lsopvrazam (PC Code 129222) Dietary Exposure and Risk Assessment DP# 409592 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: July 17, 2013 

OFFICE OF CHEMICAL 

SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Isopyrazam. Acute, Chronic and Cancer Dietary (Food Only) Exposure and Risk 

Assessments for the Proposed Tolerances with No U.S. Registration inion 

Imported Apple and Peanut. 

PC Code: 129222 DP Barcode: D409592 

Decision Number: 465123 Registration Number: Not Applicable 

Petition Number: 2E8039 Regulatory Action: Tolerance Petition 

Assessment Type: Dietary (Food Only) Case Number: Not Applicable 

TXR Number: Not Applicable CAS Number: 881685-58-1 

MRID Number: Not Applicable 40CFR §180. 654 

FROM: Bonnie Cropp-Kohlligian, Environmental Scientist --::::6...,.,.:. ~-~ it 

Risk Assessment Branch (RAB)IV, Health Effects Division (HE~_ 

THROUGH: Thurston 

RAB IV, HED 

Morton, 

(7509P) 

Chemist, Senior Scient st ~~ 

Tom Bl:~, Che~ ~·~- 11 ( 1 f'l--11 . 

William Cutchin, Chemistv '~=~ ~ Dietary Exposure Science Advisory Council (DESAC), HED (7509P) 

TO: Shaunta Hill/Driss Benmhend (RM20) 

Fungicide Branch, RD (7505P) 

Executive Summary 

lsopyrazam is not currently registered or proposed for use in the U.S. and there is no anticipated 

exposure to isopyrazam residues of concern from drinking water. Hence, acute, chronic, and 

cancer dietary assessments were conducted for isopyrazam residues of concern in food only. 

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

2012.1. 

Acute, chronic, and cancer dietary (food only) exposure and risk assessments were conducted 

with the Dietary Exposure Evaluation Model DEEM-FCID, Version 3.16 which uses food 

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Isopyrazam (PC Code 129222) Dietary Exposure and Risk Assessment DP# 409592

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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. These analyses were performed to support the proposed 

tolerances with no U.S. registrations for isopyrazam in/on apple and peanut for the uses of 

isopyrazam in Chile and Nicaragua, respectively. All established, pending and proposed uses of 

isopyrazam, as of the date of this memorandum, are included in these assessments.

Conservative acute, chronic and cancer (food only) exposure analyses were performed for the 

general U.S. population and various population subgroups using the same residue inputs. 

Maximum residues from field trials conducted at the maximum use rates were used to estimate 

residues of isopyrazam (sum of syn-(SYN534969) and anti-(SYN534968) isomers) and the syn-

(CSCD459488; free and conjugated) and anti-(CSCD459489; free and conjugated) isomers of 

the tertiary alcohol metabolite (CSCD460260). The analyses assumed 100% crop treated and 

used DEEM default processing factors. In the absence of peanut processing data, the maximum 

theoretical processing factor for peanut oil was used.

Acute and non-cancer chronic dietary risk estimates are not of concern for the general U.S. 

population or other population subgroups. At the 95th percentile, the acute exposure results in 

an estimated dietary (food) risk equivalent to ≤4.2% of the acute population adjusted dose 

(aPAD) for all populations. The estimated non-cancer chronic dietary (food) risk is equivalent to 

≤6.1% of the chronic population adjusted dose (cPAD) for all populations. The most highly 

exposed subpopulation is children 1-2 years old for both acute and non-cancer chronic estimated 

dietary risks. 

The Cancer Assessment Review Committee (CARC) classified isopyrazam as “Likely to be 

Carcinogenic to Humans” In the absence of mode of action data, the CARC recommended linear 

low dose extrapolation for cancer risk assessment. A cancer slope factor of 0.00629 

(mg/kg/day)-1 was used for the quantification of human cancer risk. The resulting estimated 

cancer dietary (food) risk is 2 x 10-6for the general U.S. population.

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and non-cancer 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. References that discuss the acute and non-cancer 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-AUG1999).
Isopyrazam (PC Code 129222) Dietary Exposure and Risk Assessment DP# 409592

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The most recent dietary risk assessment for isopyrazam was conducted by B. Daiss (8/19/11; 

DP#392682).

II. Residue Information

Isopyrazam (SYN520453) is a broad spectrum fungicide belonging to the chemical class of 

ortho-substituted phenyl amides. It is comprised of a mixture of two diasterioisomers designated 

syn-(SYN534969; enantiomer) and anti-(SYN534968; enantiomer) isomers; both of which are 

biologically active. Isopyrazam is not currently registered in the U.S.; however, a tolerance with 

no U.S. registration is currently established for residues of isopyrazam in/on banana at 0.05 ppm. 

