Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database (DEEM-FCID) Version 3.16, which uses food consumption data 

from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, 

What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 

to 2008. The analyses were conducted in support of a human health risk assessment for the 

proposed Section 3 registration of the new active ingredient (ai) fenpyrazamine for domestic uses 

on caneberry subgroup 13-07A, bushberry subgroup 13-07B, small fruit climbing subgroup 13-

07F, and low growing berry subgroup 13-07G, head lettuce, leaf lettuce, almond, pistachio and 

ginseng. 

Unrefined acute and chronic dietary assessments were performed. Tolerance level residues of 

parent fenpyrazamine plus the maximum residue of S-2188-DC (expressed as parent 

fenpyrazamine) observed in the crop field trials were used for the proposed uses. Default 

processing factors and 100% of crop treated (CT) assumptions were incorporated. Drinking 

water was incorporated directly in the dietary assessment using the Tier I acute and chronic 

estimated drinking water concentration (EDWC) for surface water generated by the FQPA Index 

Reservoir Screening Tool (FIRST).

Acute Dietary Exposure Assessment

The resulting acute dietary exposure estimates using the DEEM-FCIDTM model were less than 

100% of the acute population adjusted dose (aPAD) at the 95th percentile of exposure for the 

general U.S. population and all population subgroups. Fenpyrazamine acute dietary exposure 

(food + drinking water) was estimated at 0.023720 mg/kg/day for the general U.S. population 

(3.0% of the aPAD) and 0.073511 mg/kg/day (9.2 % of the aPAD) for the most highly exposed 

population subgroup (children 1-2 years old). The results per user and per capita are similar.

Chronic Dietary Exposure Assessment

The resulting chronic dietary exposure estimates using the DEEM-FCIDTM model were less than 

100% of the chronic population adjusted dose (cPAD) for the general U.S. population and all 

population subgroups. Fenpyrazamine chronic dietary exposure (food + drinking water) was 

estimated at 0.008022 mg/kg/day for the general U.S. population (2.7% of the cPAD) and 

0.021792 mg/kg/day (7.3 % of the cPAD) for the most highly exposed population subgroup 

(children 1-2 years old).

Fenpyrazamine was classified as "Not Likely to be Carcinogenic to Humans", based on the 

results of mice and rat carcinogenicity studies; therefore, a cancer risk assessment is not needed.
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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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 that HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to 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. HED is generally concerned when estimated cancer risk exceeds one 

in one million. References that 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: http://www.epa.gov/fedrgstr/EPAPEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999).

II. Residue Information

Plants: The Residues of Concern Knowledgebase Subcommittee (ROCKS) has determined the 

residue definition for tolerance enforcement in plants is parent fenpyrazamine only while for risk 

assessment is the parent compound and the S-2188-DC metabolite (D403378, E. Holman, 

08/31/2012). Based on this tolerances were established based on residues of parent 

fenpyrazamine (D406080, I. Negrón, 10/31/2012). For dietary assessment purposes, tolerance 

level residues for parent fenpyrazamine plus the maximum residue of S-2188-DC (expressed as 

parent fenpyrazamine) observed in the crop field trials were used to account for total residues 

in/on caneberry subgroup 13-07A, bushberry subgroup 13-07B, small fruit climbing subgroup 

13-07F, grape juice, and low growing berry subgroup 13-07G, head lettuce, leaf lettuce, almond, 

pistachio and ginseng, see attachment 1. Based on the processing study with grapes, no 

tolerances are required for raisins; however, the concentration factor of S-2188-DC (1.6x) was 

used to estimate the residue levels in raisins. For all these commodities, the corresponding 

residue levels were used for dietary exposure calculations in DEEM-FCIDTM. DEEM default 

processing factor was used for cranberry juice. For grape juice and raisins, an empirical 

processing factor was used. One hundred percent of crop treated assumptions were used for all 

food commodities. 

