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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	3/11/09

SUBJECT:	Triflumizole Amended Acute and Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Leafy Greens (Subgroup 4A) Except Spinach, Head and Stem Brassica (Subgroup 5A), Cilantro, Swiss Chard, Pineapple, Papaya, Black Sapote, Canistel, Mamey Sapote, Mango, Sapodilla, Star Apple, and Hops.

PC Code:  128879	DP Num:  361544

Decision Nos.:  383407	Registration No.:  400-518

Petition Nos.:  7E7258 and 7E7286	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  68694-11-1

MRID No.:  NA	40 CFR:  §180.476

REVIEWER:	W. Cutchin, Chemist

Alternative Risk Integration Assessment (ARIA) Team

Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

THROUGH:	D. Hrdy, Biologist

		N. Dodd, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (HED; 7509P)

TO:		S. Jackson, Risk Manager

RIMUERB/RD (7505P)

Executive Summary

CID™, Version 2.14 which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support requested Section 3 registrations.

The acute dietary exposure assessments used tolerance-level residues and 100% crop treated (CT) for all registered and proposed uses.  The assessment incorporated triflumizole residues in drinking water directly, using the maximum concentration (1-in-10-year annual peak) for surface water generated by the Pesticide Root Zone Model-Exposure Analysis Modeling System (PRZM-EXAMS) model.  These assessments conclude that the acute dietary (food + drinking water) exposure estimates (95th percentile) are below the Agency’s level of concern (<100% acute population adjusted dose; aPAD) for the general U.S. population (26% aPAD) and all population subgroups (children 1-2 years old at 40% aPAD and females 13-49 years old at 67% aPAD).

The chronic dietary (food + drinking water) exposure assessment used anticipated residues (ARs) from average field trial residues for apple, grape, pear, cherry, cucurbit, strawberry, milk commodities, leafy greens (subgroup 4A) except spinach, head and stem Brassica (subgroup 5A), cilantro, Swiss chard, pineapple, papaya, black sapote, canistel, mamey sapote, mango, sapodilla, star apple and hops.  For all other commodities, the assessment used current and proposed tolerances.  The assessment used % CT information for apples, cantaloupes, cherries, cucumbers, grapes, hazelnuts (filberts), honeydew melons, pears, pumpkins, squash, strawberries, and watermelons, but used 100% CT information for all other registered and proposed uses.  Drinking water was incorporated directly into the dietary assessment using the mean concentration (1-in-10-year annual mean) for surface water generated by the PRZM-EXAMS model.  The chronic assessment concludes that the chronic dietary exposure estimates are below the Agency’s level of concern (<100% chronic (c) PAD) for the general U.S. population (26% cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 44% cPAD.

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, the Agency is concerned when estimated dietary risk exceeds 100% of the PAD.  The Agency is generally concerned when estimated cancer risk exceeds one in one million.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for triflumizole was conducted for Brassica leafy greens, crop subgroup 5B (J. Tomerlin, 1/8/08, DP Num: 341964).

II.  Residue Information

Registered and Proposed Tolerances: Permanent tolerances are established under 40 CFR §180.476(a) for the combined residues of triflumizole and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound, in/on apples, cherries, filberts, grapes, pears, strawberries, and cucurbit vegetables.  Permanent tolerances have also been established under 40 CFR §180.476(a) for the same residue of concern in/on milk; eggs; meat, fat, and meat byproducts (mbyp) of cattle, goats, hogs, horses, and sheep; and in/on meat, fat, and mbyp of poultry.  Time-limited tolerances in conjunction with Section 18 Emergency Exemptions have been established under 40 CFR §180.476(b) for the combined residues of triflumizole and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound, in/on broccoli, Chinese (Napa) cabbage, collards, coriander, dandelion, kale, kohlrabi, mustard greens, parsley, Swiss chard, and turnip greens.

ARIA has recommended for Section 3 registrations and tolerances on:

Brassica, head and stem, subgroup 5A	8.0 ppm

Leafy greens subgroup 4A, except spinach	35 ppm

Coriander, leaves	35 ppm

Swiss chard	18 ppm

Pineapple	4.0 ppm

Papaya	2.5 ppm

Sapote, black	2.5 ppm

Canistel	2.5 ppm

Sapote, mamey	2.5 ppm

Mango	2.5 ppm

Sapodilla	2.5 ppm

Star apple	2.5 ppm

Hop, dried cones	50 ppm

Since there are no longer any poultry or swine feed items of regulatory interest, the current tolerances on eggs; poultry fat, meat, and meat byproducts; and hog fat, meat and meat byproducts should all be deleted.  Based on the previously reviewed cattle feeding study and the revised dietary burden, tolerances are required for meat byproducts and fat of cattle, sheep, goat, and horse, but below established levels.  Specifically, ARIA recommends lowering the present fat tolerance levels from 0.5 ppm to 0.10 ppm, and also lowering the meat byproduct tolerance levels from 0.5 ppm to 0.20 ppm (PP#s 7E7258 and 7E7286, DP Num: 354063, W. Cutchin, 10/1/08).  All other established livestock tolerances should be removed from 40 CFR § 180.476(a)(2).

Cattle, fat	0.10 ppm

Cattle, meat byproducts	0.20 ppm

Goat, fat	0.10 ppm

Goat, meat byproducts	0.20 ppm

Horse, fat	0.10 ppm

Horse, meat byproducts	0.20 ppm

Sheep, fat	0.10 ppm

Sheep, meat byproducts	0.20 ppm

When the permanent tolerances recommended in the registration action become final, the time-limited tolerances for the following RACs, established under Section 18 Emergency Exemptions [40 CFR §180.476(b)], may be removed:  broccoli (1.0 ppm); cabbage, Chinese, napa (20 ppm), coriander leaves (20 ppm), dandelion, leaves (7.0 ppm); kohlrabi (20 ppm); parsley leaves (20 ppm); and Swiss chard (7.0 ppm).

Nature of the Residue: The nature of the residue in fruit is adequately understood based on acceptable metabolism data on apples, cucumbers, grapes, and pears.  The residues of concern include the parent compound, triflumizole and its metabolites (free and conjugates) containing the 4-chloro-2-trifluoromethylaniline moiety (calculated as triflumizole).  In a meeting on 2/26/02, the HED Metabolism Assessment Review Committee (MARC) concluded that there was no need to revisit the residues of concern in primary crops (DP Num: 280869, J. Tyler, 3/13/02).  The MARC concurred with the current tolerance expressions for plants as stated in 40 CFR §180.476.

