UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

Office of Chemical Safety and Pollution Prevention

MEMORANDUM

Date:		24-February-2015

Subject:	Difenoconazole.  Acute and Chronic Aggregate Dietary Exposure and Risk Assessments for the Petition for Use of Difenoconazole on Pea and Bean, Dried Shelled, Except Soybean, Subgroup 6C, Bushberry Subgroup 13-07B and an amended use on Pome Fruit to add Post-Harvest Use of Difenoconazole.

PC Code:  	128847	DP Barcode:	421430 & 422995

Decision No.: 484399 & 486674	Registration No.:  100-739 & 100-RLEO

Petition Nos.:  4F8231	Regulatory Action:  Amended Section 3

Assessment Type:  Single Chemical, Dietary 	Registration Case No.:  NA

TXR No.:  None	CAS No.:  119446-68-3

MRID No.:  None	40 CFR: 180.475

Reviewer:	Thurston G. Morton, Chemist

 Risk Assessment Branch IV/Health Effects Division (RABIV/HED; 7509P)

Through:    Pete Savoia, Chemist

			 Julie Van Alstine, Environmental Health Scientist

 Dietary Exposure Science Advisory Council (DESAC)

	And

Elissa Reaves Ph,D., Branch Chief

RABIV/HED (7509P)

To:			Ivan Nieves, Risk Assessor

RABIV/HED (7509P)

	And

Tony Kish (RM 22)

	      Fungicide Branch

Registration Division (7505P)

Executive Summary

Difenoconazole acute and chronic dietary exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16.  This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).   The analyses were performed to support the Section 3 registration on Pea and Bean, Dried Shelled, Except Soybean, Subgroup 6C and Bushberry Subgroup 13-07B of the fungicide difenoconazole [1-[2-[2-chloro-4-(4-chlorophenoxy) phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole].  In addition, these analyses were performed to support the amended use of difenoconazole for post-harvest use on pome fruit.

This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

The unrefined acute analysis assumed tolerance-level residues, 100% crop treated (CT), and the available empirical or DEEM (ver. 7.81) default processing factors.  The somewhat refined chronic analysis assumed tolerance-level residues for some commodities, average field trial residues and USDA Pesticide Data Program monitoring samples for the remaining commodities, the available empirical or DEEM (ver. 7.81) default processing factors, and 100% CT.  The EDWC of 20.0 μg/L (ppb) was used for the acute dietary exposure analysis and an estimated drinking water concentrations (EDWC) of 13.6 μg/L (ppb) was used for the chronic dietary exposure analysis.

The resulting acute food plus water dietary exposure estimates were less than HED’s level of concern (<100% of the acute population-adjusted dose (aPAD)) at the 95th percentile of the exposure distribution for the general U.S. population (15% aPAD) and all population sub-groups; the most highly exposed population subgroup was children 1-2 years old with 49% aPAD.  The resulting chronic food plus water dietary exposure estimates were less than HED’s level of concern (<100% of the chronic population-adjusted dose (cPAD)) for the general U.S. population (26% cPAD) and all population sub-groups; the most highly exposed population subgroup was children 1 - 2 years old with 88% cPAD.  No cancer analysis was performed since it was determined the chronic dietary exposure assessment is protective of cancer effects.

The dietary exposure analyses for the triazole metabolites were previously updated (D414951, T. Morton, 24 Oct. 2013).

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 PAD.  The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  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 difenoconazole was conducted by T. Morton (15-January-2015; DP#412812).

II.   Residue Information

Difenoconazole tolerances are published in 40 CFR§180.475.

Residues of Concern in Plants and Livestock:

Residues of concern were determined based on recommendations from the HED Residues of Concern Knowledgebase Sub-committee (ROCKS) (D391350, 9/19/11).  The residue of concern for plant commodities for tolerance expression and risk assessment purposes is difenoconazole per se.  The HED ROCKS has determined that the parent compound and the CGA-205375 metabolite are the residues of concern in livestock commodities for both the tolerance expression and the risk assessment. In addition, metabolite OH-CGA-169374, which comprised 15% of the TRR in goat milk from the phenyl-labeled study, should be considered as a residue of concern for the dietary risk assessment.  Based on available goat metabolism data, total residues of concern in milk for dietary risk assessments (parent, CGA-205375, and OH-CGA-169374), should be calculated by multiplying the tolerance in milk by a factor of 1.5x.  Table 1 summarizes tolerance expression and the residues of concern in plant and livestock commodities.

Table 1.  Difenoconazole Residues of Concern in Plants and Ruminants.

Matrix	Residues of Concern

	For Risk Assessment	For Tolerance Expression

Plants	Primary and Rotational crops	Parent Only	Parent Only

Livestock	Ruminant and Poultry	Parent and CGA 205375	Parent and CGA 205375

	Milk	Parent, CGA 205375, and OH-CGA-169374	Parent and CGA 205375

Drinking Water	Parent Only	NA

Note:  The triazole-containing metabolites 1,2,4-T, TA, and TAA should be included in the residues of concern for risk assessment purposes only for plant and livestock commodities.  Since these metabolites are common to the entire class of traizole-derivative fungicides and because of differential toxicity between metabolites and the various parent compounds, risks associated with exposure to 1,2,4-T and to TA/TAA are addressed separately.

Recommended Tolerances:  Based on the residue chemistry data submitted with the previous petitions, HED recommended for establishment of the new food tolerances (DP# 412810, B. Cropp-Kohlligian, 22-August-2013).  The recommended, established, and revised tolerances are listed in Table 2 below.

Table 2.  Tolerance Summary for Difenoconazole (non-feed items).

Commodity	Existing/Established Tolerances (ppm)	New Tolerances (ppm) Average Field Trial Residue or average PDP Residue (ppm)

Rapeseed crop subgroup 20A	0.10	------	0.10

Brassica subgroup 5A	1.9	------	2013 PDP data = 708 samples/1 detects/highest det of 0.019 used in chronic for broccoli

Cabbage = 0.029

Brassica subgroup 5B	35	------	5.10

Citrus oil	25	------	25

Fruit, citrus, group 10	0.6	------	2011/12 PDP data = 1426 samples/0 detects/highest LOD of 0.005 used in chronic for citrus

Grape	4.0	------	0.613

2013 PDP data = 176 samples/0 detects/highest 1/2 LOD of 0.005 used in chronic for grape juice

Grape, raisin	6.0	------	0.615 (3.5x PF)

Nut, tree, group 14	0.03	------	Almond = 0.005

Pecan = 0.007

Onion, bulb, subgroup 3—07A	0.20	------	2011/12 PDP data = 744 samples/0 detects/highest ½ LOD of 0.0025 used in chronic

Onion, green, subgroup 3—07B	6.0	------	6.0

Pistachios	0.03	------	0.005

Vegetable, cucurbit, group 9	0.7	------	2011/12 PDP data = 744 samples/0 detects/highest ½ LOD of 0.0025 used in chronic for cantaloupe

Cucumber = 0.055

2011/12/13 PDP data = 1115 samples/1 detects/highest det of 0.011 used in chronic for squash/pumpkin

Fruit, Pome, group 11	1.0	------	Apple = 0.203

Pear = 0.123

Vegetable, Fruiting, Group 8-10	0.60	------	Tomato = 0.165

Pepper = 0.133

Eggplant=0.133

Okra=0.6

Vegetable, Tuberous and Corm, subgroup 1C	4.0	------	1.36

Beet, sugar	0.30	------	0.30

Papaya	0.30	------	0.30

Banana	0.2	------	2012/13 PDP data = 1267 samples/0 detects/highest ½ LOD of 0.0025 used in chronic for banana

Barley, grain	0.1	------	0.10

Cattle fat	0.10	------	0.10

Cattle, meat	0.05	------	0.05

Cattle, meat byproducts	0.10	------	0.10

Cattle, liver	0.40	------	0.40

Corn, sweet, kernel plus cob with husks removed	0.01	------	0.01

Cotton, undelinted seed	0.05	------	0.05

Egg	0.02	------	0.02

Goat, fat	0.10	------	0.10

Goat, meat	0.05	------	0.05

Goat, meat byproducts (except liver)	0.10	------	0.10

Goat, liver	0.40	------	0.40

Hog, fat	0.10	------	0.10

Hog, meat	0.05	------	0.05

Hog, meat byproducts (except liver)	0.1	------	0.10

Hog, liver	0.40	------	0.40

Horse, fat	0.10	------	0.10

Horse, meat	0.05	------	0.05

Milk	0.02 proposed to be increased from 0.01 ppm	------	0.02

Rye, grain	0.01	------	0.01

Sheep, fat	0.10	------	0.10

Sheep, meat	0.05	------	0.05

Sheep, meat byproducts (except liver)	0.10	------	0.10

Sheep, liver	0.40	------	0.40

Wheat, grain	0.1	------	0.10

Wax apple	0.07	------	0.07

Mango	0.07	------	0.07

Carrot	0.50	------	2013 PDP carrot data = 712 samples/11 detects/max detect of 0.007 used for chronic

Soybean, seed	0.15	------	0.0215

Fruit, stone, group 12	2.5	------	Cherry = 0.622

2013 PDP data = 285 samples/6 detects/highest det of 0.038 used in chronic for peach

2013 PDP data = 543 samples/5 detects/highest det of 0.004 used in chronic for nectarine

2011/12/13 PDP data = 1347 samples/0 detects/highest 1/2 LOD of 0.0025 used in chronic for plum

Strawberry	2.5	------	0.495

Turnip greens	35	------	5.10

Oat, grain	0.01	------	0.01

Wax Jambu	1.5

1.5

Dragonfruit	1.5 (translated from wax jambu)

1.5

Pea and bean, dried shelled, except soybean, subgroup 6C

0.20	Dried bean = 0.014

Dried pea = 0.034

Bushberry subgroup 13-07B

4.0	1.009

The dietary exposure analyses for the triazole metabolites (D414951, T. Morton, 24 Oct. 2013) was previously updated.  Addition of these uses did not significantly change the dietary exposure for the triazole metabolites.

