for females 13-49 years 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 pyraclostrobin from food and water will utilize 29% of the cPAD for children 1-2 years 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 pyraclostrobin is not expected. 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). Pyraclostrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pyraclostrobin. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 110 for children 1 to 2 years old, 360 for children 6 to 11 years old, 1500 for youth 11 to 16 years old, and 230 for adults. Because EPA's level of concern for pyraclostrobin is a MOE of 100 or below, these MOEs 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). Intermediate-term adverse effects were identified; however, pyraclostrobin is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pyraclostrobin. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, pyraclostrobin is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pyraclostrobin residues. IV. Other Considerations A. Analytical Enforcement Methodology Two adequate methods are available to enforce the tolerance expression for residues of pyraclostrobin and the metabolite BF 500-3 in or on plant commodities: A liquid chromatography with tandem mass spectrometry (LC/MS/MS) method, BASF Method D9908; and a high- performance LC with ultraviolet detection (HPLC/UV) method, Method D9904. The methods may be found in the Pesticide Analytical Manual, Volume I. 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 pyraclostrobin in or on various commodities including kale, collards, curly kale, Scotch kale, thousand-headed kale (not including marrow stem kale) at 1 ppm; radish leaves (including radish tops) at 20 ppm; lettuce, head at 2 ppm; banana at 0.02 ppm; mango at 0.05 ppm; papaya at 0.15 ppm; Brussels sprouts at 0.3 ppm; cabbages, head at 0.2 ppm; and flower-head brassicas (includes broccoli, broccoli Chinese and cauliflower) at 0.1 ppm. These MRLs are different than the tolerances established for pyraclostrobin in the United States, however, they cannot be harmonized because the tolerance/MRL expressions for the U.S. and Codex are not harmonized and the submitted residue data support higher tolerance levels than those set by Codex, indicating that harmonization would cause legal application of pyraclostrobin by U.S. users to result in exceedances of domestic tolerances. C. Revisions to Petitioned-for Tolerances For tolerance values that vary from what the petitioner requested, EPA is [[Page 51862]] establishing tolerance values in order to conform to current Agency policy on significant figures. The tolerance for tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B is not being established at this time. The request for a tolerance for subgroup 24B was submitted in connection with an application for registration of a pesticide product with multiple active ingredients. Because one of those active ingredients is not currently approved for use on the commodities in subgroup 24B, EPA is not approving use of the combination product on commodities in subgroup 24B. Therefore, EPA is not establishing the tolerance for subgroup 24B because it is not necessary at this time. Because a tolerance is not being established for subgroup 24B, the existing tolerances for avocado and banana are not being removed as proposed. V. Conclusion Therefore, tolerances are established for residues of pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite, methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenylcarbamate (BF 500-3), expressed as parent compound, in or on Brassica, leafy greens, subgroup 4-16B, except watercress at 16 ppm; celtuce at 29 ppm; fennel, Florence at 29 ppm; kohlrabi at 5.0 ppm; leaf petiole vegetable, subgroup 22B at 29 ppm; leafy greens, subgroup 4-16A at 40 ppm; and vegetable, Brassica, head and stem, group 5-16 at 5.0 ppm. Additionally, the following established tolerances are removed as unnecessary due to the establishment of the above tolerances: Brassica, head and stem, subgroup 5A; Brassica leafy greens, subgroup 5B; and vegetable, leafy, except brassica, group 4. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is it 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: October 2, 2018. Michael L. 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. 180.582: 0 i. Add alphabetically the commodities ``Brassica, leafy greens, subgroup 4-16B, except watercress''; ``celtuce''; ``fennel, Florence''; ``kohlrabi''; ``leaf petiole vegetable, subgroup 22B''; ``leafy greens, subgroup 4-16A''; and ``vegetable, Brassica, head and stem, group 5- 16'' to the table in paragraph (a)(1); and 0 ii. Remove the entries for ``Brassica, head and stem, subgroup 5A''; ``Brassica, leafy greens, subgroup 5B''; and ``vegetable, leafy, except brassica, group 4'' from the table in paragraph (a)(1). The additions read as follows: Sec. 180.582 Pyraclostrobin; tolerances for residues. (a) * * * (1) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Brassica, leafy greens, subgroup 4-16B, except watercress... 16 * * * * * Celtuce..................................................... 29 * * * * * Fennel, Florence............................................ 29 * * * * * Kohlrabi.................................................... 5.0 Leaf petiole vegetable, subgroup 22B........................ 29 Leafy greens, subgroup 4-16A................................ 40 * * * * * Vegetable, Brassica, head and stem, group 5-16.............. 5.0 [[Page 51863]] * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2018-22282 Filed 10-12-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations 51857
in the Notification of Compliance Status section shall be a statement that the ENVIRONMENTAL PROTECTION
under 40 CFR part 63, subpart WW and affected source was in compliance for AGENCY
subpart SS, as referred to in § 63.1404 the preceding 6-month period and no
for storage vessels; under 40 CFR part activities specified in paragraphs (f)(3) 40 CFR Part 180
63, subpart SS, as referred to in through (11) and (13) through (16) of [EPA–HQ–OPP–2017–0311; FRL–9980–56]
§ 63.1405 for continuous process vents; this section occurred during the
under § 63.1416(f)(1) through (3), preceding 6-month period. Pyraclostrobin; Pesticide Tolerances
(f)(5)(i) and (ii), and (f)(6)(i) and (ii) for * * * * *
continuous process vents; under AGENCY: Environmental Protection
(5) If there is a deviation from the Agency (EPA).