The nature of the residue in livestock is adequately understood based on acceptable metabolism data on lactating goats and poultry.  The residues of concern were determined to be the combined residues of triflumizole, the metabolite 4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate, and other metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound.  In a meeting on 2/26/02, the HED MARC concluded that there was no need to revisit the residues of concern in livestock (DP Num: 280869, J. Tyler, 3/13/02).  The MARC concurred with the current tolerance expressions for livestock as stated in 40 CFR §180.476.  There are no livestock feed commodities associated with the proposed tolerances, so the proposed registration does not have an impact on residues in edible livestock tissues.

Residue Data used for Acute, Chronic, and/or Cancer Assessments:

Anticipated Residues: Tolerance-level residues were used for all registered and proposed commodities in the acute assessment.  For the chronic assessment, anticipated residues (ARs) calculated as the mean value from field trial data were used for apple, grape, pear, cherry, most cucurbit vegetables, strawberry, leafy greens (subgroup 4A) except spinach, head and stem Brassica (subgroup 5A), cilantro, Swiss chard, pineapple, papaya, canistel, mamey sapote, mango, and hops.  See Table 1 for further information; additional information can be found in Attachment 5 of the HED risk assessment (DP Num: 280865, J. Tyler, 4/9/02) and the ARIA residue chemistry chapter (PP#: 7E7258 and 7E7286, DP Num: 344463 and 346779, W. Cutchin, 10/1/08).

TABLE 1:  Summary of Residue Values Used in the Dietary (Food + Drinking Water) Risk Assessments for Triflumizole

COMMODITY	ACUTE ASSESSMENT	CHRONIC ASSESSMENT

	Tolerance

(ppm)	Processing

Factors	Tolerance

(ppm)	AR1

(ppm)	%CT2	Processing

Factors

Established Crop Commodities

Apples	0.5	Juice – 1.0

Sauce & Dried– DEEM	NU3	0.14	20	Juice – 1.0

Sauce & Dried– DEEM

Brassica leafy greens9	40	NA	40	NC	NR	NA

Cherries	1.5	DEEM	NU	0.66	15	DEEM

Grapes	2.5	Juice – 1.0

Raisin, Leaves and Wine/Sherry – DEEM	NU	0.55	5	Juice – 1.0

Raisin, Leaves and Wine/Sherry – DEEM

Hazelnuts	0.05	DEEM	0.05	NC	15	DEEM

Muskmelons5	0.5	NA	NU	0.17	106	NA

Pears	0.5	DEEM	NU	0.23	40	DEEM

Strawberries	2.0	NA	NU	0.53	NR	NA

Summer Squash7	0.5	NA	NU	0.14	NR	NA

Established Livestock Commodities

Fat8	0.10	NA	0.10	NC	NA	NA

Meat byproducts (Mbyp)8	0.20	NA	0.20	NC	NA	NA

Proposed Commodities

Brassica, head and stem, subgroup 5A	8.0	NA	8.0	Cabbage 0.74

Broccoli 1.79 	NR	NA

Leafy greens subgroup 4A, except spinach	35	NA	35	Head Lettuce 2.97

Leaf Lettuce 11.1	NR	NA

Coriander, leaves	35	NA	35	11.1	NR	NA

Swiss chard	18	NA	18	5.48	NR	NA

Pineapple	4.0	Juice - 1.0

Dried - DEEM	4.0	2.17	NR	Juice - 1.0

Dried - DEEM

Papaya	2.5	NA	2.5	0.63	NR	NA

Sapote, black	2.5	NA	2.5	0.63	NR	NA

Canistel	2.5	NA	2.5	0.63	NR	NA

Sapote, mamey	2.5	NA	2.5	0.63	NR	NA

Mango	2.5	NA	2.5	0.63	NR	NA

Sapodilla	2.5	NA	2.5	0.63	NR	NA

Star apple	2.5	NA	2.5	0.63	NR	NA

Hop, dried cones	50	NA	50	14.4	NR	NA

1 Anticipated Residue: calculated as the mean value from field trial data

2 Percent Crop Treated: Taken from A. Grube, 12/28/07, memo titled “Screening Level Usage Analysis (SLUA) Report Package in Support of Registration for the Fungicide Triflumizole (PC 128879)”, no DP Num listed.

3 NA – Not available; NC – Not calculated; NR – Not Reported; NU – Not Used

4 Translated to Chinese waxgourd, balsam pear, and bitter melon

5 Translated to citron melon, casabas, crenshaws, cantaloupe, honeydew melons, persian melon, winter melon, watermelon.

6 Percent crop treated of 10% was used for cantaloupes and percent crop treated of 15% used for honeydew melons.  100% CT was assumed for all other melons.

7 Translated to christophine, okra/Chinese gourd, pumpkin, summer and winter squash

8 Of cattle, goats, horses, and sheep

9 Field trial data from mustard greens residue trials were translated to Brassica leafy greens, crop subgroup 5B, including the commodities: Broccoli raab, collards, kale, rape greens, and turnip greens.  Although a tolerance of 20 ppm was requested by the petitioner, ARIA recommended a tolerance of 40 ppm (DP Nums: 338653 and 341963, J. Tomerlin, 12/7/07,) based upon calculations performed according to “NAFTA Guidance Document for Guidance for Setting Pesticide Maximum Residue Limits Based on Field Trial Data”, Regulatory Proposal PRO2005-04 published jointly by the U. S. Environmental Protection Agency’s Office of Pesticide Programs and Health Canada’s Pest Management Regulatory Agency.

 3/16/89); therefore, the DEEM™ default concentration factors for these processed commodities were reduced to 1.  The dietary risk assessments used DEEM™ default concentration factors for all other processed commodities.

Percent Crop Treated: Updated percent crop treated (%CT) information was provided by the Office of Pesticide Program’s (OPP’s) Biological and Economic Analysis Division (BEAD) for apples, cantaloupes, cherries, cucumbers, grapes, hazelnuts (filberts), honeydew melons, pears, pumpkins, squash, strawberries, and watermelons (A. Grube, 12/28/07, memo titled “Screening Level Usage Analysis (SLUA) Report Package in Support of Registration for the Fungicide Triflumizole (PC 128879)”, no DP Num listed).  The %CT estimates from this SLUA are summarized in Table 2.

