Metconazole; Pesticide Tolerances
Federal Register, Volume 80 Issue 103 (Friday, May 29, 2015)
Federal Register Volume 80, Number 103 (Friday, May 29, 2015)
Rules and Regulations
Pages 30619-30625
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-12936
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2014-0230; FRL-9927-11
Metconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of metconazole 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). In addition, this regulation removes established tolerances for certain commodities/groups superseded by this action, and deletes expired tolerances.
DATES: This regulation is effective May 29, 2015. Objections and requests for hearings must be received on or before July 28, 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-2014-0230, 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: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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).
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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.
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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-2014-0230 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 28, 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-2014-0230, 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.
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Summary of Petitioned-For Tolerance
In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-
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 4E8244) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.617 be amended by establishing tolerances for residues of the fungicide metconazole, 5-(4-chlorophenyl)methyl-2,-2-dimethyl-
1-(1H-1,2,4-triazol-1-ylmethyl)-cyclopentanol, in or on fruit, stone, group 12-12 at 0.2 parts per million (ppm); nut, tree, group 14-12 at 0.04 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm; rapeseed subgroup 20A at 0.08 ppm; and sunflower subgroup 20B at 0.9 ppm. The petition also requested that current established tolerances for residues of the fungicide metconazole in or on canola seed at 0.04 ppm; fruit, stone, group 12 at 0.20 ppm; pistachio at 0.04 ppm; and nut, tree, group 14 at 0.04 ppm be removed once the proposed tolerances were approved. That document referenced a summary of the petition prepared by Valent U.S.A Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's
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response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has determined the tolerance for the sunflower subgroup 20B should be 0.7 ppm. The reason for this change is explained in Unit IV.D.
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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 metconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with metconazole follows.
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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. Metconazole affects the liver, kidney, spleen, and various blood parameters at various dose levels across species. Specifically, in the mouse, rat, and dog, liver toxicity was seen after oral exposure in both subchronic and chronic exposures. Metconazole produces liver tumors in mice through a mitogenic mode of action (i.e., non-
genotoxic), and in the absence of a genotoxic mode of action, metconazole is classified as ``not likely to be carcinogenic to humans'' at levels that do not cause mitogenesis.
Oral studies revealed critical effects of metconazole on body weight and blood erythrocyte and/or platelet parameters in the mouse, rat, dog and/or rabbit. Hyperplasia and increased weight were observed in the spleen in the mouse, rat, and dog at dose levels where liver affects were also observed. Lenticular degeneration (cataracts) were observed at the highest dose tested 114 milligrams/kilogram/day (mg/kg/
day) in dogs. In addition, there was evidence that at high dietary levels metconazole is a gastrointestinal irritant in the dog.
In rats and rabbits developmental studies displayed some evidence of developmental effects but largely at dose levels that are maternally toxic. There was no quantitative or qualitative susceptibility in rabbit fetuses after in utero exposure to metconazole. In prenatal developmental toxicity studies in rabbits there was an increase in post-implantation loss and reduced fetal body weights at the same dose level that caused maternal toxicity. In rats, the developmental study showed skeletal variations at the lowest-observed-adverse-effect-level (LOAEL) in the absence of maternal toxicity. The 2-generation reproduction studies revealed offspring and parental toxicity only at the highest tested dose. There is low concern for quantitative susceptibility (skeletal variations in the absence of maternal toxicity in the developmental study) because the endpoint and point of departure are based on the effects in the fetus, for which there is a clear NOAEL. Therefore, it is concluded that there are no residual uncertainties for pre- and/or post-natal toxicity.
Metconazole did not demonstrate neurotoxicity in the subchronic neurotoxicity study, or any of the other studies in the toxicity data base. The requirement for an acute neurotoxicity study has been waived because of the absence of neurotoxic signs throughout the database, even at the highest dose levels tested.
There was no evidence of immunotoxicity at dose levels that produced systemic toxicity. No immunotoxic effects are evident for metconazole at dose levels as high as 52 (mg/kg/day) in rats, which is 12 times higher than the chronic dietary point of departure (4.3 mg/kg/
day).
EPA has classified metconazole as: ``Not Likely to be Carcinogenic to Humans'' based on convincing evidence demonstrating the following: (1) That a non-genotoxic mode of action for liver tumors was established in the mouse; (2) that the carcinogenic effects were not likely to occur below a defined dose that does not cause mitogenesis based on bioassays in the rat and the mouse; and (3) a lack of in vitro or in vivo mutagenicity. The established chronic RfD, which is below the level at which mitogenesis occurred in the rat and mouse, is deemed to be protective of mitogenesis/carcinogenesis, and no quantification is required.
Specific information on the studies received and the nature of the adverse effects caused by metconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document at ``Metconazole. Human Health Risk Assessment for a Section 3 Registration of New Uses on Dry Shelled Pea and Beans (Except Soybean) Crop Subgroup 6C and Sunflower Crop Subgroup 20B; Crop Group Expansion to Rapeseed Subgroup 20A; and Crop Group Conversion to Fruit, Stone, Group 12-12; and Nut, Tree, Group 14-12'' in docket ID number EPA-HQ-
OPP-2014-0230.
