Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: 09-FEB-2011 

SUBJECT: Pyrasulfotole. Acute and Chronic Aggregate Dietary (Food and Drinking Water)

Exposure and Risk Assessments for the Section 3 Registration Action for Use on 

Grain Sorghum and Grass Grown for Seed.

PC Code: 000692 DP Barcode: 375390 

Decision No.: 425581 Registration No.: 264-1023

Petition No.: 9F7680 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Exposure Case No.: 7272

TXR No.: None. CAS No.: 365400-11-9

MRID No.: None. 40 CFR: 180.631

FROM: Jennifer R. Tyler, Chemist

Risk Assessment Branch 1 (RAB1)

Health Effects Division (HED; 7509P)

THROUGH: Yvonne Barnes, Chemist

Debra Rate, Ph.D., Biologist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

George F. Kramer, Ph.D., Senior Chemist

RAB1/HED (7509P)

TO: Allison Nowotarski, Biologist

RAB1/HED (7509P)

and

Bethany Benbow/Joanne Miller, RM Team 23

Registration Division (RD; 7505P)
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

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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-Food Commodity Intake Database 

(DEEM-FCID; ver. 2.03) which use food consumption data from the U.S. Department of 

Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 

1998. No cancer dietary exposure assessment was performed because pyrasulfotole is not 

carcinogenic. The analyses were performed to support Section 3 requests for use of 

pyrasulfotole on grain, sorghum and grass grown for seed.

 

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization: An unrefined, 

acute dietary exposure assessment was performed for the general U.S. population and all other 

population subgroups (including infants and children) using tolerance-level residues and 

assuming 100% crop treated (CT) for all registered and proposed uses. Drinking water was 

incorporated directly into the dietary assessment using the acute concentration for surface water 

generated by the FQPA Index Reservoir Screening Tool (FIRST) model. The results of this 

assessment indicate that the acute dietary exposure estimates (95th percentile) are below HED’s 

level of concern [<100% of the acute population-adjusted dose (aPAD)] for the general U.S. 

population (3% of the aPAD) and all other populations subgroups. The most highly exposed 

population subgroup is children 1-2 years old at 9% of the cPAD.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization: An 

unrefined, chronic dietary exposure assessment was performed for the general U.S. population 

and various population subgroups using tolerance-level residues and assuming 100% CT for all 

registered and proposed uses. Drinking water was incorporated directly into the dietary

assessment using the chronic concentration for surface water generated by the FIRST model. 

The results of the assessment concludes that the chronic dietary exposure estimates are below 

HED’s level of concern [<100% of the chronic population-adjusted dose (cPAD)] for the general 

U.S. population (4% of the cPAD) and all population subgroups. The most highly exposed 

population subgroup is children 1-2 years old at 16% of the cPAD.

I. Introduction

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

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to point 

of departure (PoD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, 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 which discuss the acute and chronic risk assessments in more detail 

are available on the EPA/pesticides web site: “Available Information on Assessing Exposure 

from Pesticides, A User’s Guide,” 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/EPAPEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

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The most recent dietary risk assessment for pyrasulfotole was conducted by Jennifer Tyler in 

conjunction with a Section 3 request for the use of pyrasulfotole on small cereal grains (Memo, 

6/7/07; D333435).

II. Residue Information

Registered and Proposed Pyrasulfotole Uses: Tolerances have been established for residues of 

pyrasulfotole and pyrasulfotole-desmethyl in/on small cereal grains, including wheat, barley, oat, 

rye and triticale; as well as several livestock commodities (See Table 1; 40 CFR 180.631). The 

current petition is for the use of pyrasulfotole on sorghum and grass grown for seed. The 

available residue chemistry database supports the establishment of the permanent tolerances for 

residues of pyrasulfotole and its metabolite pyrasulfotole-desmethyl as listed in Table 1.

Table 1. Tolerance Summary for Pyrasulfotole.