Food Residues and processing factors used in the Acute and Chronic Analysis:  The acute analysis assumed tolerance-level residues and 100% CT for all the registered and proposed crops. Tolerance-level residues were also assumed for all livestock tissues in this assessment.  The chronic analysis assumed tolerance-level residues for some commodities, average field trial residues and USDA PDP average residues for the remaining commodities, and 100 % CT.  Those commodities where field trial data were used are summarized below.  HED SOP 2000.1 Guidance for Translation of Field Trial Data from Representative Commodities in the Crop Group Regulation to Other Commodities in Each Crop Group/Subgroup dated 9/12/2000 was used in translating to other commodities in the crop group.  Experimental processing factors were used for apple juice (0.04x), grape juice (0.2x), citrus juices (0.1x), potato chips (0.5x), potato granules/flakes (0.5x), raisin (3.5x chronic only since the raisin tolerance was used in acute), sugar beet molasses (0.6x), tomato paste (1.6x), and tomato puree (0.5x); DEEM (ver. 7.81) default processing factors were assumed for other processed commodities.

Almond: Almond field trial residues were used from MRID 47586101.

Apple: Field trial residues were used from MRID 46950233.

Pea and Bean, Dried Shelled, Except Soybean, Subgroup 6C: Field trial residues were used from MRID 49227601.

Banana: Highest LOD of 0.0025 ppm in 2012/2013 USDA PDP data used. PDP found 0 detects in 1267 banana samples tested.

Broccoli: Highest residue in 2013 USDA PDP data used (0.019 ppm).  PDP found 1 detect in 708 samples tested.

Bushberry:  Field trial residues were used from MRID 49227602.

Cabbage:  Field trial residues were used from 47586102.  Residues from 1-7 day PHI were used since registered labels allow from 1-7 day PHIs.  To refine the dietary exposure data from only cabbage samples without wrapper leaves were used.

Cantaloupe: Highest LOD of 0.0025 ppm in 2011/2012 USDA PDP data used. PDP found 0 detects in 744 cantaloupe samples tested.

Carrot: Highest detect of 0.007 ppm in 2013 USDA PDP data used. PDP found 11 detects in 712 carrot samples tested.

Chickpea: Field trial residues were used from MRID 47929805.

Cucumber: Field trial residues were used from MRID 47586103.  Residues from 0-1 day PHI were used since registered labels allow from 0-1 day PHI.

Grape: Highest LOD of 0.005 ppm in 2013 USDA PDP data used for grape juice.  PDP found 0 detects in 176 grape juice samples tested.  Average field trial residue from MRID 47586105 used for grape.

Grapefruit: Highest LOD of 0.005 ppm in 2011/2012 USDA PDP data used.  PDP found 0 detects in 1426 citrus samples tested.

Lemon: Highest LOD of 0.005 ppm in 2011/2012 USDA PDP data used.  PDP found 0 detects in 1426 citrus samples tested.

Lime: Highest LOD of 0.005 ppm in 2011/2012 USDA PDP data used.  PDP found 0 detects in 1426 citrus samples tested.

Mustard Greens: Field trial residues were used from MRIDs 47417704, 47417707, and 47586102.  Residues from 1-7 day PHI were used since registered labels allow from 1-7 day PHIs.

Nectarine: Highest detect of 0.004 ppm in 2013 USDA PDP data used. PDP found 5 detects in 543 nectarine samples tested.

Onion, bulb, subgroup 3-07A: Highest LOD of 0.0025 ppm in 2011/2012 USDA PDP data used. PDP found 0 detects in 744 onion samples tested.

Orange: Highest LOD of 0.005 ppm in 2011/2012 USDA PDP data used.  PDP found 0 detects in 1426 citrus samples tested.

Peach: Highest detect of 0.038 ppm in 2013 USDA PDP data used. PDP found 6 detects in 285 peach samples tested.

Pear: Field trial residues were used from MRID 46950233.

Pecan: Field trial residues were used from MRID 47586106.

Peppers: Field trial residues were used from MRID 46950234.

Plum: Highest LOD of 0.0025 ppm in 2011/2012/2013 USDA PDP data used. PDP found 0 detects in 1347 plum samples tested.

Potato: Field trial residues were used from MRID 47929804.

Soybean: Field trial residues were used from MRID 47929801.

Stone Fruit: Field trial residues were used from MRID 47929803.

Strawberry: Field trial residues were used from MRID 47929802.

Sugar Beet: Field trial residues were used from MRID 46950236.

Summer Squash: Highest detect of 0.011 ppm in 2011/2012/2013 USDA PDP data used for squash and pumpkin. PDP found 0 detects in 744 squash samples tested.

Tomato: Field trial residues were used from MRIDs 46950234, 47417705, and 47417708.

III.  Percent Crop Treated Information

The acute dietary exposure analyses assumed 100% crop treated (CT).  Average %CT was used for the following crops:  almond 5%, cabbage 2.5%, cucumbers 5%, garlic 5%, grape 5%, grapefruit 2.5%, onions 5%, orange 2.5%, pecan 2.5%, peach 1%, peppers 2.5%, pistachio 2.5%, pumpkin 2.5%, squash 5%, strawberry 2.5%, sugar beets 15%, tangerine 2.5%, tomatoes 25%, walnut 2.5%, watermelon 5%, and wheat 10%.

IV.  Drinking Water Data

The drinking water estimates used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED; Memo, F. Khan, 13-November-2014; D421092).  The EDWCs for surface water for the requested new uses did not supersede the previously recommended drinking water concentrations.  For surface water, revised recommended EDWCs are 20.0 µg/L for peak, 13.6 µg/L for annual mean and 9.9µg/L for annual average concentrations  Recommended EDWCs for human health are 20.0 μg/L (ppb) for the acute dietary (food plus water) exposure analysis and the 1-in-10 year annual mean EDWC of 13.6 μg/L (ppb) for the chronic dietary (food plus water) exposure analysis.

V.  DEEM-FCID Program and Consumption Information

Difenoconazole acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16, which incorporates consumption data from USDA’s National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  The 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 2003-2008 WWEIA 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 50-99 years old.

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.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption 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.

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., 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, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

VI.  Toxicological Information

On 08-SEP-1998, HED’s Hazard Identification Assessment Review Committee (HIARC) evaluated the toxicology database of difenoconazole and re-assessed the RfD established in 1994, as well as the toxicological endpoints for the dietary and occupational exposure risk assessments that were selected in 1994.  At this meeting, the HIARC also addressed the potential enhanced sensitivity of infants and children from exposure to difenoconazole as required by the Food Quality Protection Act (FQPA) of 1996 (HED Doc. No. 012873, 25-SEP-1998).  In July, 2007, the RAB1 toxicologists and risk assessment team met to reevaluate the endpoints selected by the HIARC since new studies were submitted.  RAB1 toxicologists and risk assessment team also reevaluated FQPA assessments.  The risk assessment team concluded that the default 10x FQPA Safety Factor (SF) should be reduced to 1x when assessing acute and chronic dietary exposures (M.Sahafeyan, D333320, 09-AUG-07).  The relevant endpoints are shown in Table 3.

In accordance with HED’s current policy and EPA’s 2005 Cancer Guidelines, difenoconazole is classified as “Suggestive Evidence of Carcinogenic Potential,” based on excessive toxicity observed at the two highest doses, the absence of tumors at the lower doses and the absence of genotoxic effects.   A margin-of-exposure (MOE) approach in risk assessment was advocated by HED’s  CPRC in 1994.  Use of an MOE approach was reviewed and reaffirmed in 2007 by the CPRC Chair (PV Shah, 3/1/07, HED Doc. No. 0054532).  Therefore, a separate cancer dietary assessment is not being conducted for difenoconazole.

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

Exposure Scenario	Point of Departure	Uncertainty/FQPA Safety Factors RfD, PAD, for Risk Assessment	Study and Relevant Toxicological Effects

Acute Dietary (All populations)	NOAEL = 25

mg/kg	UFA = 10X

UFH = 10X

FQPA SF = 1X 	aRfD = aPAD = 0.25 mg/kg/day	Acute Neurotoxicity Study in Rats

LOAEL= 200 mg/kg in males based on reduced fore-limb grip strength in males on day 1.

Chronic Dietary (All populations)	NOAEL = 0.96

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF = 1X	cRfD = cPAD = 0.01mg/kg/day	Combined chronic toxicity/carcinogenicity (rat; dietary) LOAEL = 24.1/32.8 mg/kg/day (M/F) based on cumulative decreases in body-weight gains.

Cancer (oral, dermal, inhalation)	Difenoconazole is classified as a Group C, possible human carcinogen with a non-linear (MOE) approach for human risk characterization (CPRC Document, 7/27/94, Memo, P. V. Shah dated March 3, 2007, HED Doc. No. 0054532). The chronic dietary exposure assessment is protective of cancer effects.

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 (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.

VII.  Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the aPAD or cPAD, respectively.  The following paragraphs are summaries of the DEEM-FCID (ver. 2.03) acute and chronic exposure analyses.

Acute and chronic aggregate (food + water) analyses were performed using DEEM-FCID estimating the dietary exposure of the U.S. population and various population subgroups.  The results are summarized in Tables 4 and 5 below for acute and chronic analyses respectively.

The resulting acute food exposure estimates were less than HED’s level of concern (<100% aPAD) at the 95th percentile of the exposure distribution for general US population (15 % aPAD) and all population sub-groups; the most highly exposed population subgroup was All Infants <1 year old with 49 % aPAD.  The resulting chronic food exposure estimates were less than HED’s level of concern (<100% cPAD) for the general U.S. population (26 % cPAD) and all population sub-groups; the most highly exposed population subgroup was children 1-2 years old with 88 % cPAD.   A separate cancer dietary assessment was not conducted for difenoconazole because the cancer NOAEL is higher than the chronic RfD; therefore, the chronic dietary risk estimate is considered protective of all chronic effects including carcinogenicity.

Table 4.  Summary of Acute Dietary (Food plus Water) Exposure and Risk for Difenoconazole at the 95th Percentile.

Population Subgroup

aPAD (mg/kg/day)

Exposure (mg/kg/day)

%aPAD

General U.S. Population

0.25

0.038393	15

All Infants (< 1 year old)

0.122946	49

Children 1-2 years old

0.108065	43

Children 3-5 years old

0.074001	30

Children 6-12 years old

0.050176	20

Youth 13-19 years old

0.024832	9.9

Adults 20-49 years old

0.025978	10

Adults 50-99 years old

0.028841	12

Females 13-49 years old

0.025939	10

The bolded %aPAD is the highest.

