Source: https://www.federalregister.gov/documents/2009/12/18/E9-30039/fluoxastrobin-pesticide-tolerances
Timestamp: 2018-04-21 02:54:21
Document Index: 347755113

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

67108-67114 (7 pages)
EPA-HQ-OPP-2008-0704
FRL-8803-4
https://www.federalregister.gov/d/E9-30039 https://www.federalregister.gov/d/E9-30039
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0704. 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.
John Bazuin, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7381; e-mail address: bazuin.john@epa.gov.
In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may also 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-2008-0704 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 February 16, 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-2008-0704, by one of the following methods:
In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-8390-4), 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 8F7437) by Arysta LifeScience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 be amended by establishing tolerances for combined residues of the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on corn, field, grain at 0.02 parts per million (ppm); corn, field, aspirated grain fractions at 0.50 ppm; corn, field, forage at 3.0 ppm; corn, field, fodder/stover at 4.5 ppm; soybean, seed at 0.05 ppm; soybean, aspirated grain fractions at 0.40 ppm; soybean, forage at 9.0 ppm; soybean, hay at 1.2 ppm; and soybean, hulls at 0.40 ppm.
Also in the Federal Register of December 3, 2008 (73 FR 73644) (FRL-8386-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a another pesticide petition (PP 8F7406) by Arysta LifeScience North America, LLC. The petition requested that 40 CFR 180.609 be amended by establishing Start Printed Page 67110tolerances for the combined residues of the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime , in or on low growing berries (crop subgroup 13-07G) at 1.9 ppm. Each notice referenced a summary of the appropriate petition which had been prepared by Arysta LifeScience North America, LLC, the registrant, and 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 corrected the commodity and subgroup names, and replaced “corn, field, aspirated grain fractions” and “soybeans, aspirated grain fractions” with “aspirated grain fractions.” EPA has also substantially increased the tolerance for aspirated grain fractions and decreased the tolerance for soybean, hulls. The reasons for these changes are 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 the combined residues of fluoxastrobin and its Z isomer in or on aspirated grain fractions at 20 ppm; berry, low growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at 9.0 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.20 ppm; soybean, seed at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.
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. Fluoxastrobin shows low acute toxicity via the oral, dermal, and inhalation routes of exposure; is a moderate eye irritant; and is neither a dermal irritant nor a sensitizer. Following repeated administration, fluoxastrobin has mild or low toxicity in all tested species other than the dog which displayed adverse liver toxicity at considerably lower doses than those noted for other testing species. The most common finding across all testing species is decreased body weight. In the available toxicity studies on fluoxastrobin, there is no estrogen, androgen, and/or thyroid mediated toxicity. Fluoxastrobin does not produce developmental toxicity in rats or rabbits. In the rat and rabbit developmental toxicity studies and the two-generation reproduction rat study, there is no increased susceptibility to prenatal or postnatal exposure to fluoxastrobin and no effects on reproduction. Fluoxastrobin is not neurotoxic following acute or repeated dosing in the rat. Fluoxastrobin is not genotoxic, and it is also not carcinogenic in rats or mice. Specific information on the studies received and the nature of the adverse effects caused by fluoxastrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 16, 2005 (70 FR 54640) (FRL-7719-9).
A summary of the toxicological endpoints for fluoxastrobin used for human risk assessment can be found at http://www.regulations.gov in the document “Fluoxastrobin. Human Health Risk Assessment for Proposed Uses on Field Corn, Soybean, and the Low-Growing Berry Subgroup 13-07G,” at page 20 in docket ID number EPA-HQ-OPP-2008-0704.