Commodity Current 

Tolerance (ppm)

Proposed Tolerance 

(ppm)

HED-Recommended 

Tolerance (ppm)

Comments

(correct commodity definition)

Wheat, grain 0.02 - -

Wheat, straw 0.20 - -

Wheat, forage 0.20 - -

Wheat, hay 0.80 - -

Aspirated grain fractions 0.40 - -

Oat, grain 0.08 - -

Oat, straw 0.20 - -

Oat, forage 0.10 - -

Oat, hay 0.50 - -

Barley, grain 0.02 - -

Barley, straw 0.20 - -

Barley, hay 0.30 - -

Rye, grain 0.02 - -

Rye, straw 0.20 - -

Rye, forage 0.20 - -

Sorghum, grain - 0.8 0.70 Sorghum, grain, grain

Sorghum, forage - 1.2 1.5 Sorghum, grain, forage

Sorghum, stover - 0.35 0.80 Sorghum, grain, stover

Grass, forage - 10 25

Grass, hay - 2.5 3.5

Milk* 0.01 0.01 0.03

Cattle, meat 0.02 0.04 see current tolerance

Cattle, fat* 0.02 0.04 0.03

Cattle, meat byproducts* 0.06 2 0.70 Cattle, meat byproducts, except liver

Cattle, liver* 0.35 8 3.0

Goat, meat 0.02 0.04 see current tolerance

Goat, fat* 0.02 0.04 0.03

Goat, meat byproducts* 0.06 2 0.70 Goat, meat byproducts, except liver

Goat, liver* 0.35 8 3.0

Hog, meat 0.02 0.04 see current tolerance

Hog, fat 0.02 0.04 see current tolerance

Hog, meat byproducts* 0.06 2 0.05 Hog, meat byproducts, except liver

Hog, liver* - 8 0.30

Sheep, meat 0.02 0.04 see current tolerance
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

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Table 1. Tolerance Summary for Pyrasulfotole.

Commodity Current 

Tolerance (ppm)

Proposed Tolerance 

(ppm)

HED-Recommended 

Tolerance (ppm)

Comments

(correct commodity definition)

Sheep, fat* 0.02 0.04 0.03

Sheep, meat byproducts* 0.06 2 0.70 Sheep, meat byproducts, except liver

Sheep, liver* 0.35 8 3.0

Horse, meat 0.02 0.04 see current tolerance

Horse, fat* 0.02 0.04 0.03

Horse, meat byproducts* 0.06 2 0.70 Horse, meat byproducts, except liver

Horse, liver* 0.35 8 3.0

Poultry, meat 0.02 - see current tolerance

Poultry, fat* 0.02 - 0.03

Poultry, meat byproducts* 0.02 - 0.20

Eggs 0.02 - see current tolerance

Nature of the Residue: For plants and livestock, the residues of concern for tolerances and risk 

assessment purposes are pyrasulfotole and pyrasulfotole-desmethyl (Memo, J. Tyler et al., 

6/8/07; D328640). The residues of concern in drinking water for risk assessment purposes are 

parent only.

Percent Crop Treated: For the acute and chronic assessments, it was assumed that 100% of the 

registered and proposed crops have been treated with pyrasulfotole.

Residue and PDP Data: Tolerance-level residues were used for all registered and proposed 

commodities in the acute and chronic assessments.

Processing Factors: There are no processed commodities associated with the proposed uses on 

grain sorghum and grass grown for seed. In the previous dietary exposure assessment, HED 

determined that separate tolerances were not needed for processed commodities of small cereal 

grains, with the exception of oat bran. It was determined that a separate tolerance of 0.20 ppm is 

need for oat bran (based on a 1.6x processing factor for wheat bran, and a HAFT residue of 

0.109 ppm from the oat field trials, the maximum expected residues in oat bran would be 0.17 

ppm, which is above the recommended 0.08 ppm tolerance for oat, grain). However, according 

to current HED guidelines, HED does not currently set tolerances on oat, bran. Therefore, the 

residue level will be incorporated into the dietary exposure assessment. DEEMTM 7.81 default 

processing factors were used for all registered commodities.

