80 FR 17697 - Difenoconazole; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 63 (April 2, 2015)
Federal Register Volume 80, Issue 63 (April 2, 2015)
| Page Range | 17697-17703 | |
| FR Document | 2015-07354 |
[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)] [Rules and Regulations] [Pages 17697-17703] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07354] [[Page 17697]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0149; FRL-9923-82] Difenoconazole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of difenoconazole in or on multiple commodities which are identified and discussed later in this document. Syngenta Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 2, 2015. Objections and requests for hearings must be received on or before June 1, 2015, 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-2014-0149, 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: Susan Lewis, 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 Publishing 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-2014-0149 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 June 1, 2015. 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-2014-0149, 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 September 5, 2014 (79 FR 53009) (FRL- 9914-98), 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 4F8231) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide, difenoconazole in or on pea, and bean, dried shelled, except soybean, subgroup 6C at 0.2 parts per million (ppm); pea, vine at 10 ppm; pea, hay at 40 ppm; and bushberry, subgroup 13-07B at 3.0 ppm. The petition also requested that the existing tolerance for chickpea be removed. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket identified by docket ID number EPA-HQ-OPP-2014-0373, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C. In the Federal Register of February 11, 2015 (80 FR 7559) (FRL- 9921-94), 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 3F8209) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR part 180 be amended by increasing existing tolerances for residues of the fungicide, difenoconazole in or on fruit, pome, group 11-10 from 1.0 to 3.0 ppm, and apple, wet pomace from 4.5 to 7.5 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established. The reason for these changes are explained in Unit IV.D. [[Page 17698]] 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 difenoconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with difenoconazole follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Subchronic and chronic studies with difenoconazole in mice and rats showed decreased body weights, decreased body weight gains and effects on the liver. In an acute neurotoxicity study in rats, reduced fore-limb grip strength was observed on 1-day in males and clinical signs of neurotoxicity were observed in females at the limit dose of 2,000 milligrams/kilograms (mg/kg). In a subchronic neurotoxicity study in rats, decreased hind limb strength was observed in males only at the mid- and high-doses. However, the effects observed in acute and subchronic neurotoxicity studies are transient, and the dose-response is well characterized with identified no-observed-adverse effects- levels (NOAELs). No systemic toxicity was observed at the limit dose in the most recently submitted 28-day rat dermal toxicity study. There is no concern for increased qualitative and/or quantitative susceptibility after exposure to difenoconazole in developmental toxicity studies in rats and rabbits, and a reproduction study in rats as fetal/offspring effects occurred in the presence of maternal toxicity. Although there is some evidence that difenoconazole affects antibody levels at doses that cause systemic toxicity, there are no indications in the available studies that organs associated with immune function, such as the thymus and spleen, are affected by difenoconazole. EPA is using the non-linear (reference dose) approach to assess cancer risk. Difenoconazole is not mutagenic, and no evidence of carcinogenicity was seen in rats. Evidence for carcinogenicity was seen in mice (liver tumors), but statistically significant carcinomas tumors were only induced at excessively-high doses. Adenomas (benign tumors) and liver necrosis only were seen at 300 parts per million (ppm) (46 and 58 mg/kg/day in males and females, respectively). Based on excessive toxicity observed at the two highest doses in the study, the presence of only benign tumors and necrosis at the mid-dose, the absence of tumors at the study's lower doses, and the absence of genotoxic effects, EPA has concluded that the chronic point of departure (POD) from the chronic mouse study will be protective of any cancer effects. The POD from this study is the NOAEL of 30 ppm (4.7 and 5.6 mg/kg/day in males and females, respectively) which was chosen based upon only those biological endpoints which were relevant to tumor development (i.e., hepatocellular hypertrophy, liver necrosis, fatty changes in the liver and bile stasis). Specific information on the studies received and the nature of the adverse effects caused by difenoconazole 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 page 44 of the document titled ``Difenoconazole: Human Health Risk Assessment for proposed new foliar uses on legume subgroup 6C and bushberry subgroup 13-07B; post-harvest uses on pome fruit group 11-10; and ornamental plants and vegetable transplants grown in both indoor and outdoor production facilities'' in docket ID number EPA-HQ-OPP-2014-0149. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological 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 difenoconazole used for human risk assessment is shown in Table 1 of this unit. [[Page 17699]] Table 1--Summary of Toxicological Doses and Endpoints for Difenoconazole for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (All populations).. NOAEL = 25 mg/kg/day Acute RfD = 0.25 mg/ Acute neurotoxicity study in rats UFA = 10x........... kg/day. LOAEL= 200 mg/kg in males based on UFH = 10x........... aPAD = 0.25 mg/kg/ reduced fore-limb grip strength FQPA SF = 1x........ day. in males on day 1. Chronic dietary (All populations) NOAEL= 0.96 mg/kg/ Chronic RfD = 0.01 Combined chronic toxicity/ day. mg/kg/day. carcinogenicity rat; dietary UFA = 10x........... cPAD = 0.01 mg/kg/ LOAEL = 24.1/32.8 mg/kg/day (M/F) UFH = 10x........... day. based on cumulative decreases in FQPA SF = 1x........ body-weight gains. Dermal Short-term (1-30 days).... Oral NOAEL = 1.25 mg/ LOC for MOE = 100.. Reproduction and fertility Study kg/day dermal rat; dietary Parental/Offspring absorption rate = LOAEL = 12.5 mg/kg/day based on 6%. decreased pup weight in males on UFA = 10x........... day 21 and reduction in body- UFH = 10x........... weight gain of F0 females prior FQPA SF = 1x........ to mating, gestation and lactation. Inhalation short-term (1-30 days) Oral NOAEL = 1.25 mg/ LOC for MOE = 100.. Reproduction and fertility Study Inhalation and oral absorption kg/day. rat; dietary Parental/Offspring assumed equivalent. UFA = 10x........... LOAEL = 12.5 mg/kg/day based on UFH = 10x........... decreased pup weight in males on FQPA SF = 1x........ day 21 and reduction in body- weight gain of F0 females prior to mating, gestation and lactation. Cancer (oral, dermal, inhalation) The Agency is using a non-linear approach based on the chronic POD to assess the carcinogenic potential of difenoconazole. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to difenoconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing difenoconazole tolerances in 40 CFR 180.475. EPA assessed dietary exposures from difenoconazole 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 difenoconazole. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues and 100 percent crop treated (PCT) information. 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, EPA used USDA Pesticide Data Program (PDP) monitoring data, average field trial residues for some commodities, tolerance level residues for the remaining commodities, and average percent crop treated for some commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to difenoconazole. Therefore, a separate quantitative cancer exposure assessment is unnecessary since the chronic dietary risk estimate will be protective of potential cancer risk. 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, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. For the chronic dietary exposure analysis, the Agency estimated the PCT for existing uses as follows: Almond 5%, cabbage 2.5%, cucumbers 5%, garlic 5%, grape 5%, grapefruit 2.5%, onions 5%, orange 2.5%, pecan 2.5%, peach 1%, peppers [[Page 17700]] 2.5%, pistachio 2.5%, pumpkin 2.5%, squash 5%, strawberry 2.5%, sugar beets 15%, tangerine 2.5%, tomatoes 25%, walnut 2.5%, watermelon 5%, and wheat 10%. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (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. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%. 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 difenoconazole 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 difenoconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of difenoconazole. 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. The drinking water assessment was performed using a total toxic residue (TTR) method which considers both parent difenoconazole and its major metabolite, CGA-205375, in surface and groundwater. Based on the surface water concentration calculator (SWCC) and screening concentration in ground water (SCI-GROW) and pesticide root zone model ground water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) of difenoconazole for acute exposures are estimated to be 20.0 parts per billion (ppb) for surface water and 1.77 ppb for ground water and for chronic exposure assessments are estimated to be 13.6 ppb for surface water and not detected 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 20.0 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 13.6 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). Difenoconazole is currently registered for the following uses that could result in residential exposures: Treatment of ornamental plants in commercial and residential landscapes and interior plantscapes. EPA assessed residential exposure using the following assumptions: For residential handlers, adult short-term dermal and inhalation exposure is expected from use on ornamentals (garden/trees). For residential post-application, short-term dermal exposure is expected for both adults and children from post-application activities in treated gardens. The scenarios used in the aggregate assessment were those that resulted in the highest exposures. The highest exposures consist of the following: Short-term dermal exposure to adults from post-application activities in treated gardens, and Short-term dermal exposure to children (6-11 years old) from post-application activities in treated gardens. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf. 