Residues of Concern 

The metabolism of isopyrazam (SYN520453) has been studied in wheat, grape and lettuce. 

Previously, the HED Residues of Concern Knowledgebase Subcommittee (ROCKS) considered 

the residues of concern in bananas (D383286, E. Scollon, 11/22/10) and determined that the 

residue of concern for dietary risk assessment is the parent compound isopyrazam (sum of the synisomer (SYN534969) and anti-isomer (SYN534968)) plus its monohydroxy metabolite,

CSCD459488 (free and conjugated), the syn-isomer of the tertiary alcohol metabolite 

(CSCD460260). While both the syn-(CSCD459488) and anti-(CSCD459489) isomers of the 

tertiary alcohol metabolite (CSCD460260) are judged to have similar toxicity when compared to 

the parent, the committee decided to include only the syn-isomer of the tertiary alcohol metabolite 

(CSCD459488; free and conjugated) in the risk assessment for banana based the banana field trial 

data which found detectable residues of CSCD459488 (free and conjugated) in/on whole banana 

but not CSCD459489 (free and conjugated). However, the Committee also recommended that 

residues of CSCD459489 (free and conjugated) should be analyzed for in future residue chemistry 

studies. 

The HED isopyrazam risk assessment team has decided that it is appropriate to expand the HED 

ROCKS decision for banana to apple and peanut. The team has also decided to explicitly include 

CSCD459489 (free and conjugated) as a residue of concern for risk assessment so that there is no 

ambiguity as to what residues should be analyzed for in future residue chemistry studies. 

The metabolism of isopyrazam (SYN520453) has been studied in goat and hen. Based on 

available goat/hen metabolism and cow feeding study data, the HED isopyrazam risk assessment 

team has decided that the residue of concern in livestock commodities is isopyrazam (sum of 

syn-(SYN534969) and anti-(SYN534968) isomers) for tolerance enforcement and isopyrazam 

(sum of syn-(SYN534969) and anti-(SYN534968) isomers) plus its metabolites containing the 

CSAA798670 moiety [3-(difluromethyl)-1-methyl-pyrazole-4- methanoic acid], expressed as 

isopyrazam, for risk assessment. Assuming that isopyrazam treated peanut hay is not fed to 

cattle in Nicaragua, HED finds that for existing and proposed uses of isopyrazam, tolerances in 

livestock commodities are not needed. 
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Table 1. Compounds to be Included in the Risk Assessment and Tolerance Expression.

Matrix Residues Included in Dietary Risk Assessment Residues Included in Tolerance Expression

Plants Apple, Banana, 

Peanut

Isopyrazam + CSCD459488 (free and 

conjugated) + CSCD459489 (free and 

conjugated)

Isopyrazam 

Rotational Crop Not applicable since there are no U.S. registrations

Livestock Ruminant Isopyrazam + its metabolites convertible to 

the CSAA798670 moiety, expressed as 

isopyrazam

Poultry Isopyrazam

Drinking Water Not applicable since there are no U.S. registrations

Isopyrazam (SYN520453; sum of syn- (SYN534969) and anti- (SYN534968) isomers) = 3-(difluoromethyl)-1-methyl-N-

[1,2,3,4-tetrahydro-9-(1- methylethyl)-1,4-methanonaphthalen-5-yl]-1H-pyrazole-4-carboxamide. (CAS)

CSCD459488 (syn- isomer of the tertiary alcohol metabolite) = 3-(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9RS)-1,2,3,4-

tetrahydro-9-(2-hydroxypropan-2-yl)-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(mix of two enantiomers). (IUPAC)

CSCD459489 (anti- isomer of the tertiary alcohol metabolite) = 3-(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-

tetrahydro-9-(2-hydroxypropan-2-yl)-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(mix of two enantiomers). (IUPAC)

CSAA798670 = 3-(difluromethyl)-1-methyl-pyrazole-4- methanoic acid

Recommended Tolerances

Isopyrazam is not currently registered for use in the U.S. A tolerance with no U.S. registration is 

currently established for residues of isopyrazam in/on banana at 0.05 ppm. Based on the available

residue chemistry database for isopyrazam, HED is recommending tolerances with no U.S. 

registrations for residues of isopyrazam in/on apple and peanut at 0.70 ppm and 0.01 ppm, 

respectively. Furthermore, HED has determined that there is no reasonable expectation of finite 

isopyrazam residues of concern in livestock commodities from established (imported banana 

commodities) and proposed (imported apple and peanut commodities) uses of isopyrazam which 

are all non-domestic.