III. Drinking Water Data

The Environmental Fate and Effects Division (EFED) provided Estimated Drinking Water 

Concentrations (EDWCs) of pyrasulfotole in surface and ground water using the FIRST and 

Screening Concentration in Ground Water (SCI-GROW) models, respectively (Memo, C. Peck, 

8/4/10; D374622). The assessment was based on the proposed grain sorghum use, which has a 

maximum proposed seasonal application rate of 0.045 lb ai/A. EFED calculated the 1- in 10-

year peak acute and 1- in 10-year estimated annual mean non-cancer chronic EDWCs for 

pyrasulfotole in surface water to be 6.9 ppb and 4.8 ppb, respectively. The ground water EDWC 

for both acute and chronic exposures in estimated as 2.4 ppb. Water residues were incorporated 

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

sources.”
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

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Table 2. Summary of Estimated Surface Water and Groundwater EDWCs for Pyrasulfotole.

Surface Water Concentration (ppb)a Groundwater Concentration (ppb)b

Acute 6.9 2.4

Chronic (non-cancer) 4.8 2.4

Chronic (cancer) - -

a

From the Tier I FIRST model. Input parameters are based on aerial spray applications to grain sorghum at a rate of 0.039 lb ai/A/year.

b

From the SCI-GROW model assuming a maximum seasonal use rate of 0.039 lb ai/A, a Koc of 20 ml/gOC, and half-life of 226 days.

IV. DEEM-FCIDTM Program and Consumption Information

Pyrasulfotole acute and chronic dietary exposure assessments were conducted using the DEEMFCIDTM, Version 2.03 which incorporates consumption data from USDA’s CSFII, 1994-1996 

and 1998. The 1994-96, 98 data are based on the reported consumption of more than 20,000 

individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are 

linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; 

or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files 

developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data 

are averaged for the entire U.S. population and within population subgroups, but for acute 

exposure assessment are retained as individual consumption events. Based on analysis of the 

1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

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

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

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

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

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

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

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

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

exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant 

differences in user vs. per capita exposure and risk are specifically identified and noted in the 

risk assessment.
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

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V. Toxicological Information

A summary of the toxicological doses and endpoints selected for dietary exposure assessment is 

provided in Table 3.

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

Assessments.

Exposure 

Scenario

Point of 

Departure

Uncertainty/F

QPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Relevant Toxicological Effects

Acute Dietary 

(All 

populations)

NOAEL = 3.8

mg/kg/day

UFA = 10X

UFH = 10X

UFFQPA = 1X 

aRfD = aPAD = 

0.038 mg/kg/day

Developmental neurotoxicity (rat; dietary)

Offspring LOAEL = 37 mg/kg/day based on delayed 

preputial separation (males), decreased cerebrum 

length (PND 21 females), and decreased cerebellum 

height (PND 21 males)

Chronic Dietary 

(All 

populations)

NOAEL = 1.0

mg/kg/day

UFA = 10X

UFH = 10X

UFFQPA = 1X

cRfD = cPAD = 

0.01mg/kg/day

Combined chronic toxicity/carcinogenicity (rat; 

dietary) LOAEL = 10/14 mg/kg/day (M/F) based on 

corneal opacity, neovascularization of the cornea, 

inflammation of the cornea, regenerative corneal 

hyperplasia, corneal atrophy, and/or retinal atrophy 

(both sexes), and hepatocellular hypertrophy along 

with increased serum cholesterol (males)

Cancer (oral, 

dermal, 

inhalation)

Classification: “Suggestive Evidence of Carcinogenic Potential” based on increased incidences of corneal 

tumors in male rats (carcinogenicity study) and urinary bladder tumors in male and female mice 

(carcinogenicity study)

1

 UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of 

the human population (intraspecies), UFFQPA = FQPA Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed 

adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD = population adjusted dose.