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.'' Difenoconazole 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 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 conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. Difenoconazole 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 propiconazole, 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 [[Page 17701]] 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). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov, docket identification (ID) number EPA-HQ-OPP-2005-0497. The most recent update for the triazoles was conducted on October 24, 2013. The requested new uses of difenoconazole did not significantly change the dietary exposure estimates for free triazole or conjugated triazoles. Therefore, an updated dietary exposure analysis was not conducted. The October 24, 2013 update for triazoles may be found in docket ID number EPA-HQ-OPP-2014-0149. 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 (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The available Agency guideline studies indicated no increased qualitative or quantitative susceptibility of rats or rabbits to in utero and/or postnatal exposure to difenoconazole. In the prenatal developmental toxicity studies in rats and rabbits and the 2-generation reproduction study in rats, toxicity to the fetuses/offspring, when observed, occurred at equivalent or higher doses than in the maternal/parental animals. In a rat developmental toxicity study developmental effects were observed at doses higher than those which caused maternal toxicity. In the rabbit study, developmental effects (increases in post-implantation loss and resorptions and decreases in fetal body weight) were also seen at maternally toxic doses (decreased body weight gain and food consumption). In the 2-generation reproduction study in rats, toxicity to the fetuses/offspring, when observed, occurred at equivalent or higher doses than in the maternal/parental animals. 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 difenoconazole is complete. ii. There are no clear signs of neurotoxicity following acute, subchronic or chronic dosing in multiple species in the difenoconazole database. The effects observed in acute and subchronic neurotoxicity studies are transient, and the dose-response is well characterized with identified NOAELs. Based on the toxicity profile, and lack of concern for neurotoxicity, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that difenoconazole 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. iv. There are no residual uncertainties identified in the exposure databases. The dietary risk assessment is conservative, using tolerance level residues and 100 PCT for the acute assessment while the chronic assessment used USDA PDP monitoring data, average field trial residues for some commodities, tolerance level residues for remaining commodities, and average PCT for some commodities. These assumptions will not underestimate dietary exposure to difenoconazole. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to difenoconazole in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by difenoconazole. 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 difenoconazole will occupy 49% of the aPAD for all infants less than 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 difenoconazole from food and water will utilize 88% 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 difenoconazole 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). Difenoconazole 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 difenoconazole. 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 170 for adults and 190 for children. Because EPA's level of concern for difenoconazole 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). An intermediate-term adverse effect was identified; however, difenoconazole 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 [[Page 17702]] 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 difenoconazole. 5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A, the chronic dietary risk assessment is protective of any potential cancer effects. Based on the results of that assessment, EPA concludes that difenoconazole 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 difenoconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement method, GC/NPD method AG-575B, is available for the determination of residues of difenoconazole per se in/on plant commodities. An adequate enforcement method, liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) method REM 147.07b, is available for the determination of residues of difenoconazole and CGA- 205375 in livestock commodities. Adequate confirmatory methods are also available. 