Trifloxystrobin; Pesticide Tolerances

Federal Register, Volume 79 Issue 170 (Wednesday, September 3, 2014)

Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)

Rules and Regulations

Pages 52210-52215

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

FR Doc No: 2014-20928

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2013-0504; FRL-9915-46

Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of trifloxystrobin in or on pea, dry, seed; pea, field, hay; and pea, field, vines. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 3, 2014. Objections and requests for hearings must be received on or before November 3, 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-2013-0504, 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; main 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 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 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-2013-0504 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 November 3, 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-2013-0504, 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 October 25, 2013 (78 FR 63938) (FRL-

    9901-96), 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 3F8180) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.555 be amended by establishing tolerances for residues of the fungicide trifloxystrobin, benzeneacetic acid, (E,E)-alpha-

    (methoxyimino)-2-1-3-(trifluoromethyl)phenylethylidene aminooxymethyl-, methyl ester, and the free form of its acid metabolite CGA-321113, (E,E)-methoxyimino-2-1-(3-trifluoromethyl-

    phenyl)-ethylideneaminooxymethyl-phenylacetic acid, calculated as the stoichiometric equivalent of trifloxystrobin, in or on pea, dry, seed at 0.06 parts per million (ppm); pea, field, hay at 15 ppm; pea, field, vines at 4.0 ppm; chickpea, seed at 0.06 ppm; and lentil, seed at 0.06 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA has corrected proposed commodity definitions and eliminated certain proposed crop tolerances. The reasons for these changes are explained in Unit IV.C.

  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

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

    1. Toxicological Profile

      EPA has evaluated the available toxicity data and considered their 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.

      Trifloxystrobin exhibits very low toxicity following single oral, dermal and inhalation exposures. It is a strong dermal sensitizer and a mild dermal and eye irritant. In repeated dose tests in rats, the liver is the target organ for trifloxystrobin; toxicity is induced following oral and dermal exposure for 28 days. Liver effects characterized by an increase in liver weights and an increased incidence of hepatocellular hypertrophy and/or hepatocellular necrosis were seen in rats, mice, and dogs.

      There is no concern for neurotoxicity or immunotoxicity in the database. In the rabbit developmental toxicity study, an increase in the incidence of fused sternabrae was seen at a dose 10 times higher than the maternal lowest observed adverse effect level (LOAEL). In the rat reproduction study, both parents and offspring showed decreases in body weight during lactation. The rat and rabbit developmental and the rat reproduction toxicity data do not demonstrate an increase in susceptibility in the fetus or other offspring.

      Trifloxystrobin is classified as: ``Not likely to be Carcinogenic to Humans'' based on negative results in:

      1. The battery of mutagenicicty tests (except at a cytoxic dose in one in vitro test), and

      2. The long-term carcinogenicity studies in rats and mice.

      Specific information on the studies received and the nature of the adverse effects caused by trifloxystrobin as well as the no-observed-

      adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-

      level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of June 11, 2010 (75 FR 33190) (FRL-

      8829-2) and in the document ``Trifloxystrobin. Aggregate Human Health Risk Assessment for the Proposed New Uses on Chickpea, Dry Peas, and Lentils with Updated Residential Risk Estimates of All Existing Residential Uses (Lawns/Turf; Gardens and Trees),'' dated June 10, 2014, Appendix A, pp. 27-31 in docket ID number EPA-HQ-OPP-2013-0504.

    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 trifloxystrobin used for human risk assessment was discussed in Unit III B. of the final rule published in the Federal Register of June 11, 2010. However, subsequent to that Federal Register publication, EPA reassessed the liver effects seen in the 28-day dermal toxicity study according to current policy, and determined that since these effects should not be considered adverse, no toxicity endpoint was identified. The NOAEL for the 28-day dermal study was set at 1,000 mg/kg/day and the LOAEL was not established. Therefore, the endpoints assessed as part of this action exclude the endpoint for dermal exposure identified in the table published in the above-referenced Federal Register on June 11, 2010.

    3. Exposure Assessment

      1. Dietary exposure from food and feed uses. In evaluating dietary exposure to trifloxystrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing trifloxystrobin tolerances in 40 CFR 180.555. EPA assessed dietary exposures from trifloxystrobin 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. Such effects were identified for trifloxystrobin. In estimating acute dietary (food and water) exposure for females 13-49 years old, EPA conducted an analysis using the Dietary Exposure Evaluation Model (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). An acute dietary assessment was conducted assuming tolerance level residues (plus the additional metabolite residues as noted in this paragraph) and 100 percent crop treated (PCT) for all commodities. For the dietary assessment, a value of 0.20 ppm for the metabolite L7a was added to the tolerance level for meat byproducts of cattle, goats, horses, and sheep to account for the higher residues in liver; therefore, these commodities were assessed in the dietary assessments at 0.3 ppm. Pork was assessed in the DEEM at the established tolerance level of 0.05 ppm; pork, liver was assessed at 0.16 ppm to account for the residues of the metabolite L7a. DEEM version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities.

        ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure

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        Evaluation Model (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). A chronic dietary exposure assessment was conducted assuming 100 PCT, anticipated residues (ARs) for grapes, apples, oranges, and pears, and tolerance level residues for the rest of the commodities, including additional metabolite residues as noted in this paragraph. A value of 0.20 ppm for the metabolite L7a was added to the tolerance level for meat byproducts of cattle, goats, horses, and sheep to account for the higher residues in liver; therefore, these commodities were assessed in the dietary assessments at 0.3 ppm. Pork was assessed in the DEEM at the established tolerance level of 0.05 ppm; pork, liver was assessed at 0.16 ppm to account for residues of the metabolite L7a. DEEM version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities.

        iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that trifloxystrobin 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 (AR) and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

        EPA used anticipated residue information in the chronic dietary assessment for trifloxystrobin for grapes, apples, oranges, and pears.

      2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for trifloxystrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/

        transport characteristics of trifloxystrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

        Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and PRZMGround Water (PRZM-GW) models, the estimated drinking water concentrations (EDWCs) of total toxic residues of trifloxystrobin and its major degradation product for acute exposures are estimated to be 29 parts per billion (ppb) for surface water and 427 ppb for ground water. For chronic exposures for non-

        cancer assessments are estimated to be 23 ppb for surface water and 365 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 427 ppb was used to assess the contribution to drinking water.

        For chronic dietary risk assessment, the water concentration of value 365 ppb was used to assess the contribution to drinking water.

      3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

        Trifloxystrobin is currently registered for the following uses that could result in residential exposures: Ornamentals and turfgrass. EPA assessed residential exposure from relevant registered trifloxystrobin products using the Agency's 2012 Residential Standard Operating Procedures (SOPs) along with updates in dermal risk assessment hazard and policy regarding body weight in addition to the following assumptions:

        i. Residential handler exposures. Residential handler exposure is expected to be short-term only. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Dermal handler exposures were not assessed since no adverse systemic dermal hazard was identified for trifloxystrobin.

        ii. Residential post-application exposures. Since dermal hazard has not been identified for trifloxystrobin, a quantitative post-

        application assessment for dermal exposure is not necessary and the only exposure scenarios quantitatively assessed are for children 1 to

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