Fluoxastrobin; Pesticide Tolerances, 20100-20105 [2014-07820]

Download as PDF 20100 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations EPA-APPROVED NEW HAMPSHIRE SOURCE SPECIFIC REQUIREMENTS Name of source Permit No. * * Waste Management ........................ * ARD–01–001 State effective date 4/27/2012 EPA approval date 2 Explanations * * 11/5/2012, 77 FR 66388 ................ * * Single source NOX RACT order for facility in Rochester, NH. * * * * * * * order to determine the EPA effective date for a specific provision listed in this table, consult the FEDERAL REGISTER notice cited in this column for the particular provision. 2 In FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: OPP–2012–0576 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 10, 2014. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). [EPA–HQ–OPP–2012–0576; FRL–9907–46] I. General Information Fluoxastrobin; Pesticide Tolerances A. Does this action apply to me? Environmental Protection Agency (EPA). ACTION: Final rule. 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). 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– 2012–0576, by one of the following methods: * * * * * [FR Doc. 2014–07729 Filed 4–10–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 AGENCY: This regulation establishes tolerances for residues of fluoxastrobin in or on wheat, grain; and revises tolerances for milk; and milk, fat. Arysta LifeScience, North America, LLC, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective April 11, 2014. Objections and requests for hearings must be received on or before June 10, 2014, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0576, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West 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 https://www.epa.gov/dockets. mstockstill on DSK4VPTVN1PROD with RULES ADDRESSES: VerDate Mar<15>2010 19:04 Apr 10, 2014 Jkt 232001 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 https://ecfr.gpoaccess.gov/cgi/t/ text/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– PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 • Federal eRulemaking Portal: https:// 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 https:// www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/ dockets. II. Summary of Petitioned-for Tolerance In the Federal Register of February 27, 2013 (78 FR 13296) (FRL–9380–2), EPA issued a document pursuant to E:\FR\FM\11APR1.SGM 11APR1 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8130) by Arysta LifeScience, North America, LLC, 15401 Weston Pkwy., Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 be amended by establishing tolerances for residues of the fungicide, fluoxastrobin, (1E)-[2-[[6(2-chlorophenoxy)-5-fluoro-4pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z-isomer, (1Z)-[2[[6-(2-chlorophenoxy)-5-fluoro-4pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on wheat, grain at 0.15 parts per million (ppm). The petition also requested that 40 CFR 180.609 be amended by revising tolerances for milk from 0.02 ppm to 0.03 ppm; and milk, fat from 0.50 ppm to 0.75 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience, North America LLC, the registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit IV.C. mstockstill on DSK4VPTVN1PROD with RULES 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 VerDate Mar<15>2010 17:05 Apr 10, 2014 Jkt 232001 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 fluoxastrobin including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with fluoxastrobin follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Following repeated exposure, fluoxastrobin has mild or low toxicity in all tested species except for the dog. Repeated oral administration to dogs resulted in adverse liver toxicity at considerably lower doses than those noted in other species. Based on species sensitivity, the effects observed in the dog were used as endpoints for risk assessment. In both the 90-day and oneyear oral feeding studies in dogs, the liver appeared to be the target organ. In dogs, mice, and rats, the kidney was another target organ. There was no indication of an adverse effect attributable to a single dose. Based on developmental toxicity studies (rat and rabbit) and a two-generation reproduction study (rat), there was neither increased susceptibility of pre-/ postnatal exposure to fluoxastrobin, nor adverse effects on reproduction. Furthermore, acute neurotoxic effects were not seen in an acute neurotoxicity study in rats up to the limit dose of 2,000 milligrams/kilogram/day (mg/kg/ day). In a subchronic neurotoxicity study in rats, fluoxastrobin did not elicit any neurotoxic effects. Repeated dose studies of fluoxastrobin in the database did not show immunotoxic effects in rats. Results of genotoxicity testing were negative and there were no treatmentrelated carcinogenicity findings in adequately performed carcinogenicity studies in rats and mice. Therefore, fluoxastrobin is classified as ‘‘not likely PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 20101 to be carcinogenic to humans.’’ Specific information on the studies received and the nature of the adverse effects caused by fluoxastrobin as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document, ‘‘Fluoxastrobin. Aggregate Human Health Risk Assessment for the Proposed New Uses on Melon Subgroup 9A and Sorghum, Along with Establishment of Permanent Tolerances on Wheat, and Amendments to Established Tolerances on Milk and Milk Fat’’ on pages 26–31 in docket ID number EPA–HQ–OPP–2012–0576. 