Fluopyram; Pesticide Tolerances
Federal Register, Volume 81 Issue 45 (Tuesday, March 8, 2016)
Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)
Rules and Regulations
Pages 12015-12024
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-05025
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2015-0443; FRL-9943-21
Fluopyram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes, amends, and deletes tolerances for residues of fluopyram in or on multiple commodities which are identified and discussed later in this document. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 8, 2016. Objections and requests for hearings must be received on or before May 9, 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)
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number EPA-HQ-OPP-2015-0443, 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: Susan Lewis, 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:
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General Information
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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).
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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.
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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-2015-0443 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 May 9, 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-2015-0443, 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.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
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Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), 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 4F8284) by Bayer CropScience, 2 T. W. Alexander Drive, Research Triangle Park, North Carolina 27709. The petition requested that 40 CFR 180.661 be amended by establishing tolerances for residues of the fungicide fluopyram in or on the raw agricultural commodities artichoke, globe at 4.0 parts per million; aspirated grain fractions at 50.0 ppm; peanut hay at 40.0 ppm; hops at 60.0 ppm; root vegetables, except beet, sugar, root, crop subgroup 1B at 0.30 ppm; tuberous and corm vegetables, crop subgroup 1C at 0.10 ppm; potato wet peel at 0.30 ppm; vegetables, leaves of root and tuber, crop group 2 at 30.0 ppm; bulb vegetables, bulb onion (crop subgroup 3-07A) at 0.30 ppm; bulb vegetables, green onions (crop subgroup 3-07B) at 15.0 ppm; leafy greens (crop subgroup 4A), without spinach at 20.0 ppm; leafy greens (crop subgroup 4A) spinach at 40.0 ppm; leafy petioles subgroup, celery (crop subgroup 4B) at 20.0 ppm; brassica leafy vegetables: Head and stem (crop subgroup 5A) at 4.0 ppm; brassica leafy vegetables: Leafy greens (crop subgroup 5B) at 50.0 ppm; soybean forage at 9.0 ppm; soybean hay at 30.0 ppm; legume vegetables: Edible podded (crop subgroup 6A) at 4.0 ppm; legume vegetables: Succulent shelled peas and beans (crop subgroup 6B) at 0.20 ppm; legume vegetables: Dried shelled peas and beans (crop subgroup 6C) at 0.70 ppm; vegetable, foliage of legume vegetables, forage, hay and vines, forage (crop group 7) at 90.0 ppm; fruiting vegetables, tomato subgroup (crop subgroup 8-10A) at 1.00 ppm; fruiting vegetables, pepper/eggplant subgroup (crop subgroup 8-
10B) at 3.00 ppm; cucurbit vegetables (crop group 9A), melon subgroup at 0.90 ppm; cucurbit vegetables (crop group 9B), cucumber/squash subgroup at 0.30 ppm; citrus fruits (crop group 10-10) at 0.90 ppm; citrus oil at 8.0 ppm; pome fruit (crop group 11-10) at 2.0 ppm; stone fruit (crop group 12-12A), cherry subgroup at 2.00 ppm; stone fruit (crop group 12-12B), peach subgroup at 1.00 ppm; stone fruit (crop group 12-12C), plum subgroup at 0.50 ppm; berries and small fruit: Caneberry (crop subgroup 13-07A) at 5.0 ppm; berries and small fruit: Bushberry (crop subgroup 13-07B) at 7.0 ppm; raisins at 4.0 ppm; berries and small fruit, small fruit vine climbing, except fuzzy kiwi (crop subgroup 13-07F) at 1.5 ppm; berries and small fruit: Low growing berry (crop subgroup 13-07G) at 2.0 ppm; sorghum, grain at 1.5 ppm; wheat milled by-products at 2.0 ppm; grass forage, fodder and hay: Forage (crop group 17) at 80.0 ppm; herb crop (crop subgroup 19A) at 70.0 ppm; dill seed at 70.00 ppm; herbs, dried at 400 ppm; oilseeds, rapeseed, canola (crop subgroup 20A) at 0.70 ppm; oilseeds, sunflower, seed (crop subgroup 20B) at 0.70 ppm; and oilseeds: Cottonseed (crop subgroup 20C) at 0.80 ppm and in or on the animal commodities chicken, meat byproducts at 0.40 ppm; chicken, fat at 0.15 ppm; chicken, meat at 0.10 ppm; goat, fat at 4.00 ppm; and goat, meat at 4.00 ppm. Bayer CropScience also requests to establish a tolerance in 40 CFR 180.661 for indirect or inadvertent
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residues of the fungicide fluopyram in or on the raw agricultural commodity sugarcane, cane at 0.08 ppm. The petition also requested to amend tolerances in 40 CFR 180.661 for residues of the fungicide fluopyram in or on the raw agricultural commodities peanut at 0.20 ppm; sugar beet, roots at 0.09 ppm; soybean, seed at 0.30 ppm; soybean forage at 9.0 ppm; soybean hay at 30.0 ppm; tree nuts (crop group 14) at 0.04 ppm; almond hulls at 10.00 ppm; grain, cereal, except rice and sorghum (crop group 15) at 0.90 ppm; cereal grain, except rice, forage, fodder and straw (crop group 16) at 20.0 ppm; and cotton gin by-product at 30.00 ppm and in or on the animal commodities cattle, meat byproducts at 40.00 ppm; cattle, fat at 4.00 ppm; cattle, meat at 4.00 ppm; milk, cattle at 2.00 ppm; eggs, chicken at 0.20 ppm; hog, meat byproducts at 0.40 ppm; hog, fat at 0.04 ppm; hog, meat at 0.04 ppm; horse, meat byproducts at 40.00 ppm; horse, fat at 4.00 ppm; horse, meat at 4.00 ppm; goat, meat byproducts at 40.00 ppm; sheep, meat byproducts at 40.00 ppm; sheep, fat at 4.00 ppm; and sheep, meat at 4.00 ppm. Bayer CropScience also requests to delete tolerances in 40 CFR 180.661 for residues of the fungicide fluopyram in or on the raw agricultural commodities apple at 0.30 ppm; bean, dry at 0.09 ppm; beet, sugar, roots at 0.04 ppm; apple wet pomace at 0.60 ppm; cherry at 0.60 ppm; grape, wine at 2.0 ppm; potato at 0.02 ppm; strawberry at 1.5 ppm; and watermelon at 1.0 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 is issuing some tolerances that vary from the fluopyram tolerances as requested. The reasons for these changes are explained in Unit IV.C.
