Flupyradifurone; Pesticide Tolerances

Federal Register, Volume 81 Issue 185 (Friday, September 23, 2016)

Federal Register Volume 81, Number 185 (Friday, September 23, 2016)

Rules and Regulations

Pages 65552-65557

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

FR Doc No: 2016-22976

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2013-0226; FRL-9951-68

Flupyradifurone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of flupyradifurone in or on multiple commodities which are identified and discussed later in this document. Bayer CropScience LP requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 23, 2016. Objections and requests for hearings must be received on or before November 22, 2016, 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-2013-0226, 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: Michael Goodis, 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/Title40/40tab_02.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-2013-0226 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 22, 2016. 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-2013-0226, 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 March 16, 2016 (81 FR 14030) (FRL-9942-

    86), 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 5F8404) by Bayer CropScience LP, 2 T.W. Alexander

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    Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide, flupyradifurone, in or on abiu at 0.6 parts per million (ppm); akee apple at 0.6 ppm; avocado at 0.6 ppm; bacury at 0.6 ppm; banana at 0.6 ppm; binjai at 0.6 ppm; caneberry, subgroup 13-07A at 5 ppm; canistel at 0.6 ppm; cilantro, fresh leaves at 30 ppm; cupuacuacute at 0.6 ppm; etambe at 0.6 ppm; jatobaacute at 0.6 ppm; kava, fresh leaves at 40 ppm; kava, roots at 0.9 ppm; kei apple at 0.6 ppm; langstat at 0.6 ppm; lanjut at 0.6 ppm; lucuma at 0.6 ppm; mabolo at 0.6 ppm; mango at 0.6 ppm; mangosteen at 0.6 ppm; paho at 0.6 ppm; papaya at 0.6 ppm; pawpaw, common at 0.6 ppm; pelipisan at 0.6 ppm; pequi at 0.6 ppm; pequia at 0.6 ppm; persimmon, american at 0.6 ppm; plantain at 0.6 ppm; pomegranate at 0.6 ppm; poshte at 0.6 ppm; quandong at 0.6 ppm; quinoa at 3 ppm; sapote at 0.6 ppm; sataw at 0.6 ppm; screw-pine at 0.6 ppm; star apple at 0.6 ppm; stone fruit, stone group 12-12 at 1.5 ppm; tamarind-of-the-Indies at 0.6 ppm; and wild loquat at 0.6 ppm. That document referenced a summary of the petition prepared by Bayer CropScience LP, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

    Based upon review of the data supporting the petition, EPA has modified some of the commodity definitions that were proposed. The reason for these changes are explained in Unit IV.D.

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

      The most sensitive effects seen in the flupyradifurone database were skeletal muscle atrophy/degeneration in dogs. With repeated dosing, reductions in body weight and food consumption were commonly seen in various studies and in all species of test animals (rats, mice, dogs, and rabbits). The liver and thyroid were shown to be the common findings of flupyradifurone toxicity. The database appears to suggest that dogs are more sensitive to the effects of flupyradifurone; however, with body weight adjustments (based on a \3/4\ scaling factor), the dog and rat are almost equally as sensitive in response to flupyradifurone toxicity. The skeletal muscle atrophy/degeneration seen in the 90-day and 1-year dog studies formed the basis for chronic dietary exposure toxicity endpoints.

      The developmental toxicity study in rats demonstrated no evidence of susceptibility in developing animals. In the rabbit developmental toxicity study, there was an increase in the incidence of fetal death at 80 milligram/kilogram/day (mg/kg/day) (the highest dose tested), a dose that did not produce adverse effects in the maternal animals.

      Therefore, a quantitative increase in susceptibility was demonstrated in the rabbit developmental toxicity study. In the 2-

      generation reproduction study in rats, decreased parental body weights (>=10%) were seen at the lowest-observed-adverse-effect-level (LOAEL) of 137 mg/kg/day (parental no-observed-adverse-effect-level (NOAEL) = 37.8 mg/kg/day). In contrast, body weight decreases that were considered adverse were seen in F2 pups at 37.8 mg/kg/day (the parental NOAEL and the offspring LOAEL; offspring NOAEL = 7.7 mg/kg/day). These findings suggest quantitative susceptibility for developing young animals.

      The acute neurotoxicity study (dosing by gavage) showed that at the time of peak-effect, flupyradifurone caused increases in the incidence of piloerection and dilated pupils at 50 mg/kg. At the next higher dose level (200 mg/kg) and above, it produced a large host of clinical signs, which were related to neurotoxicity. The clinical signs included dilated pupils, lower muscle tone, low arousal, tremors, myoclonic jerks, chewing, repetitive licking of lips, gait incoordination, flattened or hunched posture, and impaired righting reflex. In the 90-

      day neurotoxicity study, no neurotoxicity or other adverse effects were seen at dose levels as high as 174 mg/kg/day. The developmental neurotoxicity study at 102 mg/kg/day yielded an increased incidence of increased amplitude in startle response.

      Flupyradifurone is classified as ``not likely to be carcinogenic to humans.'' Carcinogenicity studies in rats and mice did not yield a compound-related increase in tumor incidence, and the genotoxicity battery did not show flupyradifurone to produce any genotoxicity. Flupyradifurone did not demonstrate any immunotoxic effects.

