82 FR 2900 - Tetraconazole; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 6 (January 10, 2017)
Federal Register Volume 82, Issue 6 (January 10, 2017)
| Page Range | 2900-2906 | |
| FR Document | 2016-31824 |
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)] [Rules and Regulations] [Pages 2900-2906] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31824] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0695; FRL-9955-74] Tetraconazole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of tetraconazole in or on vegetable, fruiting (Crop Group 8-10) at 0.30 parts per million (ppm) and vegetable, cucurbit (Crop Group 9) at 0.15 ppm and revises the tolerance for residues on beet, sugar, root; beet, sugar, dried pulp; and beet, sugar molasses. Isagro S.P.A. (d/b/a Isagro USA, Inc.) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective January 10, 2017. Objections and requests for hearings must be received on or before March 13, 2017, 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-2015-0695, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0695 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 March 13, 2017. 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-2015-0695, 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 March 16, 2016 (81 FR 14030) (FRL-9942- 86), 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 5F8400) by Isagro S.P.A. (d/b/a Isagro USA, Inc.), 430 Davis Drive, Suite 240, Morrisville, NC 27560. That document provided notice that the petition requested that 40 CFR 180.557 be amended by establishing tolerances for residues of the fungicide tetraconazole, in or on Vegetable, Fruiting (Crop Group 8-10) at 0.30 parts per million (ppm) and Vegetable, Cucurbit (Crop Group 9) at 0.15 ppm. In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-22), EPA issued another document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the remainder of that petition requesting revision of the existing tolerances for tetraconazole residues on beet, sugar, root to 0.15 ppm; beet, sugar, dried pulp to 0.20 ppm; and beet, sugar molasses to 0.25 ppm. Those documents referenced a summary of the petition prepared by Isagro S.P.A. (d/b/a Isagro USA, Inc.), the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to these notices 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 [[Page 2901]] 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 tetraconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tetraconazole 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 liver and kidney are the primary target organs of tetraconazole in all species in oral toxicity studies of sub-chronic and chronic durations. Following long-term oral exposure, tetraconazole caused liver tumors in mice in both sexes. In the acute neurotoxicity study, loss of motor activity in both sexes, and clinical signs including hunched posture, decreased defecation, and/or red or yellow material on various body surfaces were observed in females. There was no evidence of immunotoxicity or neurotoxicity following sub-chronic exposure. There were no systemic effects observed in the 21-day dermal toxicity study up to the highest dose tested. Tetraconazole did not show evidence of mutagenicity in in vitro or in vivo studies. Oral rat and rabbit developmental toxicity studies showed no increased susceptibility of fetuses to tetraconazole. Maternal toxicity (decreased body weight gain and food consumption, increased water intake and increased liver and kidney weights) and developmental toxicity (increased incidence of small fetuses, supernumerary ribs and hydroureter and hydronephrosis) occurred at the same dose level in the rat study. No developmental toxicity was seen in the rabbit study, whereas maternal toxicity (decreased body weight gain) was noted at the highest dose tested. Similarly, there was no evidence of increased susceptibility of offspring in the 2-generation rat reproduction study. In contrast to the oral studies where the most sensitive effects were in the liver and kidney, inhalation exposure of tetraconazole to rats resulted in portal-of-entry effects including; squamous cell metaplasia of the laryngeal mucous, mono-nuclear cell infiltration, goblet cell hyperplasia, hypertrophy of the nasal cavity and nasopharyngeal duct, and follicular hypertrophy of the thyroid in males. At the highest concentration tested, there were treatment- related increases in absolute lung weights in both sexes. Since the last risk assessment, a 28-day in vivo cancer mode-of-action study in mice was submitted and reviewed leading to the re-evaluation of tetraconazole's cancer potential and classification. EPA has now classified tetraconazole as ``Not likely to be carcinogenic to humans at levels that do not cause increased cell proliferation in the liver.'' Quantification of carcinogenic potential is not required. Specific information on the studies received and the nature of the adverse effects caused by tetraconazole 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 Risk Assessment for the Section 3 Registration for Application to Fruiting Vegetables (Crop Group 8) and Cucurbit Vegetables (Crop Group 9) and Amending the Sugar Beet Application Scenario and Tolerance'' in docket ID number EPA-HQ- OPP-2015-0695. 