Residues Used in Acute, Chronic and Cancer Analyses

For the acute, chronic and cancer dietary analyses, maximum residues from field trials conducted 

at the maximum use rates were used to estimate residues of isopyrazam (sum of syn-

(SYN534969) and anti-(SYN534968) isomers) and the syn-(CSCD459488; free and conjugated) 

and anti-(CSCD459489; free and conjugated) isomers of the tertiary alcohol metabolite 

(CSCD460260). The analyses assumed 100% crop treated. DEEM default processing factors 

were used for all processed commodities including dried apple (8.0), apple juice/cider (1.3), 

dried banana/plantain (3.9), and peanut butter (1.89). In the absence of peanut processing data, 

the maximum theoretical concentration factor was used for peanut oil (2.8).
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Table 2. Residue Estimates (ppm) Used in the Isopyrazam Acute, Chronic, and Cancer Dietary Analyses

Based on Maximum Residues from Field Trials1

Commodity Isopyrazam Tertiary Alcohol Metabolite Total 

Residues of 

Concern

syn-isomer

(SYN534969)

anti-isomer

(SYN534968)

syn-isomer

(CSCD459488),

free and conjugated2

anti-isomer

(CSCD459489),

free and conjugated2

Apple30.180 0.081 0.0025 0.0025 0.266

Banana 

(includes 

plantain)4

0.0025 0.0025 0.0025 0.0025 0.010

Peanut 0.0025 0.0025 0.0025 0.0025 0.010

1

 Residues estimates are the single sample maximums from field trials; not the highest average field trial values. 

Residues reported in studies at <LOQ (0.005 ppm) are estimated at 1⁄2 LOQ.

2

 Given the similar molecular weights, it is not necessary to adjust the reported residues of the metabolites 

(CSCD459488 and CSCD459489; mol. wt. 375) to parent (sum of syn-(SYN534969) and anti-(SYN534968) 

isomers; mol. wt. 359) equivalents.

3

 Apple residue estimates are based on field trial data reflecting a 21-day PHI.

4

 Banana pulp samples (bagged or unbagged).

III. Percent Crop Treated Information

The acute, chronic and cancer analyses assumed 100% crop treated.

IV. Drinking Water Data

Since there are no currently registered or proposed domestic uses of isopyrazam, there is no 

anticipated exposure to residues of concern from drinking water. 

V. DEEM-FCIDTM Program and Consumption Information

Isopyrazam 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 50-99 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. 
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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.

VI. Toxicological Information

HED evaluated the toxicology data base for isopyrazam and selected doses and endpoints for acute, 

chronic and cancer dietary risk assessments which are provided in Table 3.

Table 3. Summary of Toxicological Doses and Endpoints for Isopyrazam for Use in Dietary Human Health 

Risk Assessments

Exposure/

Scenario

Point of 

Departure

(mg/kg/day)

Uncertainty/FQPA 

Safety Factors

RfD, PAD, LOC for 

Risk Assessment

(mg/kg/day)

Study and Toxicological 

Effects

Acute Dietary 

(All Populations) NOAEL= 30

UFA= 10x

UFH=10x

FQPA SF= 1x

Acute RfD = 0.30

aPAD = 0.30

Subchronic Toxicity – Dog

LOAEL = 100 mg/kg/day 

based on clinical signs of 

toxicity (side-to-side head 

wobble) in 1 of 4 male dogs.
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Table 3. Summary of Toxicological Doses and Endpoints for Isopyrazam for Use in Dietary Human Health 

Risk Assessments

Exposure/

Scenario

Point of 

Departure

(mg/kg/day)

Uncertainty/FQPA 

Safety Factors

RfD, PAD, LOC for 

Risk Assessment

(mg/kg/day)

Study and Toxicological 

Effects

Chronic Dietary 

(All Populations) NOAEL= 5.5

UFA= 10x

UFH=10x

FQPA SF= 1x

Chronic RfD = 0.055

cPAD = 0.055

Chronic 

Toxicity/Carcinogenicity in 

Rats

LOAEL = 27.6 mg/kg/day 

based on based on 

decreased body weight and 

body weight gain in 

females; increased 

incidences of hepatocellular 

hypertrophy, pigment in 

centrilobular hepatocytes, 

eosinophilic foci of altered 

hepatocytes, vacuolation of 

centrilobular hepatocytes, 

bile duct hyperplasia, and 

bile duct fibrosis in both 

sexes; and brown pigment in 

the kidney in females. 