§ 63.1416(d)(1) for batch process vents; mass emission limit specified in
and under § 63.1416(e)(1) for aggregate ACTION: Final rule.
§ 63.1406(a)(1)(iii) or (a)(2)(iii),
batch vent streams. In addition, each § 63.1407(b)(2), or § 63.1408(b)(2), the SUMMARY: This regulation establishes
owner or operator shall comply with following information, as appropriate, tolerances for residues of pyraclostrobin
paragraphs (e)(1)(i) and (ii) of this shall be included: in or on multiple commodities which
section. are identified and discussed later in this
* * * * *
* * * * * document. Interregional Research
(12) * * *
(9) Data or other information used to Project Number 4 (IR–4) requested these
demonstrate that an owner or operator (ii) The quarterly reports shall include
all information specified in paragraphs tolerances under the Federal Food,
may use engineering assessment to Drug, and Cosmetic Act (FFDCA).
estimate emissions for a batch emission (f)(3) through (11) and (13) through (16)
of this section applicable to the DATES: This regulation is effective
episode, as specified in October 15, 2018. Objections and
§ 63.1414(d)(6)(iii)(A). emission point for which quarterly
reporting is required under paragraph requests for hearings must be received
* * * * * on or before December 14, 2018, and
(f)(12)(i) of this section. Information
(f) Periodic Reports. Except as must be filed in accordance with the
applicable to other emission points
specified in paragraph (f)(12) of this instructions provided in 40 CFR part
within the affected source shall be
section, a report containing the 178 (see also Unit I.C. of the
submitted in the semiannual reports
information in paragraph (f)(2) of this SUPPLEMENTARY INFORMATION).
required under paragraph (f)(1) of this
section or containing the information in ADDRESSES: The docket for this action,
section.
paragraphs (f)(3) through (11) and (13) identified by docket identification (ID)
through (16) of this section, as * * * * *
number EPA–HQ–OPP–2017–0311, is
appropriate, shall be submitted (14) If there is a deviation from the
available at http://www.regulations.gov
semiannually no later than 60 days after mass emission limit specified in
or at the Office of Pesticide Programs
the end of each 180 day period. In § 63.1405(b)(2)(i), the report shall
Regulatory Public Docket (OPP Docket)
addition, for equipment leaks subject to include the daily average emission rate
in the Environmental Protection Agency
§ 63.1410, the owner or operator shall calculated for each operating day for
Docket Center (EPA/DC), West William
submit the information specified in 40 which a deviation occurred.