Note: Uncertainty on the stability of S-2188-DC in the crop field trial samples of bushberries 

and caneberries (stored whole) was discussed in the residue chemistry chapter of fenpyrazamine 

(D406080, I. Negrón, 10/31/2012). This has to be considered if refinement of the residue level 

estimated for dietary assessment purposes is needed in the future. Tolerances were 

recommended for the caneberry subgroup 13-07A and bushberry subgroup 13-07B at 5 ppm 

while the maximum residue of parent fenpyrazamine and S-2188-DC (expressed as parent 

fenpyrazamine) in these commodities is 2.86 ppm and 0.51ppm for caneberries, 2.43 ppm and 

0.48 ppm for bushberries, respectively. Since the total residue level included in the dietary 

assessment is overestimated, HED understands that this may account for any potential instability

of S-2188-DC for this case only. In the absence of data demonstrating the stability of S-2188-DC 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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in the field trial samples, for future dietary assessments, HED does not recommend refinement of 

the total residue level on these commodities. Nevertheless, percent of crop treated assumptions 

may be used to refine the acute and chronic dietary assessment for these commodities. 

Livestock and Rotational Crops: Tolerances were not required to support the proposed new uses 

of fenpyrazamine (D406080, I. Negrón, 10/31/2012). 

Drinking Water: The Residues of Concern Knowledgebase Subcommittee (ROCKS) has 

determined the residue definition for risk assessment purposes in drinking water is the parent 

compound and the environmental degradates S-2188-OH, S-2188-DC, and MCNI (D403378, E. 

Holman, 08/31/2012). The Environmental Fate and Effects Division (EFED) provided Tier 1 

EDWCs for the residues of concern in drinking water (D388319, G. Rotham, 09/07/2012). The 

surface water estimates were considerably higher than the ground water estimates and the highest 

applicable surface water values of 0.2135 ppm and 0.0725 ppm were then used in the acute and 

chronic dietary exposure analysis, respectively. 

III. Percent Crop Treated Information

The acute and chronic assessments were performed by assuming that 100% of the crop was 

treated for all food commodities. 

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED) in the following memorandum: “Tier I 

Drinking Water Assessment for the new chemical Fenpyrazamine (P.C. Code: 090109) proposed 

Section 3 uses on almonds, grapes, lettuce, strawberries, and ornamentals; and IR-4 uses on 

pistachios, bushberries, caneberries, and ginseng” (D388319, G. Rotham, 09/07/2012) and 

incorporated directly into this dietary assessment. Water residues were incorporated in the 

DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all 

sources.” 

Table 1. FIRST and SCI-GROW estimated upper bound concentrations in surface water (ppb) 

and ground water, respectively, of fenpyrazamine and degradates of concern including S-2188-OH, 

S-2188-DC, and MCNI. 

Source (Use Pattern) Acute EDWC (μg/L) Chronic EDWC (μg/L)

Surface Water 

(ornamentals) 213.5 72.5

Groundwater 

(ornamentals) 1.31

Fenpyrazamine foliar applications were modeled using FIRST. Acute and chronic exposure of 

fenpyrazamine total residues (e.g., S-2188, S-2188-OH, S-2188-DC, and MCNI) in surface 

drinking water sources is represented by annual peak concentrations and annual average 

concentrations, respectively. Upper-bound Tier I modeling predicts that the concentrations of 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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fenpyrazamine in surface drinking water sources are not likely to exceed 0.2135 ppm for the 

acute peak concentration and 0.0725 ppm for the chronic and cancer annual average 

concentrations. These EDWCs were obtained from FIRST analysis using the highest supported 

use rate for fenpyrazamine of 3 aerial applications of 1.089 lbs ai/A every 7 days for a maximum 

seasonal rate of 3.267 lb ai/A in ornamentals. The model used is described at the EPA internet 

website via the web link, http://www.epa.gov/oppefed1/models/water/. 