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://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for tetraconazole used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Tetraconazole for Use in Human Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (Females 13-50 NOAEL = 22.5 mg/kg/ Acute RfD = 0.225 Developmental toxicity study years of age). day. mg/kg/day. (rat). UFA = 10x........... aPAD = 0.225 mg/kg/ Developmental LOAEL = 100 mg/kg/ UFH = 10x........... day. day based on increased incidence FQPA SF = 1x........ of small fetuses, supernumerary ribs, and hydroureter and hydronephrosis. [[Page 2902]] Acute dietary (General population NOAEL = 50 mg/kg/day Acute RfD = 0.5 mg/ Acute neurotoxicity (rat). including infants and children). UFA = 10x........... kg/day. LOAEL = 200 mg/kg/day due to UFH = 10x........... aPAD = 0.5 mg/kg/ decreased motor activity on day 0 FQPA SF = 1x........ day. in both sexes, and clinical signs in females including hunched posture, decreased defecation, and/or red or yellow material on various body surfaces. Chronic dietary (All populations) NOAEL = 0.73 mg/kg/ Chronic RfD = Chronic oral toxicity (dog). day. 0.0073 mg/kg/day. LOAEL = 2.95/3.33 (M/F) mg/kg/day, UFA = 10x........... cPAD = 0.0073 mg/kg/ based on absolute and relative UFH = 10x........... day. kidney weights and FQPA SF = 1x........ histopathological changes in the male kidney. ---------------------------------------------------------------------------------------------------------------- Dermal short-term (1 to 30 days) No hazard identified and therefore quantification is not required. There are and dermal intermediate-term (1 no developmental concerns via the dermal route and no systemic toxicity was to 6 months). seen following dermal exposure. ---------------------------------------------------------------------------------------------------------------- Inhalation short-term (1 to 30 * NOAEL not LOC = 300.......... 28-Day Inhalation toxicity--rat. days) and inhalation established. LOAEL = 1.3 mg/kg/day (0.0048 mg/ intermediate-term (1 to 6 UFA = 3x............ kg/L, 0.0548 mg/L (rat)) for months). UFH = 10x........... males and females, based on UFL = 10x........... squamous cell metaplasia of laryngeal mucous, mononuclear cell infiltration, goblet hyperplasia and hypertrophy of nasal cavity and nasopharyngeal duct and follicular hypertrophy of thyroid in males. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be carcinogenic to humans at levels that do not cause increased cell proliferation in the liver.'' Quantification of carcinogenic potential is not required (TXR #0056628, J. Rowland et al., 2- Apr-2013). ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tetraconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing tetraconazole tolerances in 40 CFR 180.557. EPA assessed dietary exposures from tetraconazole 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 tetraconazole. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA utilized the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16 default processing factors and tolerance-level residues and 100 percent crop treated (PCT) for all commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/ WWEIA dietary survey conducted from 2003 to 2008. As to residue levels in food, EPA utilized residue data from field trials and feeding studies to obtain average residues and assumed the PCT figures provided below. Empirically derived processing factors were used in these assessments when available iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that tetraconazole does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated Residues 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. 100 PCT were assumed for all food commodities for the acute analysis. The chronic analysis used percent crop treated for new uses (PCTn). 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. [[Page 2903]] The Agency estimated the PCT for existing uses as follows: Sugarbeet, 70%; field corn, 9%; and soybean, 5%. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), 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 one. In those cases, 1% is used as the average PCT and 2.5% is used 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 tetraconazole 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 tetraconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tetraconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of tetraconazole for acute exposures are estimated to be 11 parts per billion (ppb) for surface water and 120 ppb for ground water. The estimated EDWCs of tetraconazole for chronic exposures for non-cancer assessments are estimated to be 5.5 ppb for surface water and 118 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 120 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 118 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). Tetraconazole is not registered for any specific use patterns that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' Tetraconazole is a member of the triazole-containing class of pesticides. 