Jefferson Clinton Bldg., Rm. 3334, 1301
CFR part 63, subpart UU, and for heat (15) If there is a deviation from the Constitution Ave. NW, Washington, DC
exchange systems subject to § 63.1409, emission rate limit specified in 20460–0001. The Public Reading Room
the owner or operator shall submit the § 63.1405(b)(2)(ii) or (iii), the report is open from 8:30 a.m. to 4:30 p.m.,
information specified in § 63.1409. shall include the following information Monday through Friday, excluding legal
Section 63.1415 shall govern the use of for each operating day for which a holidays. The telephone number for the
monitoring data to determine deviation occurred: Public Reading Room is (202) 566–1744,
compliance for emissions points (i) The calculated average hourly and the telephone number for the OPP
required to apply controls by the emission rate. Docket is (703) 305–5805. Please review
provisions of this subpart. (ii) The individual hourly emission the visitor instructions and additional
(1) Except as specified in paragraph rate data points making up the average information about the docket available
(f)(12) of this section, a report hourly emission rate. at http://www.epa.gov/dockets.
containing the information in paragraph
(16) For periods of storage vessel FOR FURTHER INFORMATION CONTACT:
(f)(2) of this section or containing the
routine maintenance in which a control Michael Goodis, Registration Division
information in paragraphs (f)(3) through
device is bypassed, the owner or (7505P), Office of Pesticide Programs,
(11) and (13) through (16) of this
operator shall submit the information Environmental Protection Agency, 1200
section, as appropriate, shall be
specified in § 63.1416(g)(6)(i) through Pennsylvania Ave. NW, Washington, DC
submitted semiannually no later than 60
(iii) of this subpart. 20460–0001; main telephone number:
days after the end of each 180 day
(h) * * * (703) 305–7090; email address:
period. The first report shall be
(7) Whenever a continuous process RDFRNotices@epa.gov.
submitted no later than 240 days after
the date the Notification of Compliance vent becomes subject to control SUPPLEMENTARY INFORMATION:
Status is due and shall cover the 6- requirements under § 63.1405, as a I. General Information
month period beginning on the date the result of a process change, the owner or
Notification of Compliance Status is operator shall submit a report within 60 A. Does this action apply to me?
due. Subsequent reports shall cover days after the performance test or You may be potentially affected by
khammond on DSK30JT082PROD with RULES
each preceding 6-month period. applicability assessment, whichever is this action if you are an agricultural
(2) If none of the compliance sooner. The report may be submitted as producer, food manufacturer, or
exceptions specified in paragraphs (f)(3) part of the next Periodic Report required pesticide manufacturer. The following
through (11) and (13) through (16) of by paragraph (f) of this section. list of North American Industrial
this section occurred during the 6- * * * * * Classification System (NAICS) codes is
month period, the Periodic Report [FR Doc. 2018–22395 Filed 10–12–18; 8:45 am] not intended to be exhaustive, but rather
required by paragraph (f)(1) of this BILLING CODE 6560–50–P provides a guide to help readers
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![51858 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations
determine whether this document delivery of boxed information, please exposure through drinking water and in
applies to them. Potentially affected follow the instructions at http:// residential settings, but does not include
entities may include: www.epa.gov/dockets/contacts.html. occupational exposure. Section
• Crop production (NAICS code 111). Additional instructions on commenting 408(b)(2)(C) of FFDCA requires EPA to
• Animal production (NAICS code or visiting the docket, along with more give special consideration to exposure
112). information about dockets generally, is of infants and children to the pesticide
• Food manufacturing (NAICS code available at http://www.epa.gov/ chemical residue in establishing a
311). dockets. tolerance and to ‘‘ensure that there is a
• Pesticide manufacturing (NAICS reasonable certainty that no harm will
code 32532). II. Summary of Petitioned-for Tolerance
result to infants and children from
In the Federal Register of October 23, aggregate exposure to the pesticide
B. How can I get electronic access to
2017 (82 FR 49020) (FRL–9967–37), chemical residue . . . .’’
other related information? EPA issued a document pursuant to Consistent with FFDCA section
You may access a frequently updated FFDCA section 408(d)(3), 21 U.S.C. 408(b)(2)(D), and the factors specified in
electronic version of EPA’s tolerance 346a(d)(3), announcing the filing of a FFDCA section 408(b)(2)(D), EPA has
regulations at 40 CFR part 180 through pesticide petition (PP 7E8569) by IR–4, reviewed the available scientific data
the Government Printing Office’s e-CFR Rutgers, The State University of New and other relevant information in
site at http://www.ecfr.gov/cgi-bin/text- Jersey, 500 College Road East, Suite 201 support of this action. EPA has
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ W, Princeton, NJ 08540. The petition sufficient data to assess the hazards of
40tab_02.tpl. requested that 40 CFR part 180 be and to make a determination on
amended by establishing tolerances for aggregate exposure for pyraclostrobin
C. How can I file an objection or hearing
residues of the fungicide pyraclostrobin, including exposure resulting from the
request?
carbamic acid, [2-[[[ 1-(4-chlorophenyl)- tolerances established by this action.