VI. Results/Discussion and Conclusions

As stated above, for acute and 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, children 3-5, children 6-12, youth 13-19, 

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

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis: An acute dietary

exposure assessment (using tolerance level residues and 100% CT information for all registered 

and proposed uses) was conducted for the general U.S. population and various population 

subgroups (including infants and children). Drinking water was incorporated directly in the 

dietary assessments using the acute concentration for surface water generated by the FIRST 

model. The results of the acute assessment indicate that the acute dietary exposure estimates 

(95th percentile) are below HED’s level of concern (<100% of the aPAD) for the general U.S.

population (3% of the aPAD) and all populations subgroups. The most highly exposed 

population subgroup is children 1-2 years old at 9% of the cPAD.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis: The chronic dietary

exposure assessment (using tolerance level residues and 100% CT information for all registered 

and proposed uses) was conducted for the general U.S. population and various population 

subgroups. Drinking water was incorporated directly into the dietary assessment using the 

chronic concentration for surface water generated by the FIRST model. The results of the 
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

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chronic assessment indicate that the chronic dietary exposure estimates are below HED’s level of 

concern (<100% of the cPAD) for the general U.S. population (4% of the cPAD) and all 

population subgroups. The most highly exposed population subgroup is children 1-2 years old at 

16% of the cPAD.

Table 4. Summary of Dietary Exposure and Risk for Pyrasulfotole.

Population

Subgroup

Acute Dietary1 Chronic Dietary2

Dietary Exposure

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

U.S. Population (total) 0.001315 3 0.000433 4

All Infants (< 1 year old) 0.002549 7 0.000829 8

Children 1-2 years old 0.003428 9 0.001567 16

Children 3-5 years old 0.002288 6 0.001150 12

Children 6-12 years old 0.001480 4 0.000699 7

Youth 13-19 years old 0.000878 2 0.000352 4

Adults 20-49 years old 0.000695 2 0.000298 3

Adults 50+ years old 0.000616 2 0.000300 3

Females 13-49 years old 0.000698 2 0.000295 3

1 Acute dietary endpoint of 0.038 mg/kg/day applies to the general U.S. population and all population subgroups.

2 Chronic dietary endpoint of 0.01 mg/kg/day applies to the general U.S. population and all population subgroups.

VII. Characterization of Inputs/Outputs

These analyses are considered to be conservative dietary exposure assessments. Residues were 

assumed to be equivalent to the tolerance levels. Tolerance-level residues should always exceed 

the residue levels found on food commodities at the time of consumption. When field trials are 

performed, the maximum allowable application rate is used and crops are harvested at the 

minimum preharvest interval (PHI). Samples are stored frozen until analysis to ensure minimal 

degradation of residues. In actual practice, however, growers will not usually use the maximum 

application rates for economic reasons. In addition, most crops are not harvested and 

immediately stored frozen. Also, 100% CT was assumed for all foods. For these reasons, HED 

is confident that this analysis does not underestimate risk to the general U.S. population or any

population subgroup. Further refinement to the analyses could be made through the use of 

monitoring data, %CT data, and additional empirical processing factors. Since risk estimates are 

not of concern to HED, a more highly refined analysis is not needed at this time.

VIII.List of Attachments

Attachment 1. Residue File for Acute DEEM-FCIDTM Analysis – All Populations.

Attachment 2. Acute DEEM-FCIDTM Analysis – All Populations.

Attachment 3: Residue File for Chronic DEEM-FCIDTM Analysis.

Attachment 4: Chronic DEEM-FCIDTM Analysis.

cc: J. Tyler (RAB1)

RDI: DE SAC [Y. Barnes (10/6/10), D. Rate (10/01/10)], G. Kramer (2/09/11)

J. Tyler: S-10943: Potomac Yard: (703) 305-5564: RAB1
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

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Attachment 1. Residue File for Acute DEEM-FCIDTM Analysis – All Populations.