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 an established MRL for the sum of difenoconazole and its metabolite, 1-[2-chloro-4-(4-chlorophenoxy)-phenyl]-2-(1,2,4- triazol)-1-yl-ethano), expressed as difenoconazole in or on milk at 0.02 ppm, which is the same as the recommended U.S. tolerance. The Codex has not established an MRL for difenoconazole in or on pea and bean, dried shelled, except soybean, subgroup 6C; bushberry subgroup 13-07B; pea, field, hay; pea, field, vines; or apple, wet pomace. The Codex has an established MRL for difenoconazole in or on pome fruit at 0.5 ppm for residues incurred from foliar uses of difenoconazole. This MRL differs from the recommended U.S. tolerance for difenoconazole in or on fruit, pome, group 11-10 at 5.0 ppm. The Codex MRL is not adequate to cover residues incurred from the proposed post-harvest uses in the United States; therefore, harmonization with Codex is not possible at this time. C. Response to Comments Several comments were received in response to the notice of filing, however, all were concerned with effects to bees and related to other petitions and chemicals contained in the same notice of filing, not difenoconazole. D. Revisions to Petitioned-for Tolerances The tolerance being established for the bushberry subgroup 13-07B is 4.0 ppm, not 3.0 ppm as proposed. This is due to the independent field trial determination which resulted in the exclusion of one of the trials from the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. The tolerance being established for the pea and bean, dried shelled, except soybean, subgroup 6C tolerance is being set at 0.20 ppm, not 0.2 ppm, and is based on the current practice of setting tolerances to 2 significant figures. The established tolerance in milk is being increased from 0.01 ppm to 0.02 ppm because of the new pea hay and vine feedstuffs which significantly increased the maximum reasonably balanced dietary estimate for dairy cattle. Furthermore, the Agency is establishing tolerances for the fruit, pome, group 11-10 and apple, wet pomace (5.0 ppm and 25 ppm, respectively) at higher levels than requested (3.0 ppm and 7.5 ppm, respectively). The established tolerances for fruit, pome, group 11-10 take into account maximum tolerance estimates that may result from post-harvest application techniques for pome fruit. The established tolerances for apple, wet pomace was calculated based on the highest average field trial residues in or on apples and the average processing factor for wet pomace. Lastly, some commodity terms were modified to be consistent with Agency's preferred food and feed commodity vocabulary. V. Conclusion Therefore, tolerances are established for residues of difenoconazole, in or on bushberry subgroup 13-07B at 4.0 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.20 ppm; pea, field, hay at 40 ppm; and pea, field, vines at 10 ppm. Additionally, existing tolerances are modified as follows: Apple, wet pomace from 7.5 ppm to 25 ppm; fruit, pome, group 11-10 from 3.0 to 5.0 ppm; and milk from 0.01 to 0.02 ppm. Lastly, the existing chickpea tolerance is removed as unnecessary since it is now covered by the pea and bean, dried shelled, except soybean, subgroup 6C tolerance. 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 [[Page 17703]] 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: March 25, 2015. Susan Lewis, 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. 180.475: 0 i. Remove ``Chickpea'' from the table in paragraph (a)(1). ii. Add alphabetically the entries for ``Bushberry subgroup 13- 07B'', ``Pea and bean, dried shelled, except soybean, subgroup 6C'', ``Pea, field, hay'', and ``Pea, field, vines'' to the table in paragraph (a)(1). 0 iii. Revise the entries for ``Apple, wet pomace'' and ``Fruit, pome, group 11-10'' in the table in paragraph (a)(1). 0 iv. Revise the entry for ``Milk'' in the table in paragraph (a)(2). The amendments read as follows: Sec. 180.475 Difenoconazole; tolerances for residues. (a) * * * (1) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Apple, wet pomace........................................... 25 * * * * * Bushberry subgroup 13-07B................................... 4.0 * * * * * Fruit, pome, group 11-10.................................... 5.0 * * * * * Pea and bean, dried shelled, except soybean, subgroup 6C.... 0.20 Pea, field, hay............................................. 40 Pea, field, vines........................................... 10 * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Milk........................................................ 0.02 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-07354 Filed 4-1-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Rules and Regulations 17697
ENVIRONMENTAL PROTECTION provides a guide to help readers • Hand Delivery: To make special
AGENCY determine whether this document arrangements for hand delivery or
applies to them. Potentially affected delivery of boxed information, please
40 CFR Part 180 entities may include: follow the instructions at http://
[EPA–HQ–OPP–2014–0149; FRL–9923–82]
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
• Animal production (NAICS code Additional instructions on
Difenoconazole; Pesticide Tolerances 112). commenting or visiting the docket,
• Food manufacturing (NAICS code along with more information about
AGENCY: Environmental Protection 311). dockets generally, is available at
Agency (EPA). • Pesticide manufacturing (NAICS http://www.epa.gov/dockets.
ACTION: Final rule. code 32532).
II. Summary of Petitioned-for Tolerance
SUMMARY: This regulation establishes B. How can I get electronic access to
tolerances for residues of other related information? In the Federal Register of September
difenoconazole in or on multiple 5, 2014 (79 FR 53009) (FRL–9914–98),
You may access a frequently updated EPA issued a document pursuant to
commodities which are identified and electronic version of EPA’s tolerance
discussed later in this document. FFDCA section 408(d)(3), 21 U.S.C.
regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
Syngenta Crop Protection requested the Government Publishing Office’s e-
these tolerances under the Federal Food, pesticide petition (PP 4F8231) by
CFR site at http://www.ecfr.gov/cgi-bin/ Syngenta Crop Protection, LLC., P.O.