Table 2:  Percent Crop Treated Estimates for Triflumizole

COMMODITY	MEAN PERCENT

CROP TREATED	MAXIMUM PERCENT

CROP TREATED

Apples	20	35

Cantaloupes	10	15

Cherries	15	20

Cucumbers	< 1	< 2.5

Cucumbers, pickles	5	5

Grapes	5	10

Hazelnuts (Filberts)	15	40

Honeydew melons	15	25

Pears	40	55

Pumpkins	5	10

Squash	< 1	< 2.5

Strawberries	15	25

Watermelons	5	5

For the acute dietary risk assessment, residues were assumed to be from100% CT of registered and proposed commodities.  For the chronic assessment, the mean %CT information was used only for the specific commodities listed.  For example, the estimate of 15% CT for honeydew melons was not used for casaba melons, for which 100% CT was assumed.

Although separate %CT estimates are available for cucumbers and pickle cucumbers, the DEEM dietary database does not differentiate consumption estimates for cucumber pickles.  Therefore, the chronic dietary risk assessment used the higher value of 5% for all cucumbers.  The chronic risk assessment assumed that 1% of squash were treated, effectively ignoring the “<” symbol.

  Drinking Water Data

Drinking Water Considerations: The Environmental Fate and Effects Division (EFED) provided revised Tier II drinking water estimated drinking water concentrations (EDWCs) to include the degradates containing the 4-chloro-2-trifluoromethylaniline moiety (MARC; DP Num: 280869, J. Tyler, 3/13/02): “Triflumizole Drinking Water Assessment in Support of New Use Registration Action for Brassica, Leafy Greens, Subgroup 5B, Leafy Greens Subgroup 4A (except Spinach), Papayas, and Hops,” 10/3/07, I. L. Maher, T. Nguyen, and T. Bailey, DP Nums: 338654 and 344465.  Water residues were incorporated in the DEEM-FCID directly into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The EDWCs derived for total residues of parent and degradates containing the 4-chloro-2-trifluoromethylaniline moiety were updated to account for an anaerobic aquatic metabolism study submitted by the registrant.  The Screening Concentration in Ground Water (SCI-GROW) and Pesticide Root Zone Model-Exposure Analysis Modeling System (PRZM-EXAMS) models were used to derive the ground and surface water EDWCs, respectively.  Although the proposed use patterns for Brassica vegetables were evaluated, maximum EDWC values were obtained using the maximum application scenario (0.5 lb ai/A/application and 6 applications/year) for cherries.  Therefore, the drinking water EDWCs were derived for cherries.  The ground water EDWC was 3.11 ppb.  The acute EDWC of 37.4 ppb was taken from the 1-in-10 year annual maximum concentration calculated by PRZM-EXAMS.  Likewise, the chronic EDWC of 15.8 ppb was taken from the 1-in-10 year annual mean concentration calculated by PRZM-EXAMS.  Consequently, the dietary (food + water) risk assessments used residue values of 0.037 and 0.016 ppm for the acute and non-cancer chronic assessments, respectively.

Additional information regarding water models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

IV.  DEEM-FCID™ Program and Consumption Information

Triflumizole acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™, Version 2.14 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

V.  Toxicological Information

With the exception of the chronic endpoint, the risk assessment team adopted toxicity endpoints used in previous risk assessments (DP Num: 325681, J. Tyler, 3/1/06; DP Num: 306463, J. Tyler, M. Dow and R. Mitkus, 1/28/05).  The chronic RfD is based on a LOAEL of 3.5 mg/kg/day based on liver toxicity (eosinophilic foci in male rats and fatty vacuolation and inflammation and necrosis in female rats) in combined chronic toxicity/carcinogenicity study in rats (DP Num: 361545, J. Redden, 3/4/09).

The former Hazard Identification Assessment Review Committee (HIARC) recommended that an acute neurotoxicity study and a subchronic neurotoxicity study be submitted in order to better characterize the neurological effects seen in the rat and mouse acute oral, the rat acute inhalation and the rat chronic studies.  The former FQPA Safety Factor Committee (SFC) recommended a UFDB of 3x be applied to the acute and chronic RfDs in order to account for any uncertainty due to the lack of these two neurotoxicity studies (TXR NO. 0050571, D. Nixon, 3/17/02).  Since that time, acceptable acute and subchronic rat neurotoxicity and subchronic rat neurotoxicity studies (GLN 870.6200) have been submitted and reviewed; therefore, the risk assessment team determined that the 3x UFDB should be removed from the acute and chronic RfDs.  In addition, the FQPA SFC recommended the FQPA Safety Factor (SF) be reduced to 1x.  Based upon a re-evaluation of the quality of the exposure and hazard data, the risk assessment team recommended that the FQPA SF remain at 1x.  The recommendation is based on the following:

The toxicity database is complete for FQPA assessment;

There was no quantitative or qualitative evidence of increased susceptibility in the rabbit fetuses following in utero exposure or the rat following pre- and post-natal exposure in the rat reproduction study;

There was evidence of qualitative susceptibility in the developmental rat study; however, there are no residual uncertainties, and the use of the developmental NOAEL and the endpoint for the aRfD for females 13-49 would be protective with respect to the pre-natal toxicity following an acute dietary exposure;

There is no evidence of increased quantitative or qualitative susceptibility in the rat developmental neurotoxicity study;

The acute dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100% CT for all commodities.  By using these screening-level assessments, actual exposures/risks will not be underestimated;

The chronic dietary food exposure assessment utilizes anticipated residues (ARs) and percent crop treated (% CT) data summarized by OPP’s BEAD for several existing uses.  For all proposed uses, tolerance-level residues and 100% CT are assumed.  The chronic assessment is somewhat refined and based on reliable data and will not underestimate exposure/risk;

The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded;

There are no registered or proposed uses of triflumizole that would result in residential exposure.

However, in a memo from J. Redden (DP Num: 361545, 3/4/09) ARIA agrees with the removal of the FQPA safety factor decision as to acute risk but believes a 3x FQPA safety factor is needed for the chronic RfD because it is derived from the use of a LOAEL established in the combined chronic toxicity/carcinogenicity study in rats.  A 3x FQPA Safety Factor for use of LOAEL instead of a NOAEL (as opposed to a 10x) is viewed to be adequate because:

The most sensitive endpoint in the target organ (liver) for this class of compounds (conazole fungicide) is used for assessing chronic risk.

 There is low concern for the observed effects since the lesions did not progress into malignancy.

The available data dose do not show this chemical to be a potent toxicant since clear NOAELs were established following dietary administrations in all the other studies such as the two-generation reproduction (3.5 m/k/d), subchronic rat (15.3 m/k/d) and mouse (33.1 m/k/d); chronic dog study (10 m/k/d) and the carcinogenicity (16.2 m/k/d) studies.

The extrapolated NOAEL of 1.2 mg/k/d (3.5/3 = 1.2) is supported by a comparable NOAEL (2.5 m/k/d) used for deriving the chronic RfD for a structurally-related chemical (imazalil).