Filename: C:\Documents and Settings\jtyler\My 

Documents\JenWork\$Pyrasulfatole\2010\Sorhum and Grass Grown for Seed\DEEM\000692a.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day NOEL(Acute): 3.8 mg/kg bw/day

Date created/last modified: 10-06-2010/11:14:23/8 Program ver. 2.03

Comment: Proposed use on grain sorghum and grass grown for seed. FQPA Safety 

Factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

15000250 15 Barley, pearled barley 0.020000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.020000 1.000 1.000 

15000260 15 Barley, flour 0.020000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.020000 1.000 1.000 

15000270 15 Barley, bran 0.020000 1.000 1.000 

21000440 M Beef, meat 0.020000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.020000 1.000 1.000 

21000450 M Beef, meat, dried 0.020000 1.920 1.000 

21000460 M Beef, meat byproducts 0.700000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.700000 1.000 1.000 

21000470 M Beef, fat 0.030000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.030000 1.000 1.000 

21000480 M Beef, kidney 0.700000 1.000 1.000 

21000490 M Beef, liver 3.000000 1.000 1.000 

21000491 M Beef, liver-babyfood 3.000000 1.000 1.000 

40000930 P Chicken, meat 0.020000 1.000 1.000 

40000931 P Chicken, meat-babyfood 0.020000 1.000 1.000 

40000940 P Chicken, liver 0.200000 1.000 1.000 

40000950 P Chicken, meat byproducts 0.200000 1.000 1.000 

40000951 P Chicken, meat byproducts-babyfoo 0.200000 1.000 1.000 

40000960 P Chicken, fat 0.030000 1.000 1.000 

40000961 P Chicken, fat-babyfood 0.030000 1.000 1.000 

40000970 P Chicken, skin 0.030000 1.000 1.000 

40000971 P Chicken, skin-babyfood 0.030000 1.000 1.000 

70001450 P Egg, whole 0.020000 1.000 1.000 

70001451 P Egg, whole-babyfood 0.020000 1.000 1.000 

70001460 P Egg, white 0.020000 1.000 1.000 

70001461 P Egg, white (solids)-babyfood 0.020000 1.000 1.000 

70001470 P Egg, yolk 0.020000 1.000 1.000 

70001471 P Egg, yolk-babyfood 0.020000 1.000 1.000 

23001690 M Goat, meat 0.020000 1.000 1.000 

23001700 M Goat, meat byproducts 0.700000 1.000 1.000 

23001710 M Goat, fat 0.030000 1.000 1.000 

23001720 M Goat, kidney 0.700000 1.000 1.000 

23001730 M Goat, liver 3.000000 1.000 1.000 

24001890 M Horse, meat 0.020000 1.000 1.000 

28002210 M Meat, game 0.020000 1.000 1.000 

27002220 D Milk, fat 0.030000 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000 

27012230 D Milk, nonfat solids 0.030000 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.030000 1.000 1.000 

27022240 D Milk, water 0.030000 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.030000 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.030000 1.000 1.000 

15002310 15 Oat, bran 0.200000 1.000 1.000 

15002320 15 Oat, flour 0.080000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.080000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.080000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.080000 1.000 1.000 

25002900 M Pork, meat 0.020000 1.000 1.000 

25002901 M Pork, meat-babyfood 0.020000 1.000 1.000 
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25002910 M Pork, skin 0.020000 1.000 1.000 

25002920 M Pork, meat byproducts 0.050000 1.000 1.000 

25002921 M Pork, meat byproducts-babyfood 0.050000 1.000 1.000 

25002930 M Pork, fat 0.020000 1.000 1.000 

25002931 M Pork, fat-babyfood 0.020000 1.000 1.000 

25002940 M Pork, kidney 0.050000 1.000 1.000 

25002950 M Pork, liver 0.300000 1.000 1.000 

60003010 P Poultry, other, meat 0.020000 1.000 1.000 

60003020 P Poultry, other, liver 0.200000 1.000 1.000 

60003030 P Poultry, other, meat byproducts 0.200000 1.000 1.000 

60003040 P Poultry, other, fat 0.030000 1.000 1.000 

60003050 P Poultry, other, skin 0.030000 1.000 1.000 

29003120 M Rabbit, meat 0.020000 1.000 1.000 

15003280 15 Rye, grain 0.020000 1.000 1.000 

15003290 15 Rye, flour 0.020000 1.000 1.000 

26003390 M Sheep, meat 0.020000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.020000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.700000 1.000 1.000 