Under FFDCA section 408(g), 21 1H-pyrazol-3-yl]oxy] EPA’s assessment of exposures and risks
U.S.C. 346a, any person may file an methyl]phenyl]methoxy-, methyl ester) associated with pyraclostrobin follows.
objection to any aspect of this regulation and its desmethoxy metabolite, methyl-
and may also request a hearing on those N-[[[1-(4-chlorophenyl)-1H-pyrazol-3- A. Toxicological Profile
objections. You must file your objection yl]oxy]methyl] phenylcarbamate EPA has evaluated the available
or request a hearing on this regulation expressed as parent compound in or on toxicity data and considered its validity,
in accordance with the instructions Brassica, leafy greens, subgroup 4–16B completeness, and reliability as well as
provided in 40 CFR part 178. To ensure at 16.0 ppm, celtuce at 29.0 ppm, the relationship of the results of the
proper receipt by EPA, you must Florence, fennel at 29.0 ppm, kohlrabi at studies to human risk. EPA has also
identify docket ID number EPA–HQ– 5.0 ppm, leaf petiole vegetable subgroup considered available information
OPP–2017–0311 in the subject line on 22B at 29.0 ppm, leafy greens subgroup concerning the variability of the
the first page of your submission. All 4–16A at 40 ppm, tropical and sensitivities of major identifiable
objections and requests for a hearing subtropical, medium to large fruit, subgroups of consumers, including
must be in writing, and must be smooth, inedible peel, subgroup 24B at infants and children.
received by the Hearing Clerk on or 0.6 ppm, and vegetable, Brassica, head The most consistently observed
before December 14, 2018. Addresses for and stem, group 5–16 at 5.0 ppm. The effects of pyraclostrobin exposure across
mail and hand delivery of objections petition also requested that the species, genders, and treatment
and hearing requests are provided in 40 following established tolerances be durations were diarrhea, decreased body
CFR 178.25(b). removed: Avocado at 0.6 ppm, banana weight, and decreased food
In addition to filing an objection or at 0.04 ppm, Brassica, head and stem, consumption. Pyraclostrobin also causes
hearing request with the Hearing Clerk subgroup 5A at 5.0 ppm, Brassica leafy intestinal disturbance as indicated by
as described in 40 CFR part 178, please greens, subgroup 5B, at 16.0 ppm, and increased incidence of diarrhea or
submit a copy of the filing (excluding vegetable, leafy, except Brassica, group duodenum mucosal thickening. These
any Confidential Business Information 4 at 29 ppm. That document referenced intestinal effects appeared to be related
(CBI)) for inclusion in the public docket. a summary of the petition prepared by to the irritating action on the mucus
Information not marked confidential BASF, the registrant, which is available membranes as demonstrated by redness
pursuant to 40 CFR part 2 may be in the docket, http:// and chemosis (i.e., swelling of the
disclosed publicly by EPA without prior www.regulations.gov. There were no conjunctiva) seen in the primary eye
notice. Submit the non-CBI copy of your comments received in response to the irritation study. In the rat acute and
objection or hearing request, identified notice of filing. subchronic neurotoxicity studies,
by docket ID number EPA–HQ–OPP– neuropathology and behavior changes
III. Aggregate Risk Assessment and
2017–0311, by one of the following were not observed.
Determination of Safety In the rat and rabbit developmental
methods:
• Federal eRulemaking Portal: http:// Section 408(b)(2)(A)(i) of FFDCA toxicity studies, developmental toxicity
www.regulations.gov. Follow the online allows EPA to establish a tolerance (the (i.e. skeletal variations, post-
instructions for submitting comments. legal limit for a pesticide chemical implantation loss, and fetal resorption)
Do not submit electronically any residue in or on a food) only if EPA was observed, as well as maternal
information you consider to be CBI or determines that the tolerance is ‘‘safe.’’ toxicity (i.e. diarrhea, decreased body
other information whose disclosure is Section 408(b)(2)(A)(ii) of FFDCA weight, food consumption, and clinical
khammond on DSK30JT082PROD with RULES
restricted by statute. defines ‘‘safe’’ to mean that ‘‘there is a signs of toxicity). In the reproduction
• Mail: OPP Docket, Environmental reasonable certainty that no harm will study, systemic toxicity manifested as
Protection Agency Docket Center (EPA/ result from aggregate exposure to the decreased body weight in both the
DC), (28221T), 1200 Pennsylvania Ave. pesticide chemical residue, including parents and offspring; no reproductive
NW, Washington, DC 20460–0001. all anticipated dietary exposures and all toxicity was observed.
