Source: https://www.federalregister.gov/documents/2010/01/27/2010-1614/triticonazole-pesticide-tolerances
Timestamp: 2018-03-24 23:59:39
Document Index: 301992902

Matched Legal Cases: ['art 180', 'art 178', 'art 178', 'art 178', 'art 2', 'art 158']

Federal Register :: Triticonazole; Pesticide Tolerances
Triticonazole; Pesticide Tolerances
75 FR 4284
4284-4288 (5 pages)
EPA-HQ-OPP-2009-0276
FRL-8808-6
2010-1614
https://www.federalregister.gov/d/2010-1614 https://www.federalregister.gov/d/2010-1614
This regulation establishes tolerances for residues of triticonazole in or on grain, cereal, group 15, except rice, and grain, cereal, forage, fodder and straw, group 16, except rice. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0276. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
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 cite at http://www.gpoaccess.gov/​ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/​oppts and select “Test Methods & Guidelines” on the left-side navigation menu.
Under section 408(g) of FFDCA, 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-2009-0276 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before March 29, 2010.
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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2009-0276, by one of the following methods:
In the Federal Register of August 19, 2009, (74 FR 41900) (FRL-8426-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8F7420) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.583 be amended by establishing tolerances for residues of the fungicide triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on grain, cereal, group 15, except rice, and grain, cereal, forage, fodder and straw, group 16, except rice, at 0.05 and 0.10 parts per million (ppm), respectively. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has modified both the crop group terminology, and tolerance levels for Start Printed Page 4285grain, cereal, group 15, except rice, at 0.01 ppm, and the crop group terminology (only) for grain, cereal, forage, fodder and straw, group 16, except rice, at 0.10 ppm. These tolerances replace previously established individual tolerances for barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw at 0.05 ppm. The reason for these changes is explained in Unit IV.C.
Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for tolerances for residues of triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol on grain, cereal, group 15, except rice, at 0.01 ppm, and grain, cereal, forage, fodder and straw, group 16, except rice, at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.
Triticonazole has low acute toxicity, is not a skin, eye, or respiratory irritant, or a dermal sensitizer. Non-acute toxicity studies show that the liver (rat, mouse, dog) and adrenals (rat, dog, rabbit) are target organs across species. Adverse body weight changes (rat, dog, rabbit, mouse) and clinical signs (rat, dog, mouse) also were observed in multiple species. In the developmental and reproductive toxicity studies, adverse effects were seen at the same dose level in the offspring and parental animals, and the offspring were not qualitatively more susceptible compared with adults. In the rat subchronic study, decreased thymus weights were reported at a dose level (~2,300 milligrams/kilogram/day (mg/kg/day)) two times higher than the limit dose (1,000 mg/kg/day). Triticonazole was negative for mutagenicity, and the cancer classification is “Not Likely to Be Carcinogenic to Humans” based on a lack of evidence of carcinogenicity in the two guideline studies conducted on rats and mice.
Specific information on the studies received and the nature of the adverse effects caused by triticonazole 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 “Triticonazole. Human Health Risk Assessment for Proposed Seed Treatment Use on Cereal Grains (Crop Group 15) Including Barley, Field Corn, Oats, Popcorn, Rye, Sorghum Grain, Sweet Corn, Triticale, and Wheat (Excluding Rice); and Forage, Fodder, and Straw of Cereal Grains (Crop Group 16), Excluding Rice,” at pages 34 to 36 in docket ID number EPA-HQ-OPP-2009-0276.
A summary of the toxicological endpoints for triticonazole used for human risk assessment can be found at http://www.regulations.gov in the document “Triticonazole. Human Health Risk Assessment for Proposed Seed Treatment Use on Cereal Grains (Crop Group 15) Including Barley, Field Corn, Oats, Popcorn, Rye, Sorghum Grain, Sweet Corn, Triticale, and Wheat (Excluding Rice); and Forage, Fodder, and Straw of Cereal Grains (Crop Group 16), Excluding Rice,” at pages 15 to 16 in docket ID number EPA-HQ-OPP-2009-0276.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to triticonazole, EPA considered exposure under the petitioned-for tolerances as well as all existing triticonazole tolerances in 40 CFR 180.583. EPA assessed dietary exposures from triticonazole in food as follows:
In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Start Printed Page 4286Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance level residues of triticonazole were found in all commodities and that all commodities consumed were 100% crop treated. Anticipated residues and/or percent crop treated (PCT) information were not used.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance level residues in all commodities, and 100% crop treated for all treated commodities. Anticipated residues and/or PCT information were not used.
iii. Cancer. Triticonazole is classified as “not likely to be carcinogenic to humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. There is no evidence that triticonazole is carcinogenic to humans, therefore an exposure assessment to evaluate cancer risk is not needed.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for triticonazole. Tolerance level residues and/or 100% crop treated were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for triticonazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of triticonazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/​oppefed1/​models/​water/​index.htm.