26003410 M Sheep, fat 0.030000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.030000 1.000 1.000 

26003420 M Sheep, kidney 0.700000 1.000 1.000 

26003430 M Sheep, liver 3.000000 1.000 1.000 

15003440 15 Sorghum, grain 0.700000 1.000 1.000 

15003810 15 Triticale, flour 0.020000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.020000 1.000 1.000 

50003820 P Turkey, meat 0.020000 1.000 1.000 

50003821 P Turkey, meat-babyfood 0.020000 1.000 1.000 

50003830 P Turkey, liver 0.200000 1.000 1.000 

50003831 P Turkey, liver-babyfood 0.200000 1.000 1.000 

50003840 P Turkey, meat byproducts 0.200000 1.000 1.000 

50003841 P Turkey, meat byproducts-babyfood 0.200000 1.000 1.000 

50003850 P Turkey, fat 0.030000 1.000 1.000 

50003851 P Turkey, fat-babyfood 0.030000 1.000 1.000 

50003860 P Turkey, skin 0.030000 1.000 1.000 

50003861 P Turkey, skin-babyfood 0.030000 1.000 1.000 

86010000 O Water, direct, all sources 0.006900 1.000 1.000 6.9 pp

 Full comment: 6.9 ppb surface water EDWC

86020000 O Water, indirect, all sources 0.006900 1.000 1.000 6.9 pp

 Full comment: 6.9 ppb surface water EDWC

15004010 15 Wheat, grain 0.020000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.020000 1.000 1.000 

15004020 15 Wheat, flour 0.020000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.020000 1.000 1.000 

15004030 15 Wheat, germ 0.020000 1.000 1.000 

15004040 15 Wheat, bran 0.020000 1.000 1.000 
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

___________________________________________________________________________________________

Page 10 of 13

Attachment 2. Acute DEEM-FCIDTM Analysis – All Populations.

U.S. Environmental Protection Agency Ver. 2.02

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

Residue file: 000692a.R98 Adjustment factor #2 used.

Analysis Date: 10-06-2010/13:27:12 Residue file dated: 10-06-2010/11:14:23/8

NOEL (Acute) = 3.800000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Proposed use on grain sorghum and grass grown for seed. FQPA Sa

fety Factor=1x; therefore, aRfD=aPAD and cRfD=cPAD."

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Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

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

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

U.S. Population:

 0.001315 3.46 2888 0.002440 6.42 1557 0.006103 16.06 622 

All infants:

 0.002549 6.71 1490 0.004861 12.79 781 0.006513 17.14 583 

Children 1-2 yrs:

 0.003428 9.02 1108 0.004806 12.65 790 0.009023 23.74 421 

Children 3-5 yrs:

 0.002288 6.02 1661 0.003193 8.40 1189 0.013998 36.84 271 

Children 6-12 yrs:

 0.001480 3.90 2567 0.002006 5.28 1894 0.004598 12.10 826 

Youth 13-19 yrs:

 0.000879 2.31 4324 0.001309 3.44 2903 0.002168 5.70 1753 

Adults 20-49 yrs:

 0.000695 1.83 5470 0.001017 2.68 3737 0.004247 11.18 894 

Adults 50+ yrs:

 0.000616 1.62 6164 0.000899 2.37 4228 0.006900 18.16 550 

Females 13-49 yrs:

 0.000698 1.84 5442 0.001050 2.76 3618 0.005506 14.49 690 
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

___________________________________________________________________________________________

Page 11 of 13

Attachment 3: Residue File for Chronic DEEM-FCIDTM Analysis.