• Hand Delivery: To make special other exposures for which there is In the rat subchronic inhalation
arrangements for hand delivery or reliable information.’’ This includes toxicity studies, inhalation toxicity
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![51862 Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations
establishing tolerance values in order to Children from Environmental Health Senate, the U.S. House of
conform to current Agency policy on Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller
significant figures. The tolerance for April 23, 1997), nor is it a regulatory General of the United States prior to
tropical and subtropical, medium to action under Executive Order 13771, publication of the rule in the Federal
large fruit, smooth, inedible peel, entitled ‘‘Reducing Regulations and Register. This action is not a ‘‘major
subgroup 24B is not being established at Controlling Regulatory Costs’’ (82 FR rule’’ as defined by 5 U.S.C. 804(2).
this time. The request for a tolerance for 9339, February 3, 2017). This action
subgroup 24B was submitted in does not contain any information List of Subjects in 40 CFR Part 180
connection with an application for collections subject to OMB approval Environmental protection,
registration of a pesticide product with under the Paperwork Reduction Act Administrative practice and procedure,
multiple active ingredients. Because one (PRA) (44 U.S.C. 3501 et seq.), nor does Agricultural commodities, Pesticides
of those active ingredients is not it require any special considerations and pests, Reporting and recordkeeping
currently approved for use on the under Executive Order 12898, entitled requirements.
commodities in subgroup 24B, EPA is ‘‘Federal Actions to Address Dated: October 2, 2018.
not approving use of the combination Environmental Justice in Minority Michael L. Goodis,
product on commodities in subgroup Populations and Low-Income
Director, Registration Division, Office of
24B. Therefore, EPA is not establishing Populations’’ (59 FR 7629, February 16, Pesticide Programs.
the tolerance for subgroup 24B because 1994).
it is not necessary at this time. Because Since tolerances and exemptions that Therefore, 40 CFR chapter I is
a tolerance is not being established for are established on the basis of a petition amended as follows:
subgroup 24B, the existing tolerances under FFDCA section 408(d), such as
for avocado and banana are not being the tolerance in this final rule, do not PART 180—[AMENDED]
removed as proposed. require the issuance of a proposed rule,
■ 1. The authority citation for part 180
the requirements of the Regulatory
V. Conclusion Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
Therefore, tolerances are established seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
for residues of pyraclostrobin carbamic This action directly regulates growers,
acid, [2-[[[1-(4-chlorophenyl)-1H- ■ 2. In § 180.582:
food processors, food handlers, and food
pyrazol-3-yl]oxy] ■ i. Add alphabetically the commodities
retailers, not States or tribes, nor does
methyl]phenyl]methoxy-, methyl ester) ‘‘Brassica, leafy greens, subgroup 4–16B,
this action alter the relationships or
and its desmethoxy metabolite, methyl- except watercress’’; ‘‘celtuce’’; ‘‘fennel,
distribution of power and
N-[[[1-(4-chlorophenyl)-1H-pyrazol-3- responsibilities established by Congress Florence’’; ‘‘kohlrabi’’; ‘‘leaf petiole
yl]oxy]methyl] phenylcarbamate (BF in the preemption provisions of FFDCA vegetable, subgroup 22B’’; ‘‘leafy greens,
500–3), expressed as parent compound, section 408(n)(4). As such, the Agency subgroup 4–16A’’; and ‘‘vegetable,
in or on Brassica, leafy greens, subgroup has determined that this action will not Brassica, head and stem, group 5–16’’ to
4–16B, except watercress at 16 ppm; have a substantial direct effect on States the table in paragraph (a)(1); and
■ ii. Remove the entries for ‘‘Brassica,
celtuce at 29 ppm; fennel, Florence at 29 or tribal governments, on the
ppm; kohlrabi at 5.0 ppm; leaf petiole relationship between the national head and stem, subgroup 5A’’;
vegetable, subgroup 22B at 29 ppm; government and the States or tribal ‘‘Brassica, leafy greens, subgroup 5B’’;
leafy greens, subgroup 4–16A at 40 governments, or on the distribution of and ‘‘vegetable, leafy, except brassica,
ppm; and vegetable, Brassica, head and power and responsibilities among the group 4’’ from the table in paragraph
stem, group 5–16 at 5.0 ppm. various levels of government or between (a)(1).