Table 5.  Summary of Chronic Dietary (Food plus Water) Exposure and Risk for Difenoconazole.

Population Subgroup

cPAD (mg/kg/day)

Exposure (mg/kg/day)

%cPAD

General U.S. Population

0.01

0.002554	26

All Infants (< 1 year old)

0.007683	77

Children 1-2 years old

0.008828	88

Children 3-5 years old

0.006009	60

Children 6-12 years old

0.003676	37

Youth 13-19 years old

0.001980	20

Adults 20-49 years old

0.001847	19

Adults 50-99 years old

0.002068	21

Females 13-49 years old

0.001814	18

The bolded %cPAD is the highest.

VIII.  Characterization of Inputs/Outputs

The acute analysis assumed tolerance-level residues, 100% CT, and empirical or DEEM default processing factors.  The chronic analysis assumed tolerance-level residues for some commodities, average field trial residues and USDA PDP monitoring data for the remaining commodities, average % CT, and empirical or DEEM default processing factors.  Therefore, these analyses are considered refined.  While they could be further refined, further refinement is not warranted as estimated risks are not of concern.

IX.  Conclusions

An acute aggregate (food + water) dietary risk assessment was conducted for difenoconazole using the DEEM-FCID Model and assumed tolerance-level residues, 100% CT, and empirical or DEEM default processing factors.  The chronic aggregate dietary risk assessment assumed tolerance-level residues for some commodities, average field trial residues and USDA PDP monitoring data for the remaining commodities, average % CT, and empirical or DEEM default processing factors.  The resulting acute and chronic aggregate exposure estimates were less than HED’s level of concern.  For the general U.S. population, the aPAD and cPAD were 11 % and 27 %, respectively.  The most highly-exposed population subgroup in the acute (at the 95th percentile of the exposure distribution) was All Infants <1 year old (49 % aPAD) and chronic analysis were children 1-2 years old (88 % cPAD), respectively.

X.  List of Attachments

Attachment 1:	DEEM-FCID( Acute Residue File

Attachment 2:	DEEM-FCID( Acute Exposure Estimates

Attachment 3:	DEEM-FCID( Chronic Residue File

Attachment 4:	DEEM-FCID( Chronic Exposure Estimates

Attachment 5:  Percent Crop Treated Memorandum

cc with all attachments:  T. Morton (RABIV)

RDI: P. Savoia and J. Van Alstine - DESAC (16-September-2014); E. Reaves (24-February-2015)

Petition Number(s): 4F8231

PC Code: 128847

T. Morton:S10838:PY1:(703)305-6691

Attachment 1:  DEEM-FCID Acute Residue File

Filename: C:\Users\tmorton\Documents\My Files\DEEM Files\128847 Difenoconazole\128847 Difenoconazole 4F8231 Sept 2014\128847 Acute Sept 2014.R08

Chemical: Difenoconazole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .25 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-16-2014/09:51:23       Program ver. 3.16, 03-08-d