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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 fluopyram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluopyram follows.
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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.
Decreased body weight and liver effects were the common and frequent findings in the fluopyram subchronic and chronic oral toxicity studies in rats, mice, and dogs, and they appeared to be the most sensitive effects. Liver effects were characterized by increased liver weight, hepatocellular hypertrophy, hepatocellular vacuolation, increased mitosis and hepatocellular necrosis. Thyroid effects were found at dose levels similar to those that produced liver effects in rats and mice; these effects consisted of follicular cell hypertrophy, increased thyroid weight, and hyperplasia at dose levels greater than or equal to 100 milligrams/kilogram/day (mg/kg/day). Changes in thyroid hormone levels were also seen in a subchronic toxicity study. In male mice, there was an increased incidence of thyroid adenomas.
Although increased liver tumors were observed in female rats in the carcinogenicity study, EPA has concluded that fluopyram is ``Not Likely to be Carcinogenic to Humans'' at doses that do not induce cellular proliferation in the liver or thyroid glands. This classification was based on convincing evidence that non-genotoxic modes of action for liver tumors in rats and thyroid tumors in mice have been established and that the carcinogenic effects have been demonstrated as a result of a mode of action dependent on activation of the CAR/PXR receptors. The Agency is using a point of departure for regulating fluopyram (NOAEL of 1.2 mg/kg/day) that is below the doses that cause cell proliferation in the liver (11 mg/kg/day) and subsequent liver tumor formation (89 mg/
kg/day); therefore, the Agency concludes that exposure to fluopyram will not be carcinogenic. Moreover, fluopyram is not genotoxic or mutagenic.
Fluopyram is not a developmental toxicant, nor did it adversely affect reproductive parameters. No evidence of qualitative or quantitative susceptibility was observed in developmental studies in rats and rabbits or in a multigeneration study in rats.
In an acute neurotoxicity study, transient decreased motor activity was seen only on the day of treatment, but no other findings demonstrating neurotoxicity were observed. In addition, no neurotoxicity was observed in the subchronic neurotoxicity study in the presence of other systemic adverse effects. Fluopyram did not produce treatment-related effects on the immune system.
Fluopyram has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Fluopyram is not a skin or eye irritant or sensitizer under the conditions of the murine lymph node assay. Specific information on the studies received and the nature of the adverse effects caused by fluopyram 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 the document entitled: ``Fluopyram: Human Health Risk Assessment for Proposed New Uses on Crop Subgroup 1B, Subgroup 1C, Crop Group 2, Subgroup 3-07A, Subgroup 3-07B, Subgroup 4A, Subgroup 4B, Subgroup 5A, Subgroup 5B, Subgroup 6A, Subgroup 6B, Dried Beans, Soybean, Subgroup 8-10A, Subgroup 8-10B, Subgroup 9A, Subgroup 9B, Subgroup 10-10, Group 11-10, Subgroup 12-12A, Subgroup 12-12B, Subgroup 12-12C, Subgroup 13-07A, Subgroup 13-07B, Subgroup 13-07F, Subgroup 13-
07G, Crop Group 15 (except corn and Rice), Crop Group 16, Subgroup 19A, Dill Seed, Subgroup 20A, Subgroup 20B, Subgroup 20C, Artichoke (Globe), Hops, and Sugarcane (Rotated). Amended Tolerance Requests for the Registered Uses due to Crop Group/Subgroup Expansion Requests. Proposed New Uses on Turf Grass, Ornamentals, and Christmas trees, and as a seed treatment to Peanuts'' in
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docket ID number EPA-HQ-OPP-2015-0443.