Cancer (all routes)

Classification: CARC classified isopyrazam as “Likely to be Carcinogenic to Humans” 

based on increased liver and uterine endometrial epithelial tumors in female rats and increased 

thyroid follicular cell tumors in male rats. A cancer slope factor 0.00629 (mg/kg/day)-1 was 

calculated based on an increase in liver adenomas and/or carcinomas in female rats.

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 non-cancer chronic assessments, HED is concerned when dietary 

risk exceeds 100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of 

the U.S. population and various population subgroups. The results reported in Table 4 are for the 

general U.S. Population, all infants (<1 year old), children 1-2 years old, children 3-5 years old, 

children 6-12 years old, youth 13-19 years old, females 13-49 years old, adults 20-49 years old,

and adults 50-99 years old.

Results of the Acute, Chronic and Cancer Dietary Exposure Analyses

The results of the acute, chronic and cancer (food only) dietary exposure analyses are reported in 

Table 4. Acute and non-cancer chronic dietary risk estimates are not of concern for the general 

U.S. population or other population subgroups. At the 95th percentile, the acute exposure results 
Isopyrazam (PC Code 129222) Dietary Exposure and Risk Assessment DP# 409592

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in an estimated dietary (food) risk equivalent to ≤4.2% of the acute population adjusted dose 

(aPAD) for all populations. The estimated non-cancer chronic dietary (food) risk is equivalent to 

≤6.1% of the chronic population adjusted dose (cPAD) for all populations. The most highly 

exposed subpopulation is children 1-2 years old for both acute and non-cancer chronic estimated 

dietary risks. The resulting estimated cancer dietary (food) risk is 2 x 10-6for the general U.S. 

population. 

Table 4. Summary of Dietary (Food Only) Exposure and Risk for Isopyrazam

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 0.001943 < 1 0.000379 < 1 0.000379 2 x10-6

All Infants (< 1 year old) 0.008291 2.8 0.001873 3.4

NA NA

Children 1-2 years old 0.012554 4.2 0.003379 6.1

Children 3-5 years old 0.007506 2.5 0.001802 3.3

Children 6-12 years old 0.003241 1.1 0.000652 1.2

Youth 13-19 years old 0.001262 < 1 0.000222 < 1

Adults 20-49 years old 0.000776 < 1 0.000139 < 1

Adults 50-99 years old 0.000712 < 1 0.000130 < 1

Females 13-49 years old 0.000905 < 1 0.000156 < 1

VIII. Characterization of Inputs/Outputs

For the acute, chronic and cancer dietary analyses, maximum residues from field trials conducted 

at the maximum use rates were used to estimate residues of isopyrazam (sum of syn-

(SYN534969) and anti-(SYN534968) isomers) and the syn-(CSCD459488; free and conjugated) 

and anti-(CSCD459489; free and conjugated) isomers of the tertiary alcohol metabolite 

(CSCD460260). The analyses assumed 100% crop treated and used DEEM default processing 

factors. In the absence of peanut processing data, the maximum theoretical processing factor for 

peanut oil was used. The Agency considers these to be highly conservative assessments. 

Additional refinements including the use of crop treated information and monitoring data could 

be incorporated into the assessment; however, since risks are not of concern, further refinement 

is not needed.

IX. Conclusions

Acute, chronic and cancer dietary (food) exposure analyses were performed to support the 

proposed tolerances with no U.S. registrations for isopyrazam in/on apple and peanut for the uses

of isopyrazam in Chile and Nicaragua, respectively. Acute and non-cancer chronic risk 

estimates are not of concern. The estimated cancer dietary (food) risk is 2 x 10-6for the general 

U.S. population. HED is confident that the assessments do not underestimate risk. 
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X. List of Attachments

1. Acute/Chronic/Cancer DEEM-FCID Residue Input File.

2. Results of Acute DEEM-FCID Dietary Exposure Analysis.

3. Results of Chronic DEEM-FCID Dietary Exposure Analysis.

4. Results of Cancer DEEM-FCID Dietary Exposure Analysis 
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Attachment 1 Acute and Chronic DEEM-FCID Residue Input File

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID Acute analysis for ISOPYRAZAM