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

   EPA     Crop                                   Def Res     Adj.Factors   Comment

   Code     Grp  Commodity Name                    (ppm)       #1    #2

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

0101052000 1A   Beet, sugar                        0.300000   1.000  1.000

0101052001 1A   Beet, sugar-babyfood               0.300000   1.000  1.000

0101053000 1A   Beet, sugar, molasses              0.300000   0.600  1.000

0101053001 1A   Beet, sugar, molasses-babyfood     0.300000   0.600  1.000

0101078000 1AB  Carrot                             0.500000   1.000  1.000

0101078001 1AB  Carrot-babyfood                    0.500000   1.000  1.000

0101079000 1AB  Carrot, juice                      0.500000   1.000  1.000

0103015000 1CD  Arrowroot, flour                   4.000000   1.000  1.000

0103015001 1CD  Arrowroot, flour-babyfood          4.000000   1.000  1.000

0103017000 1CD  Artichoke, Jerusalem               4.000000   1.000  1.000

0103082000 1CD  Cassava                            4.000000   1.000  1.000

0103082001 1CD  Cassava-babyfood                   4.000000   1.000  1.000

0103139000 1CD  Dasheen, corm                      4.000000   1.000  1.000

0103166000 1CD  Ginger                             4.000000   1.000  1.000

0103166001 1CD  Ginger-babyfood                    4.000000   1.000  1.000

0103167000 1CD  Ginger, dried                      4.000000   1.000  1.000

0103296000 1C   Potato, chips                      4.000000   0.500  1.000

0103297000 1C   Potato, dry (granules/ flakes)     4.000000   0.500  1.000

0103297001 1C   Potato, dry (granules/ flakes)-b   4.000000   0.500  1.000

0103298000 1C   Potato, flour                      4.000000   0.500  1.000

0103298001 1C   Potato, flour-babyfood             4.000000   0.500  1.000

0103299000 1C   Potato, tuber, w/peel              4.000000   1.000  1.000

0103299001 1C   Potato, tuber, w/peel-babyfood     4.000000   1.000  1.000

0103300000 1C   Potato, tuber, w/o peel            4.000000   1.000  1.000

0103300001 1C   Potato, tuber, w/o peel-babyfood   4.000000   1.000  1.000

0103366000 1CD  Sweet potato                       4.000000   1.000  1.000

0103366001 1CD  Sweet potato-babyfood              4.000000   1.000  1.000

0103371000 1CD  Tanier, corm                       4.000000   1.000  1.000

0103387000 1CD  Turmeric                           4.000000   1.000  1.000

0103406000 1CD  Yam, true                          4.000000   1.000  1.000

0103407000 1CD  Yam bean                           4.000000   1.000  1.000

0301165000 3A   Garlic, bulb                       0.200000   1.000  1.000

0301165001 3A   Garlic, bulb-babyfood              0.200000   1.000  1.000

0301237000 3A   Onion, bulb                        0.200000   1.000  1.000

0301237001 3A   Onion, bulb-babyfood               0.200000   1.000  1.000

0301238000 3A   Onion, bulb, dried                 0.200000   9.000  1.000

0301238001 3A   Onion, bulb, dried-babyfood        0.200000   9.000  1.000

0301338000 3A   Shallot, bulb                      0.200000   1.000  1.000

0302103000 3B   Chive, fresh leaves                6.000000   1.000  1.000

0302198000 3B   Leek                               6.000000   1.000  1.000

0302239000 3B   Onion, green                       6.000000   1.000  1.000

0302338500 3B   Shallot, fresh leaves              6.000000   1.000  1.000

0501061000 5A   Broccoli                           1.900000   1.000  1.000

0501061001 5A   Broccoli-babyfood                  1.900000   1.000  1.000

0501062000 5A   Broccoli, Chinese                  1.900000   1.000  1.000

0501064000 5A   Brussels sprouts                   1.900000   1.000  1.000

0501069000 5A   Cabbage                            1.900000   1.000  1.000

0501071000 5A   Cabbage, Chinese, napa             1.900000   1.000  1.000

0501072000 5A   Cabbage, Chinese, mustard          1.900000   1.000  1.000

0501083000 5A   Cauliflower                        1.900000   1.000  1.000

0501196000 5A   Kohlrabi                           1.900000   1.000  1.000

0502063000 5B   Broccoli raab                     35.000000   1.000  1.000

0502070000 5B   Cabbage, Chinese, bok choy        35.000000   1.000  1.000

0502117000 5B   Collards                          35.000000   1.000  1.000

0502194000 5B   Kale                              35.000000   1.000  1.000

0502229000 5B   Mustard greens                    35.000000   1.000  1.000

0502318000 5B   Rape greens                       35.000000   1.000  1.000

0502389000 5B   Turnip, greens                    35.000000   1.000  1.000

0600347000 6    Soybean, seed                      0.150000   1.000  1.000

0600349000 6    Soybean, soy milk                  0.150000   1.000  1.000

0600349001 6    Soybean, soy milk-babyfood or in   0.150000   1.000  1.000

0600350000 6    Soybean, oil                       0.150000   1.000  1.000

0600350001 6    Soybean, oil-babyfood              0.150000   1.000  1.000

0601349500 6AB  Soybean, vegetable                 0.150000   1.000  1.000

0603030000 6C   Bean, black, seed                  0.200000   1.000  1.000

0603032000 6C   Bean, broad, seed                  0.200000   1.000  1.000

0603034000 6C   Bean, cowpea, seed                 0.200000   1.000  1.000

0603035000 6C   Bean,  great northern, seed        0.200000   1.000  1.000

0603036000 6C   Bean, kidney, seed                 0.200000   1.000  1.000

0603038000 6C   Bean, lima, seed                   0.200000   1.000  1.000

0603039000 6C   Bean, mung, seed                   0.200000   1.000  1.000

0603040000 6C   Bean, navy, seed                   0.200000   1.000  1.000

0603041000 6C   Bean, pink, seed                   0.200000   1.000  1.000

0603042000 6C   Bean, pinto, seed                  0.200000   1.000  1.000

0603098000 6C   Chickpea, seed                     0.200000   1.000  1.000

0603098001 6C   Chickpea, seed-babyfood            0.200000   1.000  1.000

0603099000 6C   Chickpea, flour                    0.200000   1.000  1.000

0603182000 6C   Guar, seed                         0.200000   1.000  1.000

0603182001 6C   Guar, seed-babyfood                0.200000   1.000  1.000

0603203000 6C   Lentil, seed                       0.200000   1.000  1.000

0603256000 6C   Pea, dry                           0.200000   1.000  1.000

0603256001 6C   Pea, dry-babyfood                  0.200000   1.000  1.000

0603258000 6C   Pea, pigeon, seed                  0.200000   1.000  1.000

0603348000 6C   Soybean, flour                     0.150000   1.000  1.000

0603348001 6C   Soybean, flour-babyfood            0.150000   1.000  1.000

0801374000 8A   Tomatillo                          0.600000   1.000  1.000

0801375000 8A   Tomato                             0.600000   1.000  1.000

0801375001 8A   Tomato-babyfood                    0.600000   1.000  1.000

0801376000 8A   Tomato, paste                      0.600000   1.600  1.000

0801376001 8A   Tomato, paste-babyfood             0.600000   1.600  1.000

0801377000 8A   Tomato, puree                      0.600000   0.500  1.000

0801377001 8A   Tomato, puree-babyfood             0.600000   0.500  1.000

0801378000 8A   Tomato, dried                      0.600000  14.300  1.000

0801378001 8A   Tomato, dried-babyfood             0.600000  14.300  1.000

0801379000 8A   Tomato, juice                      0.600000   1.500  1.000

0801380000 8A   Tomato, Tree                       0.600000   1.000  1.000

0802148000 8BC  Eggplant                           0.600000   1.000  1.000

0802234000 8BC  Okra                               0.600000   1.000  1.000

0802270000 8B   Pepper, bell                       0.600000   1.000  1.000

0802270001 8B   Pepper, bell-babyfood              0.600000   1.000  1.000

0802271000 8B   Pepper, bell, dried                0.600000   1.000  1.000

0802271001 8B   Pepper, bell, dried-babyfood       0.600000   1.000  1.000

0802272000 8BC  Pepper, nonbell                    0.600000   1.000  1.000

0802272001 8BC  Pepper, nonbell-babyfood           0.600000   1.000  1.000

0802273000 8BC  Pepper, nonbell, dried             0.600000   1.000  1.000

0901075000 9A   Cantaloupe                         0.700000   1.000  1.000

0901187000 9A   Honeydew melon                     0.700000   1.000  1.000

0901399000 9A   Watermelon                         0.700000   1.000  1.000

0901400000 9A   Watermelon, juice                  0.700000   1.000  1.000

0902021000 9B   Balsam pear                        0.700000   1.000  1.000

0902088000 9B   Chayote, fruit                     0.700000   1.000  1.000

0902102000 9B   Chinese waxgourd                   0.700000   1.000  1.000

0902135000 9B   Cucumber                           0.700000   1.000  1.000

0902308000 9B   Pumpkin                            0.700000   1.000  1.000

0902309000 9B   Pumpkin, seed                      0.700000   1.000  1.000

0902356000 9B   Squash, summer                     0.700000   1.000  1.000

0902356001 9B   Squash, summer-babyfood            0.700000   1.000  1.000

0902357000 9B   Squash, winter                     0.700000   1.000  1.000

0902357001 9B   Squash, winter-babyfood            0.700000   1.000  1.000

1001106000 10A  Citron                             0.600000   1.000  1.000

1001107000 10A  Citrus hybrids                     0.600000   1.000  1.000

1001108000 10A  Citrus, oil                       25.000000   1.000  1.000

1001240000 10A  Orange                             0.600000   1.000  1.000

1001241000 10A  Orange, juice                      0.600000   0.100  1.000

1001241001 10A  Orange, juice-babyfood             0.600000   0.100  1.000

1001242000 10A  Orange, peel                       0.600000   1.000  1.000

1001369000 10A  Tangerine                          0.600000   1.000  1.000

1001370000 10A  Tangerine, juice                   0.600000   0.100  1.000

1002197000 10B  Kumquat                            0.600000   1.000  1.000

1002199000 10B  Lemon                              0.600000   1.000  1.000

1002200000 10B  Lemon, juice                       0.600000   0.100  1.000

1002200001 10B  Lemon, juice-babyfood              0.600000   0.100  1.000

1002201000 10B  Lemon, peel                        0.600000   1.000  1.000

1002206000 10B  Lime                               0.600000   1.000  1.000

1002207000 10B  Lime, juice                        0.600000   0.100  1.000

1002207001 10B  Lime, juice-babyfood               0.600000   0.100  1.000

1003180000 10C  Grapefruit                         0.600000   1.000  1.000

1003181000 10C  Grapefruit, juice                  0.600000   0.100  1.000

1003307000 10C  Pummelo                            0.600000   1.000  1.000

1100007000 11   Apple, fruit with peel             5.000000   1.000  1.000

1100008000 11   Apple, peeled fruit                5.000000   1.000  1.000

1100008001 11   Apple, peeled fruit-babyfood       5.000000   1.000  1.000

1100009000 11   Apple, dried                       5.000000   8.000  1.000

1100009001 11   Apple, dried-babyfood              5.000000   8.000  1.000

1100010000 11   Apple, juice                       5.000000   0.040  1.000

1100010001 11   Apple, juice-babyfood              5.000000   0.040  1.000

1100011000 11   Apple, sauce                       5.000000   1.000  1.000

1100011001 11   Apple, sauce-babyfood              5.000000   1.000  1.000

1100129000 11   Crabapple                          5.000000   1.000  1.000

1100173500 11   Goji berry                         5.000000   1.000  1.000

1100210000 11   Loquat                             5.000000   1.000  1.000

1100266000 11   Pear                               5.000000   1.000  1.000

1100266001 11   Pear-babyfood                      5.000000   1.000  1.000

1100267000 11   Pear, dried                        5.000000   6.250  1.000

1100268000 11   Pear, juice                        5.000000   1.000  1.000

1100268001 11   Pear, juice-babyfood               5.000000   1.000  1.000

1100310000 11   Quince                             5.000000   1.000  1.000

1201090000 12A  Cherry                             2.500000   1.000  1.000

1201090001 12A  Cherry-babyfood                    2.500000   1.000  1.000

1201091000 12A  Cherry, juice                      2.500000   1.500  1.000

1201091001 12A  Cherry, juice-babyfood             2.500000   1.500  1.000

1202012000 12B  Apricot                            2.500000   1.000  1.000

1202012001 12B  Apricot-babyfood                   2.500000   1.000  1.000

1202013000 12B  Apricot, dried                     2.500000   6.000  1.000

1202014000 12B  Apricot, juice                     2.500000   1.000  1.000

1202014001 12B  Apricot, juice-babyfood            2.500000   1.000  1.000

1202230000 12B  Nectarine                          2.500000   1.000  1.000

1202260000 12B  Peach                              2.500000   1.000  1.000

1202260001 12B  Peach-babyfood                     2.500000   1.000  1.000

1202261000 12B  Peach, dried                       2.500000   7.000  1.000

1202261001 12B  Peach, dried-babyfood              2.500000   7.000  1.000

1202262000 12B  Peach, juice                       2.500000   1.000  1.000

1202262001 12B  Peach, juice-babyfood              2.500000   1.000  1.000

1203285000 12C  Plum                               2.500000   1.000  1.000