      Specific information on the studies received and the nature of the adverse effects caused by flupyradifurone as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Flupyradifurone (122304) Human Health Risk Assessment in Support of Proposed Uses on Kava, Cilantro, Stone Fruit, Group 12-12, Caneberry, Subgroup 13-07A, Quinoa, and Tropical Fruits; Amended Use Requests for Soil Applications to Leafy Vegetables, Group 4 and Brassica (Cole) Leafy Vegetables, Group 5; Use on Greenhouse Grown Tomato, Pepper, Cucumber, and Lettuce; Label Amendment to Add Commodities of Tree Nuts, Group 14-12 to label; and Label Amendment to Add Use Directions for Clover Grown for Forage, Fodder, Seed, Straw, and Hay'' on page 49 in docket ID number EPA-HQ-

      OPP-2013-0226.

    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

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      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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

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

      Table 1--Summary of Toxicological Doses and Endpoints for Flupyradifurone for Use in Human Health Risk

      Assessment

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      Point of departure

      Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects

      safety factors risk assessment

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      Acute dietary (All populations).. NOAEL = 35 mg/kg/day Acute RfD = 0.35 mg/ Acute neurotoxicity study--rat

      UFA = 10 x.......... kg/day. LOAEL = 50 mg/kg/day based on

      UFH = 10 x.......... aPAD = 0.35 mg/kg/ increased incidences of

      FQPA SF = 1 x....... day. piloerection in both sexes and

      pupil dilation in females on Day

      1. At the next higher dose level

      (200 mg/kg) or above, lower

      muscle tone, rapid respiration,

      low arousal, tremors, myoclonic

      jerks, chewing, repetitive

      licking of lips, gait

      incoordination, flattened or

      hunched posture, dilated pupils,

      impaired (uncoordinated or slow)

      righting reflex, impaired flexor

      and tail pinch responses and

      reduced rectal temperature.

      Automated measures of motor

      activity were also reduced in

      both sexes, compared to controls.

      Chronic dietary (All populations) NOAEL= 7.8 mg/kg/day Chronic RfD = 0.078 Oral toxicity study--dog (1-year)

      UFA = 10 x.......... mg/kg/day. LOAEL = 28 mg/kg/day based on

      UFH = 10 x.......... cPAD = 0.078 mg/kg/ minimal to slight, focal to

      FQPA SF = 1 x....... day. multifocal areas of skeletal

      muscle degeneration in

      gastrocnemius and/or biceps

      femoris muscle.

      Dermal short-term (1 to 30 days). Dermal (or oral) LOC for MOE = 100.. Oral toxicity study--dog (90-day)

      study NOAEL = 12 mg/ LOAEL = 33 mg/kg/day based

      kg/day (dermal skeletal muscle atrophy/

      absorption rate = degeneration.

      7.42%. 2-Generation reproduction study--

      UFA = 10 x.......... rat (co-critical study)

      UFH = 10 x.......... NOAEL = 7.7 mg/kg/day.

      FQPA SF = 1 x....... Offspring LOAEL = 38.7 mg/kg/day

      based on pup body weight

      decrease.

      Inhalation short-term (1 to 30 Oral study NOAEL = LOC for MOE = 100.. Oral toxicity study--dog (90-day)

      days). 12 mg/kg/day LOAEL = 33 mg/kg/day based on

      (inhalation skeletal muscle atrophy/

      absorption rate = degeneration.

      100%). 2-Generation reproduction study--

      UFA = 10 x.......... rat (co-critical study)

      UFH = 10 x.......... NOAEL = 7.7 mg/kg/day.

      FQPA SF = 1 x....... Offspring LOAEL = 38.7 mg/kg/day

      based on pup body weight

      decrease.

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      Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans--based on data

      showing no treatment-related increase in tumors incidence in rat and mouse

      carcinogenicity studies. No mutagenic concern was reported in the

      genotoxicity studies.

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      FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level

      of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-

      level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.

      UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among

      members of the human population (intraspecies).

    3. Exposure Assessment

      1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flupyradifurone, EPA considered exposure under the petitioned-for tolerances as well as all existing flupyradifurone tolerances in 40 CFR 180.679. EPA assessed dietary exposures from flupyradifurone 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 flupyradifurone. In estimating acute dietary exposure, EPA used food consumption data from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed 100% crop treated (PCT), tolerance level residues and Dietary Exposure Evaluation Model (DEEM) (ver. 7.81) default processing factors.

      ii. Chronic exposure. In conducting the chronic dietary exposure assessment

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      EPA used the food consumption data from the USDA's NHANES/WWEIA; 2003-

      2008. As to residue levels in food, EPA assumed 100 PCT, tolerance level residues and DEEM (ver. 7.81) default processing factors.

      iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that flupyradifurone 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 PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for flupyradifurone. Tolerance level residues and 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 flupyradifurone in drinking water. These simulation models take into account data on the physical, chemical, and fate/

      transport characteristics of flupyradifurone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

      Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of flupyradifurone for acute exposures are estimated to be 112 parts per billion (ppb) for surface water and 352 ppb for ground water, and for chronic exposures are estimated to be 112 ppb for surface water and 307 ppb for ground water.

      Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 352 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 307 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).

      Currently there are no registered uses for flupyradifurone that could result in residential exposures. However, there is a proposal to register uses that could result in residential exposures for application to ornamental plants (gardens, trees, shrubs, flowers). Therefore, the EPA considered the proposed residential uses and assessed residential exposure using the following assumptions: For residential handlers, short-term dermal and inhalation exposures were assessed for adults mixing, loading and applying liquids and ready to use formulations to gardens and trees using a variety of application equipment. For post-application exposure, short-term dermal exposures to adults and children (6 to

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