V. DEEM-FCID Program and Consumption Information

Fenpyrazamine 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 

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. However, for acute exposure assessment, consumption data 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+ years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

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

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup.

For an acute exposure assessment, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for analyses performed at all levels of refinement. However, for 

deterministic assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment.
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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VI. Toxicological Information

The following toxicological profile is a brief summary of the data relevant for this dietary 

analysis. For a more complete discussion of the toxicological information pertaining to 

fenpyrazamine, see the ToxSAC memo (J. Kidwell, 26-Sept-2012). ToxSAC selected an acute 

dietary toxicity endpoint based on weight of evidence from acute neurotoxicity studies with rats. 

A chronic dietary toxicity endpoint based on weight of evidence from developmental toxicity 

studies with rabbits. Based on the data available in the literature and historical precedence, the 

UF for the toxicity studies is 100x for inter- and intra-species variations. The selected acute and 

chronic reference dose (RfD) of 0.80 and 0.30 mg/kg/day are based on the NOAEL of 80 and 30 

mg/kg/day, respectively, and a standard 100-fold uncertainty factor to account for inter- and 

intra-species variations. The Special FQPA Safety Factor is 1x. Therefore, the chronic 

population adjusted dose (cPAD) is equal to the chronic reference dose (cRfD). 

Fenpyrazamine was classified by the ToxSAC as "Not Likely to be Carcinogenic to Humans", 

based on the results of mice and rat carcinogenicity studies.

Toxicological doses and endpoints for fenpyrazamine are summarized in Table 2.

Table 2. Toxicological Doses and Endpoints for Fenpyrazamine for Use in Dietary Health Risk 

Assessments

Exposure/

Scenario

Point of 

Departure

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population)

NOAEL= 80 

mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF= 1x

Acute RfD = 0.80

mg/kg/day

aPAD = 0.80

mg/kg/day

Acute Neurotoxicity Screening 

Battery-Rats

LOAEL = based on a statistically 

significant decrease in total motor 

activity (total distance) in males at 

400 mg/kg/day on day 1. 

Chronic 

Dietary (All 

Populations)

NOAEL = 30 

mg/kg/day

UF = 100

UFA= 10x

UFH=10x

FQPA SF= 1x

Chronic RfD = 0.30 

mg/kg/day

cPAD = 0.30 

mg/kg/day

Developmental Toxicity StudyRabbit

Maternal LOAEL = 50 mg/kg/day 

based on decreased food 

consumption, and decreased body 

weight. 

Cancer (oral, 

dermal, 

inhalation)

Based on the lack evidence of carcinogenicity in mice and rats, in accordance with the Agency's 

2005 Guidelines for Cancer Risk Assessment, fenpyrazamine is classified a "Not Likely to be 

Carcinogenic to Humans".

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. LOC = level of concern. 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 2 are for the general 

U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The results of the acute dietary exposure analysis at the 95th percentile of exposure are reported 

in the summary table below. An unrefined acute dietary risk assessment for fenpyrazamine

showed that acute dietary risk estimates are below HED’s level of concern (i.e. <100% 

aPAD) for the general population and all population subgroups. The highest risk was observed

for children 1-2 years old (9.2% of the aPAD). 

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The results of the chronic dietary exposure analysis are reported in the summary table below. 

The chronic dietary risk assessment for fenpyrazamine showed that chronic dietary risk 

estimates are below HED’s level of concern (i.e. >100% cPAD) for the general population and 

all population subgroups; in particular, children 1-2 year old were the highest exposed population 

subgroup (7.3% of the cPAD).