1203285001 12C  Plum-babyfood                      2.500000   1.000  1.000

1203286000 12C  Plum, prune, fresh                 2.500000   1.000  1.000

1203286001 12C  Plum, prune, fresh-babyfood        2.500000   1.000  1.000

1203287000 12C  Plum, prune, dried                 2.500000   5.000  1.000

1203287001 12C  Plum, prune, dried-babyfood        2.500000   5.000  1.000

1203288000 12C  Plum, prune, juice                 2.500000   1.400  1.000

1203288001 12C  Plum, prune, juice-babyfood        2.500000   1.400  1.000

1302057000 13B  Blueberry                          4.000000   1.000  1.000

1302057001 13B  Blueberry-babyfood                 4.000000   1.000  1.000

1302136000 13B  Currant                            4.000000   1.000  1.000

1302137000 13B  Currant, dried                     4.000000   1.000  1.000

1302149000 13B  Elderberry                         4.000000   1.000  1.000

1302174000 13B  Gooseberry                         4.000000   1.000  1.000

1302191000 13B  Huckleberry                        4.000000   1.000  1.000

1304175000 13D  Grape                              4.000000   1.000  1.000

1304176000 13D  Grape, juice                       4.000000   0.200  1.000

1304176001 13D  Grape, juice-babyfood              4.000000   0.200  1.000

1304179000 13D  Grape, wine and sherry             4.000000   1.000  1.000

1307130000 13G  Cranberry                          4.000000   1.000  1.000

1307130001 13G  Cranberry-babyfood                 4.000000   1.000  1.000

1307131000 13G  Cranberry, dried                   4.000000   1.000  1.000

1307132000 13G  Cranberry, juice                   4.000000   1.100  1.000

1307132001 13G  Cranberry, juice-babyfood          4.000000   1.100  1.000

1307359000 13G  Strawberry                         2.500000   1.000  1.000

1307359001 13G  Strawberry-babyfood                2.500000   1.000  1.000

1307360000 13G  Strawberry, juice                  2.500000   1.000  1.000

1307360001 13G  Strawberry, juice-babyfood         2.500000   1.000  1.000

1400003000 14   Almond                             0.030000   1.000  1.000

1400003001 14   Almond-babyfood                    0.030000   1.000  1.000

1400004000 14   Almond, oil                        0.030000   1.000  1.000

1400004001 14   Almond, oil-babyfood               0.030000   1.000  1.000

1400059000 14   Brazil nut                         0.030000   1.000  1.000

1400068000 14   Butternut                          0.030000   1.000  1.000

1400081000 14   Cashew                             0.030000   1.000  1.000

1400092000 14   Chestnut                           0.030000   1.000  1.000

1400155000 14   Hazelnut                           0.030000   1.000  1.000

1400156000 14   Hazelnut, oil                      0.030000   1.000  1.000

1400185000 14   Hickory nut                        0.030000   1.000  1.000

1400213000 14   Macadamia nut                      0.030000   1.000  1.000

1400269000 14   Pecan                              0.030000   1.000  1.000

1400278000 14   Pine nut                           0.030000   1.000  1.000

1400282000 14   Pistachio                          0.030000   1.000  1.000

1400391000 14   Walnut                             0.030000   1.000  1.000

1500025000 15   Barley, pearled barley             0.100000   1.000  1.000

1500025001 15   Barley, pearled barley-babyfood    0.100000   1.000  1.000

1500026000 15   Barley, flour                      0.100000   1.000  1.000

1500026001 15   Barley, flour-babyfood             0.100000   1.000  1.000

1500027000 15   Barley, bran                       0.100000   1.000  1.000

1500127000 15   Corn, sweet                        0.010000   1.000  1.000

1500127001 15   Corn, sweet-babyfood               0.010000   1.000  1.000

1500231000 15   Oat, bran                          0.010000   1.000  1.000

1500232000 15   Oat, flour                         0.010000   1.000  1.000

1500232001 15   Oat, flour-babyfood                0.010000   1.000  1.000

1500233000 15   Oat, groats/rolled oats            0.010000   1.000  1.000

1500233001 15   Oat, groats/rolled oats-babyfood   0.010000   1.000  1.000

1500328000 15   Rye, grain                         0.010000   1.000  1.000

1500329000 15   Rye, flour                         0.010000   1.000  1.000

1500381000 15   Triticale, flour                   0.100000   1.000  1.000

1500381001 15   Triticale, flour-babyfood          0.100000   1.000  1.000

1500401000 15   Wheat, grain                       0.100000   1.000  1.000

1500401001 15   Wheat, grain-babyfood              0.100000   1.000  1.000

1500402000 15   Wheat, flour                       0.100000   1.000  1.000

1500402001 15   Wheat, flour-babyfood              0.100000   1.000  1.000

1500403000 15   Wheat, germ                        0.100000   1.000  1.000

1500404000 15   Wheat, bran                        0.100000   1.000  1.000

2001163000 20A  Flax seed, oil                     0.100000   1.000  1.000

2001319000 20A  Rapeseed, oil                      0.100000   1.000  1.000

2001319001 20A  Rapeseed, oil-babyfood             0.100000   1.000  1.000

2001336000 20A  Sesame, seed                       0.100000   1.000  1.000

2001336001 20A  Sesame, seed-babyfood              0.100000   1.000  1.000

2001337000 20A  Sesame, oil                        0.100000   1.000  1.000

2001337001 20A  Sesame, oil-babyfood               0.100000   1.000  1.000

2003128000 20C  Cottonseed, oil                    0.050000   1.000  1.000

2003128001 20C  Cottonseed, oil-babyfood           0.050000   1.000  1.000

3100044000 31   Beef, meat                         0.050000   1.000  1.000

3100044001 31   Beef, meat-babyfood                0.050000   1.000  1.000

3100045000 31   Beef, meat, dried                  0.050000   1.920  1.000

3100046000 31   Beef, meat byproducts              0.100000   1.000  1.000

3100046001 31   Beef, meat byproducts-babyfood     0.100000   1.000  1.000

3100047000 31   Beef, fat                          0.100000   1.000  1.000

3100047001 31   Beef, fat-babyfood                 0.100000   1.000  1.000

3100048000 31   Beef, kidney                       0.100000   1.000  1.000

3100049000 31   Beef, liver                        0.400000   1.000  1.000

3100049001 31   Beef, liver-babyfood               0.400000   1.000  1.000

3200169000 32   Goat, meat                         0.050000   1.000  1.000

3200170000 32   Goat, meat byproducts              0.100000   1.000  1.000

3200171000 32   Goat, fat                          0.100000   1.000  1.000

3200172000 32   Goat, kidney                       0.100000   1.000  1.000

3200173000 32   Goat, liver                        0.400000   1.000  1.000

3300189000 33   Horse, meat                        0.050000   1.000  1.000

3400290000 34   Pork, meat                         0.050000   1.000  1.000

3400290001 34   Pork, meat-babyfood                0.050000   1.000  1.000

3400291000 34   Pork, skin                         0.100000   1.000  1.000

3400292000 34   Pork, meat byproducts              0.100000   1.000  1.000

3400292001 34   Pork, meat byproducts-babyfood     0.100000   1.000  1.000

3400293000 34   Pork, fat                          0.100000   1.000  1.000

3400293001 34   Pork, fat-babyfood                 0.100000   1.000  1.000

3400294000 34   Pork, kidney                       0.100000   1.000  1.000

3400295000 34   Pork, liver                        0.400000   1.000  1.000

3500339000 35   Sheep, meat                        0.050000   1.000  1.000

3500339001 35   Sheep, meat-babyfood               0.050000   1.000  1.000

3500340000 35   Sheep, meat byproducts             0.100000   1.000  1.000

3500341000 35   Sheep, fat                         0.100000   1.000  1.000

3500341001 35   Sheep, fat-babyfood                0.100000   1.000  1.000

3500342000 35   Sheep, kidney                      0.100000   1.000  1.000

3500343000 35   Sheep, liver                       0.400000   1.000  1.000

3600222000 36   Milk, fat                          0.020000   1.000  1.000

3600222001 36   Milk, fat-baby food/infant formu   0.020000   1.000  1.000

3600223000 36   Milk, nonfat solids                0.020000   1.000  1.000

3600223001 36   Milk, nonfat solids-baby food/in   0.020000   1.000  1.000

3600224000 36   Milk, water                        0.020000   1.000  1.000

3600224001 36   Milk, water-babyfood/infant form   0.020000   1.000  1.000

3600225001 36   Milk, sugar (lactose)-baby food/   0.020000   1.000  1.000

7000145000 70   Egg, whole                         0.020000   1.000  1.000

7000145001 70   Egg, whole-babyfood                0.020000   1.000  1.000

7000146000 70   Egg, white                         0.020000   1.000  1.000

7000146001 70   Egg, white (solids)-babyfood       0.020000   1.000  1.000

7000147000 70   Egg, yolk                          0.020000   1.000  1.000

7000147001 70   Egg, yolk-babyfood                 0.020000   1.000  1.000

8601000000 86A  Water, direct, all sources         0.020000   1.000  1.000

8602000000 86B  Water, indirect, all sources       0.020000   1.000  1.000

9500023000 O    Banana                             0.200000   1.000  1.000

9500023001 O    Banana-babyfood                    0.200000   1.000  1.000

9500024000 O    Banana, dried                      0.200000   3.900  1.000

9500024001 O    Banana, dried-babyfood             0.200000   3.900  1.000

9500177000 O    Grape, leaves                      4.000000   1.000  1.000

9500178000 O    Grape, raisin                      6.000000   1.000  1.000

9500215000 O    Mango                              0.070000   1.000  1.000

9500215001 O    Mango-babyfood                     0.070000   1.000  1.000

9500216000 O    Mango, dried                       0.070000   1.000  1.000

9500217000 O    Mango, juice                       0.070000   1.000  1.000

9500217001 O    Mango, juice-babyfood              0.070000   1.000  1.000

9500245000 O    Papaya                             0.300000   1.000  1.000

9500245001 O    Papaya-babyfood                    0.300000   1.000  1.000

9500246000 O    Papaya, dried                      0.300000   1.800  1.000

9500247000 O    Papaya, juice                      0.300000   1.500  1.000

9500283000 O    Plantain                           0.200000   1.000  1.000

9500284000 O    Plantain, dried                    0.200000   3.900  1.000

Attachment 2:  DEEM-FCID Acute Exposure Estimates

US EPA                                                      Ver. 3.18, 03-08-d

DEEM-FCID ACUTE Analysis for DIFENOCONAZOLE              NHANES 2003-2008 2-Day

Residue file: 128847 Acute Sept 2014.R08              Adjustment factor #2 used.

Analysis Date: 02-24-2015/07:13:19    Residue file dated: 10-16-2014/09:51:23

RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Total US Population:

                    0.038393    15.36    0.080503    32.20    0.159163    63.67

All Infants:

                    0.122946    49.18    0.188019    75.21    0.266271   106.51

Children 1-2:

                    0.108065    43.23    0.167396    66.96    0.407441   162.98

Children 3-5:

                    0.074001    29.60    0.120143    48.06    0.230017    92.01

Children 6-12:

                    0.050176    20.07    0.084194    33.68    0.145195    58.08

Youth 13-19:

                    0.024832     9.93    0.043239    17.30    0.121900    48.76

Adults 20-49:

                    0.025978    10.39    0.044412    17.76    0.102809    41.12

Adults 50-99:

                    0.028841    11.54    0.058172    23.27    0.127048    50.82

Female 13-49:

                    0.025939    10.38    0.044395    17.76    0.103499    41.40

FOOD ONLY

US EPA                                                      Ver. 3.18, 03-08-d

DEEM-FCID ACUTE Analysis for DIFENOCONAZOLE              NHANES 2003-2008 2-Day

Residue file: 128847 Acute Sept 2014 Food Only.R08

    Adjustment factor #2 used.

Analysis Date: 02-24-2015/07:08:32    Residue file dated: 02-24-2015/07:06:21

RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Total US Population:

                    0.037881    15.15    0.079960    31.98    0.158184    63.27

All Infants:

                    0.121522    48.61    0.185721    74.29    0.265664   106.27

Children 1-2:

                    0.107552    43.02    0.166250    66.50    0.404915   161.97

Children 3-5:

                    0.073500    29.40    0.118901    47.56    0.228389    91.36

Children 6-12:

                    0.049825    19.93    0.083096    33.24    0.145125    58.05

Youth 13-19:

                    0.024464     9.79    0.042631    17.05    0.121952    48.78

Adults 20-49:

                    0.025354    10.14    0.043922    17.57    0.102618    41.05

Adults 50-99:

                    0.028255    11.30    0.057708    23.08    0.126734    50.69

Female 13-49:

                    0.025424    10.17    0.043839    17.54    0.102408    40.96

Attachment 3:  DEEM-FCID Chronic Residue File

Filename: C:\Users\tmorton\Documents\My Files\DEEM Files\128847 Difenoconazole\128847 Difenoconazole 4F8231 Sept 2014\128847Chronic Sept 2014 AVG FT PDP percent CT.R08

Chemical: Difenoconazole

RfD(Chronic): .01 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .25 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 10-08-2014/07:58:46       Program ver. 3.16, 03-08-d