Residue file name: C:\129222ISOPYRAZAM4-22-13.R08

Analysis Date 04-22-2013 Residue file dated: 04-22-2013/10:44:29

Reference dose (aRfD) = 0.3 mg/kg bw/day

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Food Name (ppm) #1 #2 

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

1100007000 11 Apple, fruit with peel 0.266000 1.000 1.000

1100008000 11 Apple, peeled fruit 0.266000 1.000 1.000

1100008001 11 Apple, peeled fruit-babyfood 0.266000 1.000 1.000

1100009000 11 Apple, dried 0.266000 8.000* 1.000

1100009001 11 Apple, dried-babyfood 0.266000 8.000* 1.000

1100010000 11 Apple, juice 0.266000 1.300* 1.000

1100010001 11 Apple, juice-babyfood 0.266000 1.300* 1.000

1100011000 11 Apple, sauce 0.266000 1.000 1.000

1100011001 11 Apple, sauce-babyfood 0.266000 1.000 1.000

9500023000 O Banana 0.010000 1.000 1.000

9500023001 O Banana-babyfood 0.010000 1.000 1.000

9500024000 O Banana, dried 0.010000 3.900* 1.000

9500024001 O Banana, dried-babyfood 0.010000 3.900* 1.000

9500263000 O Peanut 0.010000 1.000 1.000

9500264000 O Peanut, butter 0.010000 1.890* 1.000

9500265000 O Peanut, oil 0.010000 2.800** 1.000

9500283000 O Plantain 0.010000 1.000 1.000

9500284000 O Plantain, dried 0.010000 3.900* 1.000

* Used Deem default processing factor

** In the absence of peanut processing data, used the maximum theoretical concentration 

factor for peanut, oil.
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Attachment 2. Results of Acute DEEM-FCID Dietary Exposure Analysis

U.S. EPA Ver. 3.16, 03-08-d

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

Residue file: 129222ISOPYRAZAM4-22-13.R08 Adjustment factor #2 used.

Analysis Date: 04-22-2013/10:46:46 Residue file dated: 04-22-2013/10:44:29

RAC/FF intake summed over 24 hours

Reference dose (RfD, Acute) = 0.30 mg/kg/day

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

Total US Population:

 0.001943 0.65 0.006625 2.21 0.018439 6.15 

All Infants:

 0.008291 2.76 0.017178 5.73 0.024450 8.15 

Children 1-2:

 0.012554 4.18 0.023888 7.96 0.040909 13.64 

Children 3-5:

 0.007506 2.50 0.013218 4.41 0.022956 7.65 

Children 6-12:

 0.003241 1.08 0.006942 2.31 0.014494 4.83 

Youth 13-19:

 0.001262 0.42 0.003051 1.02 0.005745 1.92 

Adults 20-49:

 0.000776 0.26 0.002002 0.67 0.004814 1.60 

Adults 50-99:

 0.000712 0.24 0.001635 0.55 0.003453 1.15 

Female 13-49:

 0.000905 0.30 0.002350 0.78 0.004893 1.63 
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Attachment 3. Results of Chronic DEEM-FCID Dietary Exposure Analysis

U.S. EPA Ver. 3.16, 03-08-d

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

Residue file name: C:129222ISOPYRAZAM4-22-13.R08

 Adjustment factor #2 used.

Analysis Date 04-22-2013/10:48:28 Residue file dated: 04-22-2013/10:44:29

Reference dose (RfD, Chronic) = .055 mg/kg bw/day

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000379 0.7%

Hispanic 0.000566 1.0%

Non-Hisp-White 0.000324 0.6%

Non-Hisp-Black 0.000448 0.8%

Non-Hisp-Other 0.000455 0.8%

Nursing Infants 0.001153 2.1%

Non-Nursing Infants 0.002195 4.0%

Female 13+ PREG 0.000302 0.5%

Children 1-6 0.002254 4.1%

Children 7-12 0.000562 1.0%

Male 13-19 0.000204 0.4%

Female 13-19/NP 0.000237 0.4%

Male 20+ 0.000132 0.2%

Female 20+/NP 0.000133 0.2%

Seniors 55+ 0.000132 0.2%

All Infants 0.001873 3.4%

Female 13-50 0.000156 0.3%

Children 1-2 0.003379 6.1%

Children 3-5 0.001802 3.3%

Children 6-12 0.000652 1.2%

Youth 13-19 0.000222 0.4%

Adults 20-49 0.000139 0.3%

Adults 50-99 0.000130 0.2%

Female 13-49 0.000156 0.3%

---------------------------------------------------------------------------------
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Attachment 4. Results of Cancer DEEM-FCID Dietary Exposure Analysis

U.S. EPA Ver. 3.16, 03-08-d

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

Residue file name: C:129222ISOPYRAZAM4-22-13.R08

 Adjustment factor #2 used.

Analysis Date 04-22-2013/10:49:05 Residue file dated: 04-22-2013/10:44:29

Q* = 0.00629 

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 Total exposure by population subgroup

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 Total Exposure

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 Population mg/kg Lifetime risk

 Subgroup body wt/day (Q*= .00629)

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Total US Population 0.000379 2.38E-06

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