Additionally, the following established the Federal Government and Indian The additions read as follows:
tolerances are removed as unnecessary tribes. Thus, the Agency has determined § 180.582 Pyraclostrobin; tolerances for
due to the establishment of the above that Executive Order 13132, entitled residues.
tolerances: Brassica, head and stem, ‘‘Federalism’’ (64 FR 43255, August 10, (a) * * * (1) * * *
subgroup 5A; Brassica leafy greens, 1999) and Executive Order 13175,
subgroup 5B; and vegetable, leafy, entitled ‘‘Consultation and Coordination Parts per
except brassica, group 4. Commodity
with Indian Tribal Governments’’ (65 FR million
VI. Statutory and Executive Order 67249, November 9, 2000) do not apply
Reviews to this action. In addition, this action
* * * * *
does not impose any enforceable duty or
This action establishes tolerances Brassica, leafy greens, subgroup
contain any unfunded mandate as 4–16B, except watercress ...... 16
under FFDCA section 408(d) in described under Title II of the Unfunded
response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C. * * * * *
Agency. The Office of Management and 1501 et seq.). Celtuce ........................................ 29
Budget (OMB) has exempted these types This action does not involve any
of actions from review under Executive technical standards that would require * * * * *
Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary Fennel, Florence ......................... 29
Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
October 4, 1993). Because this action 12(d) of the National Technology * * * * *
has been exempted from review under Kohlrabi ....................................... 5.0
Transfer and Advancement Act
khammond on DSK30JT082PROD with RULES
Executive Order 12866, this action is Leaf petiole vegetable, subgroup
(NTTAA) (15 U.S.C. 272 note). 22B .......................................... 29
not subject to Executive Order 13211,
VII. Congressional Review Act Leafy greens, subgroup 4–16A .. 40
entitled ‘‘Actions Concerning
Regulations That Significantly Affect Pursuant to the Congressional Review * * * * *
Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will Vegetable, Brassica, head and
FR 28355, May 22, 2001) or Executive submit a report containing this rule and stem, group 5–16 .................... 5.0
Order 13045, entitled ‘‘Protection of other required information to the U.S.
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![Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Rules and Regulations 51863
Parts per SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
Commodity million www.regulations.gov. Follow the online
I. General Information
instructions for submitting comments.
* * * * * A. Does this action apply to me? Do not submit electronically any
You may be potentially affected by information you consider to be CBI or
* * * * * other information whose disclosure is
[FR Doc. 2018–22282 Filed 10–12–18; 8:45 am] this action if you are an agricultural
producer, food manufacturer, or restricted by statute.
BILLING CODE 6560–50–P
pesticide manufacturer. The following • Mail: OPP Docket, Environmental
list of North American Industrial Protection Agency Docket Center (EPA/
ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave.
AGENCY not intended to be exhaustive, but rather NW, Washington, DC 20460–0001.
provides a guide to help readers • Hand Delivery: To make special
40 CFR Part 180 determine whether this document arrangements for hand delivery or
applies to them. Potentially affected delivery of boxed information, please
[EPA–HQ–OPP–2017–0273; FRL–9983–96]
entities may include: follow the instructions at http://
Etoxazole; Pesticide Tolerances • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
• Animal production (NAICS code Additional instructions on
AGENCY: Environmental Protection 112). commenting or visiting the docket,
Agency (EPA). • Food manufacturing (NAICS code along with more information about
ACTION: Final rule. 311). dockets generally, is available at http://
SUMMARY: This regulation establishes • Pesticide manufacturing (NAICS www.epa.gov/dockets.