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if Start Printed Page 67111a 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 fluoxastrobin; therefore, a quantitative acute dietary exposure assessment was not performed.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture 1994-1996 and 1998 CSFII. As to residue levels in food, EPA performed an unrefined dietary (food and drinking water) exposure assessment. The assumptions of this dietary assessment included tolerance level residues and 100% crop treated. Experimentally derived processing factors were applied for tomato puree, potato chips, dry potato granules/flakes, and potato flour. For all other processed commodities, DEEM version 7.81 default processing factors were assumed.
iii. Cancer. The Agency has concluded that fluoxastrobin is not likely to be carcinogenic to humans. Therefore cancer risk is not of concern for this chemical.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or less than 100% crop treated information in the dietary assessment for fluoxastrobin. Tolerance level residues and 100% CT were assumed for all food commodities.
Based on the FQPA Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluoxastrobin for chronic exposures for non-cancer assessments are estimated to be 28 parts per billion (ppb) for surface water and less than 1 ppb for ground water. The modeled estimate of surface drinking water concentration was directly entered into the dietary exposure model. For chronic dietary risk assessment, a water concentration value of 28 ppb was used to assess the contribution of 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, termite control, and flea and tick control on pets).
Fluoxastrobin is currently registered for the following uses that could result in postapplication residential exposures: Turf, including lawns and golf courses. No residential handler exposure uses have been registered because all applications to residential turf must be made by a certified pest control operator. EPA assessed residential exposure using the following assumptions: Maximum application rates, no dissipation of residues after the day of application, and no dissipation of residues because of periodic growth and recutting of the grass. The Agency believes that the calculated risks represent screening level estimates. Principal potential routes of exposure include dermal and incidental oral ingestion. The Agency has assumed that most residential use will result in short-term exposures but that intermediate-term exposures are also possible. It should be noted that the new fluoxastrobin uses assessed for this final rule do not include any residential uses.
2. Prenatal and postnatal sensitivity. The toxicity database for fluoxastrobin, including acceptable developmental toxicity studies in rats and rabbits, as well as a two-generation reproduction toxicity study, provides no indication of prenatal and/or postnatal sensitivity.
i. The toxicity database for fluoxastrobin is considered adequate to support endpoint selection for risk assessment and FQPA evaluation. The submitted studies are of good quality and provide sufficient information to determine whether fluoxastrobin poses a human health hazard. The only data deficiency that exists is the requirement for additional information concerning the mouse subchronic immunotoxicity study, for potential upgrade of the study. To address the immunotoxicity data requirement as presented in 40 CFR part 158 the Agency has examined the entire toxicity database for fluoxastrobin and drawn the following conclusion: There is no evidence of biologically relevant effects on the immune system that are related to fluoxastrobin and the overall weight of the evidence indicates that this chemical does not directly target the immune system.
iii. There is no indication of increased quantitative or qualitative susceptibility in rats or rabbits following in utero and/or postnatal exposure to fluoxastrobin.
iv. There are no residual uncertainties identified in the exposure database. The chronic dietary food exposure assessment utilizes proposed tolerance-level residues and 100% crop treated information for all commodities. Use of these screening-level assessment values helps ensure that chronic exposures and risks will not be underestimated. EPA additionally made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluoxastrobin in Start Printed Page 67112drinking water. EPA used similarly conservative assumptions to assess residential post-application exposure of children as well as incidental oral exposure of toddlers to fluoxastrobin. These assessments will not underestimate the exposure and risks posed by fluoxastrobin.
1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, fluoxastrobin is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluoxastrobin from food and water will utilize 38% of the cPAD for children 1 to 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 fluoxastrobin is not expected.
3. Short- and intermediate-term risk. Fluoxastrobin is currently registered for uses that could result in both short- and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to fluoxastrobin. Short- and intermediate-term aggregate exposure assessments take into account short- and intermediate-term residential exposure, respectively, plus chronic exposure to food and water (considered to be a background exposure level). Because all short- and intermediate-term quantitative hazard estimates (via the dermal and incidental oral routes) for fluoxastrobin are based on the same endpoint, a screening-level, conservative aggregate risk assessment was conducted that combined the short-term incidental oral and intermediate-term exposure estimates (i.e., the highest exposure estimates). The Agency believes that most residential exposure will be short-term, based on the use pattern.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short- and intermediate-term food, water, and residential exposures aggregated result in aggregate MOEs of 750 for adult males, 840 for adult females, and 160 for children 1 to 2 years old. For adult males and adult females, residential exposure is via the oral (background) and dermal (primary) routes. For children 1 to 2 years old, residential exposure is via the oral (background) and incidental oral and dermal (primary) routes.
