Fen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 2 of 14 

### Executive Summary

Acute and chronic aggregate dietary ( food and drinking water ) exposure and risk assessments were cond ucted 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 W e 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 (a i ) 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 a nd 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 R eservoir Screening Tool (FIRST)

. Acute Dietary Exposure Assessment

The resulting acute dietary exposure estimates using the DEEM

- FCID TM model were less than 100% of the acute population adjusted dose (aPAD) at the 95 th 

### percentile of exposure for the general U.S. population and all population subgroups. Fenpyrazamine acute dietary exposure (food + drinking water) was estimated at 0.023 720 mg/kg/day for the general U.S. population ( 3.0 % of the aPAD) and 0.0735 11 mg/kg/day ( 9.2 % of the a PAD) 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

- FCID TM 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 0.0 08022 mg/kg/day for the general U.S. population ( 2.7 % of the cPAD) and 0.0 21792 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 stud ies; therefore, a cancer risk assessment is not needed.Fen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 3 of 14 

### 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 acce ptable 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 b y 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/EPA

PEST/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 i n 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 (D 406080 , 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 caneb erry 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 grap es, 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 i n DEEM

- FCID TM



### . 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: U ncertainty 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 (D 406080 , I. Negrón, 10/31/2012 ). This has to be considered if refinemen t 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 understand s 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

- DCFen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 4 of 14 

### in the field trial samples, for future dietary assessments , HED does not recommend refinement of the total resid ue level on these commodities. Nevertheless, p ercent 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 (D 406080 , I. Negró n, 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 (D 388319

, G. Rotham

, 09/07/2012 ). The surface water estimates were considerably higher than the ground water estimates and the highest applicable surface water value s of 0.213 5 ppm and 0. 0 72 5 ppm w ere then used in the acute and chronic dietary exposure analysis , respectively

.

I I I. Percent Crop T reated 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” a nd “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 ( μ g/L) Chronic EDWC ( μ g/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 ofFen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 5 of 14 

### fenpyrazamine in surface drinking water sources are not likely to exceed 0.21 35 ppm for the acute peak concentration and 0.072 5 ppm for the chronic and c ancer 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 chr onic 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 co nducted 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 food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumptio n 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 a nalyses performed at all levels of refinement . However, for determin istic assessments , any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.Fen pyrazamine 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 sel ected 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, re spectively, 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 (c RfD )

. Fenp yrazamine 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 Dose s 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 UF A = 10x

UF H = 10x FQPA SF= 1x Acute RfD = 0.8 0

mg/kg/day

aPAD = 0.8 0 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 UF A = 10x

UF H =10x FQPA SF= 1x Chronic RfD = 0. 30

mg/kg/day cPAD = 0.30 mg/kg/day Developmental Toxicity Study

Rabbit 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 wi th 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 t o 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. UF A = extrapolation from animal to human (interspecies). UF H = 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 = lev el of concern.Fen pyrazamine 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 95 th 

### 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%

a PAD ) 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. T he 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 genera l 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.Fen pyrazamine 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 grow ing 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 retreat ment 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; th erefore, a 1x processing factor was used. For cranberry juice, a DEEM default processing factor of 1.1 x was used. To account for residues of the metabolite S

- 2188

- DC in each commodity, the maximum residue of this metabolite (expressed as parent fenpyraza mi ne) observed in the crop field trial was added to the tolerance. For grape juice and raisins, t he concentration factor of S

- 2188

- DC was used to convert the maximum r esidue observed in grapes to the residue level that may be expected in grape juice and r aisins 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 wa s used to establish the EDWCs used in the assessment. Various refinements could be made to the assessments . H owever, 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 dis tribution 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 populati on. 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 "No t 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. populat ion or any population subgroup.Fen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 9 of 14 

### X. List of Attachments

• Data and Residue Estimates Used in the Dietary Exposure Analyses

• Acute R esidue Input file

• Acute Results file

• Chronic Residue Input file

• Chronic Results FileFen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 10 of 14 

### 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 HED

Recommended Tolerance (ppm) Maximum residue of S

2188

- DC, expressed as parent (ppm) Total residue (fenpyrazamine + S

2188

- 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 separat e residue level was estimated to account for total residues of fenpyrazamine in raisins.Fen pyrazamine 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 Le ttuce, 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 Strawberr y 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 1.000Fen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 12 of 14 

### 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 p e ak (FIRST model)"

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aRfD MOE Exposure % aRfD MOE Ex posure % 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 C hildren 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 1186Fen pyrazamine Dietary Exposure and Risk Assessment DP Number: 406081

Page 13 of 14 

### 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

- 218 8

- DC; EDWC of 0.0725 ppm based on annual peak (FIRST model)

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity N ame (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 1.00 0 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 Raspb erry 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 Huc kleberry 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

- b abyfood 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 86020000 00 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 1.000Fen pyrazamine 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 m g/kg bw/day COMMENT 1: Fenpyrazamine + S

- 2188

- DC; EDWC of 0.2135 ppm based on annual peak (FIRST model)

=============================================================================== Total exposure by population subgroup

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

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 0.00705 8 2.4% Adults 50

- 99 0.007401 2.5% Female 13

- 49 0.007268 2.4%

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