Drug, and Cosmetic Act (FFDCA). text-idx?&c=ecfr&tpl=/ecfrbrowse/
DATES: This regulation is effective April
Box 18300, Greensboro, NC 27419–
Title40/40tab_02.tpl. 8300. The petition requested that 40
2, 2015. Objections and requests for
hearings must be received on or before C. How can I file an objection or hearing CFR part 180 be amended by
June 1, 2015, and must be filed in request? establishing tolerances for residues of
accordance with the instructions the fungicide, difenoconazole in or on
Under FFDCA section 408(g), 21
provided in 40 CFR part 178 (see also pea, and bean, dried shelled, except
U.S.C. 346a, any person may file an
Unit I.C. of the SUPPLEMENTARY soybean, subgroup 6C at 0.2 parts per
objection to any aspect of this regulation
INFORMATION).
million (ppm); pea, vine at 10 ppm; pea,
and may also request a hearing on those
hay at 40 ppm; and bushberry, subgroup
ADDRESSES: The docket for this action, objections. You must file your objection
13–07B at 3.0 ppm. The petition also
identified by docket identification (ID) or request a hearing on this regulation
requested that the existing tolerance for
number EPA–HQ–OPP–2014–0149, is in accordance with the instructions
chickpea be removed. That document
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
referenced a summary of the petition
or at the Office of Pesticide Programs proper receipt by EPA, you must
prepared by Syngenta, the registrant,
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
which is available in the docket
in the Environmental Protection Agency OPP–2014–0149 in the subject line on
identified by docket ID number EPA–
Docket Center (EPA/DC), West William the first page of your submission. All
HQ–OPP–2014–0373, http://
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
www.regulations.gov. Comments were
Constitution Ave. NW., Washington, DC must be in writing, and must be
received on the notice of filing. EPA’s
20460–0001. The Public Reading Room received by the Hearing Clerk on or
response to these comments is
is open from 8:30 a.m. to 4:30 p.m., before June 1, 2015. Addresses for mail
discussed in Unit IV.C.
Monday through Friday, excluding legal and hand delivery of objections and
hearing requests are provided in 40 CFR In the Federal Register of February
holidays. The telephone number for the
178.25(b). 11, 2015 (80 FR 7559) (FRL–9921–94),
Public Reading Room is (202) 566–1744,
In addition to filing an objection or EPA issued a document pursuant to
and the telephone number for the OPP
hearing request with the Hearing Clerk FFDCA section 408(d)(3), 21 U.S.C.
Docket is (703) 305–5805. Please review
as described in 40 CFR part 178, please 346a(d)(3), announcing the filing of a
the visitor instructions and additional
submit a copy of the filing (excluding pesticide petition (PP 3F8209) by
information about the docket available
any Confidential Business Information Syngenta Crop Protection, LLC., P.O.
at http://www.epa.gov/dockets.
(CBI)) for inclusion in the public docket. Box 18300, Greensboro, NC 27419–
FOR FURTHER INFORMATION CONTACT: 8300. The petition requested that 40
Information not marked confidential
Susan Lewis, Registration Division CFR part 180 be amended by increasing
pursuant to 40 CFR part 2 may be
(7505P), Office of Pesticide Programs, existing tolerances for residues of the
disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 fungicide, difenoconazole in or on fruit,
notice. Submit the non-CBI copy of your
Pennsylvania Ave. NW., Washington, pome, group 11–10 from 1.0 to 3.0 ppm,
objection or hearing request, identified
DC 20460–0001; main telephone and apple, wet pomace from 4.5 to 7.5
by docket ID number EPA–HQ–OPP–
number: (703) 305–7090; email address: ppm. That document referenced a
2014–0149, by one of the following
RDFRNotices@epa.gov. summary of the petition prepared by
methods:
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// Syngenta Crop Protection, the registrant,
I. General Information www.regulations.gov. Follow the online which is available in the docket,
instructions for submitting comments. http://www.regulations.gov. There were
A. Does this action apply to me? Do not submit electronically any no comments received in response to
You may be potentially affected by information you consider to be CBI or the notice of filing.
tkelley on DSK3SPTVN1PROD with RULES
this action if you are an agricultural other information whose disclosure is Based upon review of the data
producer, food manufacturer, or restricted by statute. supporting the petition, EPA has
pesticide manufacturer. The following • Mail: OPP Docket, Environmental modified the levels at which some of the
list of North American Industrial Protection Agency Docket Center (EPA/ tolerances are being established. The
Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. reason for these changes are explained
not intended to be exhaustive, but rather NW., Washington, DC 20460–0001. in Unit IV.D.