Based on these weight-of-evidence considerations, the Agency is confident that a 3x FQPA Safety Factor is adequate to address the concerns for the lack of a NOAEL in the critical study and that the chronic RfD would not underestimate dietary risk from chronic exposure to triflumizole.

Based on the proposed use pattern, the toxicology database for triflumizole is adequate for risk assessment.  However, an immunotoxicity study in rats is required under the current (revised) Part 158 Toxicology Data requirements (40 CFR).  This study was not submitted to the Agency in support of the proposed registration for products containing triflumizole.  Therefore, registration of triflumizole should be made conditional pending receipt of an acceptable immunotoxicity study.

The toxicity endpoints used to evaluate acute and chronic dietary risk are summarized in Table 3.

Table 3.  Summary of Toxicological Doses and Endpoints for Triflumizole for Use in Dietary Exposure Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	NOAEL = 25 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x	Acute RfD = 0.25 mg/kg/day	Acute Neurotoxicity – Rat

LOAEL = 100 mg/kg/day based on FOB findings (neuromuscular impairment) and decreased locomotor activity.

Acute Dietary

(Females 13-49 years of age)	NOAEL= 10 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x	Acute RfD = 0.1 mg/kg/day	Developmental Toxicity – Rat

LOAEL = 35 mg/kg/day based upon decreased numbers of viable fetuses, increased dead or resorbed fetuses, increased numbers of late resorptions, decreased fetal body weight, and increased incidences of cervical ribs.

Chronic Dietary (All Populations)	LOAEL= 3.5 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 3x	Chronic RfD = 0.035

mg/kg/day

cPAD = 0.0117 mg/kg/day	Combined Chronic Toxicity/Carcinog. Study -  Rat

Based on liver toxicity (eosinophilic foci in male rats and fatty vacuolation and inflammation and necrosis in female rats).

Cancer	Classification: “Evidence for non-carcinogenicity for Humans” based on adequate studies in two animal species.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (intraspecies).  UFH = potential variation in sensitivity among members of the human population (interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use of a short-term study for long-term risk assessment.  UFDB = to account for the absence of key data (i.e., lack of a critical study).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level of concern.  N/A = not applicable.

VI.  Results/Discussion

As stated above, for acute and chronic assessments, the Agency is concerned when dietary risk exceeds 100% of the appropriate PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  With respect to carcinogenicity, triflumizole has been classified as “Evidence for non-carcinogenicity for Humans;” therefore, a triflumizole cancer risk assessment was not performed.

Results of Acute Dietary (Food + Drinking Water) Exposure Analysis:

The results of the acute dietary exposure analysis are reported in Table 4.  The acute dietary (food + drinking water) exposure assessments used tolerance-level residues and 100% CT for all registered and proposed uses.  Drinking water was incorporated directly in the dietary assessment using the maximum concentration for surface water generated by the PRZM/EXAMS model.  These assessments conclude that the acute dietary exposure estimates (95th percentile) are below the Agency’s level of concern (<100% aPAD) for the general U.S. population (26% aPAD) and all population subgroups.  Exposure was equivalent to 40% of the aPAD for the most highly exposed population subgroup (children 1-2 years old) and 67% of the aPAD for females 13-49 years old.

Results of Chronic Dietary (Food + Drinking Water) Exposure Analysis:

The results of the chronic dietary exposure analysis are reported in Table 4.  The chronic dietary exposure assessment used ARs from average field trial residues for apple, grape, pear, cherry, most cucurbit vegetables, strawberry, leafy greens (subgroup 4A) except spinach, head and stem Brassica (subgroup 5A), cilantro, Swiss chard, pineapple, papaya, canistel, mamey sapote, mango, and hops, and registered and proposed tolerances for all other commodities.  The assessment used % CT information for apples, cantaloupes, cherries, cucumbers, grapes, hazelnuts (filberts), honeydew melons, pears, pumpkins, squash, strawberries, and watermelons; and 100% CT for all other registered and proposed uses.  The chronic dietary (food + drinking water) risk assessment was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the PRAM/EXAMS model.  This assessment concludes that the chronic dietary exposure estimates are below the Agency’s level of concern (<100% cPAD) for the general U.S. population (26% cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 44% cPAD.

Table 4.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Triflumizole.

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD*	Dietary Exposure

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	0.064679	26	0.003082	26	N/A	N/A

All Infants (< 1 year old)	0.039008	16	0.002318	20

Children 1-2 years old	0.099522	40	0.005132	44

Children 3-5 years old	0.086530	35	0.004747	41

Children 6-12 years old	0.067118	27	0.002720	23

Youth 13-19 years old	0.054418	22	0.002714	23

Adults 20-49 years old	0.064733	26	0.002743	23

Adults 50+ years old	0.059468	24	0.003453	30

Females 13-49 years old	0.067180	67	0.002729	23

	VII.  Characterization of Inputs/Outputs

Adequate data are available for the determination of tolerance levels, as discussed in the applicable residue chemistry memos.  The triflumizole ARs used in the chronic dietary exposure assessment (listed in Table 1) are based on field trial data submitted by the registrant to support tolerances.  Field trial residue data are generally considered by the Agency as an upper-end or a worst case scenario of possible residues, because field trials require the highest rates of application and shortest preharvest interval (PHI).

Field trial data were translated from some commodities to other commodities in the same crop group.  Residue data from cucumbers were translated to Chinese waxgourd, balsam pear, and bitter melon; residue data from muskmelons were translated to citron melon, casabas, crenshaws, cantaloupe, honeydew melons, persian melons, winter melon, and watermelon; residue data from mustard greens were translated to Brassica leafy greens, crop subgroup 5B: broccoli raab, Chinese (Napa) cabbage, collards, kale, rape greens, and turnip greens; residue data from leaf lettuce were translated to coriander and the leafy greens subgroup 4A, except spinach and head lettuce; and residue data from papaya were translated to black sapote, canistel, mamey sapote, mango, sapodilla, and star apple.  In all cases, data was translated from a representative commodity only to other commodities in the same crop group.  This practice is consistent with Agency data usage policy and practice.

The use of 100%CT for most of the commodities that could be treated with triflumizole is a conservative measure that overestimates dietary exposure and risk from triflumizole residues.