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

   EPA     Crop                                   Def Res     Adj.Factors   Comment

   Code     Grp  Commodity Name                    (ppm)       #1    #2

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

0101052000 1A   Beet, sugar                        0.300000   1.000  0.150

0101052001 1A   Beet, sugar-babyfood               0.300000   1.000  0.150

0101053000 1A   Beet, sugar, molasses              0.300000   0.600  0.150

0101053001 1A   Beet, sugar, molasses-babyfood     0.300000   0.600  0.150

0101078000 1AB  Carrot                             0.007000   1.000  1.000

0101078001 1AB  Carrot-babyfood                    0.007000   1.000  1.000

0101079000 1AB  Carrot, juice                      0.007000   1.000  1.000

0103015000 1CD  Arrowroot, flour                   1.360000   1.000  1.000

0103015001 1CD  Arrowroot, flour-babyfood          1.360000   1.000  1.000

0103017000 1CD  Artichoke, Jerusalem               1.360000   1.000  1.000

0103082000 1CD  Cassava                            1.360000   1.000  1.000

0103082001 1CD  Cassava-babyfood                   1.360000   1.000  1.000

0103139000 1CD  Dasheen, corm                      1.360000   1.000  1.000

0103166000 1CD  Ginger                             1.360000   1.000  1.000

0103166001 1CD  Ginger-babyfood                    1.360000   1.000  1.000

0103167000 1CD  Ginger, dried                      1.360000   1.000  1.000

0103296000 1C   Potato, chips                      1.360000   0.500  1.000

0103297000 1C   Potato, dry (granules/ flakes)     1.360000   0.500  1.000

0103297001 1C   Potato, dry (granules/ flakes)-b   1.360000   0.500  1.000

0103298000 1C   Potato, flour                      1.360000   0.500  1.000

0103298001 1C   Potato, flour-babyfood             1.360000   0.500  1.000

0103299000 1C   Potato, tuber, w/peel              1.360000   1.000  1.000

0103299001 1C   Potato, tuber, w/peel-babyfood     1.360000   1.000  1.000

0103300000 1C   Potato, tuber, w/o peel            1.360000   1.000  1.000

0103300001 1C   Potato, tuber, w/o peel-babyfood   1.360000   1.000  1.000

0103366000 1CD  Sweet potato                       1.360000   1.000  1.000

0103366001 1CD  Sweet potato-babyfood              1.360000   1.000  1.000

0103371000 1CD  Tanier, corm                       1.360000   1.000  1.000

0103387000 1CD  Turmeric                           1.360000   1.000  1.000

0103406000 1CD  Yam, true                          1.360000   1.000  1.000

0103407000 1CD  Yam bean                           1.360000   1.000  1.000

0301165000 3A   Garlic, bulb                       0.005000   1.000  0.050

0301165001 3A   Garlic, bulb-babyfood              0.005000   1.000  0.050

0301237000 3A   Onion, bulb                        0.005000   1.000  0.050

0301237001 3A   Onion, bulb-babyfood               0.005000   1.000  0.050

0301238000 3A   Onion, bulb, dried                 0.005000   9.000  0.050

0301238001 3A   Onion, bulb, dried-babyfood        0.005000   9.000  0.050

0301338000 3A   Shallot, bulb                      0.005000   1.000  1.000

0302103000 3B   Chive, fresh leaves                6.000000   1.000  1.000

0302198000 3B   Leek                               6.000000   1.000  1.000

0302239000 3B   Onion, green                       6.000000   1.000  0.050

0302338500 3B   Shallot, fresh leaves              6.000000   1.000  1.000

0501061000 5A   Broccoli                           0.003000   1.000  1.000

0501061001 5A   Broccoli-babyfood                  0.003000   1.000  1.000

0501062000 5A   Broccoli, Chinese                  0.003000   1.000  1.000

0501064000 5A   Brussels sprouts                   0.029000   1.000  1.000

0501069000 5A   Cabbage                            0.029000   1.000  0.025

0501071000 5A   Cabbage, Chinese, napa             0.029000   1.000  1.000

0501072000 5A   Cabbage, Chinese, mustard          0.003000   1.000  1.000

0501083000 5A   Cauliflower                        0.003000   1.000  1.000

0501196000 5A   Kohlrabi                           0.029000   1.000  1.000

0502063000 5B   Broccoli raab                      5.100000   1.000  1.000

0502070000 5B   Cabbage, Chinese, bok choy         5.100000   1.000  1.000

0502117000 5B   Collards                           5.100000   1.000  1.000

0502194000 5B   Kale                               5.100000   1.000  1.000

0502229000 5B   Mustard greens                     5.100000   1.000  1.000

0502318000 5B   Rape greens                        5.100000   1.000  1.000

0502389000 5B   Turnip, greens                     5.100000   1.000  1.000

0600347000 6    Soybean, seed                      0.021500   1.000  1.000

0600349000 6    Soybean, soy milk                  0.021500   1.000  1.000

0600349001 6    Soybean, soy milk-babyfood or in   0.021500   1.000  1.000

0600350000 6    Soybean, oil                       0.021500   1.000  1.000

0600350001 6    Soybean, oil-babyfood              0.021500   1.000  1.000

0601349500 6AB  Soybean, vegetable                 0.021500   1.000  1.000

0603030000 6C   Bean, black, seed                  0.014000   1.000  1.000

0603032000 6C   Bean, broad, seed                  0.014000   1.000  1.000

0603034000 6C   Bean, cowpea, seed                 0.014000   1.000  1.000

0603035000 6C   Bean,  great northern, seed        0.014000   1.000  1.000

0603036000 6C   Bean, kidney, seed                 0.014000   1.000  1.000

0603038000 6C   Bean, lima, seed                   0.014000   1.000  1.000

0603039000 6C   Bean, mung, seed                   0.014000   1.000  1.000

0603040000 6C   Bean, navy, seed                   0.014000   1.000  1.000

0603041000 6C   Bean, pink, seed                   0.014000   1.000  1.000

0603042000 6C   Bean, pinto, seed                  0.014000   1.000  1.000

0603098000 6C   Chickpea, seed                     0.034000   1.000  1.000

0603098001 6C   Chickpea, seed-babyfood            0.034000   1.000  1.000

0603099000 6C   Chickpea, flour                    0.034000   1.000  1.000

0603182000 6C   Guar, seed                         0.014000   1.000  1.000

0603182001 6C   Guar, seed-babyfood                0.014000   1.000  1.000

0603203000 6C   Lentil, seed                       0.034000   1.000  1.000

0603256000 6C   Pea, dry                           0.034000   1.000  1.000

0603256001 6C   Pea, dry-babyfood                  0.034000   1.000  1.000

0603258000 6C   Pea, pigeon, seed                  0.034000   1.000  1.000

0603348000 6C   Soybean, flour                     0.021500   1.000  1.000

0603348001 6C   Soybean, flour-babyfood            0.021500   1.000  1.000

0801374000 8A   Tomatillo                          0.165000   1.000  1.000

0801375000 8A   Tomato                             0.165000   1.000  0.250

0801375001 8A   Tomato-babyfood                    0.165000   1.000  0.250

0801376000 8A   Tomato, paste                      0.165000   1.600  0.250

0801376001 8A   Tomato, paste-babyfood             0.165000   1.600  0.250

0801377000 8A   Tomato, puree                      0.165000   0.500  0.250

0801377001 8A   Tomato, puree-babyfood             0.165000   0.500  0.250

0801378000 8A   Tomato, dried                      0.165000  14.300  0.250

0801378001 8A   Tomato, dried-babyfood             0.165000  14.300  0.250

0801379000 8A   Tomato, juice                      0.165000   1.500  0.250

0801380000 8A   Tomato, Tree                       0.165000   1.000  1.000

0802148000 8BC  Eggplant                           0.133000   1.000  1.000

0802234000 8BC  Okra                               0.600000   1.000  1.000

0802270000 8B   Pepper, bell                       0.133000   1.000  0.025

0802270001 8B   Pepper, bell-babyfood              0.133000   1.000  0.025

0802271000 8B   Pepper, bell, dried                0.133000   1.000  0.025

0802271001 8B   Pepper, bell, dried-babyfood       0.133000   1.000  0.025

0802272000 8BC  Pepper, nonbell                    0.133000   1.000  0.025

0802272001 8BC  Pepper, nonbell-babyfood           0.133000   1.000  0.025

0802273000 8BC  Pepper, nonbell, dried             0.133000   1.000  0.025

0901075000 9A   Cantaloupe                         0.005000   1.000  0.025

0901187000 9A   Honeydew melon                     0.005000   1.000  1.000

0901399000 9A   Watermelon                         0.005000   1.000  0.050

0901400000 9A   Watermelon, juice                  0.005000   1.000  0.050

0902021000 9B   Balsam pear                        0.055000   1.000  1.000

0902088000 9B   Chayote, fruit                     0.031000   1.000  1.000

0902102000 9B   Chinese waxgourd                   0.055000   1.000  1.000

0902135000 9B   Cucumber                           0.055000   1.000  0.050

0902308000 9B   Pumpkin                            0.011000   1.000  0.025

0902309000 9B   Pumpkin, seed                      0.011000   1.000  0.025

0902356000 9B   Squash, summer                     0.011000   1.000  0.050

0902356001 9B   Squash, summer-babyfood            0.011000   1.000  0.050

0902357000 9B   Squash, winter                     0.011000   1.000  0.050

0902357001 9B   Squash, winter-babyfood            0.011000   1.000  0.050

1001106000 10A  Citron                             0.005000   1.000  1.000

1001107000 10A  Citrus hybrids                     0.005000   1.000  1.000

1001108000 10A  Citrus, oil                        0.005000   1.000  1.000

1001240000 10A  Orange                             0.005000   1.000  0.025

1001241000 10A  Orange, juice                      0.005000   0.100  0.025

1001241001 10A  Orange, juice-babyfood             0.005000   0.100  0.025

1001242000 10A  Orange, peel                       0.005000   1.000  0.025

1001369000 10A  Tangerine                          0.005000   1.000  0.025

1001370000 10A  Tangerine, juice                   0.005000   0.100  0.025

1002197000 10B  Kumquat                            0.005000   1.000  1.000

1002199000 10B  Lemon                              0.005000   1.000  1.000

1002200000 10B  Lemon, juice                       0.005000   0.100  1.000

1002200001 10B  Lemon, juice-babyfood              0.005000   0.100  1.000

1002201000 10B  Lemon, peel                        0.005000   1.000  1.000

1002206000 10B  Lime                               0.005000   1.000  1.000

1002207000 10B  Lime, juice                        0.005000   0.100  1.000

1002207001 10B  Lime, juice-babyfood               0.005000   0.100  1.000

1003180000 10C  Grapefruit                         0.005000   1.000  0.025

1003181000 10C  Grapefruit, juice                  0.005000   0.100  0.025

1003307000 10C  Pummelo                            0.005000   1.000  1.000

1100007000 11   Apple, fruit with peel             1.420000   1.000  1.000

1100008000 11   Apple, peeled fruit                1.420000   1.000  1.000

1100008001 11   Apple, peeled fruit-babyfood       1.420000   1.000  1.000

1100009000 11   Apple, dried                       1.420000   8.000  1.000

1100009001 11   Apple, dried-babyfood              1.420000   8.000  1.000

1100010000 11   Apple, juice                       1.420000   0.040  1.000

1100010001 11   Apple, juice-babyfood              1.420000   0.040  1.000

1100011000 11   Apple, sauce                       1.420000   1.000  1.000

1100011001 11   Apple, sauce-babyfood              1.420000   1.000  1.000

1100129000 11   Crabapple                          1.420000   1.000  1.000

1100173500 11   Goji berry                         1.350000   1.000  1.000