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![17702 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Rules and Regulations
at least as protective as the POD used to EPA explain the reasons for departing that may result from post-harvest
assess intermediate-term risk), no from the Codex level. application techniques for pome fruit.
further assessment of intermediate-term The Codex has an established MRL for The established tolerances for apple,
risk is necessary, and EPA relies on the the sum of difenoconazole and its wet pomace was calculated based on the
chronic dietary risk assessment for metabolite, 1-[2-chloro-4-(4- highest average field trial residues in or
evaluating intermediate-term risk for chlorophenoxy)-phenyl]-2-(1,2,4- on apples and the average processing
difenoconazole. triazol)-1-yl-ethano), expressed as factor for wet pomace. Lastly, some
5. Aggregate cancer risk for U.S. difenoconazole in or on milk at 0.02 commodity terms were modified to be
population. As discussed in Unit III.A, ppm, which is the same as the consistent with Agency’s preferred food
the chronic dietary risk assessment is recommended U.S. tolerance. and feed commodity vocabulary.
protective of any potential cancer The Codex has not established an
MRL for difenoconazole in or on pea V. Conclusion
effects. Based on the results of that
assessment, EPA concludes that and bean, dried shelled, except soybean, Therefore, tolerances are established
difenoconazole is not expected to pose subgroup 6C; bushberry subgroup 13– for residues of difenoconazole, in or on
a cancer risk to humans. 07B; pea, field, hay; pea, field, vines; or bushberry subgroup 13–07B at 4.0 ppm;
6. Determination of safety. Based on apple, wet pomace. pea and bean, dried shelled, except
these risk assessments, EPA concludes The Codex has an established MRL for soybean, subgroup 6C at 0.20 ppm; pea,
that there is a reasonable certainty that difenoconazole in or on pome fruit at field, hay at 40 ppm; and pea, field,
no harm will result to the general 0.5 ppm for residues incurred from vines at 10 ppm. Additionally, existing
population, or to infants and children foliar uses of difenoconazole. This MRL tolerances are modified as follows:
from aggregate exposure to differs from the recommended U.S. Apple, wet pomace from 7.5 ppm to 25
difenoconazole residues. tolerance for difenoconazole in or on ppm; fruit, pome, group 11–10 from 3.0
fruit, pome, group 11–10 at 5.0 ppm. to 5.0 ppm; and milk from 0.01 to 0.02
IV. Other Considerations The Codex MRL is not adequate to cover ppm. Lastly, the existing chickpea
A. Analytical Enforcement Methodology residues incurred from the proposed tolerance is removed as unnecessary
post-harvest uses in the United States; since it is now covered by the pea and
An adequate enforcement method, therefore, harmonization with Codex is
GC/NPD method AG–575B, is available bean, dried shelled, except soybean,
not possible at this time. subgroup 6C tolerance.
for the determination of residues of
difenoconazole per se in/on plant C. Response to Comments
VI. Statutory and Executive Order
commodities. An adequate enforcement Several comments were received in Reviews
method, liquid chromatography/mass response to the notice of filing,
spectrometry/mass spectrometry (LC/ however, all were concerned with This action establishes tolerances
MS/MS) method REM 147.07b, is effects to bees and related to other under FFDCA section 408(d) in
available for the determination of petitions and chemicals contained in response to a petition submitted to the
residues of difenoconazole and CGA– the same notice of filing, not Agency. The Office of Management and
205375 in livestock commodities. difenoconazole. Budget (OMB) has exempted these types
Adequate confirmatory methods are also of actions from review under Executive
D. Revisions to Petitioned-for Order 12866, entitled ‘‘Regulatory
available.
The method may be requested from: Tolerances Planning and Review’’ (58 FR 51735,
Chief, Analytical Chemistry Branch, The tolerance being established for October 4, 1993). Because this action
Environmental Science Center, 701 the bushberry subgroup 13–07B is 4.0 has been exempted from review under
Mapes Rd., Ft. Meade, MD 20755–5350; ppm, not 3.0 ppm as proposed. This is Executive Order 12866, this action is
telephone number: (410) 305–2905; due to the independent field trial not subject to Executive Order 13211,
email address: residuemethods@ determination which resulted in the entitled ‘‘Actions Concerning
epa.gov. exclusion of one of the trials from the Regulations That Significantly Affect
Organization for Economic Cooperation Energy Supply, Distribution, or Use’’ (66
B. International Residue Limits and Development (OECD) tolerance FR 28355, May 22, 2001) or Executive
In making its tolerance decisions, EPA calculation procedures. The tolerance Order 13045, entitled ‘‘Protection of
seeks to harmonize U.S. tolerances with being established for the pea and bean, Children from Environmental Health
international standards whenever dried shelled, except soybean, subgroup Risks and Safety Risks’’ (62 FR 19885,
possible, consistent with U.S. food 6C tolerance is being set at 0.20 ppm, April 23, 1997). This action does not
safety standards and agricultural not 0.2 ppm, and is based on the current contain any information collections
practices. EPA considers the practice of setting tolerances to 2 subject to OMB approval under the
international maximum residue limits significant figures. The established Paperwork Reduction Act (PRA) (44
(MRLs) established by the Codex tolerance in milk is being increased U.S.C. 3501 et seq.), nor does it require
Alimentarius Commission (Codex), as from 0.01 ppm to 0.02 ppm because of any special considerations under
required by FFDCA section 408(b)(4). the new pea hay and vine feedstuffs Executive Order 12898, entitled
The Codex Alimentarius is a joint which significantly increased the ‘‘Federal Actions to Address
United Nations Food and Agriculture maximum reasonably balanced dietary Environmental Justice in Minority
Organization/World Health estimate for dairy cattle. Furthermore, Populations and Low-Income
Organization food standards program, the Agency is establishing tolerances for Populations’’ (59 FR 7629, February 16,
and it is recognized as an international the fruit, pome, group 11–10 and apple, 1994).
tkelley on DSK3SPTVN1PROD with RULES
food safety standards-setting wet pomace (5.0 ppm and 25 ppm, Since tolerances and exemptions that
organization in trade agreements to respectively) at higher levels than are established on the basis of a petition
which the United States is a party. EPA requested (3.0 ppm and 7.5 ppm, under FFDCA section 408(d), such as
may establish a tolerance that is respectively). The established tolerances the tolerance in this final rule, do not
different from a Codex MRL; however, for fruit, pome, group 11–10 take into require the issuance of a proposed rule,
FFDCA section 408(b)(4) requires that account maximum tolerance estimates the requirements of the Regulatory
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![Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Rules and Regulations 17703
Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. ENVIRONMENTAL PROTECTION
seq.), do not apply. AGENCY
This action directly regulates growers, ■ 2. In § 180.475:
food processors, food handlers, and food ■ i. Remove ‘‘Chickpea’’ from the table 40 CFR Part 300
retailers, not States or tribes, nor does in paragraph (a)(1).
this action alter the relationships or [EPA–HQ–SFUND–2014–0620; FRL–9924–
ii. Add alphabetically the entries for 66–OSWER]
distribution of power and
‘‘Bushberry subgroup 13–07B’’, ‘‘Pea
responsibilities established by Congress RIN 2050–AG76
and bean, dried shelled, except soybean,
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency subgroup 6C’’, ‘‘Pea, field, hay’’, and
National Oil and Hazardous
has determined that this action will not ‘‘Pea, field, vines’’ to the table in Substances Pollution Contingency
have a substantial direct effect on States paragraph (a)(1). Plan (NCP); Amending the NCP for
or tribal governments, on the ■ iii. Revise the entries for ‘‘Apple, wet Public Notices for Specific Superfund
relationship between the national pomace’’ and ‘‘Fruit, pome, group 11– Activities
government and the States or tribal 10’’ in the table in paragraph (a)(1).
governments, or on the distribution of AGENCY: Environmental Protection
■ iv. Revise the entry for ‘‘Milk’’ in the Agency (EPA).
power and responsibilities among the
table in paragraph (a)(2). ACTION: Final rule.
various levels of government or between
the Federal Government and Indian The amendments read as follows:
tribes. Thus, the Agency has determined SUMMARY: The Environmental Protection
§ 180.475 Difenoconazole; tolerances for Agency (EPA or the Agency) is adding
that Executive Order 13132, entitled
residues. language to the National Oil and
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175, (a) * * * (1) * * * Hazardous Substances Pollution
entitled ‘‘Consultation and Coordination Contingency Plan (NCP) to broaden the
with Indian Tribal Governments’’ (65 FR Parts per methods by which the EPA can notify
Commodity the public about certain Superfund
67249, November 9, 2000) do not apply million
to this action. In addition, this action activities.
does not impose any enforceable duty or DATES: This final rule is effective on
contain any unfunded mandate as * * * * *
May 4, 2015.
described under Title II of the Unfunded Apple, wet pomace ..................... 25
ADDRESSES: EPA has established a
Mandates Reform Act (UMRA) (2 U.S.C. docket for this action under Docket ID
1501 et seq.). * * * * *
Bushberry subgroup 13–07B ...... 4.0 No. EPA–HQ–SFUND–2014–0620. All
This action does not involve any
documents in the docket are listed in
technical standards that would require
* * * * * the www.regulations.gov index.
Agency consideration of voluntary
Fruit, pome, group 11–10 ........... 5.0 Although listed in the index, some
consensus standards pursuant to section
information is not publicly available,
12(d) of the National Technology
* * * * * e.g., Confidential Business Information
Transfer and Advancement Act
Pea and bean, dried shelled, ex- (CBI) or other information whose
(NTTAA) (15 U.S.C. 272 note).
cept soybean, subgroup 6C .... 0.20 disclosure is restricted by statute.
VII. Congressional Review Act Pea, field, hay ............................. 40 Certain other material, such as
Pursuant to the Congressional Review Pea, field, vines .......................... 10 copyrighted material, will be publicly
Act (5 U.S.C. 801 et seq.), EPA will available only in hard copy. Publicly
submit a report containing this rule and * * * * * available docket materials are available
other required information to the U.S. either electronically in
Senate, the U.S. House of (2) * * * www.regulations.gov or in hard copy at
Representatives, and the Comptroller the Superfund Docket (Docket ID No.
General of the United States prior to Parts per EPA–HQ–SFUND–2014–0620). This
Commodity
publication of the rule in the Federal million Docket Facility is open from 8:30 a.m.
Register. This action is not a ‘‘major to 4:30 p.m., Monday through Friday,
rule’’ as defined by 5 U.S.C. 804(2). excluding legal holidays. The telephone
* * * * * number for the Reading Room is (202)
List of Subjects in 40 CFR Part 180 Milk ............................................. 0.02 566–1744 and the telephone number for
Environmental protection, the Superfund Docket is (202) 566–
Administrative practice and procedure, * * * * * 0276. The EPA Docket Center (EPA/DC)
Agricultural commodities, Pesticides is located at WJC West Building, Room
and pests, Reporting and recordkeeping * * * * * 3334, 1301 Constitution Ave. NW.,
[FR Doc. 2015–07354 Filed 4–1–15; 8:45 am]
requirements. Washington, DC.
BILLING CODE 6560–50–P
Dated: March 25, 2015. FOR FURTHER INFORMATION CONTACT:
Susan Lewis, General Information: Superfund,
Director, Registration Division, Office of Toxics Release Inventory (TRI),
Pesticide Programs. Emergency Planning and Community
Right-to-Know Act (EPCRA), Risk
tkelley on DSK3SPTVN1PROD with RULES
Therefore, 40 CFR chapter I is
Management Program (RMP) and Oil
amended as follows:
Information Center at (800) 424–9346 or
PART 180—[AMENDED] TDD (800) 553–7672 (hearing impaired).
In the Washington, DC metropolitan
■ 1. The authority citation for part 180 area, call (703) 412–9810 or TDD (703)
continues to read as follows: 412–3323.
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Document Created: 2018-02-21 10:03:30
Document Modified: 2018-02-21 10:03:30
| 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 April 2, 2015. Objections and requests for hearings must be received on or before June 1, 2015, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 17697 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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