4. Aggregate cancer risk for the U.S. population. The Agency has concluded that fluoxastrobin is not likely to be carcinogenic to humans. Therefore cancer risk is not of concern for this chemical.
Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry method) is available to enforce the tolerance expression. Method No. 00604 is available for plant commodities and Method No. 00691, Modification 001, is available for animal commodities. The 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 currently no established Codex, Canadian, or Mexican Maximum Residue Levels (MRLs) for fluoxastrobin for the low-growing berry subgroup 13-07G, soybean, or field corn commodities.
EPA converted “corn, field, fodder/stover” to “corn, field, stover” to conform to the terminology in the current pesticide commodity vocabulary. The Agency also replaced “corn, field, aspirated grain fractions” and “soybean, aspirated grain fractions” with “aspirated grain fractions” to conform to the terminology in the current pesticide commodity vocabulary. The proposed tolerances of 0.50 ppm in or on corn, field, aspirated grain fractions and 0.40 ppm in or on soybean, aspirated grain fractions were changed to a tolerance of 20 ppm in or on aspirated grain fractions based on current guidance, which recommends that the established tolerance be based on the aspirated grain fraction that has the highest residues. In this case it is soybean. The soybean highest available field trial (HAFT) residue of 0.031 ppm multiplied by the expected processing factor for aspirated grain fractions of 611x produces calculated expected residues in aspirated grain fractions of 18.9 ppm. The fluoxastrobin tolerance in/on aspirated grain fractions was therefore set at 20 ppm. The proposed tolerance of 0.40 ppm in/on soybean hulls was reduced to 0.20 ppm because the HAFT residue for soybean of 0.031 ppm is expected to concentrate 4x in soybean hulls. This produces a calculated residue of 0.124 ppm and a decision that a tolerance of 0.20 ppm is appropriate. In addition, the establishment of tolerances on field corn commodities requires that the tolerance for indirect and inadvertent residues for fluoxastrobin and its Z isomer in/on grain, cereal, forage, fodder, and straw, group 16, be modified to apply to grain, cereal, forage, fodder, and straw, group 16, except corn instead. The tolerance expressions in 40 CFR 180.609 are also being modified to conform to new Agency guidance on the language tolerance expressions should conform to, but this change does not have any other effect on the existing fluoxastrobin tolerances.
Therefore, tolerances are established for the combined residues of fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on aspirated grain fractions at 20 ppm; berry, low growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at 9.0 ppm; soybean, Start Printed Page 67113hay at 1.2 ppm; soybean, hulls at 0.20 ppm; and soybean, seed at 0.05 ppm.
2. Section 180.609 is revised to read as follows:
(a) General. (1) Tolerances are established for residues of fluoxastrobin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, calculated as the stoichiometric equivalent of fluoxastrobin.
Aspirated grain fractions 20
Berry, low growing, subgroup 13-07G 1.9
Soybean, forage 9.0
(2) Tolerances are established for residues of fluoxastrobin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, calculated as the stoichiometric equivalent of fluoxastrobin.
Horse, meat, byproducts 0.10
(d) Indirect or inadvertent residues. Tolerances are established for the indirect or inadvertent residues of Start Printed Page 67114fluoxastrobin, including its metabolites and degradates, in or on the commodities in the table below, when present therein as a result of the application of fluoxastrobin to the growing crops listed in paragraph (a)(1) of this section. Compliance with the tolerance levels specified below is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, calculated as the stoichiometric equivalent of fluoxastrobin.
Grain, cereal, forage, fodder, and straw, group 16, except corn 0.10
[FR Doc. E9-30039 Filed 12-17-09; 8:45 am]