1100210000 11   Loquat                             1.350000   1.000  1.000

1100266000 11   Pear                               1.350000   1.000  1.000

1100266001 11   Pear-babyfood                      1.350000   1.000  1.000

1100267000 11   Pear, dried                        1.350000   6.250  1.000

1100268000 11   Pear, juice                        1.350000   1.000  1.000

1100268001 11   Pear, juice-babyfood               1.350000   1.000  1.000

1100310000 11   Quince                             1.350000   1.000  1.000

1201090000 12A  Cherry                             0.622000   1.000  1.000

1201090001 12A  Cherry-babyfood                    0.622000   1.000  1.000

1201091000 12A  Cherry, juice                      0.622000   1.500  1.000

1201091001 12A  Cherry, juice-babyfood             0.622000   1.500  1.000

1202012000 12B  Apricot                            0.038000   1.000  1.000

1202012001 12B  Apricot-babyfood                   0.038000   1.000  1.000

1202013000 12B  Apricot, dried                     0.038000   6.000  1.000

1202014000 12B  Apricot, juice                     0.038000   1.000  1.000

1202014001 12B  Apricot, juice-babyfood            0.038000   1.000  1.000

1202230000 12B  Nectarine                          0.004000   1.000  1.000

1202260000 12B  Peach                              0.038000   1.000  0.010

1202260001 12B  Peach-babyfood                     0.038000   1.000  0.010

1202261000 12B  Peach, dried                       0.038000   7.000  0.010

1202261001 12B  Peach, dried-babyfood              0.038000   7.000  0.010

1202262000 12B  Peach, juice                       0.038000   1.000  0.010

1202262001 12B  Peach, juice-babyfood              0.038000   1.000  0.010

1203285000 12C  Plum                               0.005000   1.000  1.000

1203285001 12C  Plum-babyfood                      0.005000   1.000  1.000

1203286000 12C  Plum, prune, fresh                 0.005000   1.000  1.000

1203286001 12C  Plum, prune, fresh-babyfood        0.005000   1.000  1.000

1203287000 12C  Plum, prune, dried                 0.005000   2.600  1.000

1203287001 12C  Plum, prune, dried-babyfood        0.005000   2.600  1.000

1203288000 12C  Plum, prune, juice                 0.005000   1.400  1.000

1203288001 12C  Plum, prune, juice-babyfood        0.005000   1.400  1.000

1302057000 13B  Blueberry                          1.009000   1.000  1.000

1302057001 13B  Blueberry-babyfood                 1.009000   1.000  1.000

1302136000 13B  Currant                            1.009000   1.000  1.000

1302137000 13B  Currant, dried                     1.009000   1.000  1.000

1302149000 13B  Elderberry                         1.009000   1.000  1.000

1302174000 13B  Gooseberry                         1.009000   1.000  1.000

1302191000 13B  Huckleberry                        1.009000   1.000  1.000

1304175000 13D  Grape                              0.613000   1.000  0.050

1304176000 13D  Grape, juice                       0.005000   1.000  0.050

1304176001 13D  Grape, juice-babyfood              0.005000   1.000  0.050

1304179000 13D  Grape, wine and sherry             0.613000   1.000  0.050

1307130000 13G  Cranberry                          1.009000   1.000  1.000

1307130001 13G  Cranberry-babyfood                 1.009000   1.000  1.000

1307131000 13G  Cranberry, dried                   1.009000   1.000  1.000

1307132000 13G  Cranberry, juice                   1.009000   1.100  1.000

1307132001 13G  Cranberry, juice-babyfood          1.009000   1.100  1.000

1307359000 13G  Strawberry                         0.495000   1.000  0.025

1307359001 13G  Strawberry-babyfood                0.495000   1.000  0.025

1307360000 13G  Strawberry, juice                  0.495000   1.000  0.025

1307360001 13G  Strawberry, juice-babyfood         0.495000   1.000  0.025

1400003000 14   Almond                             0.005000   1.000  0.050

1400003001 14   Almond-babyfood                    0.005000   1.000  0.050

1400004000 14   Almond, oil                        0.005000   1.000  0.050

1400004001 14   Almond, oil-babyfood               0.005000   1.000  0.050

1400059000 14   Brazil nut                         0.007000   1.000  1.000

1400068000 14   Butternut                          0.007000   1.000  1.000

1400081000 14   Cashew                             0.007000   1.000  1.000

1400092000 14   Chestnut                           0.005000   1.000  1.000

1400155000 14   Hazelnut                           0.007000   1.000  1.000

1400156000 14   Hazelnut, oil                      0.007000   1.000  1.000

1400185000 14   Hickory nut                        0.007000   1.000  1.000

1400213000 14   Macadamia nut                      0.007000   1.000  1.000

1400269000 14   Pecan                              0.007000   1.000  0.025

1400282000 14   Pistachio                          0.005000   1.000  0.025

1400391000 14   Walnut                             0.007000   1.000  0.025

1500025000 15   Barley, pearled barley             0.100000   1.000  1.000

1500025001 15   Barley, pearled barley-babyfood    0.100000   1.000  1.000

1500026000 15   Barley, flour                      0.100000   1.000  1.000

1500026001 15   Barley, flour-babyfood             0.100000   1.000  1.000

1500027000 15   Barley, bran                       0.100000   1.000  1.000

1500127000 15   Corn, sweet                        0.010000   1.000  1.000

1500127001 15   Corn, sweet-babyfood               0.010000   1.000  1.000

1500231000 15   Oat, bran                          0.010000   1.000  1.000

1500232000 15   Oat, flour                         0.010000   1.000  1.000

1500232001 15   Oat, flour-babyfood                0.010000   1.000  1.000

1500233000 15   Oat, groats/rolled oats            0.010000   1.000  1.000

1500233001 15   Oat, groats/rolled oats-babyfood   0.010000   1.000  1.000

1500328000 15   Rye, grain                         0.010000   1.000  1.000

1500329000 15   Rye, flour                         0.010000   1.000  1.000

1500381000 15   Triticale, flour                   0.100000   1.000  1.000

1500381001 15   Triticale, flour-babyfood          0.100000   1.000  1.000

1500401000 15   Wheat, grain                       0.100000   1.000  0.100

1500401001 15   Wheat, grain-babyfood              0.100000   1.000  0.100

1500402000 15   Wheat, flour                       0.100000   1.000  0.100

1500402001 15   Wheat, flour-babyfood              0.100000   1.000  0.100

1500403000 15   Wheat, germ                        0.100000   1.000  0.100

1500404000 15   Wheat, bran                        0.100000   1.000  0.100

2001163000 20A  Flax seed, oil                     0.100000   1.000  1.000

2001319000 20A  Rapeseed, oil                      0.100000   1.000  1.000

2001319001 20A  Rapeseed, oil-babyfood             0.100000   1.000  1.000

2001336000 20A  Sesame, seed                       0.100000   1.000  1.000

2001336001 20A  Sesame, seed-babyfood              0.100000   1.000  1.000

2001337000 20A  Sesame, oil                        0.100000   1.000  1.000

2001337001 20A  Sesame, oil-babyfood               0.100000   1.000  1.000

2003128000 20C  Cottonseed, oil                    0.050000   1.000  1.000

2003128001 20C  Cottonseed, oil-babyfood           0.050000   1.000  1.000

3100044000 31   Beef, meat                         0.050000   1.000  1.000

3100044001 31   Beef, meat-babyfood                0.050000   1.000  1.000

3100045000 31   Beef, meat, dried                  0.050000   1.920  1.000

3100046000 31   Beef, meat byproducts              0.100000   1.000  1.000

3100046001 31   Beef, meat byproducts-babyfood     0.100000   1.000  1.000

3100047000 31   Beef, fat                          0.100000   1.000  1.000

3100047001 31   Beef, fat-babyfood                 0.100000   1.000  1.000

3100048000 31   Beef, kidney                       0.100000   1.000  1.000

3100049000 31   Beef, liver                        0.400000   1.000  1.000

3100049001 31   Beef, liver-babyfood               0.400000   1.000  1.000

3200169000 32   Goat, meat                         0.050000   1.000  1.000

3200170000 32   Goat, meat byproducts              0.100000   1.000  1.000

3200171000 32   Goat, fat                          0.100000   1.000  1.000

3200172000 32   Goat, kidney                       0.100000   1.000  1.000

3200173000 32   Goat, liver                        0.400000   1.000  1.000

3300189000 33   Horse, meat                        0.050000   1.000  1.000

3400290000 34   Pork, meat                         0.050000   1.000  1.000

3400290001 34   Pork, meat-babyfood                0.050000   1.000  1.000

3400291000 34   Pork, skin                         0.100000   1.000  1.000

3400292000 34   Pork, meat byproducts              0.100000   1.000  1.000

3400292001 34   Pork, meat byproducts-babyfood     0.100000   1.000  1.000

3400293000 34   Pork, fat                          0.100000   1.000  1.000

3400293001 34   Pork, fat-babyfood                 0.100000   1.000  1.000

3400294000 34   Pork, kidney                       0.100000   1.000  1.000

3400295000 34   Pork, liver                        0.400000   1.000  1.000

3500339000 35   Sheep, meat                        0.050000   1.000  1.000

3500339001 35   Sheep, meat-babyfood               0.050000   1.000  1.000

3500340000 35   Sheep, meat byproducts             0.100000   1.000  1.000

3500341000 35   Sheep, fat                         0.100000   1.000  1.000

3500341001 35   Sheep, fat-babyfood                0.100000   1.000  1.000

3500342000 35   Sheep, kidney                      0.100000   1.000  1.000

3500343000 35   Sheep, liver                       0.400000   1.000  1.000

3600222000 36   Milk, fat                          0.020000   1.000  1.000

3600222001 36   Milk, fat-baby food/infant formu   0.020000   1.000  1.000

3600223000 36   Milk, nonfat solids                0.020000   1.000  1.000

3600223001 36   Milk, nonfat solids-baby food/in   0.020000   1.000  1.000

3600224000 36   Milk, water                        0.020000   1.000  1.000

3600224001 36   Milk, water-babyfood/infant form   0.020000   1.000  1.000

3600225001 36   Milk, sugar (lactose)-baby food/   0.020000   1.000  1.000

7000145000 70   Egg, whole                         0.020000   1.000  1.000

7000145001 70   Egg, whole-babyfood                0.020000   1.000  1.000

7000146000 70   Egg, white                         0.020000   1.000  1.000

7000146001 70   Egg, white (solids)-babyfood       0.020000   1.000  1.000

7000147000 70   Egg, yolk                          0.020000   1.000  1.000

7000147001 70   Egg, yolk-babyfood                 0.020000   1.000  1.000

8601000000 86A  Water, direct, all sources         0.013600   1.000  1.000

8602000000 86B  Water, indirect, all sources       0.013600   1.000  1.000

9500023000 O    Banana                             0.005000   1.000  1.000

9500023001 O    Banana-babyfood                    0.005000   1.000  1.000

9500024000 O    Banana, dried                      0.005000   3.900  1.000

9500024001 O    Banana, dried-babyfood             0.005000   3.900  1.000

9500177000 O    Grape, leaves                      0.613000   1.000  0.050

9500178000 O    Grape, raisin                      0.613000   3.500  0.050

9500215000 O    Mango                              0.070000   1.000  1.000

9500215001 O    Mango-babyfood                     0.070000   1.000  1.000

9500216000 O    Mango, dried                       0.070000   1.000  1.000