Table 3. Summary of Dietary (Food and Drinking Water) Exposure and Risk for 

Fenpyrazamine.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary Cancer

Dietary 

Exposure 

(mg/kg/day)

% aPAD*

Dietary 

Exposure

(mg/kg/day)

% cPAD*

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. Population 0.023720 3.0 0.008022 2.7

All Infants (<1 year old) 0.053592 6.7 0.016624 5.5

N/A N/A

Children 1-2 years old* 0.073511 9.2 0.021792 7.3

Children 3-5 years old 0.050147 6.3 0.015293 5.1

Children 6-12 years old 0.027948 3.5 0.008542 2.8

Youth 13-19 years old 0.016521 2.1 0.005348 1.8

Adults 20-49 years old 0.020282 2.5 0.007058 2.4

Adults 50+ years old 0.019653 2.5 0.007401 2.5

Females 13-49 years old 0.020894 2.6 0.007268 2.4

*The subpopulation with the highest risk estimates.
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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VIII. Characterization of Inputs/Outputs

The acute and chronic dietary exposure assessments for fenpyrazamine are unrefined, making 

use of tolerance level residue levels, and 100% crop treated assumptions for all crops. 

Tolerances were determined for caneberry subgroup 13-07A, bushberry subgroup 13-07B, small 

fruit climbing subgroup 13-07F, low growing berry subgroup 13-07G, head lettuce, leaf lettuce, 

almond, pistachio and ginseng based on the quantification of fenpyrazamine (parent only) in/on 

these commodities after treatment at the maximum application rate, maximum seasonal rate, 

shortest retreatment interval and shortest pre-harvest interval. Moreover, tolerances are proposed 

for grape juice since processing studies show that residues concentrate in this commodity. 

Currently, theoretical processing factors are not available for grape leaves; therefore, a 1x 

processing factor was used. For cranberry juice, a DEEM default processing factor of 1.1x was 

used. To account for residues of the metabolite S-2188-DC in each commodity, the maximum 

residue of this metabolite (expressed as parent fenpyrazamine) observed in the crop field trial 

was added to the tolerance. For grape juice and raisins, the concentration factor of S-2188-DC 

was used to convert the maximum residue observed in grapes to the residue level that may be 

expected in grape juice and raisins upon concentration during processing.

This conservative analysis proved adequate for the acute and chronic dietary assessments, as the 

population subgroup with the highest risk associated was children 1-2 years old with 9.2% of the 

aPAD and 5.8% of the cPAD.

The acute and chronic dietary exposure analyses are based on tolerance level residues (plus the 

maximum residue of S-2188-DC expressed as parent), 100% crop treated assumptions, and 

default processing factors. In addition, a Tier 1 analysis was used to establish the EDWCs used 

in the assessment. Various refinements could be made to the assessments. However, as there are 

no risk estimates of concern, no refinements were incorporated.

IX. Conclusions

This acute and chronic dietary risk assessment made with DEEM-FCIDTM indicates that food 

exposures to residues of fenpyrazamine (parent and S-2188-DC) are well below HED’s level of 

concern. It is an unrefined evaluation utilizing the entire consumption distribution and tolerance 

level residue value for parent fenpyrazamine and the maximum residue of the metabolite S-2188-

DC observed in the crop field trials for all included foods. Default processing factors and 100% 

CT assumptions were used in the analysis. In addition, the FIRST model was used to establish 

the EDWCs used in the assessment. As such, the resulting acute and chronic dietary exposures 

to residues of fenpyrazamine were estimated to be well below HED’s level of concern for the 

general population. For the most highly exposed population subgroup, children 1-2 years of age, 

the acute and chronic dietary risk were estimated to be below HED’s level of concern, 9.2% of 

the aPAD and 7.2% of the cPAD. Fenpyrazamine was classified by the ToxSAC as "Not Likely 

to be Carcinogenic to Humans”. Based on this a cancer risk assessment is not germane to this 

assessment. Overall, HED is confident that the assessment does not underestimate risk to the 

general U.S. population or any population subgroup.
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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X. List of Attachments

• Data and Residue Estimates Used in the Dietary Exposure Analyses

• Acute Residue Input file

• Acute Results file

• Chronic Residue Input file

• Chronic Results File
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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Attachment 1. Data and Residue Estimates Used in the Dietary Exposure Analyses.