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 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 https:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for fluoxastrobin used for human risk assessment is shown in Table 1 of this unit. E:\FR\FM\11APR1.SGM 11APR1 20102 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOXASTROBIN FOR USE IN DIETARY, NONOCCUPATIONAL, AND OCCUPATIONAL HUMAN HEALTH RISK ASSESSMENT Point of departure and uncertainty/ safety factors Exposure/scenario Acute dietary (General population including infants and children) and Females 13–49 years of age. RfD, PAD, LOC for risk assessment Study and toxicological effects None: There is no indication of an adverse effect attributable to a single dose. An aRfD was not established. Chronic dietary (All populations) ............ NOAEL = 1.5 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.015 mg/kg/day. cPAD = 0.015 mg/ kg/day. Chronic toxicity dog LOAEL = M/F 8.1/7.7 mg/kg/day based on body weight reductions and hepatocytomegaly and cytoplasmic changes associated with increased serum liver alkaline phosphatase indicative of cholestasis. Incidental oral short-term (1 to 30 days) and Intermediate-term (1–6 months). NOAEL = 3.0 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100. 90-day subchronic dog LOAEL = M/F 24.8/24.2 mg/kg/day based on dose-related reductions in net body weight gain and food efficiency in addition to toxicity findings in the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of the proximal tubular epithelium in males). Dermal short-term (1 to 30 days) ........... None: There were no systemic or dermal toxicity findings in a 28-day dermal toxicity study in the rat up to the limit dose (1,000 mg/kg/day) and there were no developmental or neurotoxicity concerns raised in other studies. Dermal intermediate-term months). 6 NOAEL = 3.0 mg/ kg/day. dermal absorption factor = 2.3%. Residential LOC for MOE = 100. Occupational LOC for MOE = 100. 90-day subchronic dog LOAEL = M/F 24.8/24.2 mg/kg/day based on dose-related reductions in net body weight gain and food efficiency in addition to toxicity findings in the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of the proximal tubular epithelium in males). Inhalation b Short-Term (1–30 days) and Intermediate-Term (1–6 months). NOAEL = 3.0 mg/ kg/day. Residential LOC for MOE = 100. Occupational LOC for MOE = 100. 90-day subchronic dog LOAEL = M/F 24.8/24.2 mg/kg/day based on dose-related reductions in net body weight gain and food efficiency in addition to toxicity findings in the liver (cholestasis) in both sexes, and kidneys (increased relative weights in females and degeneration of the proximal tubular epithelium in males). Cancer (Oral, dermal, inhalation) ........... Classification: ‘‘Not likely to be Carcinogenic to Humans.’’ (1 to a ‘‘Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.’’ NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. b Toxicity by the oral route is assumed to be equivalent to the inhalation route. A subchronic inhalation toxicity study is not required for fluoxastrobin at this time. Although no subchronic inhalation data is available EPA has waived the data requirement. In determining the need for a subchronic inhalation study, EPA’s weight of evidence decision process included both hazard and exposure considerations as well as incorporation of a presumed 10X Database Uncertainty Factor (UFdb) for the lack of this study. Specifically, with regard to exposure considerations, the Agency’s Level of Concern in the evaluating the need for the subchronic inhalation study is a Margin of Exposure (MOE) of 1,000 for inhalation exposure, which includes the 10X inter-species extrapolation factor, 10X intra-species variation factor, and the 10X UFdb. For fluoxystrobin, residential inhalation exposures resulted in MOEs higher than the LOC of 1,000 when using an oral Point of Departure (POD). This indicates that the lack of an inhalation study does not reduce the overall confidence in the risk assessment or result in an uncertainty (i.e., the study will not provide a POD sufficiently low to result in a risk of concern). Because EPA’s decision to waive the subchronic inhalation study essentially incorporates an additional 10X UFdb (i.e. the study was only waived because risks were at least 10X lower than required by use of the inter- and intraspecies safety factors), a second additional 10X FQPA safety factor is not being retained for the protection of infants and children due to the absence of this study. mstockstill on DSK4VPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluoxastrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing fluoxastrobin tolerances in 40 CFR 180.609. EPA assessed dietary VerDate Mar<15>2010 17:05 Apr 10, 2014 Jkt 232001 exposures from fluoxastrobin 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 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 for fluoxastrobin; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. A slightly refined chronic dietary exposure assessment was performed for fluoxastrobin using tolerance-level residues, average field trial residues, and 100 percent crop treated (PCT). This risk assessment was conducted using E:\FR\FM\11APR1.SGM 11APR1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations the DEEM–FCID Version 3.16. This model uses 2003–2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fluoxastrobin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the 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 fluoxastrobin. Tolerance level residues and/or 100 PCT 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 fluoxastrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluoxastrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/ oppefed1/models/water/index.htm. In addition to evaluating the EDWCs from the proposed uses, EDWCs were reevaluated for all existing uses with Pesticide Root Zone Model Ground Water (PRZM–GW), which models continued use of fluoxastrobin over many years. For the chronic dietary assessment, the most conservative EDWC (137 mg/L) was based on an existing turf use modeled with a 100 year simulation of 100 years of repeated applications, using the highest single maximum application rate and the highest yearly application rate. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluoxastrobin is currently registered for the following uses that could result in residential exposures: Spot treatment and/or broadcast control of diseases on turf, including lawns and golf courses. EPA assessed residential exposure using the following assumptions: Residential handler exposure for adults is expected to be short-term only. Intermediate-term and chronic exposures are not likely because of the intermittent nature of applications by homeowners. Since there are no toxicity findings for the short-term dermal route of exposure up VerDate Mar<15>2010 17:05 Apr 10, 2014 Jkt 232001 to the limit dose, the residential handler assessment only includes the inhalation route of exposure. There is also potential for homeowners and their families (of varying ages) to be exposed as a result of entering areas that have previously been treated with fluoxastrobin. Exposure might occur on areas such as lawns used by children or recreational areas such as golf courses used by adults and youths. Potential routes of exposure include dermal (adults and children) and incidental oral ingestion (children). Since no acute hazard has been identified, an assessment of episodic granular ingestion was not conducted. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticides/science/ residential-exposure-sop.html. 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.’’ EPA has not found fluoxastrobin to share a common mechanism of toxicity with any other substances, and fluoxastrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluoxastrobin 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 Web site at https://www.epa.gov/pesticides/ cumulative. 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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 20103 data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The available studies used to evaluate pre- and postnatal exposure susceptibility do not indicate increased susceptibility of rats or rabbits to fluoxastrobin. These studies include the following: i. Developmental toxicity studies in rats. ii. Developmental toxicity studies in rabbits. iii. A 2-generation reproduction study in rats. 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 fluoxastrobin is complete. EPA waived the requirement for a subchronic inhalation data based on, among other things, its conclusion that even if an additional 10X safety factor was applied, inhalation exposure would not raise a risk of concern. ii. There is no indication that fluoxastrobin 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 fluoxastrobin 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. The rat developmental study was tested up to the limit dose (1,000 mg/kg/day), and the rabbit developmental study was tested up to 400 mg/kg/day (highest dose tested). At the highest dose tested, there were decreases in food consumption and body weight in the maternal animals, but there were no developmental effects. Furthermore, in the rat reproduction study, there was no sensitivity in the offspring of the pups relative to the parental animals. iv. The exposure databases are estimated based on data that reasonably account for potential exposures. The chronic dietary food exposure assessment was conservatively based on 100 PCT assumptions, tolerance-level residues, and conservative ground and surface drinking water modeling estimates. New 2012 Residential Standard Operating Procedures (SOPs) were used to assess post-application exposure to children including incidental oral exposure. The residential post-application assessment assumes maximum application rates and conservative day zero hand-to-mouth E:\FR\FM\11APR1.SGM 11APR1 20104 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES activities. Although EPA has required additional data on transferable residues from treated turf for fluoxastrobin, EPA is confident that it has not underestimated turf exposure due to the conservativeness of the default turf transfer value and conservative assumptions in the short-term turf assessment procedures (e.g., assuming residues do not degrade over the thirty day assessment period and assuming high-end activities on turf for every day of the assessment period). All of the exposure estimates for fluoxastrobin are based on conservative high-end assumptions and are not likely to result in underestimated risk. 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. An acute aggregate risk assessment takes into account acute exposure estimates from 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 30% of the cPAD for the general population, and 66% of the cPAD for all infants <1 year old, the population subgroup with the highest estimated chronic dietary exposure to fluoxastrobin. 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. Short- and intermediate-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluoxastrobin 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 VerDate Mar<15>2010 17:05 Apr 10, 2014 Jkt 232001 exposures to fluoxastrobin. Because all short- and intermediate-term quantitative hazard assessments (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 shortterm incidental oral and intermediateterm exposure estimates (i.e., the highest exposure estimates) in the risk assessments for adults. The Agency believes that most residential exposure will be short-term, based on the use pattern. There is potential short- and intermediate-term exposure to fluoxastrobin via the dietary (which is considered background exposure) and residential (which is considered primary) pathways. For adults, these pathways lead to exposure via the oral (background), and dermal and inhalation (primary) routes. For children, these pathways lead to exposure via the oral (background), and incidental oral and dermal (primary) routes. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 610 for adults and 170 for children (1–2 years old). Because EPA’s level of concern for fluoxastrobin is a MOE of 100 or below, these MOEs are not of concern. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fluoxastrobin is not expected to pose a cancer risk to humans. 5. 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 fluoxastrobin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry) is available to enforce the tolerance expression. Method No. 00604 is available for plant commodities and Method No. 00691 is available for animal commodities. 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: residuemethods@epa.gov. PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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 established for fluoxastrobin. However, there are Canadian MRLs established on sorghum and milk at 0.02 ppm, milk fat at 0.15 ppm, wheat bran at 0.15 ppm, and wheat grain at 0.1 ppm. Furthermore, the Canadian tolerance expression is not harmonized with the US tolerance expression. For plants and livestock, the Canadian tolerance expression does not include the Z-isomer. C. Response to Comments Two comments were received to the docket from members of the public. Both comments were the same. The commenters objected to the proposed tolerance on the ground that it would result in fluoride being added to treated crops. The commenters offered no basis for this claim. The Agency reviewed all plant, livestock, and environmental degradation data and determined that the fluorine will not be released into the environment when applied to crops or non-agricultural areas. Neither free fluorine nor de-fluorinated fluoxastrobin was observed in food or water in any of the metabolism, degradation, and magnitude of residue studies. V. Conclusion Therefore, tolerances are established for residues of fluoxastrobin, in or on wheat, grain at 0.15 ppm; and tolerances are revised for milk and milk, fat at 0.03 ppm and 0.75 ppm respectively. Additionally, the established tolerance for wheat bran at 0.15 ppm is no longer needed and should be revoked because the recommended tolerance of 0.15 ppm for wheat, grain will cover expected residues in wheat bran. E:\FR\FM\11APR1.SGM 11APR1 20105 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations VI. Statutory and Executive Order Reviews This final rule 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule 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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the VerDate Mar<15>2010 19:04 Apr 10, 2014 Jkt 232001 Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note). * * * Milk ....................................... Milk, fat ................................. VII. Congressional Review Act * List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 28, 2014. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.609: a. Remove ‘‘Wheat, bran’’ from the table in paragraph (a)(1). ■ b. Add ‘‘Wheat, grain’’ in alphabetical order to the table in paragraph (a)(1). ■ c. Revise ‘‘Milk’’ and ‘‘Milk, fat’’ in the table in paragraph (a)(2). The amendments read as follows: ■ ■ § 180.609 Fluoxastrobin; tolerances for residues. (a) General. (1) * * * Parts per million * * * Wheat, grain ......................... PO 00000 * * * * * 0.15 * * (2) * * * Frm 00015 Fmt 4700 Sfmt 4700 * * * * * * 0.03 0.75 * * * * * [FR Doc. 2014–07820 Filed 4–10–14; 8:45 am] 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). Commodity Parts per million Commodity BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 90 [WT Docket No. 96–86; DA 12–1942] Service Rules Governing Public Safety Narrowband Operations in the 769– 775/799–805 MHz Bands Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Commission amends its rules to change the date of the ‘‘substantial service’’ benchmarks applicable to 700 MHz narrowband State licenses. This is intended to conform the dates used for the substantial service benchmarks under the Commission rules to the deadlines specified in the Commission’s July 2011 Declaratory Ruling. DATES: Effective April 11, 2014. FOR FURTHER INFORMATION CONTACT: Difie Osborne, Esq., Policy and Licensing Division, Public Safety and Homeland Security Bureau, (202) 418– 3627, or by email at Difie.Osborne@ fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Order in WT Docket No. 96–86, DA 12–1942, adopted on December 2, 2012, and released on December 3, 2012. The document is available for download at https:// fjallfoss.fcc.gov/edocs_public/. The complete text of this document is also available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY–A257, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to FCC504@ fcc.gov or call the Consumer & Governmental Affairs Bureau at 202– 418–0530 (voice), 202–418–0432 (TTY). 1. In 1998, the Commission established the initial band plan and service rules for the 24 megahertz of public safety spectrum in the 700 MHz SUMMARY: E:\FR\FM\11APR1.SGM 11APR1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Rules and Regulations]
[Pages 20100-20105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07820]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0576; FRL-9907-46]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
fluoxastrobin in or on wheat, grain; and revises tolerances for milk;
and milk, fat. Arysta LifeScience, North America, LLC, requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 11, 2014. Objections and
requests for hearings must be received on or before June 10, 2014, 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-2012-0576, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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 https://ecfr.gpoaccess.gov/cgi/t/text/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-2012-0576 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 10, 2014. 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-2012-0576, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