9500217000 O    Mango, juice                       0.070000   1.000  1.000

9500217001 O    Mango, juice-babyfood              0.070000   1.000  1.000

9500245000 O    Papaya                             0.016000   1.000  1.000

9500245001 O    Papaya-babyfood                    0.016000   1.000  1.000

9500246000 O    Papaya, dried                      0.016000   1.800  1.000

9500247000 O    Papaya, juice                      0.016000   1.500  1.000

9500283000 O    Plantain                           0.005000   1.000  1.000

9500284000 O    Plantain, dried                    0.005000   3.900  1.000

Attachment 4:  DEEM-FCID Chronic Exposure Estimates

US EPA                                                          Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for DIFENOCONAZOLE              NHANES 2003-2008 2-day

Residue file name: C:\Users\tmorton\Documents\My Files\DEEM Files\128847 Difenoconazole\128847 Difenoconazole 4F8231 Sept 2014\128847Chronic Sept 2014 AVG FT PDP percent CT.R08

                                                     Adjustment factor #2 used.

Analysis Date 02-24-2015/07:41:16     Residue file dated: 10-16-2014/13:34:31

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

Total US Population                         0.002554                25.5%

Hispanic                                    0.002723                27.2%

Non-Hisp-White                              0.002470                24.7%

Non-Hisp-Black                              0.002653                26.5%

Non-Hisp-Other                              0.002999                30.0%

Nursing Infants                             0.004977                49.8%

Non-Nursing Infants                         0.008892                88.9%

Female 13+ PREG                             0.002191                21.9%

Children 1-6                                0.006902                69.0%

Children 7-12                               0.003380                33.8%

Male 13-19                                  0.002040                20.4%

Female 13-19/NP                             0.001927                19.3%

Male 20+                                    0.001970                19.7%

Female 20+/NP                               0.001903                19.0%

Seniors 55+                                 0.002073                20.7%

All Infants                                 0.007683                76.8%

Female 13-50                                0.001817                18.2%

Children 1-2                                0.008828                88.3%

Children 3-5                                0.006009                60.1%

Children 6-12                               0.003676                36.8%

Youth 13-19                                 0.001980                19.8%

Adults 20-49                                0.001847                18.5%

Adults 50-99                                0.002068                20.7%

Female 13-49                                0.001814                18.1%

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

FOOD ONLY

US EPA                                                          Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for DIFENOCONAZOLE              NHANES 2003-2008 2-day

Residue file name: C:\Users\tmorton\Documents\My Files\DEEM Files\128847 Difenoconazole\128847 Difenoconazole 4F8231 Sept 2014\128847Chronic Sept 2014 AVG FT PDP percent CT Food Only.R08

                                                     Adjustment factor #2 used.

Analysis Date 02-24-2015/07:41:44     Residue file dated: 02-24-2015/07:40:09

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

Total US Population                         0.002269                22.7%

Hispanic                                    0.002452                24.5%

Non-Hisp-White                              0.002177                21.8%

Non-Hisp-Black                              0.002418                24.2%

Non-Hisp-Other                              0.002671                26.7%

Nursing Infants                             0.004719                47.2%

Non-Nursing Infants                         0.007945                79.4%

Female 13+ PREG                             0.001923                19.2%

Children 1-6                                0.006537                65.4%

Children 7-12                               0.003143                31.4%

Male 13-19                                  0.001844                18.4%

Female 13-19/NP                             0.001707                17.1%

Male 20+                                    0.001704                17.0%

Female 20+/NP                               0.001604                16.0%

Seniors 55+                                 0.001797                18.0%

All Infants                                 0.006949                69.5%

Female 13-50                                0.001534                15.3%

Children 1-2                                0.008417                84.2%

Children 3-5                                0.005663                56.6%

Children 6-12                               0.003426                34.3%

Youth 13-19                                 0.001773                17.7%

Adults 20-49                                0.001563                15.6%

Adults 50-99                                0.001787                17.9%

Female 13-49                                0.001531                15.3%

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

Attachment 5:  Percent Crop Treated Memorandum

Difenoconazole (128847)

Screening Level Usage Analysis (SLUA)

Date: October 2, 2014

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

Pesticide usage data obtained from various sources.  The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used on.

Available pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.

Annual percent of crop treated (average & maximum) for each agricultural crop.

Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by merging pesticide usage data sources together; averaging across all observations, then rounding.  Note:  If the estimated value is less than 500, then that value is labeled <500.  Estimated values between 500 & <1,000,000 are rounded to 1 significant digit.  Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.  If the estimated value is less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National Agricultural Statistics Service) – pesticide usage data from 2004 to 2012.

Private pesticide market research – pesticide usage data from 2004 to 2012.

California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 2004 to 2011.

What are the limitations to the data?

Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply zero usage.

Usage data on a particular site may be noted in data sources, but not quantified.  In these instances, the site would not be reported in the SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not reported in the SLUA.  A separate request must be made to receive these estimates.

Some sites show some use, even though they are not on the label.  This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs).

Date: October 2, 2014

Screening Level Estimates of Agricultural Uses of Difenoconazole (128847)

Sorted Alphabetically

Reporting Years: 2004-2012

Average	Percent Crop Treated

	Crop	Lbs. A.I.	Average	Maximum

1	Almonds	7,000	5	15

2	Apples	7,000	15	25

3	Brussels Sprouts   * 	<500	NC	NC

4	Cabbage	<500	<2.5	5

5	Cantaloupes	<500	<2.5	<2.5

6	Cucumbers	3,000	5	10

7	Garlic	<500	5	5

8	Grapefruit	<500	<2.5	<2.5

9	Grapes	9,000	5	10

10	Onions	2,000	5	10

11	Oranges	1,000	<2.5	<2.5

12	Peaches	<500	<1	<2.5

13	Pears	<500	5	10

14	Pecans	1,000	<2.5	<2.5

15	Peppers	<500	<2.5	5

16	Pistachios	<500	<2.5	5

17	Potatoes	20,000	15	30

18	Pumpkins	<500	<2.5	5

19	Squash	<500	5	10

20	Strawberries	<500	<2.5	<2.5

21	Sugar Beets	20,000	15	30

22	Tangerines	1,000	<2.5	<2.5

23	Tomatoes	7,000	25	40

24	Walnuts	<500	<2.5	<2.5

25	Watermelons	2,000	5	10

26	Wheat (Seed Treatment)	40,000	10	15

All numbers are rounded.

<500: less than 500 pounds of active ingredients.

  	<2.5: less than 2.5 percent of crop is treated.

 	 <1: less than 1 percent of crop is treated.

* Based on CA DPR data only (80% or more of U.S. acres grown are in California)

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i. available.

 SLUA data sources include:

USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service)

Private Pesticide Market Research

California DPR (Department of Pesticide Regulation)

These results reflect amalgamated data developed by the Agency and are releasable to the public.

Difenoconazole	Dietary Exposure Assessment	DP#: 421430

PC Code: 128847

  PAGE  1  of   NUMPAGES  18


[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Page 22756]
[FR Doc No: 2014-09219]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Federal Environmental Statutes, Regulations, and Executive Orders
Applicable to the Development and Review of Transportation
Infrastructure Projects

AGENCY: Office of the Secretary, DOT.

ACTION: Notice of availability.

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

SUMMARY: The United States Department of Transportation (Department)
has prepared a document listing Federal environmental statutes,
regulations, and Executive Orders that establish requirements
applicable to the development and review of transportation
infrastructure projects. The Department strives to ensure compliance
with these requirements in a manner that is both environmentally sound
and expeditious. The goal of this document is to contribute to this
important effort by providing a brief description of the primary
statutes, regulations, and Executive Orders applicable to the
development and review of these transportation infrastructure projects.

FOR FURTHER INFORMATION CONTACT: Amy Coyle, Senior Attorney Advisor,
U.S. Department of Transportation, Office of the General Counsel; 1200
New Jersey Avenue SE., Washington, DC 20590. Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The United States Department of
Transportation (Department or DOT) has prepared a document listing
Federal environmental statutes, regulations, and Executive Orders that
establish requirements applicable to the development and review of
transportation infrastructure projects that receive financial support
from the Department. DOT strives to meet these requirements in a manner
that is both environmentally sound and expeditious. The goal of this
list is to contribute to this important effort by providing a brief
description of the primary statutes, regulations, and Executive Orders
applicable to the development and review of these transportation
infrastructure projects. Additionally, many agencies have developed
guidance to assist in implementation of the law, and this document
references certain guidance. This summary is not, and should not be
relied upon as, a complete list of statutes, regulations, and Executive
Orders that could apply to a transportation infrastructure project or
an official or independent interpretation or expression of policy on
the matters summarized. This document replaces the notice, ``Federal
Environmental Laws and Executive Orders Applicable to Development and
Review of Transportation Infrastructure Projects,'' 69 FR 25451, May 6,
2004.
    The document is available online at http://www.dot.gov/policy/transportation-policy/environment/laws.

    Issued in Washington, DC on April 10, 2014.
Kathryn B. Thomson,
General Counsel.
[FR Doc. 2014-09219 Filed 4-22-14; 8:45 am]
BILLING CODE 4910-9X-P