Table A.1 Residue Levels of Fenpyrazamine plus S-2188-DC included in the dietary assessment.

Commodity HEDRecommended 

Tolerance (ppm)

Maximum residue of S2188-DC, expressed as 

parent (ppm)

Total residue (fenpyrazamine + S2188-DC) to be included in the 

DEEM input file (ppm)

Almond and Pistachio 0.02 0.02 0.04

Caneberry subgroup 13-07A 5 0.51 5.51

Bushberry subgroup 13-07B 5 0.48 5.48

Small fruit vine climbing 

subgroup, except fuzzy kiwi 

fruit, crop subgroup 13-07F

3 0.55 3.55

Grape, Juice 4 0.88 (1) 4.88

Raisins 3 (2) 0.88 (2) 3.88

Low growing berry subgroup 

13-07G

3 0.36 3.36

Lettuce, head 1.5 0.92 2.42

Lettuce, leaf 2 1.08 3.08

Ginseng 0.7 0.02 0.72

1 The maximum residue in grape juice was obtained by multiplying the maximum residue in grapes by the 

concentration factor (1.6x) of S-2188-DC in grape juice.

2

Since residues of the metabolite S-2188-DC concentrate significantly (1.6x) in raisins a separate residue level was 

estimated to account for total residues of fenpyrazamine in raisins. 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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Attachment 2: Acute Input File

Filename: F:\Dietary Assessments\Fenpyrazamine\Fenpyrazamine_Dietary_AcuteEDWC.r08

Chemical: Fenpyrazamine

RfD(Chronic): .3 mg/kg bw/day NOEL(Chronic): 30 mg/kg bw/day

RfD(Acute): .8 mg/kg bw/day NOEL(Acute): 80 mg/kg bw/day

Date created/last modified: 10-23-2012/18:15:35 Program ver. 3.16, 03-08-d

Comment: Fenpyrazamine + S-2188-DC; EDWC of 0.2135 ppm based on annual peak (FIRST model)

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0101168000 1AB Ginseng, dried 0.720000 1.000 1.000 

0401204000 4A Lettuce, head 2.420000 1.000 1.000 

0401205000 4A Lettuce, leaf 3.080000 1.000 1.000 

1301055000 13A Blackberry 5.510000 1.000 1.000 

1301056000 13A Blackberry, juice 5.510000 1.000 1.000 

1301056001 13A Blackberry, juice-babyfood 5.510000 1.000 1.000 

1301058000 13A Boysenberry 5.510000 1.000 1.000 

1301208000 13A Loganberry 5.510000 1.000 1.000 

1301320000 13A Raspberry 5.510000 1.000 1.000 

1301320001 13A Raspberry-babyfood 5.510000 1.000 1.000 

1301321000 13A Raspberry, juice 5.510000 1.000 1.000 

1301321001 13A Raspberry, juice-babyfood 5.510000 1.000 1.000 

1302057000 13B Blueberry 5.480000 1.000 1.000 

1302057001 13B Blueberry-babyfood 5.480000 1.000 1.000 

1302136000 13B Currant 5.480000 1.000 1.000 

1302137000 13B Currant, dried 5.480000 1.000 1.000 

1302149000 13B Elderberry 5.480000 1.000 1.000 

1302174000 13B Gooseberry 5.480000 1.000 1.000 

1302191000 13B Huckleberry 5.480000 1.000 1.000 

1304175000 13D Grape 3.550000 1.000 1.000 

1304176000 13D Grape, juice 3.550000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 3.550000 1.000 1.000 

1304179000 13D Grape, wine and sherry 3.550000 1.000 1.000 

1307130000 13G Cranberry 3.360000 1.000 1.000 

1307130001 13G Cranberry-babyfood 3.360000 1.000 1.000 

1307131000 13G Cranberry, dried 3.360000 1.000 1.000 

1307132000 13G Cranberry, juice 3.360000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 3.360000 1.100 1.000 