In the Federal Register of February 27, 2013 (78 FR 13296) (FRL-
9380-2), EPA issued a document pursuant to

[[Page 20101]]

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of
a pesticide petition (PP 2F8130) by Arysta LifeScience, North America,
LLC, 15401 Weston Pkwy., Suite 150, Cary, NC 27513. The petition
requested that 40 CFR 180.609 be amended by establishing tolerances for
residues of the fungicide, fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimydinyl]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-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, in or on wheat, grain at 0.15
parts per million (ppm). The petition also requested that 40 CFR
180.609 be amended by revising tolerances for milk from 0.02 ppm to
0.03 ppm; and milk, fat from 0.50 ppm to 0.75 ppm. That document
referenced a summary of the petition prepared by Arysta LifeScience,
North America LLC, the registrant, which is available in the docket,
https://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.

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 fluoxastrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluoxastrobin
follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Following repeated exposure, fluoxastrobin has mild or low toxicity
in all tested species except for the dog. Repeated oral administration
to dogs resulted in adverse liver toxicity at considerably lower doses
than those noted in other species. Based on species sensitivity, the
effects observed in the dog were used as endpoints for risk assessment.
In both the 90-day and one-year oral feeding studies in dogs, the liver
appeared to be the target organ. In dogs, mice, and rats, the kidney
was another target organ. There was no indication of an adverse effect
attributable to a single dose. Based on developmental toxicity studies
(rat and rabbit) and a two-generation reproduction study (rat), there
was neither increased susceptibility of pre-/postnatal exposure to
fluoxastrobin, nor adverse effects on reproduction. Furthermore, acute
neurotoxic effects were not seen in an acute neurotoxicity study in
rats up to the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day).
In a subchronic neurotoxicity study in rats, fluoxastrobin did not
elicit any neurotoxic effects. Repeated dose studies of fluoxastrobin
in the database did not show immunotoxic effects in rats. Results of
genotoxicity testing were negative and there were no treatment-related
carcinogenicity findings in adequately performed carcinogenicity
studies in rats and mice. Therefore, fluoxastrobin is classified as
``not likely to be carcinogenic to humans.'' 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 can be found at https://www.regulations.gov in document,
``Fluoxastrobin. Aggregate Human Health Risk Assessment for the
Proposed New Uses on Melon Subgroup 9A and Sorghum, Along with
Establishment of Permanent Tolerances on Wheat, and Amendments to
Established Tolerances on Milk and Milk Fat'' on pages 26-31 in docket
ID number EPA-HQ-OPP-2012-0576.