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 (EPA, 2002). In the case of 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 evidence to indicate that tetraconazole shares a common mechanism of toxicity with any other conazole pesticide, and EPA is not following a cumulative risk approach for this tolerance action. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. Tetraconazole is a triazole-derived pesticide. This class of compounds 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-derivative pesticides, including tetraconazole, 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-derived 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. An updated dietary exposure and risk analysis for the common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was completed on April 9, 2015, in association with registration requests for several triazole fungicides, propiconazole, difenoconazole, and flutriafol. The requested new uses of tetraconazole did not significantly change the dietary exposure estimates for free triazole or conjugated triazoles. Therefore, an updated dietary exposure [[Page 2904]] analysis was not conducted. The April 9, 2015 update for triazoles may be found in docket ID number EPA-HQ-OPP-2014-0788. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There are no residual uncertainties for pre- and post-natal toxicity. There is no evidence of increased quantitative susceptibility of rat or rabbit fetuses to in utero exposure to tetraconazole. There is evidence of increased qualitative susceptibility to fetuses in the rat prenatal developmental toxicity study (increased incidences of supernumerary ribs, and hydroureter and hydronephrosis). The LOC is low however because the fetal effects were seen at the same dose as the maternal effects, a clear NOAEL was established, the developmental NOAEL from a study in rats is being used as the POD for the acute dietary endpoint (females 13-49 years of age), and there were no developmental effects in the rabbit study. There is also no evidence of increased quantitative or qualitative susceptibility to offspring in the two-generation reproduction study. 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 tetraconazole is complete. ii. There were effects indicative of neurotoxicity in the acute neurotoxicity study in rats. However, the level of concern (LOC) is low since a clear NOAEL was established which is being used in endpoint selection. Furthermore, the dose at which these neurotoxic effects were observed is 2 to 100-fold higher than the primary effects seen in the other studies in the database (liver and kidney). After preliminary review, a sub-chronic neurotoxicity study has shown no evidence for neurotoxicity. Finally, there are no other signs of neurotoxicity in any of the other studies in the database. Therefore, there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. There is no evidence that tetraconazole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. There is evidence of increased qualitative susceptibility to fetuses in the rat prenatal developmental toxicity study (increased incidences of supernumerary ribs, and hydroureter and hydronephrosis). The LOC is low however because: The fetal effects were seen at the same dose as the maternal effects, a clear NOAEL was established, the developmental NOAEL from a study in rats is being used as the POD for the acute dietary endpoint (females 13-49 years of age), and there were no developmental effects in the rabbit study. There is also no evidence of increased quantitative or qualitative susceptibility to offspring in the two-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. There are no residual uncertainties identified for pre- and post-natal toxicity in the exposure databases. Tolerance-level residues, 100 PCT, and modeled water estimates were incorporated into the acute dietary exposure analysis. Therefore, the acute analysis is highly conservative. The chronic and cancer dietary exposure analyses utilized empirical processing factors, average field trial residues, average residues from the feeding studies, percent crop treated estimates, and modeled drinking water estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tetraconazole in drinking water. These assessments will not underestimate the exposure and risks posed by tetraconazole. 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 tetraconazole will occupy 4.6% 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 tetraconazole from food and water will utilize 92% of the cPAD for all infants (<1 year old) the population group receiving the greatest exposure. There are no residential uses for tetraconazole 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). A short-term adverse effect was identified; however, tetraconazole is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for tetraconazole. 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). An intermediate-term adverse effect was identified; however, tetraconazole 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 tetraconazole. [[Page 2905]] 5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has concluded that tetraconazole is ``Not likely to be carcinogenic to humans at levels that do not cause increased cell proliferation in the liver.'' Because the chronic endpoint is protective of cell proliferation in the liver, there is not likely to be a cancer risk from exposure to tetraconazole. 