1307359000 13G Strawberry 3.360000 1.000 1.000 

1307359001 13G Strawberry-babyfood 3.360000 1.000 1.000 

1307360000 13G Strawberry, juice 3.360000 1.000 1.000 

1307360001 13G Strawberry, juice-babyfood 3.360000 1.000 1.000 

1400003000 14 Almond 0.040000 1.000 1.000 

1400003001 14 Almond-babyfood 0.040000 1.000 1.000 

1400004000 14 Almond, oil 0.040000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.040000 1.000 1.000 

1400282000 14 Pistachio 0.040000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.213500 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.213500 1.000 1.000 

9500177000 O Grape, leaves 3.550000 1.000 1.000 

9500178000 O Grape, raisin 3.880000 1.000 1.000 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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Attachment 3: Acute Results File (Food and Drinking Water)

US EPA Ver. 3.16, 03-08-d

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

Residue file: Fenpyrazamine_Dietary_AcuteEDWC.r08 Adjustment factor #2 NOT used.

Analysis Date: 10-23-2012/18:22:11 Residue file dated: 10-23-2012/18:15:35

NOEL (Acute) = 80.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Fenpyrazamine + S-2188-DC; EDWC of 0.2135 ppm based on annual peak (FIRST 

model)"

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Total US Population:

 0.023720 2.97 3372 0.047567 5.95 1681 0.106410 13.30 751 

All Infants:

 0.053592 6.70 1492 0.109606 13.70 729 0.169491 21.19 472 

Female 13-50:

 0.020865 2.61 3834 0.035559 4.44 2249 0.067082 8.39 1192 

Children 1-2:

 0.073511 9.19 1088 0.134402 16.80 595 0.224005 28.00 357 

Children 3-5:

 0.050147 6.27 1595 0.093430 11.68 856 0.157460 19.68 508 

Children 6-12:

 0.027948 3.49 2862 0.050125 6.27 1595 0.086276 10.78 927 

Youth 13-19:

 0.016521 2.07 4842 0.026659 3.33 3000 0.066755 8.34 1198 

Adults 20-49:

 0.020282 2.54 3944 0.033841 4.23 2364 0.066494 8.31 1203 

Adults 50-99:

 0.019653 2.46 4070 0.030421 3.80 2629 0.054691 6.84 1462 

Female 13-49:

 0.020894 2.61 3828 0.035409 4.43 2259 0.067434 8.43 1186 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

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Attachment 4: Chronic Input File

Filename: F:\Dietary Assessments\Fenpyrazamine\Fenpyrazamine_Dietary_ChronicEDWC.r08

Chemical: Fenpyrazamine

RfD(Chronic): .3 mg/kg bw/day NOEL(Chronic): 30 mg/kg bw/day

RfD(Acute): .8 mg/kg bw/day NOEL(Acute): 80 mg/kg bw/day

Date created/last modified: 10-23-2012/18:16:34 Program ver. 3.16, 03-08-d

Comment: Fenpyrazamine + S-2188-DC; EDWC of 0.0725 ppm based on annual peak (FIRST model)

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 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0101168000 1AB Ginseng, dried 0.720000 1.000 1.000 