tolerances for residues of etoxazole in or code 32532). II. Summary of Petitioned-For
on multiple commodities which are B. How can I get electronic access to Tolerance
identified and discussed later in this other related information? In the Federal Register of October 23,
document. In addition, it removes 2017 (82 FR 49020) (FRL–9967–37),
You may access a frequently updated
certain previously established EPA issued a document pursuant to
electronic version of EPA’s tolerance
tolerances that are superseded by this FFDCA section 408(d)(3), 21 U.S.C.
regulations at 40 CFR part 180 through
final rule. Interregional Research Project 346a(d)(3), announcing the filing of a
the Government Printing Office’s e-CFR
Number 4 (IR–4) requested these pesticide petition (PP 7E8559) by IR–4
site at http://www.ecfr.gov/cgi-bin/text-
tolerances under the Federal Food, Project Headquarters, 500 College Road
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Drug, and Cosmetic Act (FFDCA). East, Suite 201 W, Princeton, New
40tab_02.tpl.
DATES: This regulation is effective Jersey 08540. The petition requested
October 15, 2018. Objections and C. How can I file an objection or hearing that 40 CFR 180.593 be amended by
requests for hearings must be received request? establishing tolerances for residues of
on or before December 14, 2018, and Under FFDCA section 408(g), 21 the miticide/insecticide etoxazole, (2-
must be filed in accordance with the U.S.C. 346a, any person may file an (2,6-difluorophenyl)-4-[4-(1,1-
instructions provided in 40 CFR part objection to any aspect of this regulation dimethylethyl)-2-ethoxyphenyl]-4,5-
178 (see also Unit I.C. of the and may also request a hearing on those dihydrooxazole), in or on Corn, sweet,
SUPPLEMENTARY INFORMATION). objections. You must file your objection kernel plus cob with husks removed at
ADDRESSES: The docket for this action, or request a hearing on this regulation 0.01 parts per million (ppm); Corn,
identified by docket identification (ID) in accordance with the instructions sweet, forage at 1.5 ppm; Corn, sweet,
number EPA–HQ–OPP–2017–0273, is provided in 40 CFR part 178. To ensure stover at 5.0 ppm; Fruit, pome, group
available at http://www.regulations.gov proper receipt by EPA, you must 11–10 at 0.20 ppm; Nut, tree, group 14–
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– 12 at 0.01 ppm; Fruit, stone, group 12–
Regulatory Public Docket (OPP Docket) OPP–2017–0273 in the subject line on 12 at 1.0 ppm; and Cottonseed subgroup
in the Environmental Protection Agency the first page of your submission. All 20C at 0.05 ppm. In addition, upon
Docket Center (EPA/DC), West William objections and requests for a hearing establishment of new tolerances
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be referenced above, the petitioner
Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or requested the removal of existing
20460–0001. The Public Reading Room before December 14, 2018. Addresses for tolerances in 40 CFR 180.593 for
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections residues of etoxazole in or on Fruit,
Monday through Friday, excluding legal and hearing requests are provided in 40 pome, group 11 at 0.20 ppm; Fruit,
holidays. The telephone number for the CFR 178.25(b). stone, group 12, except plum at 1.0
Public Reading Room is (202) 566–1744, In addition to filing an objection or ppm; Nut, tree, group 14 at 0.01 ppm;
and the telephone number for the OPP hearing request with the Hearing Clerk Cotton, undelinted seed at 0.05 ppm;
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please Pistachio at 0.01 ppm; Plum at 0.15
the visitor instructions and additional submit a copy of the filing (excluding ppm; and Plum, prune, dried at 0.30
information about the docket available any Confidential Business Information ppm. That document referenced a
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. summary of the petition prepared by
FOR FURTHER INFORMATION CONTACT: Information not marked confidential Valent U.S.A. Corporation, the
khammond on DSK30JT082PROD with RULES
Michael L. Goodis, Registration Division pursuant to 40 CFR part 2 may be registrant, which is available in the
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior docket, http://www.regulations.gov.
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your There were no comments received in
Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified response to the notice of filing.
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– Consistent with the authority in
(703) 305–7090; email address: 2017–0273, by one of the following FFDCA 408(d)(4)(A)(i), EPA is issuing
RDFRNotices@epa.gov. methods: tolerances that vary from what the
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Document Created: 2018-10-13 10:04:06
Document Modified: 2018-10-13 10:04:06
| 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 October 15, 2018. Objections and requests for hearings must be received on or before December 14, 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, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 51857 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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