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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://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.
A summary of the toxicological endpoints for fluopyram used for human risk assessment is shown in Table 1.
Table 1--Summary of Toxicological Doses and Endpoints for Fluopyram 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 (General population NOAEL = 50 mg/kg/day Acute RfD = 0.50 mg/ Acute Neurotoxicity Study in Rats
including infants and children). UFA = 10x........... kg/day. LOAEL = 100 mg/kg/day based on
UFH =10x............ aPAD = 0.50 mg/kg/ decreased motor and locomotor
FQPA SF = 1x........ day. activity in females. The LOAEL in
males was 125 mg/kg/day.
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Acute dietary (Females 13-50 An endpoint attributable to a single dose exposure has not been identified
years of age). for this subpopulation.
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Chronic dietary (All populations) NOAEL = 1.2 mg/kg/ Chronic RfD = 0.012 Combined Chronic/Carcinogenicity
day. mg/kg/day. in Rats
UFA = 10x........... cPAD = 0.012 mg/kg/ LOAEL = 6.0 mg/kg/day based on
UFH = 10x........... day. follicular cell hypertrophy in
FQPA SF = 1x........ the thyroid, and increased liver
weight with gross pathological
and histopathological findings.
Incidental oral short-term (1 to NOAEL = 14.5 mg/kg/ LOC for MOE = 100.. Reproduction study in rats
30 days) and intermediate-term day. LOAEL = 82.8 mg/kg/day based on
(1 to 6 months). UFA = 10x........... clinical pathology changes,
UFH = 10x........... decreased spleen and thymus
FQPA SF = 1x........ weights, increased liver weight
and centrilobular hypertrophy in
parents, and decreased body
weight and body weight gain with
decreases in spleen and thymus
weights and slight delay in
preputial separation in
offspring.
Dermal short-term (1 to 30 days) NOAEL = 300 mg/kg/ Residential LOC for 28-day dermal study in rats
and intermediate-term (1 to 6 day. MOE = 100. LOAEL = 1000 mg/kg/day based on
months). UFA = 10x........... increased cholesterol (F),
UFH = 10x........... increased prothrombin time (M).
FQPA SF = 1x........
Inhalation short-term (1 to 30 NOAEL = 14.5 mg/kg/ Residential LOC for Reproduction study in rats
days) and intermediate-term (1-6 day. MOE = 100. LOAEL = 82.8 mg/kg/day based on
months). UFA = 10x........... clinical chemistry changes and
UFH = 10x........... increased kidney weight in
FQPA SF = 1x........ parents, and decreased body
weight and body weight gain with
decreases in spleen and thymus
weights in offspring.
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Cancer (Oral, dermal, inhalation) ``Not Likely to be Carcinogenic to Humans'' at doses that do not induce
cellular proliferation in the liver or thyroid glands.
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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). UF = uncertainty factor. UFA = extrapolation
from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies).
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Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluopyram, EPA considered exposure under the petitioned-for tolerances as well as all existing fluopyram tolerances in 40 CFR 180.661. EPA assessed dietary exposures from fluopyram 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 fluopyram. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA included tolerance residue levels, the assumption
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of 100% crop treated, and processing factors (empirical and default).
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA included average residue levels, % crop treated, and processing factors (empirical and default).
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fluopyram does not pose a cancer risk to humans at doses that do not induce cellular proliferation in the liver or thyroid glands. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the PCT for the chronic dietary exposure assessment for existing uses as follows:
Almonds 33%; apples 40%; blackberries 55%; blueberries 54%; broccoli 24%; cantaloupes 22%; celery 60%; corn field 9%; corn, sweet 15%; cucumbers 41%; dry beans/peas 7%; fresh tomatoes 64%; grape wine 79% (used for grape, wine and sherry); head lettuce 67%; leaf lettuce 62%; oranges 39%; peaches 56%; pears 43%; peanuts 67%; potatoes 64%; processed tomatoes 57%; pumpkins 45%; snap beans 44%; soybeans 17%; spinach 43%; squash 47%; strawberries 75%; sugar beets 48%; watermelons 54%; and wheat 17% (from spring wheat at 17% and winter wheat at 6%).
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fluopyram may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk assessment for fluopyram in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluopyram. 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 Ground Water (PRZM GW) and the surface water concentration calculator (SWCC), the estimated drinking water concentrations (EDWCs) of fluopyram for acute exposures are estimated to be 50.6 parts per billion (ppb) for surface water and 97.6 ppb for ground water. The chronic exposures for non-cancer assessments are estimated to be 17.3 ppb for surface water and 90.5 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 97.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 90.5 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).
Fluopyram is proposed for use that could result in residential exposures: golf course turf, residential lawns, fruit trees, nut trees, ornamentals and gardens. EPA assessed residential exposure using the following assumptions: short-term dermal, oral (derived from incidental oral hand to mouth post-application exposures to treated lawn in children), and inhalation exposures derived from treating lawns by hose-end sprayers (adults); residential post-application exposures: adults and children (1 to
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