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 tetraconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate analytical methods are available to enforce the currently established tetraconazole plant and livestock tolerances (D280006, W. Donovan, 10-Jan-2002, D267481, 12-Oct-2000; D278236, W. Donovan, 22- Oct-2001). Isagro has also submitted adequate method validation and independent laboratory validation (ILV) data which indicates that the QuEChERS multi-residue method L00.00-115 (48135104.der) is capable of quantifying tetraconazole residues in/on a variety of fruit, cereal grain, root, oilseed, and livestock commodities. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for tetraconazole. C. Revisions to Petitioned-for Tolerances EPA revised two commodity definitions for vegetable, fruiting, group 8-10 and vegetable, cucurbit, group 9. V. Conclusion Therefore, tolerances are established for residues of tetraconazole, in or on vegetable, fruiting, group 8-10 at 0.30 ppm and vegetable, cucurbit, group 9 at 0.15 ppm and revised for beet, sugar, root; beet, sugar, dried pulp; and beet, sugar, molasses. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income 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: December 14, 2016. Daniel J. Rosenblatt, Acting 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 the table in paragraph (a) of Sec. 180.557: 0 a. Revise the commodities of ``Beet, sugar, dried pulp'', ``Beet, sugar, molasses'', and ``Beet, sugar, root''; and 0 b. Add alphabetically the commodities of ``Vegetable, cucurbit, group 9'' and ``Vegetable, fruiting, group 8-10'' to read as follows: [[Page 2906]] Sec. 180.557 Tetraconazole; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Beet, sugar, dried pulp.................................... 0.20 Beet, sugar, molasses...................................... 0.25 Beet, sugar, root.......................................... 0.15 * * * * * Vegetable, cucurbit, group 9............................... 0.15 Vegetable, fruiting, group 8-10............................ 0.30 ------------------------------------------------------------------------ * * * * * [FR Doc. 2016-31824 Filed 1-9-17; 8:45 am] BILLING CODE 6560-50-P
![2900 Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Rules and Regulations
[FR Doc. 2016–31830 Filed 1–9–17; 8:45 am] I. General Information instructions for submitting comments.
BILLING CODE 6560–50–P Do not submit electronically any
A. Does this action apply to me?
information you consider to be CBI or
You may be potentially affected by other information whose disclosure is
ENVIRONMENTAL PROTECTION this action if you are an agricultural restricted by statute.
AGENCY producer, food manufacturer, or • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
40 CFR Part 180 list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.,
Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
[EPA–HQ–OPP–2015–0695; FRL–9955–74] not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
Tetraconazole; Pesticide Tolerances determine whether this document delivery of boxed information, please
applies to them. Potentially affected follow the instructions at http://
AGENCY: Environmental Protection entities may include: www.epa.gov/dockets/contacts.html.
Agency (EPA). • Crop production (NAICS code 111). Additional instructions on
ACTION: Final rule. • Animal production (NAICS code commenting or visiting the docket,
112). along with more information about
• Food manufacturing (NAICS code dockets generally, is available at http://
SUMMARY: This regulation establishes
311). www.epa.gov/dockets.
tolerances for residues of tetraconazole
• Pesticide manufacturing (NAICS
in or on vegetable, fruiting (Crop Group II. Summary of Petitioned-For
code 32532).
8–10) at 0.30 parts per million (ppm) Tolerance
and vegetable, cucurbit (Crop Group 9) B. How can I get electronic access to In the Federal Register of March 16,
at 0.15 ppm and revises the tolerance for other related information? 2016 (81 FR 14030) (FRL–9942–86),
residues on beet, sugar, root; beet, sugar, You may access a frequently updated EPA issued a document pursuant to
dried pulp; and beet, sugar molasses. electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
Isagro S.P.A. (d/b/a Isagro USA, Inc.) regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
requested these tolerances under the the Government Printing Office’s e-CFR pesticide petition (PP 5F8400) by Isagro
Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text- S.P.A. (d/b/a Isagro USA, Inc.), 430
(FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Davis Drive, Suite 240, Morrisville, NC
DATES: This regulation is effective 40tab_02.tpl. 27560. That document provided notice
January 10, 2017. Objections and that the petition requested that 40 CFR
C. How can I file an objection or hearing 180.557 be amended by establishing
requests for hearings must be received request?