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 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fluoxastrobin used for
human risk assessment is shown in Table 1 of this unit.

[[Page 20102]]

Table 1--Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Dietary, Non-Occupational,
and Occupational 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 (General population None: There is no indication of an adverse effect attributable to a single
including infants and children) dose. An aRfD was not established.
and Females 13-49 years of age.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 1.5 mg/kg/ Chronic RfD = 0.015 Chronic toxicity dog LOAEL = M/F
day. mg/kg/day. 8.1/7.7 mg/kg/day based on body
UFA = 10x........... cPAD = 0.015 mg/kg/ weight reductions and
UFH = 10x........... day.. hepatocytomegaly and cytoplasmic
FQPA SF = 1x........ changes associated with increased
serum liver alkaline phosphatase
indicative of cholestasis.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to NOAEL = 3.0 mg/kg/ LOC for MOE = 100.. 90-day subchronic dog LOAEL = M/F
30 days) and Intermediate-term day. 24.8/24.2 mg/kg/day based on dose-
(1-6 months). UFA = 10x........... related reductions in net body
UFH = 10x........... weight gain and food efficiency
FQPA SF = 1x........ in addition to toxicity findings
in the liver (cholestasis) in
both sexes, and kidneys
(increased relative weights in
females and degeneration of the
proximal tubular epithelium in
males).
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days). None: There were no systemic or dermal toxicity findings in a 28-day dermal
toxicity study in the rat up to the limit dose (1,000 mg/kg/day) and there
were no developmental or neurotoxicity concerns raised in other studies.
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (1 to 6 NOAEL = 3.0 mg/kg/ Residential LOC for 90-day subchronic dog LOAEL = M/F
months). day. MOE = 100. 24.8/24.2 mg/kg/day based on dose-
dermal absorption Occupational LOC related reductions in net body
factor = 2.3%.. for MOE = 100.. weight gain and food efficiency
in addition to toxicity findings
in the liver (cholestasis) in
both sexes, and kidneys
(increased relative weights in
females and degeneration of the
proximal tubular epithelium in
males).
----------------------------------------------------------------------------------------------------------------
Inhalation \b\ Short-Term (1-30 NOAEL = 3.0 mg/kg/ Residential LOC for 90-day subchronic dog LOAEL = M/F
days) and Intermediate-Term (1-6 day. MOE = 100. 24.8/24.2 mg/kg/day based on dose-
months). Occupational LOC related reductions in net body
for MOE = 100.. weight gain and food efficiency
in addition to toxicity findings
in the liver (cholestasis) in
both sexes, and kidneys
(increased relative weights in
females and degeneration of the
proximal tubular epithelium in
males).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
\a\ ``Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response
data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures.'' NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
level of concern.
\b\ Toxicity by the oral route is assumed to be equivalent to the inhalation route. A subchronic inhalation
toxicity study is not required for fluoxastrobin at this time. Although no subchronic inhalation data is
available EPA has waived the data requirement. In determining the need for a subchronic inhalation study,
EPA's weight of evidence decision process included both hazard and exposure considerations as well as
incorporation of a presumed 10X Database Uncertainty Factor (UFdb) for the lack of this study. Specifically,
with regard to exposure considerations, the Agency's Level of Concern in the evaluating the need for the
subchronic inhalation study is a Margin of Exposure (MOE) of 1,000 for inhalation exposure, which includes the
10X inter-species extrapolation factor, 10X intra-species variation factor, and the 10X UFdb. For
fluoxystrobin, residential inhalation exposures resulted in MOEs higher than the LOC of 1,000 when using an
oral Point of Departure (POD). This indicates that the lack of an inhalation study does not reduce the overall
confidence in the risk assessment or result in an uncertainty (i.e., the study will not provide a POD
sufficiently low to result in a risk of concern). Because EPA's decision to waive the subchronic inhalation
study essentially incorporates an additional 10X UFdb (i.e. the study was only waived because risks were at
least 10X lower than required by use of the inter- and intraspecies safety factors), a second additional 10X
FQPA safety factor is not being retained for the protection of infants and children due to the absence of this
study.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin 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 fluoxastrobin; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. A slightly refined chronic dietary exposure
assessment was performed for fluoxastrobin using tolerance-level
residues, average field trial residues, and 100 percent crop treated
(PCT). This risk assessment was conducted using