Regarding the level of refinement of the assessments, the acute dietary assessment is unrefined in that it assumes that 100% of eligible commodities contain tolerance-level residues of triflumizole.  Therefore, the acute assessment provides a conservative estimate of acute dietary risk to triflumizole which is protective of public health.  The chronic dietary assessment is partially refined in that it uses anticipated residues for numerous commodities, as well as %CT data for several other commodities.  However, the chronic assessment does assume that the other commodities contain tolerance level residues.  Consequently, the chronic assessment provides a reasonably conservative assessment of potential risk to residues of triflumizole in the diet.

	VIII.  Conclusions

  The DEEM-FCID™ analysis estimates the dietary exposure of the U.S. population and 26 population subgroups.  Table 4 summarizes dietary exposure and risk for the U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, males 20-49, and adults 50+ years.

The unrefined acute dietary (food + drinking water) assessment used tolerance-level residues in 100% of eligible commodities.  Drinking water was incorporated directly in the assessment.  These assessments conclude that estimated exposure at the 95th percentile is below the Agency’s level of concern for all population subgroups evaluated.  Estimated exposure was equivalent to 26% and 40% of the aPAD for the general U.S. population and children 1-2 years old, respectively.  Estimated exposure for females 13-49 years old was equivalent to 67% of the aPAD.

The chronic dietary (food + drinking water) exposure assessment used ARs for some commodities and tolerance values for the remainder.  The assessment used 100% CT for most commodities, but did use estimates of %CT for several crops.  Drinking water was incorporated directly into the assessment.  Exposure estimates for all population subgroups are below the Agency’s level of concern (<100% chronic cPAD).  Estimated exposure was equivalent to 26% and 44% of the cPAD for the general U.S. population and children 1-2 years old (the most highly exposed subgroup), respectively.

IX.  List of Attachments

1: Acute Food + Drinking Water Residue Input file.

2: Acute Results file, except Females 13-49

3. Acute Results file, Females 13-49

4: Chronic Food + Drinking Water Residue Input file.

5: Chronic Results file.

6: Triflumizole SLUA

ATTACHMENT 1:  Residue File for Acute Dietary (Food + Drinking Water)

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for TRIFLUMIZOLE

Residue file name: G:\working\Triflum\128879a.R98

Analysis Date 09-22-2008             Residue file dated: 09-22-2008/11:12:29/8

Reference dose (aRfD) = 0.25 mg/kg bw/day

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

04010050 4A   Amaranth, leafy                   35.000000   1.000  1.000

11000070 11   Apple, fruit with peel             0.500000   1.000  1.000

11000080 11   Apple, peeled fruit                0.500000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.500000   1.000  1.000

11000090 11   Apple, dried                       0.500000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.500000   8.000  1.000

11000100 11   Apple, juice                       0.500000   1.000  1.000

11000101 11   Apple, juice-babyfood              0.500000   1.000  1.000

11000110 11   Apple, sauce                       0.500000   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.500000   1.000  1.000

04010180 4A   Arugula                           35.000000   1.000  1.000

09020210 9B   Balsam pear                        0.500000   1.000  1.000

21000460 M    Beef, meat byproducts              0.200000   1.000  1.000

21000461 M    Beef, meat byproducts-babyfood     0.200000   1.000  1.000

21000470 M    Beef, fat                          0.100000   1.000  1.000

21000471 M    Beef,fat-babyfood                  0.100000   1.000  1.000

05010610 5A   Broccoli                           8.000000   1.000  1.000

05010611 5A   Broccoli-babyfood                  8.000000   1.000  1.000

05010620 5A   Broccoli, Chinese                  8.000000   1.000  1.000

05020630 5B   Broccoli raab                     40.000000   1.000  1.000

05010640 5A   Brussels sprouts                   8.000000   1.000  1.000

05010690 5A   Cabbage                            8.000000   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy        40.000000   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             8.000000   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          8.000000   1.000  1.000