The estimated drinking water concentrations (EDWCs) used in the dietary risk assessment were provided by OPP's Environmental Fate and Effects Division and incorporated directly into the dietary assessment. The EDWCs used in the dietary assessment were modeled using the surface water model, Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS). For the acute point estimate, the PRZM-EXAMS 1-in-10 year annual maximum EDWC was used. For the chronic point estimate, the PRZM-EXAMS 1-in-10 year annual mean EDWC was used. PRZM-EXAMS EDWCs were used because they were higher (and therefore more protective) than the groundwater model’s, (Screening Concentration in Groudwater model (SCI-GROW’s)) EDWC. Based on the PRZM/EXAMS, the EDWCs of triticonazole for acute exposures are 75.5 parts per billion (ppb) for surface water and 5.7 ppb for ground water, and chronic exposures for non-cancer assessments are estimated to be 32.8 ppb for surface 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 75.5 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 32.8 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). Triticonazole is currently registered for the following uses that could result in residential exposures: Residential and commercial turfgrass, golf courses, and sod farms. EPA quantitatively assessed the risk from residential exposure to children from children’s incidental oral post-application scenarios (hand to mouth, mouthing grass, and soil ingestion). Children and adults may also have post-application dermal exposure but dermal toxicity studies with triticonazole did not identify any adverse effects from such exposure.
EPA has not found triticonazole to share a common mechanism of toxicity with any other substances, and triticonazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that triticonazole does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/​pesticides/​cumulative.
Triticonazole 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. In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice; some induce thyroid tumors in rats; and 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 website at http://www.epa.gov/​pesticides/​cumulative.
Triticonazole and other triazole-containing pesticides 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 triticonazole, 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). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency’s complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov, Docket Start Printed Page 4287Identification (ID) Number EPA-HQ-OPP-2005-0497.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for triticonazole includes rat and rabbit developmental toxicity studies and a two generation reproduction study in rats. There is no evidence of increased susceptibility following in utero and/or postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study.
i. The toxicity database for triticonazole is complete with the exception of a newly required immunotoxicity study. In accordance with 40 CFR Part 158 toxicity data requirements, an immunotoxicity study (Harmonized guideline 870.7800) is required for triticonazole. In the absence of specific immunotoxicity studies, EPA has evaluated the available triticonazole toxicity data to determine whether an additional uncertainty factor is needed to account for potential immunotoxicity. The toxicological database for triticonazole does not indicate that the immune system is the primary target organ. Decreased thymus weight was observed in only one species (rat) at the highest dose tested (~2x the limit dose of 1,000 mg/kg/day); these findings may be due to secondary effects of overt systemic toxicity. Based on this evidence, EPA does not believe that conducting immunotoxicity testing will result in a point of departure lower than those already selected for triticonazole risk assessment, and an additional uncertainty factor is not needed to account for potential immunotoxicity.
ii. There are no indications that triticonazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that triticonazole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure database. The dietary food exposure assessments were performed based on 100% crop treated and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to triticonazole in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the combined acute dietary exposure from food and water to triticonazole will occupy < 1% of the aPAD for (females 13 to 49 years old), the population subgroups 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 triticonazole from food and water will utilize 1.4% of the cPAD for all infants (< 1 year old), the subgroup receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of triticonazole 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). Triticonazole is currently registered for use(s) 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 triticonazole.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of: 1,100 for children 1 to 2 years old, and 1,100 for all infants < 1 year old. Because the level of concern is for MOEs below 100, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Triticonazole is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure to triticonazole through food and water with intermediate-term exposures for triticonazole.
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 aggregated result in aggregate MOEs of: 780 for children 1 to 2 years old, and 740 for all infants < 1 year old. Because the level of concern is for MOEs below 100, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Triticonazole is classified as “not likely to be carcinogenic to humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. Thus, triticonazole is not expected to pose a cancer risk.
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 triticonazole residues.
Adequate enforcement methodology (liquid chromatography/mass spectrometry (LC/MS), and liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) methods (Method 148.02) is available to Start Printed Page 4288enforce the tolerance expression. These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
There are no established Codex or Mexican maximum residue levels (MRLs)/tolerances for triticonazole on wheat or barley. Triticonazole is registered as a seed treatment in Canada for oats, barley, and wheat, and has established MRL levels at 0.01 ppm on barley, oats, and wheat and for livestock commodities at 0.05 ppm. The Canadian MRLs on barley, oats, and wheat are in harmony with the United States' 0.01 ppm tolerance level for grain, cereal, group 15, except rice. Additionally, no U.S. tolerances have been established on livestock commodities. No harmonization issues exist in connection with the proposed use on turf.
EPA determined the tolerances for grain, cereal, group 15, except rice, should be established at 0.01 ppm, based on a harmonization concern with Canada, and residue data which supported this tolerance level. Thus the proposed tolerance level of 0.05 ppm was deemed excessive. Upon establishing the grain, cereal, group 15, except rice, tolerance at 0.01 ppm, the individual tolerances established for barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw at 0.05 ppm are being removed from 40 CFR 180.583(a).
Therefore, tolerances are established for residues of triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on grain, cereal, group 15, except rice, at 0.01 ppm, and grain, cereal, forage, fodder and straw, group 16, except rice, at 0.10 ppm.
2. Section 180.583 is amended by revising the table in paragraph (a) to read as follows:
Grain, cereal, forage, fodder and straw, group 16, except rice 0.10
[FR Doc. 2010-1614 Filed 1-26-10; 8:45 am]