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Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
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Table 1--Summary of Toxicological Doses and Endpoints for Metconazole for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-50 NOAEL = 12 mg/kg/day Acute RfD = 0.12 mg/ Developmental toxicity in rats:
years of age). UFA = 10x........... kg/day. LOAEL = 30 mg/kg/day based on
UFH = 10x........... aPAD = 0.12 mg/kg/ increases in skeletal variations.
FQPA SF = 1x........ day.. At 75 mg/kg/day (the next higher
dose level) increased incidence
of post-implantation loss,
hydrocephaly and visceral
anomaliea (cranial hemorrhage,
dilated renal pelvis, dilated
ureters, and displaced testis)
were reported.
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Acute dietary (General population An appropriate dose/endpoint attributable to a single dose was not observed
including infants and children). in the available oral toxicity studies reviewed.
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Chronic dietary (All populations) NOAEL= 4.3 mg/kg/day Chronic RfD = 0.04 Chronic oral toxicity study in
UFA = 10x........... mg/kg/day. rats:
UFH = 10x........... cPAD = 0.04 mg/kg/ LOAEL = 13.1 mg/kg/day based on
FQPA SF = 1x........ day.. increased liver (M) weights and
associated hepatocellular lipid
vacuolation (M) and centrilobular
hypertrophy (M). Similar effects
were observed in females at 54 mg/
kg/day, plus increased spleen
weight.
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Incidental oral short-term (1 to NOAEL= 9.1 mg/kg/day Residential LOC for 28-Day oral toxicity study in
30 days). UFA = 10x........... MOE = 100. rats:
UFH = 10x........... LOAEL = 90.5 mg/kg/day based on
FQPA SF = 1x........ decreased body weight (M),
increased liver and kidney weight
and hepatocellular hypertrophy
and vacuolation (M/F).
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Dermal short-term (1 to 30 days). Quantification of dermal risk is not required due to lack of systemic or
dermal toxicity at the Limit Dose in a 21-day dermal toxicity study in the
rat, the lack of neurotoxicity, and the lack of developmental and/or
reproductive toxicity in the absence of parental effects, which were not
looked for in the dermal toxicity.
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Inhalation short-term (1 to 30 Inhalation (or oral) Residential LOC for 28-Day oral toxicity study in
days). study NOAEL= 9.1 mg/ MOE = 1000. rats:
kg/day (inhalation LOAEL = 90.5 mg/kg/day based on
absorption rate = decreased body weight (M),
100%). increased liver and kidney weight
UFA = 10x........... and hepatocellular hypertrophy
UFH = 10x........... and vacuolation (M/F).
FQPA SF = 10x (UFDB)
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Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans''.
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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). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies).
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Exposure Assessment
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Dietary exposure from food and feed uses. In evaluating dietary exposure to metconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing metconazole tolerances in 40 CFR 180.617. EPA assessed dietary exposures from metconazole 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.
No such effects were identified in the toxicological studies for metconazole for the general population including infants and children; therefore, a quantitative acute dietary exposure assessment is unnecessary for the general population.
Such effects were identified for metconazole for females 13-49 years old. In estimating acute dietary exposure, EPA used food consumption information from the Dietary Exposure Evaluation Model with the Food Commodity Intake Database (DEEM-FCID). This software incorporates 2003-2008 food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues for most crops. For cereal grains and livestock commodities, maximum residue levels of metabolites from field trials were added to the metconazole tolerance levels.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used food consumption information from the DEEM-FCID. This software incorporates 2003-2008 food consumption data from the NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and tolerance-level residues for most crops. For cereal grains and livestock commodities, maximum residue levels of metabolites from field trials were added to the metconazole tolerance levels.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that metconazole does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the
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purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for metconazole. Tolerance-level and metabolite residues and/or 100 PCT were assumed for all food commodities.
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Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk assessment for metconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier I Pesticide Root Zone Model-Ground Water (PRZM-
GW), the estimated drinking water concentrations (EDWC) of metconazole are estimated to be 51.8 parts per billion (ppb) for acute exposures and not applicable for chronic (non-cancer) exposures. Based on the Tier II Surface Water Concentration Calculator (SWCC) model, the EDWCs are estimated to be 49.6 ppb for acute exposures and 43.9 ppb for chronic (non-cancer) exposures.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment for females, the water concentration value of 51.8 ppb-was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 43.9 ppb was used to assess the contribution to drinking water.
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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).
Metconazole is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. EPA assessed residential exposure using the following assumptions: For residential handler exposure, the Agency assumed that residential use will result in short-term (1-30 days) dermal and inhalation exposures. Because there was no dermal endpoint chosen for metconazole, residential handler risk from exposure to metconazole was assessed for the inhalation route only.
The Agency assumed that post-application exposure in residential settings is short-term in duration only. No dermal endpoint was chosen for metconazole; therefore a dermal post-application risk assessment was not conducted for adults or children. Residential post-application inhalation exposure in outdoor settings is considered negligible. The scenarios evaluated were short-term post-application incidental oral exposure to children 1 to
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