on or before March 13, 2017, and must tolerances for residues of the fungicide
Under FFDCA section 408(g), 21 tetraconazole, in or on Vegetable,
be filed in accordance with the
U.S.C. 346a, any person may file an Fruiting (Crop Group 8–10) at 0.30 parts
instructions provided in 40 CFR part
objection to any aspect of this regulation per million (ppm) and Vegetable,
178 (see also Unit I.C. of the
and may also request a hearing on those Cucurbit (Crop Group 9) at 0.15 ppm. In
SUPPLEMENTARY INFORMATION).
objections. You must file your objection the Federal Register of August 29, 2016
ADDRESSES: The docket for this action, or request a hearing on this regulation (81 FR 59165) (FRL–9950–22), EPA
identified by docket identification (ID) in accordance with the instructions issued another document pursuant to
number EPA–HQ–OPP–2015–0695, is provided in 40 CFR part 178. To ensure FFDCA section 408(d)(3), 21 U.S.C.
available at http://www.regulations.gov proper receipt by EPA, you must 346a(d)(3), announcing the remainder of
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– that petition requesting revision of the
Regulatory Public Docket (OPP Docket) OPP–2015–0695 in the subject line on existing tolerances for tetraconazole
in the Environmental Protection Agency the first page of your submission. All residues on beet, sugar, root to 0.15
Docket Center (EPA/DC), West William objections and requests for a hearing ppm; beet, sugar, dried pulp to 0.20
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be ppm; and beet, sugar molasses to 0.25
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or ppm. Those documents referenced a
20460–0001. The Public Reading Room before March 13, 2017. Addresses for summary of the petition prepared by
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections Isagro S.P.A. (d/b/a Isagro USA, Inc.),
Monday through Friday, excluding legal and hearing requests are provided in 40 the registrant, which is available in the
holidays. The telephone number for the CFR 178.25(b). docket, http://www.regulations.gov.
Public Reading Room is (202) 566–1744, In addition to filing an objection or There were no comments received in
and the telephone number for the OPP hearing request with the Hearing Clerk response to these notices of filing.
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
the visitor instructions and additional submit a copy of the filing (excluding III. Aggregate Risk Assessment and
information about the docket available any Confidential Business Information Determination of Safety
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(i) of FFDCA
Information not marked confidential allows EPA to establish a tolerance (the
FOR FURTHER INFORMATION CONTACT:
pursuant to 40 CFR part 2 may be legal limit for a pesticide chemical
Michael Goodis, Registration Division
disclosed publicly by EPA without prior residue in or on a food) only if EPA
pmangrum on DSK3GDR082PROD with RULES
(7505P), Office of Pesticide Programs,
notice. Submit the non-CBI copy of your determines that the tolerance is ‘‘safe.’’