[[Page 20103]]

the DEEM-FCID Version 3.16. This model uses 2003-2008 food consumption
data from the U.S. Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA).
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluoxastrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the 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 fluoxastrobin. Tolerance level residues and/or
100 PCT 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 fluoxastrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluoxastrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm. In
addition to evaluating the EDWCs from the proposed uses, EDWCs were
reevaluated for all existing uses with Pesticide Root Zone Model Ground
Water (PRZM-GW), which models continued use of fluoxastrobin over many
years. For the chronic dietary assessment, the most conservative EDWC
(137 [mu]g/L) was based on an existing turf use modeled with a 100 year
simulation of 100 years of repeated applications, using the highest
single maximum application rate and the highest yearly application
rate.
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). Fluoxastrobin is
currently registered for the following uses that could result in
residential exposures: Spot treatment and/or broadcast control of
diseases on turf, including lawns and golf courses. EPA assessed
residential exposure using the following assumptions: Residential
handler exposure for adults is expected to be short-term only.
Intermediate-term and chronic exposures are not likely because of the
intermittent nature of applications by homeowners. Since there are no
toxicity findings for the short-term dermal route of exposure up to the
limit dose, the residential handler assessment only includes the
inhalation route of exposure. There is also potential for homeowners
and their families (of varying ages) to be exposed as a result of
entering areas that have previously been treated with fluoxastrobin.
Exposure might occur on areas such as lawns used by children or
recreational areas such as golf courses used by adults and youths.
Potential routes of exposure include dermal (adults and children) and
incidental oral ingestion (children). Since no acute hazard has been
identified, an assessment of episodic granular ingestion was not
conducted. Further information regarding EPA standard assumptions and
generic inputs for residential exposures may be found at https://www.epa.gov/pesticides/science/residential-exposure-sop.html.
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.''
EPA has not found fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin 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 Web site at https://www.epa.gov/pesticides/cumulative.

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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The available studies used
to evaluate pre- and postnatal exposure susceptibility do not indicate
increased susceptibility of rats or rabbits to fluoxastrobin. These
studies include the following:
i. Developmental toxicity studies in rats.
ii. Developmental toxicity studies in rabbits.
iii. A 2-generation reproduction study in rats.
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 fluoxastrobin is complete. EPA waived
the requirement for a subchronic inhalation data based on, among other
things, its conclusion that even if an additional 10X safety factor was
applied, inhalation exposure would not raise a risk of concern.
ii. There is no indication that fluoxastrobin 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 fluoxastrobin 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. The rat developmental study was tested up to the limit dose
(1,000 mg/kg/day), and the rabbit developmental study was tested up to
400 mg/kg/day (highest dose tested). At the highest dose tested, there
were decreases in food consumption and body weight in the maternal
animals, but there were no developmental effects. Furthermore, in the
rat reproduction study, there was no sensitivity in the offspring of
the pups relative to the parental animals.
iv. The exposure databases are estimated based on data that
reasonably account for potential exposures. The chronic dietary food
exposure assessment was conservatively based on 100 PCT assumptions,
tolerance-level residues, and conservative ground and surface drinking
water modeling estimates. New 2012 Residential Standard Operating
Procedures (SOPs) were used to assess post-application exposure to
children including incidental oral exposure. The residential post-
application assessment assumes maximum application rates and
conservative day zero hand-to-mouth