95000740 O    Canistel                           2.500000   1.000  1.000

09010750 9A   Cantaloupe                         0.500000   1.000  1.000

09010800 9A   Casaba                             0.500000   1.000  1.000

05010830 5A   Cauliflower                        8.000000   1.000  1.000

09020880 9B   Chayote, fruit                     0.500000   1.000  1.000

12000900 12   Cherry                             1.500000   1.000  1.000

12000901 12   Cherry-babyfood                    1.500000   1.000  1.000

12000910 12   Cherry, juice                      1.500000   1.500  1.000

12000911 12   Cherry, juice-babyfood             1.500000   1.500  1.000

09021020 9B   Chinese waxgourd                   0.500000   1.000  1.000

04011040 4A   Chrysanthemum, garland            35.000000   1.000  1.000

05021170 5B   Collards                          40.000000   1.000  1.000

19011180 19A  Coriander, leaves                 35.000000   1.000  1.000

19011181 19A  Coriander, leaves-babyfood        35.000000   1.000  1.000

04011330 4A   Cress, garden                     35.000000   1.000  1.000

04011340 4A   Cress, upland                     35.000000   1.000  1.000

09021350 9B   Cucumber                           0.500000   1.000  1.000

04011380 4A   Dandelion, leaves                 35.000000   1.000  1.000

04011500 4A   Endive                            35.000000   1.000  1.000

14001550 14   Filbert                            0.050000   1.000  1.000

14001560 14   Filbert, oil                       0.050000   1.000  1.000

23001700 M    Goat, meat byproducts              0.200000   1.000  1.000

23001710 M    Goat, fat                          0.100000   1.000  1.000

95001750 O    Grape                              2.500000   1.000  1.000

95001760 O    Grape, juice                       2.500000   1.000  1.000

95001761 O    Grape, juice-babyfood              2.500000   1.000  1.000

95001770 O    Grape, leaves                      2.500000   1.000  1.000

95001780 O    Grape, raisin                      2.500000   4.300  1.000

95001790 O    Grape, wine and sherry             2.500000   1.000  1.000

09011870 9A   Honeydew melon                     0.500000   1.000  1.000

95001880 O    Hop                               50.000000   1.000  1.000

05021940 5B   Kale                              40.000000   1.000  1.000

05011960 5A   Kohlrabi                           8.000000   1.000  1.000

04012040 4A   Lettuce, head                     35.000000   1.000  1.000

04012050 4A   Lettuce, leaf                     35.000000   1.000  1.000

95002150 O    Mango                              2.500000   1.000  1.000

95002151 O    Mango-babyfood                     2.500000   1.000  1.000

95002160 O    Mango, dried                       2.500000   1.000  1.000

95002170 O    Mango, juice                       2.500000   1.000  1.000

95002171 O    Mango, juice-babyfood              2.500000   1.000  1.000

05022290 5B   Mustard greens                    40.000000   1.000  1.000

95002450 O    Papaya                             2.500000   1.000  1.000

95002451 O    Papaya-babyfood                    2.500000   1.000  1.000

95002460 O    Papaya, dried                      2.500000   1.800  1.000

95002470 O    Papaya, juice                      2.500000   1.500  1.000

04012480 4A   Parsley, leaves                   35.000000   1.000  1.000

19012490 19A  Parsley, dried leaves             35.000000   1.000  1.000

19012491 19A  Parsley, dried leaves-babyfood    35.000000   1.000  1.000

11002660 11   Pear                               0.500000   1.000  1.000

11002661 11   Pear-babyfood                      0.500000   1.000  1.000

11002670 11   Pear, dried                        0.500000   6.250  1.000

11002680 11   Pear, juice                        0.500000   1.000  1.000

11002681 11   Pear, juice-babyfood               0.500000   1.000  1.000

95002790 O    Pineapple                          4.000000   1.000  1.000

95002791 O    Pineapple-babyfood                 4.000000   1.000  1.000

95002800 O    Pineapple, dried                   4.000000   5.000  1.000

95002810 O    Pineapple, juice                   4.000000   1.000  1.000

95002811 O    Pineapple, juice-babyfood          4.000000   1.000  1.000

09023080 9B   Pumpkin                            0.500000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.500000   1.000  1.000

04013130 4A   Radicchio                         35.000000   1.000  1.000

05023180 5B   Rape greens                       40.000000   1.000  1.000

26003391 M    Sheep, meat-babyfood               0.200000   1.000  1.000

26003400 M    Sheep, meat byproducts             0.200000   1.000  1.000

26003410 M    Sheep, fat                         0.100000   1.000  1.000

26003411 M    Sheep, fat-babyfood                0.100000   1.000  1.000

09023560 9B   Squash, summer                     0.500000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.500000   1.000  1.000

09023570 9B   Squash, winter                     0.500000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.500000   1.000  1.000

95003590 O    Strawberry                         2.000000   1.000  1.000

95003591 O    Strawberry-babyfood                2.000000   1.000  1.000

95003600 O    Strawberry, juice                  2.000000   1.000  1.000

95003601 O    Strawberry, juice-babyfood         2.000000   1.000  1.000

04023670 4B   Swiss chard                       18.000000   1.000  1.000

05023890 5B   Turnip, greens                    40.000000   1.000  1.000

86010000 O    Water, direct, all sources         0.037000   1.000  1.000

86020000 O    Water, indirect, all sources       0.037000   1.000  1.000

09013990 9A   Watermelon                         0.500000   1.000  1.000

09014000 9A   Watermelon, juice                  0.500000   1.000  1.000

ATTACHMENT 2:  Acute Dietary (Food + Water) Exposure Analysis, Except Females

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for TRIFLUMIZOLE                        (1994-98 data)

Residue file: 128879a.R98                         Adjustment factor #2 NOT used.

Analysis Date: 09-22-2008/11:19:09    Residue file dated: 09-22-2008/11:12:29/8

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

U.S. Population:

                    0.064679    25.87    0.120094    48.04    0.222048    88.82

All infants:

                    0.039008    15.60    0.083833    33.53    0.237666    95.07

Children 1-2 yrs:

                    0.099522    39.81    0.189346    75.74    0.402569   161.03

Children 3-5 yrs:

                    0.086530    34.61    0.171124    68.45    0.458449   183.38

Children 6-12 yrs:

                    0.067118    26.85    0.118731    47.49    0.241756    96.70

Youth 13-19 yrs:

                    0.054418    21.77    0.127038    50.82    0.200944    80.38

Adults 20-49 yrs:

                    0.064733    25.89    0.115985    46.39    0.212482    84.99

Adults 50+ yrs:

                    0.059468    23.79    0.109666    43.87    0.179040    71.62

Note: The aPAD is 0.1 mg/kg bw/day for females 13-49 and 0.25 mg/kg bw/day for all other population groups.  ATTACHMENT 3:  Acute Dietary (Food + Water) Exposure Analysis, Females

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for TRIFLUMIZOLE                        (1994-98 data)

Residue file: 128879a.R98                         Adjustment factor #2 NOT used.

Analysis Date: 09-22-2008/11:18:04    Residue file dated: 09-22-2008/11:12:29/8

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aPAD    Exposure   % aPAD    Exposure   % aPAD

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

Females 13-49 yrs:

                    0.067180    67.18    0.118034   118.03    0.212362   212.36

Note: The aPAD is 0.1 mg/kg bw/day for females 13-49 and 0.25 mg/kg bw/day for all other population groups.  ATTACHMENT 4: Residue File for Chronic Dietary (Food + Drinking Water)

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for TRIFLUMIZOLE                       1994-98 data

Residue file: G:\working\Triflum\128879cAR.R98                 Adjust. #2 used

Analysis Date 01-21-2009             Residue file dated: 01-21-2009/09:58:25/8

Reference dose (RfD) = 0.0117 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

04010050 4A   Amaranth, leafy                   11.100000   1.000      1.000

11000070 11   Apple, fruit with peel             0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000080 11   Apple, peeled fruit                0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000081 11   Apple, peeled fruit-babyfood       0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000090 11   Apple, dried                       0.140000   8.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000091 11   Apple, dried-babyfood              0.140000   8.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000100 11   Apple, juice                       0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000101 11   Apple, juice-babyfood              0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000110 11   Apple, sauce                       0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

11000111 11   Apple, sauce-babyfood              0.140000   1.000      0.200   Per up

  Full comment: Per updated SLUA of Dec 07

04010180 4A   Arugula                           11.100000   1.000      1.000

09020210 9B   Balsam pear                        0.500000   1.000      1.000

21000460 M    Beef, meat byproducts              0.200000   1.000      1.000

21000461 M    Beef, meat byproducts-babyfood     0.200000   1.000      1.000

21000470 M    Beef, fat                          0.100000   1.000      1.000

21000471 M    Beef,fat-babyfood                  0.100000   1.000      1.000

05010610 5A   Broccoli                           1.790000   1.000      1.000

05010611 5A   Broccoli-babyfood                  1.790000   1.000      1.000

05010620 5A   Broccoli, Chinese                  1.790000   1.000      1.000

05020630 5B   Broccoli raab                     40.000000   1.000      1.000

05010640 5A   Brussels sprouts                   1.790000   1.000      1.000

05010690 5A   Cabbage                            0.740000   1.000      1.000

05020700 5B   Cabbage, Chinese, bok choy        40.000000   1.000      1.000

05010710 5A   Cabbage, Chinese, napa             0.740000   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          0.740000   1.000      1.000