Environmental Protection Agency, 1200
objection or hearing request, identified Section 408(b)(2)(A)(ii) of FFDCA
Pennsylvania Ave. NW., Washington,
by docket ID number EPA–HQ–OPP– defines ‘‘safe’’ to mean that ‘‘there is a
DC 20460–0001; main telephone
2015–0695, by one of the following reasonable certainty that no harm will
number: (703) 305–7090; email address:
methods: result from aggregate exposure to the
RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http:// pesticide chemical residue, including
SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online all anticipated dietary exposures and all
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![Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Rules and Regulations 2905
5. Aggregate cancer risk for U.S. The Codex has not established a MRL relationship between the national
population. As discussed in Unit III.A., for tetraconazole. government and the States or tribal
EPA has concluded that tetraconazole is governments, or on the distribution of
C. Revisions to Petitioned-for Tolerances
‘‘Not likely to be carcinogenic to power and responsibilities among the
humans at levels that do not cause EPA revised two commodity various levels of government or between
increased cell proliferation in the liver.’’ definitions for vegetable, fruiting, group the Federal Government and Indian
Because the chronic endpoint is 8–10 and vegetable, cucurbit, group 9. tribes. Thus, the Agency has determined
protective of cell proliferation in the V. Conclusion that Executive Order 13132, entitled
liver, there is not likely to be a cancer ‘‘Federalism’’ (64 FR 43255, August 10,
risk from exposure to tetraconazole. Therefore, tolerances are established 1999) and Executive Order 13175,
for residues of tetraconazole, in or on entitled ‘‘Consultation and Coordination
6. Determination of safety. Based on vegetable, fruiting, group 8–10 at 0.30
these risk assessments, EPA concludes with Indian Tribal Governments’’ (65 FR
ppm and vegetable, cucurbit, group 9 at 67249, November 9, 2000) do not apply
that there is a reasonable certainty that 0.15 ppm and revised for beet, sugar,
no harm will result to the general to this action. In addition, this action
root; beet, sugar, dried pulp; and beet, does not impose any enforceable duty or
population, or to infants and children sugar, molasses.
from aggregate exposure to tetraconazole contain any unfunded mandate as
residues. VI. Statutory and Executive Order described under Title II of the Unfunded
Reviews Mandates Reform Act (UMRA) (2 U.S.C.
IV. Other Considerations 1501 et seq.).
This action establishes tolerances
A. Analytical Enforcement Methodology under FFDCA section 408(d) in This action does not involve any
response to a petition submitted to the technical standards that would require
Adequate analytical methods are Agency consideration of voluntary
Agency. The Office of Management and
available to enforce the currently consensus standards pursuant to section
Budget (OMB) has exempted these types
established tetraconazole plant and 12(d) of the National Technology
of actions from review under Executive
livestock tolerances (D280006, W. Transfer and Advancement Act
Order 12866, entitled ‘‘Regulatory
Donovan, 10-Jan-2002, D267481, 12-Oct- (NTTAA) (15 U.S.C. 272 note).
Planning and Review’’ (58 FR 51735,
2000; D278236, W. Donovan, 22-Oct-
October 4, 1993). Because this action VII. Congressional Review Act
2001). Isagro has also submitted
has been exempted from review under
adequate method validation and Pursuant to the Congressional Review
Executive Order 12866, this action is
independent laboratory validation (ILV) Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211,
data which indicates that the submit a report containing this rule and
entitled ‘‘Actions Concerning
QuEChERS multi-residue method other required information to the U.S.
Regulations That Significantly Affect
L00.00–115 (48135104.der) is capable of Senate, the U.S. House of
Energy Supply, Distribution, or Use’’ (66
quantifying tetraconazole residues in/on Representatives, and the Comptroller
FR 28355, May 22, 2001) or Executive
a variety of fruit, cereal grain, root, General of the United States prior to
Order 13045, entitled ‘‘Protection of
oilseed, and livestock commodities. publication of the rule in the Federal
Children from Environmental Health
The method may be requested from: Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
Chief, Analytical Chemistry Branch, April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
Environmental Science Center, 701 contain any information collections
Mapes Rd., Ft. Meade, MD 20755–5350; List of Subjects in 40 CFR Part 180
subject to OMB approval under the
telephone number: (410) 305–2905; Paperwork Reduction Act (PRA) (44 Environmental protection,
email address: residuemethods@ U.S.C. 3501 et seq.), nor does it require Administrative practice and procedure,
epa.gov. any special considerations under Agricultural commodities, Pesticides
B. International Residue Limits Executive Order 12898, entitled and pests, Reporting and recordkeeping
‘‘Federal Actions to Address requirements.
