Fluoxastrobin; Pesticide Tolerances

Federal Register, Volume 79 Issue 190 (Wednesday, October 1, 2014)

Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)

Rules and Regulations

Pages 59115-59119

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2014-23398

=======================================================================

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2012-0576; FRL-9916-28

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues of fluoxastrobin and its Z-isomer in or on melon subgroup 9A; sorghum, grain, grain; sorghum, grain, forage; and sorghum, grain, stover. Arysta LifeScience, North America, LLC, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 1, 2014. Objections and requests for hearings must be received on or before December 1, 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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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:

1. General Information

   1. 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).

   2. How an I get electronic access to other related information?

      You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-

      idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.tpl.

   3. 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 December 1, 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: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

      Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

      Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

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

2. Summary of Petitioned-For Tolerance

   In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-

   9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8047) 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 combined residues of the fungicide, fluoxastrobin, (1E)-2-6-(2-chlorophenoxy)-5-fluoro-4-

   pyrimydinyloxyphenyl(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-

   methyloxime, and its Z-isomer, (1Z)-2-6-(2-chlorophenoxy)-5-fluoro-

   4-pyrimydinyloxyphenyl(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-

   methyloxime, in or on melon, subgroup 9A, at 1.5 parts per million (ppm); sorghum grain at 1.5 ppm; sorghum forage at 4 ppm; and sorghum stover at 4 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience, North America LLC, the registrant, which is available in the docket, http://www.regulations.gov.

   Page 59116

   Comments were not received on the notice of filing.

3. 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.

   1. 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 1-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 2-generation reproduction study (rat), there was neither increased susceptibility of pre-/postnatal exposure to fluoxastrobin, nor adverse effects on reproduction. Furthermore, neurotoxic effects were not seen in an acute neurotoxicity study in rats up to the limit dose of 2,000 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 http://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 page 26 in docket ID number EPA-HQ-OPP-2012-

      0576.

   2. Toxicological Points of Departure/Levels of Concern

      Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

      A summary of the toxicological endpoints for fluoxastrobin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 11, 2014 (79 FR 20100, 20101-02) (FRL-9907-46), docket number EPA-HQ-OPP-2012-0576.

   3. 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% crop treated (CT). This risk assessment was conducted using 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, average field-trial residues, and/or 100% CT were assumed for all food commodities.

      Page 59117

      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 http://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 ground water EDWC (137 microg/L) was more conservative than the surface water EDWC (18.6 microg/L); the ground water EDWC 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: Broadcast control of diseases on turf, including lawns and golf courses. EPA assessed residential exposure using the following assumptions:

      i. Residential handler exposure. 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.

      ii. Post-application 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. Residential post-application exposure for adults and children is expected to be short-term only because residues are not expected to be present for longer periods of time. 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: http://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 http://www.epa.gov/pesticides/cumulative.

   4. 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 slightly refined but still based on 100 PCT assumptions, tolerance-level residues, some average field-trial residues, and conservative ground water modeling estimates. New 2012 Residential Standard Operating Procedures (SOPs) were used to assess post-application exposure to children including incidental oral exposure. In addition, the Agency has obtained a Turf Transferable Residue (TTR) study, which provides slightly refined chemical-specific assumptions to estimate exposure for the hand-to-mouth post-application assessment. The assessment is still considered highly conservative because it assumes maximum application rates and conservative day zero hand-to-mouth activities.

      Page 59118

   5. 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