95000740 O    Canistel                           0.630000   1.000      1.000

09010750 9A   Cantaloupe                         0.170000   1.000      0.100   Per up

  Full comment: Per updated SLUA of Dec 07

09010800 9A   Casaba                             0.170000   1.000      1.000

05010830 5A   Cauliflower                        1.790000   1.000      1.000

09020880 9B   Chayote, fruit                     0.500000   1.000      1.000

12000900 12   Cherry                             0.660000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

12000901 12   Cherry-babyfood                    0.660000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

12000910 12   Cherry, juice                      0.660000   1.500      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

12000911 12   Cherry, juice-babyfood             0.660000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

09021020 9B   Chinese waxgourd                   0.500000   1.000      1.000

04011040 4A   Chrysanthemum, garland            11.100000   1.000      1.000

05021170 5B   Collards                          40.000000   1.000      1.000

19011180 19A  Coriander, leaves                 11.100000   1.000      1.000

19011181 19A  Coriander, leaves-babyfood        11.100000   1.000      1.000

04011330 4A   Cress, garden                     11.100000   1.000      1.000

04011340 4A   Cress, upland                     11.100000   1.000      1.000

09021350 9B   Cucumber                           0.130000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

04011380 4A   Dandelion, leaves                 11.100000   1.000      1.000

04011500 4A   Endive                            11.100000   1.000      1.000

14001550 14   Filbert                            0.050000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

14001560 14   Filbert, oil                       0.050000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

23001700 M    Goat, meat byproducts              0.200000   1.000      1.000

23001710 M    Goat, fat                          0.100000   1.000      1.000

95001750 O    Grape                              0.550000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001760 O    Grape, juice                       0.550000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001761 O    Grape, juice-babyfood              0.550000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001770 O    Grape, leaves                      0.550000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001780 O    Grape, raisin                      0.550000   4.300      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

95001790 O    Grape, wine and sherry             0.550000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

09011870 9A   Honeydew melon                     0.170000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95001880 O    Hop                               14.400000   1.000      1.000

05021940 5B   Kale                              40.000000   1.000      1.000

05011960 5A   Kohlrabi                           1.790000   1.000      1.000

04012040 4A   Lettuce, head                      2.970000   1.000      1.000

04012050 4A   Lettuce, leaf                     11.100000   1.000      1.000

95002150 O    Mango                              0.630000   1.000      1.000

95002151 O    Mango-babyfood                     0.630000   1.000      1.000

95002160 O    Mango, dried                       0.630000   1.000      1.000

95002170 O    Mango, juice                       0.630000   1.000      1.000

95002171 O    Mango, juice-babyfood              0.630000   1.000      1.000

05022290 5B   Mustard greens                    40.000000   1.000      1.000

95002450 O    Papaya                             0.630000   1.000      1.000

95002451 O    Papaya-babyfood                    0.630000   1.000      1.000

95002460 O    Papaya, dried                      0.630000   1.800      1.000

95002470 O    Papaya, juice                      0.630000   1.500      1.000

04012480 4A   Parsley, leaves                   11.100000   1.000      1.000

19012490 19A  Parsley, dried leaves             35.000000   1.000      1.000

19012491 19A  Parsley, dried leaves-babyfood    35.000000   1.000      1.000

11002660 11   Pear                               0.230000   1.000      0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002661 11   Pear-babyfood                      0.230000   1.000      0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002670 11   Pear, dried                        0.230000   6.250      0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002680 11   Pear, juice                        0.230000   1.000      0.400   Per up

  Full comment: Per updated SLUA of Dec 07

11002681 11   Pear, juice-babyfood               0.230000   1.000      0.400   Per up

  Full comment: Per updated SLUA of Dec 07

95002790 O    Pineapple                          2.170000   1.000      1.000

95002791 O    Pineapple-babyfood                 2.170000   1.000      1.000

95002800 O    Pineapple, dried                   2.170000   5.000      1.000

95002810 O    Pineapple, juice                   2.170000   1.000      1.000

95002811 O    Pineapple, juice-babyfood          2.170000   1.000      1.000

09023080 9B   Pumpkin                            0.140000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

09023090 9B   Pumpkin, seed                      0.140000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

04013130 4A   Radicchio                         11.100000   1.000      1.000

05023180 5B   Rape greens                       40.000000   1.000      1.000

95003330 O    Sapote, Mamey                      0.630000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.200000   1.000      1.000

26003410 M    Sheep, fat                         0.100000   1.000      1.000

26003411 M    Sheep, fat-babyfood                0.100000   1.000      1.000

09023560 9B   Squash, summer                     0.140000   1.000      0.010   Per up

  Full comment: Per updated SLUA of Dec 07

09023561 9B   Squash, summer-babyfood            0.140000   1.000      0.010   Per up

  Full comment: Per updated SLUA of Dec 07

09023570 9B   Squash, winter                     0.140000   1.000      0.010   Per up

  Full comment: Per updated SLUA of Dec 07

09023571 9B   Squash, winter-babyfood            0.140000   1.000      0.010   Per up

  Full comment: Per updated SLUA of Dec 07

95003590 O    Strawberry                         0.530000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95003591 O    Strawberry-babyfood                0.530000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95003600 O    Strawberry, juice                  0.530000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

95003601 O    Strawberry, juice-babyfood         0.530000   1.000      0.150   Per up

  Full comment: Per updated SLUA of Dec 07

04023670 4B   Swiss chard                        5.480000   1.000      1.000

05023890 5B   Turnip, greens                    40.000000   1.000      1.000

86010000 O    Water, direct, all sources         0.016000   1.000      1.000

86020000 O    Water, indirect, all sources       0.016000   1.000      1.000

09013990 9A   Watermelon                         0.170000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

09014000 9A   Watermelon, juice                  0.170000   1.000      0.050   Per up

  Full comment: Per updated SLUA of Dec 07

ATTACHMENT 5: Chronic Dietary (Food + Water) Exposure Analysis

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for TRIFLUMIZOLE                     (1994-98 data)

Residue file name: G:\working\Triflum\128879cAR.R98

                                                     Adjustment factor #2 used.