In making its tolerance decisions, EPA Environmental Justice in Minority Dated: December 14, 2016.
seeks to harmonize U.S. tolerances with Populations and Low-Income Daniel J. Rosenblatt,
international standards whenever Populations’’ (59 FR 7629, February 16,
possible, consistent with U.S. food Acting Director, Registration Division, Office
1994). of Pesticide Programs.
safety standards and agricultural Since tolerances and exemptions that
practices. EPA considers the are established on the basis of a petition Therefore, 40 CFR chapter I is
international maximum residue limits under FFDCA section 408(d), such as amended as follows:
(MRLs) established by the Codex the tolerance in this final rule, do not
Alimentarius Commission (Codex), as require the issuance of a proposed rule, PART 180—[AMENDED]
required by FFDCA section 408(b)(4). the requirements of the Regulatory
The Codex Alimentarius is a joint Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180
United Nations Food and Agriculture seq.), do not apply. continues to read as follows:
Organization/World Health This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371.
Organization food standards program, food processors, food handlers, and food
and it is recognized as an international retailers, not States or tribes, nor does ■ 2. In the table in paragraph (a) of
food safety standards-setting this action alter the relationships or § 180.557:
pmangrum on DSK3GDR082PROD with RULES
organization in trade agreements to distribution of power and ■ a. Revise the commodities of ‘‘Beet,
which the United States is a party. EPA responsibilities established by Congress sugar, dried pulp’’, ‘‘Beet, sugar,
may establish a tolerance that is in the preemption provisions of FFDCA molasses’’, and ‘‘Beet, sugar, root’’; and
different from a Codex MRL; however, section 408(n)(4). As such, the Agency ■ b. Add alphabetically the
FFDCA section 408(b)(4) requires that has determined that this action will not commodities of ‘‘Vegetable, cucurbit,
EPA explain the reasons for departing have a substantial direct effect on States group 9’’ and ‘‘Vegetable, fruiting, group
from the Codex level. or tribal governments, on the 8–10’’ to read as follows:
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![2906 Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Rules and Regulations
§ 180.557 Tetraconazole; tolerances for who use a telecommunications device outlined in the 2007 rule. As a matter
residues. for the deaf (TDD) may call the Federal of practice, the FS will have the same
(a) * * * Relay Service at 1–800–877–8339 to access to the BLM’s e-filing system and
contact the above individuals during the same user privileges as BLM
Commodity Parts per normal business hours. The Service is employees to process APDs and NOSs
million available 24 hours a day, 7 days a week electronically for wells proposed on
to leave a message or question with the National Forest Service (NFS) lands.
above individuals. You will receive a An APD is a request to drill an oil or
* * * * *
reply during normal business hours. gas well on Federal or Indian lands. An
Beet, sugar, dried pulp ............. 0.20 SUPPLEMENTARY INFORMATION: operator must have an approved APD
Beet, sugar, molasses .............. 0.25 prior to drilling. Prior to submitting an
I. Background
Beet, sugar, root ....................... 0.15 II. Discussion of Final Order, Section-by- APD, an applicant may file an NOS
Section Analysis, and Response to requesting the BLM to conduct an onsite
* * * * * Comments review of an operator’s proposed oil and
III. Procedural Matters gas drilling project. The purpose of an
Vegetable, cucurbit, group 9 .... 0.15 NOS is to provide the operator with an
Vegetable, fruiting, group 8–10 0.30 I. Background opportunity to gather information and
The BLM regulations governing better address site-specific resource
* * * * * onshore oil and gas operations are found concerns associated with a project while
[FR Doc. 2016–31824 Filed 1–9–17; 8:45 am] at 43 Code of Federal Regulations (CFR) preparing its APD package. Operators
BILLING CODE 6560–50–P part 3160, Onshore Oil and Gas are not required to submit an NOS prior
Operations. Section 3164.1 provides for to filing an APD.
the issuance of Onshore Oil and Gas The BLM has recently experienced a
DEPARTMENT OF THE INTERIOR Orders to implement and supplement decrease in the number of APDs
the regulations found in part 3160. received due to changes in market
Bureau of Land Management Onshore Order 1 has been in effect since conditions. Since 2009, the BLM
October 21, 1983, and was most recently received an average of about 5,000 APDs
43 CFR Part 3160 revised in 2007 (see 72 FR 10308 (March per year for wells on Federal and Indian
[WO–300–L13100000.PP0000] 7, 2007)) as part of a joint effort with the lands, of which Indian lands account for
Department of Agriculture and the about 16%. In FY 2015, the BLM
RIN 1004–AE37 Forest Service (FS), in response to new received approximately 4,500 APDs.