0401204000 4A Lettuce, head 2.420000 1.000 1.000 

0401205000 4A Lettuce, leaf 3.080000 1.000 1.000 

1301055000 13A Blackberry 5.510000 1.000 1.000 

1301056000 13A Blackberry, juice 5.510000 1.000 1.000 

1301056001 13A Blackberry, juice-babyfood 5.510000 1.000 1.000 

1301058000 13A Boysenberry 5.510000 1.000 1.000 

1301208000 13A Loganberry 5.510000 1.000 1.000 

1301320000 13A Raspberry 5.510000 1.000 1.000 

1301320001 13A Raspberry-babyfood 5.510000 1.000 1.000 

1301321000 13A Raspberry, juice 5.510000 1.000 1.000 

1301321001 13A Raspberry, juice-babyfood 5.510000 1.000 1.000 

1302057000 13B Blueberry 5.480000 1.000 1.000 

1302057001 13B Blueberry-babyfood 5.480000 1.000 1.000 

1302136000 13B Currant 5.480000 1.000 1.000 

1302137000 13B Currant, dried 5.480000 1.000 1.000 

1302149000 13B Elderberry 5.480000 1.000 1.000 

1302174000 13B Gooseberry 5.480000 1.000 1.000 

1302191000 13B Huckleberry 5.480000 1.000 1.000 

1304175000 13D Grape 3.550000 1.000 1.000 

1304176000 13D Grape, juice 3.550000 1.000 1.000 

1304176001 13D Grape, juice-babyfood 3.550000 1.000 1.000 

1304179000 13D Grape, wine and sherry 3.550000 1.000 1.000 

1307130000 13G Cranberry 3.360000 1.000 1.000 

1307130001 13G Cranberry-babyfood 3.360000 1.000 1.000 

1307131000 13G Cranberry, dried 3.360000 1.000 1.000 

1307132000 13G Cranberry, juice 3.360000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 3.360000 1.100 1.000 

1307359000 13G Strawberry 3.360000 1.000 1.000 

1307359001 13G Strawberry-babyfood 3.360000 1.000 1.000 

1307360000 13G Strawberry, juice 3.360000 1.000 1.000 

1307360001 13G Strawberry, juice-babyfood 3.360000 1.000 1.000 

1400003000 14 Almond 0.040000 1.000 1.000 

1400003001 14 Almond-babyfood 0.040000 1.000 1.000 

1400004000 14 Almond, oil 0.040000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.040000 1.000 1.000 

1400282000 14 Pistachio 0.040000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.072500 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.072500 1.000 1.000 

9500177000 O Grape, leaves 3.550000 1.000 1.000 

9500178000 O Grape, raisin 3.880000 1.000 1.000 
Fenpyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 14 of 14

Attachment 5: Chronic Results File (Food and Drinking Water)

US EPA Ver. 3.16, 03-08-d

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

Residue file name: F:\Dietary Assessments\Fenpyrazamine\Fenpyrazamine_Dietary_AcuteEDWC.r08

 Adjustment factor #2 NOT used.

Analysis Date 10-23-2012/18:19:11 Residue file dated: 10-23-2012/18:15:35

Reference dose (RfD, Chronic) = .3 mg/kg bw/day

COMMENT 1: Fenpyrazamine + S-2188-DC; EDWC of 0.2135 ppm based on annual peak (FIRST model)

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 Total exposure by population subgroup

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 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.008022 2.7%

Hispanic 0.007104 2.4%

Non-Hisp-White 0.008361 2.8%

Non-Hisp-Black 0.006899 2.3%

Non-Hisp-Other 0.008550 2.9%

Nursing Infants 0.006032 2.0%

Non-Nursing Infants 0.021355 7.1%

Female 13+ PREG 0.006688 2.2%

Children 1-6 0.017273 5.8%

Children 7-12 0.007707 2.6%

Male 13-19 0.004961 1.7%

Female 13-19/NP 0.005739 1.9%

Male 20+ 0.006567 2.2%

Female 20+/NP 0.007796 2.6%

Seniors 55+ 0.007438 2.5%

All Infants 0.016624 5.5%

Female 13-50 0.007273 2.4%

Children 1-2 0.021792 7.3%

Children 3-5 0.015293 5.1%

Children 6-12 0.008542 2.8%

Youth 13-19 0.005348 1.8%

Adults 20-49 0.007058 2.4%

Adults 50-99 0.007401 2.5%

Female 13-49 0.007268 2.4%

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