Analysis Date 01-21-2009/09:59:05     Residue file dated: 01-21-2009/09:58:25/8

Reference dose (RfD, Chronic) = .0117 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.003082                26.3%

U.S. Population (spring season)             0.003069                26.2%

U.S. Population (summer season)             0.003159                27.0%

U.S. Population (autumn season)             0.003228                27.6%

U.S. Population (winter season)             0.002851                24.4%

Northeast region                            0.002943                25.2%

Midwest region                              0.002678                22.9%

Southern region                             0.003440                29.4%

Western region                              0.003070                26.2%

Hispanics                                   0.002164                18.5%

Non-hispanic whites                         0.002334                19.9%

Non-hispanic blacks                         0.006927                59.2%

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Non-nursing infants                         0.002846                24.3%

Children 1-6  yrs                           0.004680                40.0%

Children 7-12 yrs                           0.002567                21.9%

Females 13-19 (not preg or nursing)         0.002372                20.3%

Females 20+ (not preg or nursing)           0.003129                26.7%

Females 13-50 yrs                           0.002707                23.1%

Females 13+ (preg/not nursing)              0.002254                19.3%

Females 13+ (nursing)                       0.002300                19.7%

Males 13-19 yrs                             0.003033                25.9%

Males 20+ yrs                               0.002889                24.7%

Seniors 55+                                 0.003541                30.3%

Children 1-2 yrs                            0.005132                43.9%

Children 3-5 yrs                            0.004747                40.6%

Children 6-12 yrs                           0.002720                23.2%

Youth 13-19 yrs                             0.002714                23.2%

Adults 20-49 yrs                            0.002743                23.4%

Adults 50+ yrs                              0.003453                29.5%

Females 13-49 yrs                           0.002729                23.3%

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

ATTACHMENT 6.  Triflumizole SLUA

Triflumizole	Dietary Exposure and Risk Assessment	DP Number: 354065

PC Code: 128879

________________________________________________________________________ ______________

Page   PAGE  23  of   NUMPAGES  23


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Notices]
[Page 13329]
[FR Doc No: 2017-04729]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[EG17-35-000, EG17-36-000]

Grady Wind Energy Center, LLC; Innovative Solar 42, LLC; Notice
of Effectiveness of Exempt Wholesale Generator Status

    Take notice that during the month of February 2017, the status of
the above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR 366.7(a)
(2017).

    Dated: March 6, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-04729 Filed 3-9-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Notices]
[Page 78409-78411]
[DOCID:fr22de08-140]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59095; File No. SR-BATS-2008-012]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Fees for Use of the Exchange

December 12, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 9, 2008, BATS Exchange, Inc. (``BATS'' or the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. BATS has designated the
proposed rule change as one establishing or changing a member due, fee,
or other charge imposed by the Exchange under Section 19(b)(3)(A)(ii)
of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the
proposed rule change effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify its fee schedule applicable to use
of the Exchange effective December 12, 2008 in order to (i) implement
new pricing for orders routed away from the Exchange that are executed
at dark liquidity venues as part of the Exchange's routing strategies,
and (ii) substitute the current fee schedule with a fee schedule in a
revised format.
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the

proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify its fee schedule in order to
implement new pricing for orders routed away from the Exchange that are
executed at dark liquidity venues as part of the Exchange's routing
strategies. In addition, the Exchange proposes to reformat the fee
schedule to better reflect the routing charges applicable to Members.
(a) Orders Routed to and Executed at Dark Liquidity Venues
    The Exchange recently amended its Rule 11.13 to provide additional
flexibility to the Exchange's affiliated routing broker-dealer, BATS
Trading, Inc. (the ``Outbound Router'') in making routing
determinations.\5\ This rule change was primarily made to permit the
Outbound Router to send orders to Trading Centers (as defined in
Exchange Rule 2.11),\6\ without limiting the permissible destinations
to execution venues with ``protected quotations'' (as defined in Rule
600(b)(58) of the Act).\7\ Such Trading Centers may include execution
venues known as dark liquidity venues, which do not publish quotations.
Because dark liquidity venues provide the possibility of executions at
reduced rates, the Exchange is proposing to charge Members $0.0020 per
share executed at such a dark liquidity venue. The Exchange will
continue to charge $0.0029 per share executed at any other Trading
Center. The proposed fee schedule also notes, consistent with the
Exchange's technical specifications, that the default best execution
routing strategy first attempts to route to dark liquidity venues
(``DART'' routing) and then to other Trading Centers (``CYCLE''
routing).
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 34-58776 (October
14, 2008), 73 FR 63529 (October 24, 2008) (SR-BATS-2008-007).
    \6\ The Exchange's definition of Trading Center, contained in
Rule 2.11, is consistent with the definition of ``trading center''
contained in Rule 600(b)(78) of Regulation NMS.
    \7\ 17 CFR 242.600(b)(58).
---------------------------------------------------------------------------

(b) Non-Substantive, Structural Changes
    In addition to the proposed change above related to orders routed
to and executed at dark liquidity venues, the Exchange is proposing to
make certain non-substantive, structural changes to its fee schedule.
First, the Exchange is proposing to restructure its fee schedule to
distinguish between its standard routing charges (i.e., those charges
for orders routed away by the Outbound Router under its best execution
strategies) and non-standard routing charges imposed for specific order
types and securities (e.g., Destination Specific Orders, odd lot orders
and securities priced below $1.00 per share). In addition, the Exchange
proposes to consolidate into one list certain Destination Specific
Orders \8\ which were previously listed separately, as such order types
are each charged the same fee.\9\ The Exchange believes that the
revised format of the fee schedule is more transparent and easy to
understand with respect to fees charged for routed orders.
---------------------------------------------------------------------------

    \8\ As defined in BATS Rule 11.9(c)(10).
    \9\ The Exchange charges $0.0029 per share for Destination
Specific Orders routed to the NASDAQ Stock Market, the International
Securities Exchange, and the National Securities Exchange.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\10\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\11\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive. The Exchange believes that its fees
and credits are competitive with those charged by other venues, and
that reduced transaction fees for shares executed at dark liquidity
venues will benefit market participants. Also, although routing options
are available to all Members, Members are not required to use the
Exchange's Outbound Router for routing to other Trading Centers. The
Exchange also believes that the reformatted fee schedule sets forth the
fees applicable to routed orders in a more transparent manner. Finally,
the Exchange believes that the proposed rates are equitable in that
they apply uniformly to all Members.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \12\ and Rule
19b-4(f)(2) thereunder,\13\ because it establishes or changes a due,
fee or other charge imposed on members by the Exchange. Accordingly,
the proposal is effective upon filing with the Commission.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \13\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2008-012 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-BATS-2008-012. This file

number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of the filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to
makeavailable publicly. All submissions should refer to File Number SR-
BATS-2008-012 and should be submitted on or before January 12, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Florence E. Harmon,
Acting Secretary.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

 [FR Doc. E8-30318 Filed 12-19-08; 8:45 am]

BILLING CODE 8011-01-P