requirements imposed under Section From October 1, 2015, through the end
Onshore Oil and Gas Operations;
366 of the Energy Policy Act of 2005. of September 2016 (FY 2016), the BLM
Federal and Indian Oil and Gas Leases; On July 29, 2016, the BLM published estimates that it received only
Onshore Oil and Gas Order Number 1, in the Federal Register a proposed approximately 1,600 APDs. In coming
Approval of Operations Order that would revise sections III.A., years, due to the recent drop in oil
AGENCY: Bureau of Land Management, III.C., III.E., and III.I. in Onshore Order prices and persistently low natural gas
Interior. 1. The Order proposed to require e-filing prices, the BLM conservatively
of all APDs and NOSs. The comment estimates that an average of 3,000 APDs
ACTION: Final order.
period for the proposed Order closed on will be submitted per year. The BLM
SUMMARY: The Bureau of Land August 28, 2016. This final Order anticipates these market conditions to
Management (BLM) hereby amends its adopts all of the revisions identified in continue for the near term.
existing Onshore Oil and Gas Order the proposed Order. The available data show that use of
Number 1 (Onshore Order 1) to require Through this change, the BLM the BLM’s e-filing system for APDs and
the electronic filing (or e-filing) of all modifies Onshore Order 1 to require NOSs is common and broad-based
Applications for Permit to Drill (APD) operators to submit NOSs and APDs among operators, and therefore is not a
and Notices of Staking (NOS). through the e-filing system, Automated novel concept. Specifically, over the last
Previously, Onshore Order 1 stated that Fluid Mineral’s Support System few years, roughly half of the APDs
an ‘‘operator must file an APD or any (AFMSS II), as opposed to the previous submitted to the BLM were submitted
other required documents in the BLM system, which allowed either hardcopy using the e-filing system (Well
Field Office having jurisdiction over the or electronic submission. Under the Information System, or WIS). The other
lands described in the application,’’ but final Order, the BLM will consider half of the APDs were submitted in hard
allowed for e-filing of such documents granting waivers to the e-filing copy. More importantly, the data show
as an alternative. This change makes e- requirement for individuals who request that the use of e-filing has increased
filing the required method of a waiver because they would experience over time, with the rate nearly doubling
submission, subject to limited hardship if required to e-file (e.g., if an from 26 percent in FY 2010 to 51
exceptions. The BLM is making this operator is prevented from e-filing or is percent in FY 2014. As of 2014,
change to improve the efficiency and in a situation that would make e-filing approximately 411 operators had used
transparency of the APD and NOS so difficult to perform that it would the BLM’s WIS to e-file NOSs, APDs,
processes. significantly delay an operator’s APD well completion reports, sundry notices,
submission). and other application materials. Those
DATES: The final Order is effective on The change to Onshore Order 1 that operators represent an estimated 85
pmangrum on DSK3GDR082PROD with RULES
February 9, 2017. the BLM is implementing in this final percent of the operators that conduct
FOR FURTHER INFORMATION CONTACT: Order will not affect other provisions of drilling and completion operations on
Steven Wells, Division Chief, Fluid Onshore Order 1 that are not discussed Federal and Indian leases nationwide.
Minerals Division, 202–912–7143 for in this preamble or this final The BLM’s WIS system is a web-based
information regarding the substance of rulemaking, including the Onshore application that operators could use to
the final Order or information about the Order 1 provisions relating to the roles submit permit applications and other
BLM’s Fluid Minerals Program. Persons and responsibilities of the FS that are types of information electronically over
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Document Created: 2018-02-01 14:53:54
Document Modified: 2018-02-01 14:53:54
| 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 January 10, 2017. Objections and requests for hearings must be received on or before March 13, 2017, 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 | 82 FR 2900 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR