80 FR 79711 - Propiconazole; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 246 (December 23, 2015)
Federal Register Volume 80, Issue 246 (December 23, 2015)
| Page Range | 79711-79718 | |
| FR Document | 2015-32327 |
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)] [Rules and Regulations] [Pages 79711-79718] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32327] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0788; FRL-9939-83] Propiconazole; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of propiconazole in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 23, 2015. Objections and requests for hearings must be received on or before February 22, 2016, 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-2014-0788, 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 [[Page 79712]] 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 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-2014-0788 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 February 22, 2016. 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-2014-0788, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-for Tolerance In the Federal Register of October 21, 2015 (80 FR 63731) (FRL- 9935-29), 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 4E8321) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.434 be amended by establishing tolerances for residues of the fungicide, propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,- dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric equivalent of propiconazole, in or on the following raw agricultural commodities: Dill, dried at 80 parts per million (ppm); dill, fresh at 30 ppm; dill, seed at 15 ppm; fruit, stone, group 12-12, except plum at 4 ppm and nut, tree, group 14-12 at 0.1 ppm; leafy Brassica greens, subgroup 5B at 20 ppm; quinoa, grain, at 3.0 ppm; radish, roots at 0.04 ppm; radish, tops at 0.2 ppm; ti palm, leaves at 10 ppm; ti palm, roots at 0.3 ppm, and watercress at 6 ppm. IR-4 also requested that upon establishment of the above tolerances, that the existing tolerances for ``fruit, stone, group 12, except plum'' and ``nut, tree, group 14'' be removed. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket, http://www.regulations.gov. The October 21, 2015 notice supersedes a notice of filing published in the Federal Register on February 11, 2015 (80 FR 7559) (FRL-9921-94). The October 21, 2015 notice includes the commodity ``quinoa, grain'' as well as the other commodities that were originally requested in the February 11, 2015 notice. Two comments were received in response to the October 21, 2015 notice of filing. EPA's response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has modified some of the commodity vocabulary and rounded the significant figures of some of the tolerances. The reason for these changes are explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in 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 propiconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with propiconazole follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as [[Page 79713]] 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 primary target organ for propiconazole toxicity in animals is the liver. Increased liver weights were seen in mice after subchronic or chronic oral exposures to propiconazole. Liver lesions such as vacuolation of hepatocytes, ballooned liver cells, foci of enlarged hepatocytes, hypertrophy, and necrosis are characteristic of propiconazole toxicity in rats and mice. Decreased body weight gain was also seen in subchronic, chronic, developmental and reproductive studies in animal studies. Dogs appeared to be more sensitive to the localized toxicity of propiconazole as manifested by stomach irritations at 6 milligram/kilogram/day (mg/kg/day) and above. In rabbits, developmental toxicity occurred at a higher dose than the maternally toxic dose, while in rats, developmental toxicity occurred at lower doses than maternal toxic doses. Increased incidences of rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft palate malformations were noted in two studies in rats. In one published study in rats, developmental effects (malformations of the lung and kidneys, incomplete ossification of the skull, caudal vertebrae and digits, extra rib (14th rib) and missing sternbrae) were reported at doses that were not maternally toxic. In the two generation reproduction study in rats, offspring toxicity occurred at a higher dose than the parental toxic dose suggesting lower susceptibility of the offspring to the toxic doses of propiconazole. The acute neurotoxicity study produced severe clinical signs of toxicity (decreased activity, cold, pale, decreased motor activity, etc.) in rats at the high dose of 300 milligram/kilogram (mg/kg). Limited clinical signs (piloerection, diarrhea, tip toe gait) were observed in the mid-dose animals (100 mg/kg), while no treatment related signs were observed at 30 mg/kg. The current acute dietary assessment for the general population is based on the NOAEL of 30 mg/kg from the acute neurotoxicity study. A subchronic neurotoxicity study in rats did not produce neurotoxic signs at the highest dose tested that was associated with decreased body weight. Propiconazole was negative for mutagenicity in the in vitro BALB/ 3T3 cell transformation assay, bacterial reverse mutation assay, Chinese hamster bone marrow chromosomal aberration assay, unscheduled DNA synthesis studies in human fibroblasts and primary rat hepatocytes, mitotic gene conversion assay, and the dominant lethal assay in mice. It caused proliferative changes in the rat liver with or without pretreatment with an initiator, like phenobarbital, a known liver tumor promoter. Liver enzyme induction studies with propiconazole in mice demonstrated that propiconazole is a strong phenobarbital type inducer of xenobiotic metabolizing enzymes. Hepatocellular proliferation studies in mice suggest that propiconazole induces cell proliferation followed by treatment-related hypertrophy in a manner similar to the known hypertrophic agent phenobarbital. Propiconazole was carcinogenic to male mice but was not carcinogenic to rats or to female mice. The Agency classified propiconazole as a possible human carcinogen and recommended that, for the purpose of risk characterization, the reference dose (RfD) approach be used for quantification of human risk. Propiconazole is not genotoxic and this fact, together with special mechanistic studies, indicates that propiconazole is a threshold carcinogen. Propiconazole produced liver tumors in male mice only at a high dose that was toxic to the liver. At doses below the RfD, liver toxicity is not expected; therefore, tumors are also not expected. Specific information on the studies received and the nature of the adverse effects caused by propiconazole as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled, ``Propiconazole Human Health Risk Assessment for the New Uses of Propiconazole on dill, leafy brassicas crop subgroup 5B, ti palm, watercress, and quinoa, along with expansion to fruit, stone, group 12-12; except plum, and nut, tree, group 14-12'' on pp. 37 in docket ID number EPA-HQ-OPP-2014-0788. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population- adjusted dose (PAD) or a RfD--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for propiconazole used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Propiconazole 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 (Females 13-50 NOAEL = 30 mg/kg/day Acute RfD = 0.3 mg/ Developmental Study--Rat years of age). UFA = 10x........... kg/day. LOAEL = 90 mg/kg/day based on UFH = 10x........... aPAD = 0.3 mg/kg/ increased incidence of FQPA SF = 1x........ day. rudimentary ribs, un-ossified sternebrae, as well as increased incidence of shortened and absent renal papillae and increased cleft palate. [[Page 79714]] Acute dietary (General population NOAEL = 30 mg/kg/day Acute RfD = 0.3 mg/ Acute neurotoxicity study--Rat including infants and children). UFA = 10x........... kg/day. LOAEL = 100 mg/kg/day based on UFH = 10x........... aPAD = 0.3 mg/kg/ clinical signs of toxicity FQPA SF = 1x........ day. (piloerection in one male, diarrhea in one female, tip toe gait in 3 females). Chronic dietary (Adult Males and NOAEL= 10 mg/kg/day. Chronic RfD = 0.1 24-Month carcinogenicity study on Females 50+ yrs). UFA = 10x........... mg/kg/day. CD-1 mice. MRID 00129918 UFH = 10x........... cPAD = 0.1 mg/kg/ LOAEL = 50 mg/kg/day based on non- FQPA SF = 1x........ day. neoplastic liver effects (increased liver weight in males and increase in liver lesions: Masses/raised areas/swellings/ nodular areas mainly). Incidental oral short-term (1 to NOAEL= 30 mg/kg/day. LOC for MOE = 100.. Acute Neurotoxicity Study--Rats 30 days). UFA = 10x........... LOAEL = 100 mg/kg/day based on UFH = 10x........... clinical signs of toxicity FQPA SF = 1x........ (piloerection in one male, diarrhea in one female, tip toe gait in 3 females). Incidental oral intermediate-term NOAEL= 10 mg/kg/day. LOC for MOE = 100.. 24-Month carcinogenicity Study-- (1 to 6 months). UFA= 10x............ Mice UFH= 10x............ LOAEL = 50 mg/kg/day based on non- FQPA SF = 1x........ neoplastic liver effects (increased liver weight in males and increase in liver lesions: Masses/raised areas/swellings/ nodular areas mainly). Dermal short-term (1 to 30 days). Oral study NOAEL = LOC for MOE = 100.. Acute Neurotoxicity Study--Rats 30 mg/kg/day LOAEL = 100 mg/kg/day based on (dermal absorption clinical signs of toxicity rate = 40%). (piloerection in one male, UFA = 10x........... diarrhea in one female, tip toe UFH = 10x........... gait in 3 females). FQPA SF = 1x........ Dermal intermediate-term (1 to 6 Oral study NOAEL= 10 LOC for MOE = 100.. 24-Month carcinogenicity Study-- months). mg/kg/day (dermal Mice absorption rate = LOAEL = 50 mg/kg/day based on non- 40%). neoplastic liver effects UFA = 10x........... (increased liver weight in males UFH = 10x........... and increase in liver lesions: FQPA SF = 1x........ Masses/raised areas/swellings/ nodular areas mainly). Inhalation short-term (1 to 30 Oral study NOAEL= 30 LOC for MOE = 100.. Acute Neurotoxicity Study--Rats days). mg/kg/day LOAEL = 100 mg/kg/day based on (inhalation clinical signs of toxicity absorption rate = (piloerection in one male, 100%). diarrhea in one female, tip toe UFA = 10x........... gait in 3 females). UFH = 10x........... FQPA SF = 1x........ ------------------------------------------------------------------------------ Cancer (Oral, dermal, inhalation) Classification: Group C, possible human carcinogen, RfD approach for risk characterization. ---------------------------------------------------------------------------------------------------------------- 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 propiconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing propiconazole tolerances in 40 CFR 180.434. EPA assessed dietary exposures from propiconazole 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 propiconazole. 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 conducted an acute dietary analysis for propiconazole residues of concern using tolerance levels and 100 percent crop treated (PCT) for all existing and proposed uses. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's NHANES/ WWEIA. This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA conducted a chronic dietary analysis for propiconazole residues of concern using tolerance levels for some commodities, average field trial residues for the remaining commodities, and 100 PCT for all existing and proposed uses. iii. Cancer. Based on the data summarized in Unit III.A., EPA has [[Page 79715]] concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to propiconazole. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure. iv. Anticipated residue 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. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for propiconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of propiconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Surface Water Concentration Calculator (SWCC) and Pesticide Root Zone Model--Ground Water (PRZM-GW) models, the estimated drinking water concentrations (EDWCs) of propiconazole for acute exposures are estimated to be 35.2 parts per billion (ppb) for surface water and 37.9 ppb for ground water, and for chronic exposures are estimated to be 18.6 ppb for surface water and 35.1 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 37.9 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 35.1 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). Propiconazole is currently registered for the following uses that could result in residential exposures: Turf, ornamentals, and in paint. The highest incidental oral and dermal exposure scenarios are expected from residential use on turf. EPA assessed short-term risk to toddlers from incidental oral and dermal exposure and short-term risk to adults from dermal and inhalation residential handler exposure as well as from post-application dermal exposure. The highest post-application exposure from residential use on turf was used to assess risk to short-term aggregate exposures. The only residential use scenario that will result in potential intermediate term exposure to propiconazole is wood treatment, which the Agency assumes may result in dermal and incidental oral post- application exposures to children. No chronic exposures are expected. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' Propiconazole 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. Propiconazole 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 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 DNT. 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 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. That analysis concluded that risk estimates were below the Agency's level of concern for all population groups. This assessment may be found on http://www.regulations.gov by searching for the following title and docket number: ``Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address The New Section 3 Registrations For Use of Propiconazole on Tea, Dill, Mustard [[Page 79716]] Greens, Radish, and Watercress; Use of Difenoconazole on Globe Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.; and Use of Flutriafol on Hops'' (located 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. In the developmental toxicity study in rats, fetal effects observed in this study at a dose lower than that evoking maternal toxicity are considered to be quantitative evidence of increased susceptibility of fetuses to in utero exposure to propiconazole. Neither quantitative nor qualitative evidence of increased susceptibility was observed in utero or postnatally in either the rabbit developmental or 2-generation reproduction rat study. There is no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with propiconazole. In the rat acute neurotoxicity study, there was evidence of clinical toxicity at the high dose of 300 mg/kg, but no evidence of neuropathology from propiconazole administration. Although there was quantitative evidence of increased susceptibility of the young following exposure to propiconazole in the developmental rat study, the Agency determined there is a low degree of concern for this finding and no residual uncertainties because the increased susceptibility was based on minimal toxicity at high doses of administration, clear NOAELs and LOAELs have been identified for all effects of concern, and a clear dose-response has been well defined. 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 propiconazole is complete. ii. Other than the mild effects seen at 300 mg/kg in the acute neurotoxicity study, neurotoxicity and neurobehavioral effects were not seen in the propiconazole toxicity database. The liver, not the nervous system, is the primary target organ of propiconazole toxicity. iii. Although an apparent increased quantitative susceptibility was observed in fetuses and offspring, for the reasons noted in this Unit residual uncertainties or concerns for prenatal and/or postnatal toxicity are minimal. iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues, while the chronic used a combination of tolerance-level residues and reliable data on average field trial residues and 100 PCT. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to propiconazole in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. A turf transferable residue study is unavailable but being requested from the registrant for registration review of propiconazole. In all probability this study will reduce exposure estimates for both the incidental oral and post-application exposure to children. These assessments will not underestimate the exposure and risks posed by propiconazole. 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 propiconazole will occupy 84% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to propiconazole from food and water will utilize 25% 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 propiconazole 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). Propiconazole 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 propiconazole. 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 from post- application activities (the highest exposure scenario) of 200 for adults and 96 for children 1-2 years old. Although the MOE for children 1-2 years old is slightly below the target MOE of 100, the Agency does not believe that propiconazole poses short-term risks of concern because the difference is small and more than offset by the use of conservative endpoints and conservative exposure assumptions. This assessment is considered conservative since the short-term endpoints are based on a conservative LOAEL that is 3x higher than the NOAEL. Therefore, the true NOAEL is likely higher and would result in MOEs greater than 100. Further, the assessment combines conservative assumptions by using tolerance-level residues and reliable data on average field-trial residues and 100 PCT, conservative assumptions in the ground and surface water modeling, and conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. Refining any one of these conservatisms would result in MOEs for this age group that are not of concern. Although dietary (food and water) is not the aggregate exposure driver, incorporating PCT would likely increase the aggregate MOE further above 100. For example, using the Agency's highest average PCT [[Page 79717]] reported for propiconazole residues on crops (i.e., 55%), which is approximately half the currently assumed dietary exposure, the MOE for this age group would exceed the target MOE of 100 and not be of concern. Therefore, the Agency has determined that there is no short- term risk of concern from exposure to propiconazole. 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). Propiconazole is currently registered for use as a wood treatment that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to propiconazole. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 110 for children 1-2 years old. Because EPA's level of concern for propiconazole is a MOE of 100 or below, this MOE is not of concern. 5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., EPA considers the chronic aggregate risk assessment to be protective of any aggregate cancer risk. As there is no chronic risk of concern, EPA does not expect any cancer risk to the U.S. population from aggregate exposure to propiconazole. 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 propiconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, a high performance liquid chromatography with ultraviolet detection method (HPLC/UV Method AG- 671A) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. There are no Codex MRLs for dillweed (fresh or dried), dill seed, the brassica leafy greens subgroup 5B, ti palm, watercress, quinoa or radish. Codex does have MRLs in place for peach and plums (part of the U.S. stone fruit group), and pecans (part of the U.S. tree nut group) that are different than the U.S. tolerances. The U.S. tolerance expression is not harmonized with the Codex expression, which is expressed in terms of propiconazole per se, and therefore, the U.S. tolerance level for stone fruit and tree nuts cannot be harmonized with the Codex MRLs that are currently established. C. Response to Comments Two comments were received in response to the October 21, 2015 notice of filing. The first comment asserted that no residues should be allowed and that the pesticide should not be approved for sale or use. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. The second comment was from the Center for Biological Diversity and concerned endangered species; specifically stating that EPA cannot approve this new use prior to completion of consultations with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (``the Services''). This comment is not relevant to the Agency's evaluation of safety of the propiconazole tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment. D. Revisions to Petitioned-for Tolerances The Agency is revising the petitioned-for tolerance requests for ``dill, fresh'' and ``dill, dried'' to ``dillweed, fresh leaves'' and ``dillweed, dried leaves'', respectively, for consistency with the Agency's commodity vocabulary for those commodities. For the same reason, the Agency is revising the petitioned-for tolerance request for ``leafy Brassica greens, subgroup 5B'' to ``Brassica leafy greens, subgroup 5B''. In addition, EPA is revising the tolerance values for radish, tops; ti palm, roots; and watercress to be consistent with EPA's policy on significant figures for tolerances. V. Conclusion Therefore, tolerances are established for residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,- dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric equivalent of propiconazole, in or on brassica leafy greens, subgroup 5B at 20 ppm; dill seed at 15 ppm; dillweed, dried leaves at 80 ppm; dillweed, fresh leaves at 30 ppm; quinoa, grain at 3.0 ppm; radish, roots at 0.04 ppm; radish, tops at 0.20 ppm; ti palm, leaves at 10 ppm; ti palm, roots at 0.30 ppm; and watercress at 6.0 ppm. In addition, the existing fruit, stone, group 12, except plum and nut, tree, group 14 tolerances are modified to read ``fruit, stone, group 12-12, except plum'' and ``nut, tree, group 14-12,'' respectively. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of [[Page 79718]] 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, 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. 180.434: 0 a. Revise the entries for ``Fruit, stone, group 12, except plum'' and ``Nut, tree, group 14.'' 0 b. Add alphabetically the following commodities to the table in paragraph (a). The revisions and additions read as follows: Sec. 180.434 Propiconazole; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Brassica leafy greens, subgroup 5B...................... 20 * * * * * Dill, seed.............................................. 15 Dillweed, dried leaves.................................. 80 Dillweed, fresh leaves.................................. 30 * * * * * Fruit, stone, group 12-12, except plum.................. 4.0 * * * * * Nut, tree, group 14-12.................................. 0.10 * * * * * Quinoa, grain........................................... 3.0 Radish, roots........................................... 0.04 Radish, tops............................................ 0.20 * * * * * Ti palm, leaves......................................... 10 Ti palm, roots.......................................... 0.30 * * * * * Watercress.............................................. 6.0 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-32327 Filed 12-22-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations 79711
food safety standards-setting this action alter the relationships or § 180.960 Polymers; exemptions from the
organization in trade agreements to distribution of power and requirement of a tolerance.
which the United States is a party. EPA responsibilities established by Congress * * * * *
may establish a tolerance that is in the preemption provisions of FFDCA
different from a Codex MRL; however, section 408(n)(4). As such, the Agency Polymer CAS No.
FFDCA section 408(b)(4) requires that has determined that this action will not
EPA explain the reasons for departing have a substantial direct effect on States * * * * *
from the Codex level. or tribal governments, on the 2-propenoic acid,
The Codex has not established a MRL relationship between the national homopolymer, ester with
for 2-propenoic acid, homopolymer, government and the States or tribal a-[2,4,6-tris(1-
ester with a-[2,4,6-tris(1- governments, or on the distribution of phenylethyl)phenyl]-w-
phenylethyl)phenyl]-w- power and responsibilities among the hydroxypoly(oxy-1,2-
hydroxypoly(oxy-1,2-ethanediyl), various levels of government or between ethanediyl), compd. with
compd. with 2,2′,2″-nitrilotris[ethanol]. the Federal Government and Indian 2,2′,2″-nitrilotris[ethanol]),
tribes. Thus, the Agency has determined minimum number average
IX. Conclusion molecular weight (in amu),
that Executive Order 13132, entitled 10,000 ............................... 1477613–46–9
Accordingly, EPA finds that ‘‘Federalism’’ (64 FR 43255, August 10,
exempting residues of 2-propenoic acid, 1999) and Executive Order 13175, * * * * *
homopolymer, ester with a-[2,4,6-tris(1- entitled ‘‘Consultation and Coordination
phenylethyl)phenyl]-w- with Indian Tribal Governments’’ (65 FR [FR Doc. 2015–32176 Filed 12–22–15; 8:45 am]
hydroxypoly(oxy-1,2-ethanediyl), 67249, November 9, 2000) do not apply BILLING CODE 6560–50–P
compd. with 2,2′,2″-nitrilotris[ethanol] to this action. In addition, this action
from the requirement of a tolerance will does not impose any enforceable duty or
be safe. contain any unfunded mandate as ENVIRONMENTAL PROTECTION
X. Statutory and Executive Order described under Title II of the Unfunded AGENCY
Reviews Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.). 40 CFR Part 180
This action establishes a tolerance
under FFDCA section 408(d) in This action does not involve any [EPA–HQ–OPP–2014–0788; FRL–9939–83]
response to a petition submitted to the technical standards that would require
Agency consideration of voluntary Propiconazole; Pesticide Tolerances
Agency. The Office of Management and
Budget (OMB) has exempted these types consensus standards pursuant to section AGENCY: Environmental Protection
of actions from review under Executive 12(d) of the National Technology Agency (EPA).
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
ACTION: Final rule.
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
October 4, 1993). Because this action XI. Congressional Review Act SUMMARY: This regulation establishes
has been exempted from review under tolerances for residues of propiconazole
Pursuant to the Congressional Review in or on multiple commodities which
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, are identified and discussed later in this
submit a report containing this rule and document. Interregional Research
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect Project Number 4 (IR–4) requested these
Senate, the U.S. House of tolerances under the Federal Food,
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
FR 28355, May 22, 2001) or Executive Drug, and Cosmetic Act (FFDCA).
General of the United States prior to DATES: This regulation is effective
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
Children from Environmental Health December 23, 2015. Objections and
Register. This action is not a ‘‘major requests for hearings must be received
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
April 23, 1997). This action does not on or before February 22, 2016, and
contain any information collections List of Subjects in 40 CFR Part 180 must be filed in accordance with the
subject to OMB approval under the instructions provided in 40 CFR part
Environmental protection,
Paperwork Reduction Act (PRA) (44 178 (see also Unit I.C. of the
Administrative practice and procedure,
U.S.C. 3501 et seq.), nor does it require SUPPLEMENTARY INFORMATION).
Agricultural commodities, Pesticides
any special considerations under ADDRESSES: The docket for this action,
and pests, Reporting and recordkeeping
Executive Order 12898, entitled requirements. identified by docket identification (ID)
‘‘Federal Actions to Address number EPA–HQ–OPP–2014–0788, is
Dated: December 11, 2015. available at http://www.regulations.gov
Environmental Justice in Minority
Populations and Low-Income Susan Lewis, or at the Office of Pesticide Programs
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of Regulatory Public Docket (OPP Docket)
1994). Pesticide Programs. in the Environmental Protection Agency
Since tolerances and exemptions that Therefore, 40 CFR chapter I is Docket Center (EPA/DC), West William
are established on the basis of a petition amended as follows: Jefferson Clinton Bldg., Rm. 3334, 1301
under FFDCA section 408(d), such as Constitution Ave. NW., Washington, DC
asabaliauskas on DSK5VPTVN1PROD with RULES
PART 180—[AMENDED] 20460–0001. The Public Reading Room
the tolerance in this final rule, do not
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 is open from 8:30 a.m. to 4:30 p.m.,
the requirements of the Regulatory continues to read as follows: Monday through Friday, excluding legal
Flexibility Act (RFA) (5 U.S.C. 601 et holidays. The telephone number for the
Authority: 21 U.S.C. 321(q), 346a and 371. Public Reading Room is (202) 566–1744,
seq.), do not apply.
This action directly regulates growers, ■ 2. In § 180.960, add alphabetically the and the telephone number for the OPP
food processors, food handlers, and food following polymer to the table to read as Docket is (703) 305–5805. Please review
retailers, not States or tribes, nor does follows: the visitor instructions and additional
VerDate Sep<11>2014 16:43 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 E:\FR\FM\23DER1.SGM 23DER1](https://thefederalregister.org/doc/80_FR_79957/page/1.svg)
![79712 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations
information about the docket available any Confidential Business Information document referenced a summary of the
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. petition prepared by Syngenta, the
FOR FURTHER INFORMATION CONTACT: Information not marked confidential registrant, which is available in the
Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be docket, http://www.regulations.gov. The
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior October 21, 2015 notice supersedes a
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your notice of filing published in the Federal
Pennsylvania Ave. NW., Washington, objection or hearing request, identified Register on February 11, 2015 (80 FR
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP– 7559) (FRL–9921–94). The October 21,
number: (703) 305–7090; email address: 2014–0788, by one of the following 2015 notice includes the commodity
RDFRNotices@epa.gov. methods: ‘‘quinoa, grain’’ as well as the other
• Federal eRulemaking Portal: http:// commodities that were originally
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online requested in the February 11, 2015
I. General Information instructions for submitting comments. notice. Two comments were received in
Do not submit electronically any response to the October 21, 2015 notice
A. Does this action apply to me?
information you consider to be CBI or of filing. EPA’s response to these
You may be potentially affected by other information whose disclosure is comments is discussed in Unit IV.C.
this action if you are an agricultural restricted by statute. Based upon review of the data
producer, food manufacturer, or • Mail: OPP Docket, Environmental supporting the petition, EPA has
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ modified some of the commodity
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. vocabulary and rounded the significant
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. figures of some of the tolerances. The
not intended to be exhaustive, but rather • Hand Delivery: To make special reason for these changes are explained
provides a guide to help readers arrangements for hand delivery or in Unit IV.D.
determine whether this document delivery of boxed information, please
follow the instructions at http:// III. Aggregate Risk Assessment and
applies to them. Potentially affected
www.epa.gov/dockets/contacts.html. Determination of Safety
entities may include:
• Crop production (NAICS code 111). Additional instructions on commenting Section 408(b)(2)(A)(i) of FFDCA
• Animal production (NAICS code or visiting the docket, along with more allows EPA to establish a tolerance (the
112). information about dockets generally, is legal limit for a pesticide chemical
• Food manufacturing (NAICS code available at http://www.epa.gov/ residue in or on a food) only if EPA
311). dockets. determines that the tolerance is ‘‘safe.’’
• Pesticide manufacturing (NAICS Section 408(b)(2)(A)(ii) of FFDCA
code 32532). II. Summary of Petitioned-for Tolerance defines ‘‘safe’’ to mean that ‘‘there is a
In the Federal Register of October 21, reasonable certainty that no harm will
B. How can I get electronic access to 2015 (80 FR 63731) (FRL–9935–29), result from aggregate exposure to the
other related information? EPA issued a document pursuant to pesticide chemical residue, including
You may access a frequently updated FFDCA section 408(d)(3), 21 U.S.C. all anticipated dietary exposures and all
electronic version of EPA’s tolerance 346a(d)(3), announcing the filing of a other exposures for which there is
regulations at 40 CFR part 180 through pesticide petition (PP 4E8321) by IR–4, reliable information.’’ This includes
the Government Printing Office’s e-CFR IR–4 Project Headquarters, Rutgers, The exposure through drinking water and in
site at http://www.ecfr.gov/cgi-bin/text- State University of New Jersey, 500 residential settings, but does not include
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ College Road East, Suite 201 W, occupational exposure. Section
40tab_02.tpl. Princeton, NJ 08540. The petition 408(b)(2)(C) of FFDCA requires EPA to
requested that 40 CFR 180.434 be give special consideration to exposure
C. How can I file an objection or hearing amended by establishing tolerances for
request? of infants and children to the pesticide
residues of the fungicide, chemical residue in establishing a
Under FFDCA section 408(g), 21 propiconazole, 1-[[2-(2,4- tolerance and to ‘‘ensure that there is a
U.S.C. 346a, any person may file an dichlorophenyl)-4-propyl-1,3-dioxolan- reasonable certainty that no harm will
objection to any aspect of this regulation 2-yl] methyl]-1H-1,2,4-triazole and its result to infants and children from
and may also request a hearing on those metabolites determined as 2,4,- aggregate exposure to the pesticide
objections. You must file your objection dichlorobenzoic acid (2,4–DCBA), chemical residue. . . .’’
or request a hearing on this regulation expressed as the stoichiometric Consistent with FFDCA section
in accordance with the instructions equivalent of propiconazole, in or on 408(b)(2)(D), and the factors specified in
provided in 40 CFR part 178. To ensure the following raw agricultural FFDCA section 408(b)(2)(D), EPA has
proper receipt by EPA, you must commodities: Dill, dried at 80 parts per reviewed the available scientific data
identify docket ID number EPA–HQ– million (ppm); dill, fresh at 30 ppm; and other relevant information in
OPP–2014–0788 in the subject line on dill, seed at 15 ppm; fruit, stone, group support of this action. EPA has
the first page of your submission. All 12–12, except plum at 4 ppm and nut, sufficient data to assess the hazards of
objections and requests for a hearing tree, group 14–12 at 0.1 ppm; leafy and to make a determination on
must be in writing, and must be Brassica greens, subgroup 5B at 20 ppm; aggregate exposure for propiconazole
received by the Hearing Clerk on or quinoa, grain, at 3.0 ppm; radish, roots including exposure resulting from the
asabaliauskas on DSK5VPTVN1PROD with RULES
before February 22, 2016. Addresses for at 0.04 ppm; radish, tops at 0.2 ppm; ti tolerances established by this action.
mail and hand delivery of objections palm, leaves at 10 ppm; ti palm, roots EPA’s assessment of exposures and risks
and hearing requests are provided in 40 at 0.3 ppm, and watercress at 6 ppm. associated with propiconazole follows.
CFR 178.25(b). IR–4 also requested that upon
In addition to filing an objection or establishment of the above tolerances, A. Toxicological Profile
hearing request with the Hearing Clerk that the existing tolerances for ‘‘fruit, EPA has evaluated the available
as described in 40 CFR part 178, please stone, group 12, except plum’’ and ‘‘nut, toxicity data and considered its validity,
submit a copy of the filing (excluding tree, group 14’’ be removed. That completeness, and reliability as well as
VerDate Sep<11>2014 16:43 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 E:\FR\FM\23DER1.SGM 23DER1](https://thefederalregister.org/doc/80_FR_79957/page/2.svg)
![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations 79717
reported for propiconazole residues on international standards whenever Services’’). This comment is not
crops (i.e., 55%), which is possible, consistent with U.S. food relevant to the Agency’s evaluation of
approximately half the currently safety standards and agricultural safety of the propiconazole tolerances;
assumed dietary exposure, the MOE for practices. EPA considers the section 408 of the FFDCA focuses on
this age group would exceed the target international maximum residue limits potential harms to human health and
MOE of 100 and not be of concern. (MRLs) established by the Codex does not permit consideration of effects
Therefore, the Agency has determined Alimentarius Commission (Codex), as on the environment.
that there is no short-term risk of required by FFDCA section 408(b)(4).
D. Revisions to Petitioned-for
concern from exposure to The Codex Alimentarius is a joint
Tolerances
propiconazole. United Nations Food and Agriculture
4. Intermediate-term risk. Organization/World Health The Agency is revising the petitioned-
Intermediate-term aggregate exposure Organization food standards program, for tolerance requests for ‘‘dill, fresh’’
takes into account intermediate-term and it is recognized as an international and ‘‘dill, dried’’ to ‘‘dillweed, fresh
residential exposure plus chronic food safety standards-setting leaves’’ and ‘‘dillweed, dried leaves’’,
exposure to food and water (considered organization in trade agreements to respectively, for consistency with the
to be a background exposure level). which the United States is a party. EPA Agency’s commodity vocabulary for
Propiconazole is currently registered may establish a tolerance that is those commodities. For the same reason,
for use as a wood treatment that could different from a Codex MRL; however, the Agency is revising the petitioned-for
result in intermediate-term residential FFDCA section 408(b)(4) requires that tolerance request for ‘‘leafy Brassica
exposure, and the Agency has EPA explain the reasons for departing greens, subgroup 5B’’ to ‘‘Brassica leafy
determined that it is appropriate to from the Codex level. greens, subgroup 5B’’. In addition, EPA
aggregate chronic exposure through food There are no Codex MRLs for is revising the tolerance values for
and water with intermediate-term dillweed (fresh or dried), dill seed, the radish, tops; ti palm, roots; and
residential exposures to propiconazole. brassica leafy greens subgroup 5B, ti watercress to be consistent with EPA’s
Using the exposure assumptions palm, watercress, quinoa or radish. policy on significant figures for
described in this unit for intermediate- Codex does have MRLs in place for tolerances.
term exposures, EPA has concluded that peach and plums (part of the U.S. stone
the combined intermediate-term food, V. Conclusion
fruit group), and pecans (part of the U.S.
water, and residential exposures result tree nut group) that are different than Therefore, tolerances are established
in an aggregate MOE of 110 for children the U.S. tolerances. The U.S. tolerance for residues of propiconazole, 1-[[2-(2,4-
1–2 years old. Because EPA’s level of expression is not harmonized with the dichlorophenyl)-4-propyl-1,3-dioxolan-
concern for propiconazole is a MOE of Codex expression, which is expressed in 2-yl] methyl]-1H-1,2,4-triazole and its
100 or below, this MOE is not of terms of propiconazole per se, and metabolites determined as 2,4,-
concern. therefore, the U.S. tolerance level for dichlorobenzoic acid (2,4-DCBA),
5. Aggregate cancer risk for U.S. stone fruit and tree nuts cannot be expressed as the stoichiometric
population. Based on the discussion in harmonized with the Codex MRLs that equivalent of propiconazole, in or on
Unit III.A., EPA considers the chronic are currently established. brassica leafy greens, subgroup 5B at 20
aggregate risk assessment to be ppm; dill seed at 15 ppm; dillweed,
protective of any aggregate cancer risk. C. Response to Comments dried leaves at 80 ppm; dillweed, fresh
As there is no chronic risk of concern, Two comments were received in leaves at 30 ppm; quinoa, grain at 3.0
EPA does not expect any cancer risk to response to the October 21, 2015 notice ppm; radish, roots at 0.04 ppm; radish,
the U.S. population from aggregate of filing. The first comment asserted that tops at 0.20 ppm; ti palm, leaves at 10
exposure to propiconazole. no residues should be allowed and that ppm; ti palm, roots at 0.30 ppm; and
6. Determination of safety. Based on the pesticide should not be approved for watercress at 6.0 ppm. In addition, the
these risk assessments, EPA concludes sale or use. The Agency understands the existing fruit, stone, group 12, except
that there is a reasonable certainty that commenter’s concerns and recognizes plum and nut, tree, group 14 tolerances
no harm will result to the general that some individuals believe that are modified to read ‘‘fruit, stone, group
population, or to infants and children pesticides should be banned on 12–12, except plum’’ and ‘‘nut, tree,
from aggregate exposure to agricultural crops. However, the existing group 14–12,’’ respectively.
propiconazole residues. legal framework provided by section
408 of the FFDCA states that tolerances VI. Statutory and Executive Order
IV. Other Considerations Reviews
may be set when persons seeking such
A. Analytical Enforcement Methodology tolerances or exemptions have This action establishes tolerances
Adequate enforcement methodology, demonstrated that the pesticide meets under FFDCA section 408(d) in
a high performance liquid the safety standard imposed by that response to a petition submitted to the
chromatography with ultraviolet statute. The comment appears to be Agency. The Office of Management and
detection method (HPLC/UV Method directed at the underlying statute and Budget (OMB) has exempted these types
AG–671A) is available to enforce the not EPA’s implementation of it; the of actions from review under Executive
tolerance expression. The method may citizen has made no contention that Order 12866, entitled ‘‘Regulatory
be requested from: Chief, Analytical EPA has acted in violation of the Planning and Review’’ (58 FR 51735,
Chemistry Branch, Environmental statutory framework. October 4, 1993). Because this action
asabaliauskas on DSK5VPTVN1PROD with RULES
Science Center, 701 Mapes Rd., Ft. The second comment was from the has been exempted from review under
Meade, MD 20755–5350; telephone Center for Biological Diversity and Executive Order 12866, this action is
number: (410) 305–2905; email address: concerned endangered species; not subject to Executive Order 13211,
residuemethods@epa.gov. specifically stating that EPA cannot entitled ‘‘Actions Concerning
approve this new use prior to Regulations That Significantly Affect
B. International Residue Limits completion of consultations with the Energy Supply, Distribution, or Use’’ (66
In making its tolerance decisions, EPA U.S. Fish and Wildlife Service and the FR 28355, May 22, 2001) or Executive
seeks to harmonize U.S. tolerances with National Marine Fisheries Service (‘‘the Order 13045, entitled ‘‘Protection of
VerDate Sep<11>2014 16:43 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 E:\FR\FM\23DER1.SGM 23DER1](https://thefederalregister.org/doc/80_FR_79957/page/7.svg)
![79718 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations
Children from Environmental Health General of the United States prior to * * * * *
Risks and Safety Risks’’ (62 FR 19885, publication of the rule in the Federal [FR Doc. 2015–32327 Filed 12–22–15; 8:45 am]
April 23, 1997). This action does not Register. This action is not a ‘‘major BILLING CODE 6560–50–P
contain any information collections rule’’ as defined by 5 U.S.C. 804(2).
subject to OMB approval under the
List of Subjects in 40 CFR Part 180
Paperwork Reduction Act (PRA) (44 DEPARTMENT OF TRANSPORTATION
U.S.C. 3501 et seq.), nor does it require Environmental protection,
any special considerations under Administrative practice and procedure, National Highway Traffic Safety
Executive Order 12898, entitled Agricultural commodities, Pesticides Administration
‘‘Federal Actions to Address and pests, Reporting and recordkeeping
Environmental Justice in Minority requirements. 49 CFR Parts 591 and 592
Populations and Low-Income Dated: December 14, 2015.
Populations’’ (59 FR 7629, February 16, [Docket No. NHTSA–2015–0076]
Susan Lewis,
1994). Director, Registration Division, Office of RIN 2127–AL63
Since tolerances and exemptions that Pesticide Programs.
are established on the basis of a petition Allowing Importers To Provide
Therefore, 40 CFR chapter I is
under FFDCA section 408(d), such as Information to U.S. Customs and
amended as follows:
the tolerance in this final rule, do not Border Protection in Electronic Format
require the issuance of a proposed rule, PART 180—[AMENDED]
the requirements of the Regulatory AGENCY: National Highway Traffic
Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180 Safety Administration (NHTSA),
seq.), do not apply. continues to read as follows: Department of Transportation (DOT).
This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371. ACTION: Final rule.
food processors, food handlers, and food
retailers, not States or tribes, nor does ■ 2. In § 180.434: SUMMARY: On September 2, 2015, the
this action alter the relationships or ■ a. Revise the entries for ‘‘Fruit, stone, National Highway Traffic Safety
distribution of power and group 12, except plum’’ and ‘‘Nut, tree, Administration (NHTSA) published an
responsibilities established by Congress group 14.’’ interim final rule and request for
■ b. Add alphabetically the following comment entitled ‘‘Allowing Importers
in the preemption provisions of FFDCA
commodities to the table in paragraph to Provide Information to U.S. Customs
section 408(n)(4). As such, the Agency
(a). and Border Protection in Electronic
has determined that this action will not The revisions and additions read as
have a substantial direct effect on States Format.’’ No comments were received in
follows: response to the interim final rule.
or tribal governments, on the
relationship between the national § 180.434 Propiconazole; tolerances for Accordingly, this final rule confirms
government and the States or tribal residues. that the September 2, 2015 interim final
governments, or on the distribution of (a) * * * rule will not be changed and its
power and responsibilities among the effective date is September 2, 2015.
various levels of government or between Commodity Parts per mil- DATES : Effective December 23, 2015.
the Federal Government and Indian lion
FOR FURTHER INFORMATION CONTACT:
tribes. Thus, the Agency has determined Arija Flowers, Trial Attorney, Office of
that Executive Order 13132, entitled * * * * * the Chief Counsel, National Highway
‘‘Federalism’’ (64 FR 43255, August 10, Brassica leafy greens, sub- Traffic Safety Administration, 1200 New
1999) and Executive Order 13175, group 5B ......................... 20 Jersey Avenue SE., Washington, DC
entitled ‘‘Consultation and Coordination 20590 (telephone: 202–366–5263).
with Indian Tribal Governments’’ (65 FR * * * * *
SUPPLEMENTARY INFORMATION: As
67249, November 9, 2000) do not apply Dill, seed ............................. 15
Dillweed, dried leaves ........ 80 NHTSA received no comments on its
to this action. In addition, this action interim final rule published on
Dillweed, fresh leaves ........ 30
does not impose any enforceable duty or September 2, 2015 (80 FR 53011), the
contain any unfunded mandate as * * * * * agency is making no changes to the rule
described under Title II of the Unfunded Fruit, stone, group 12–12, and its effective date is September 2,
Mandates Reform Act (UMRA) (2 U.S.C. except plum ..................... 4.0 2015. For regulatory analyses and
1501 et seq.). notices associated with this action,
This action does not involve any * * * * *
please see the interim final rule
technical standards that would require Nut, tree, group 14–12 ....... 0.10
published at 80 FR 53011.
Agency consideration of voluntary Accordingly, the interim rule
* * * * *
consensus standards pursuant to section amending 49 CFR parts 591 and 592,
Quinoa, grain ...................... 3.0
12(d) of the National Technology Radish, roots ...................... 0.04 published at 80 FR 53011 on September
Transfer and Advancement Act Radish, tops ........................ 0.20 2, 2015, is adopted as final without
(NTTAA) (15 U.S.C. 272 note). change.
* * * * *
VII. Congressional Review Act Issued in Washington, DC, on December
asabaliauskas on DSK5VPTVN1PROD with RULES
Ti palm, leaves ................... 10
Pursuant to the Congressional Review Ti palm, roots ...................... 0.30 17, 2015 under authority delegated in 49 CFR
Act (5 U.S.C. 801 et seq.), EPA will part 1.95.
submit a report containing this rule and * * * * * Mark R. Rosekind,
other required information to the U.S. Watercress .......................... 6.0 Administrator.
Senate, the U.S. House of * * * * *
[FR Doc. 2015–32260 Filed 12–22–15; 8:45 am]
Representatives, and the Comptroller BILLING CODE 4910–59–P
VerDate Sep<11>2014 16:43 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00064 Fmt 4700 Sfmt 9990 E:\FR\FM\23DER1.SGM 23DER1](https://thefederalregister.org/doc/80_FR_79957/page/8.svg)
Document Created: 2018-03-02 09:21:53
Document Modified: 2018-03-02 09:21:53
| 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 December 23, 2015. Objections and requests for hearings must be received on or before February 22, 2016, 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 79711 | |
| 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