[[Page 20104]]

activities. Although EPA has required additional data on transferable
residues from treated turf for fluoxastrobin, EPA is confident that it
has not underestimated turf exposure due to the conservativeness of the
default turf transfer value and conservative assumptions in the short-
term turf assessment procedures (e.g., assuming residues do not degrade
over the thirty day assessment period and assuming high-end activities
on turf for every day of the assessment period). All of the exposure
estimates for fluoxastrobin are based on conservative high-end
assumptions and are not likely to result in underestimated risk.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from 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 30% of the cPAD for the
general population, and 66% of the cPAD for all infants <1 year old,
the population subgroup with the highest estimated chronic dietary
exposure to fluoxastrobin. 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. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level).
Fluoxastrobin 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 fluoxastrobin. Because all
short- and intermediate-term quantitative hazard assessments (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) in the risk assessments for adults. The Agency believes that
most residential exposure will be short-term, based on the use pattern.
There is potential short- and intermediate-term exposure to
fluoxastrobin via the dietary (which is considered background exposure)
and residential (which is considered primary) pathways. For adults,
these pathways lead to exposure via the oral (background), and dermal
and inhalation (primary) routes. For children, these pathways lead to
exposure via the oral (background), and incidental oral and dermal
(primary) routes.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 610 for adults
and 170 for children (1-2 years old). Because EPA's level of concern
for fluoxastrobin is a MOE of 100 or below, these MOEs are not of
concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
5. 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 fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry) is available to enforce the tolerance
expression. Method No. 00604 is available for plant commodities and
Method No. 00691 is available for animal commodities. 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: residuemethods@epa.gov.

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 established for fluoxastrobin. However,
there are Canadian MRLs established on sorghum and milk at 0.02 ppm,
milk fat at 0.15 ppm, wheat bran at 0.15 ppm, and wheat grain at 0.1
ppm. Furthermore, the Canadian tolerance expression is not harmonized
with the US tolerance expression. For plants and livestock, the
Canadian tolerance expression does not include the Z-isomer.

C. Response to Comments

Two comments were received to the docket from members of the
public. Both comments were the same. The commenters objected to the
proposed tolerance on the ground that it would result in fluoride being
added to treated crops. The commenters offered no basis for this claim.
The Agency reviewed all plant, livestock, and environmental
degradation data and determined that the fluorine will not be released
into the environment when applied to crops or non-agricultural areas.
Neither free fluorine nor de-fluorinated fluoxastrobin was observed in
food or water in any of the metabolism, degradation, and magnitude of
residue studies.

V. Conclusion

Therefore, tolerances are established for residues of
fluoxastrobin, in or on wheat, grain at 0.15 ppm; and tolerances are
revised for milk and milk, fat at 0.03 ppm and 0.75 ppm respectively.
Additionally, the established tolerance for wheat bran at 0.15 ppm is
no longer needed and should be revoked because the recommended
tolerance of 0.15 ppm for wheat, grain will cover expected residues in
wheat bran.

[[Page 20105]]

VI. Statutory and Executive Order Reviews

This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: March 28, 2014.
Lois Rossi,
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. 180.609:
0
a. Remove ``Wheat, bran'' from the table in paragraph (a)(1).
0
b. Add ``Wheat, grain'' in alphabetical order to the table in paragraph
(a)(1).
0
c. Revise ``Milk'' and ``Milk, fat'' in the table in paragraph (a)(2).
The amendments read as follows:

Sec. 180.609 Fluoxastrobin; tolerances for residues.

(a) General. (1) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Wheat, grain............................................ 0.15

* * * * *
------------------------------------------------------------------------

(2) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Milk.................................................... 0.03
Milk, fat............................................... 0.75

* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-07820 Filed 4-10-14; 8:45 am]
BILLING CODE 6560-50-P

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