Filename: C:\Documents and Settings\jtyler\My 

Documents\JenWork\$Pyrasulfatole\2010\Sorhum and Grass Grown for Seed\DEEM\000692c.R98

Chemical: Pyrasulfotole

RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 1 mg/kg bw/day

RfD(Acute): .038 mg/kg bw/day NOEL(Acute): 3.8 mg/kg bw/day

Date created/last modified: 10-06-2010/11:14:49/8 Program ver. 2.03

Comment: Proposed use on grain sorghum and grass grown for seed. FQPA safety 

factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

15000250 15 Barley, pearled barley 0.020000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.020000 1.000 1.000 

15000260 15 Barley, flour 0.020000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.020000 1.000 1.000 

15000270 15 Barley, bran 0.020000 1.000 1.000 

21000440 M Beef, meat 0.020000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.020000 1.000 1.000 

21000450 M Beef, meat, dried 0.020000 1.920 1.000 

21000460 M Beef, meat byproducts 0.700000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.700000 1.000 1.000 

21000470 M Beef, fat 0.030000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.030000 1.000 1.000 

21000480 M Beef, kidney 0.700000 1.000 1.000 

21000490 M Beef, liver 3.000000 1.000 1.000 

21000491 M Beef, liver-babyfood 3.000000 1.000 1.000 

40000930 P Chicken, meat 0.020000 1.000 1.000 

40000931 P Chicken, meat-babyfood 0.020000 1.000 1.000 

40000940 P Chicken, liver 0.200000 1.000 1.000 

40000950 P Chicken, meat byproducts 0.200000 1.000 1.000 

40000951 P Chicken, meat byproducts-babyfoo 0.200000 1.000 1.000 

40000960 P Chicken, fat 0.030000 1.000 1.000 

40000961 P Chicken, fat-babyfood 0.030000 1.000 1.000 

40000970 P Chicken, skin 0.030000 1.000 1.000 

40000971 P Chicken, skin-babyfood 0.030000 1.000 1.000 

70001450 P Egg, whole 0.020000 1.000 1.000 

70001451 P Egg, whole-babyfood 0.020000 1.000 1.000 

70001460 P Egg, white 0.020000 1.000 1.000 

70001461 P Egg, white (solids)-babyfood 0.020000 1.000 1.000 

70001470 P Egg, yolk 0.020000 1.000 1.000 

70001471 P Egg, yolk-babyfood 0.020000 1.000 1.000 

23001690 M Goat, meat 0.020000 1.000 1.000 

23001700 M Goat, meat byproducts 0.700000 1.000 1.000 

23001710 M Goat, fat 0.030000 1.000 1.000 

23001720 M Goat, kidney 0.700000 1.000 1.000 

23001730 M Goat, liver 3.000000 1.000 1.000 

24001890 M Horse, meat 0.020000 1.000 1.000 

28002210 M Meat, game 0.020000 1.000 1.000 

27002220 D Milk, fat 0.030000 1.000 1.000 

27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000 

27012230 D Milk, nonfat solids 0.030000 1.000 1.000 

27012231 D Milk, nonfat solids-baby food/in 0.030000 1.000 1.000 

27022240 D Milk, water 0.030000 1.000 1.000 

27022241 D Milk, water-babyfood/infant form 0.030000 1.000 1.000 

27032251 D Milk, sugar (lactose)-baby food/ 0.030000 1.000 1.000 

15002310 15 Oat, bran 0.200000 1.000 1.000 

15002320 15 Oat, flour 0.080000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.080000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.080000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.080000 1.000 1.000 

25002900 M Pork, meat 0.020000 1.000 1.000 

25002901 M Pork, meat-babyfood 0.020000 1.000 1.000 
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

___________________________________________________________________________________________

Page 12 of 13

25002910 M Pork, skin 0.020000 1.000 1.000 

25002920 M Pork, meat byproducts 0.050000 1.000 1.000 

25002921 M Pork, meat byproducts-babyfood 0.050000 1.000 1.000 

25002930 M Pork, fat 0.020000 1.000 1.000 

25002931 M Pork, fat-babyfood 0.020000 1.000 1.000 

25002940 M Pork, kidney 0.050000 1.000 1.000 

25002950 M Pork, liver 0.300000 1.000 1.000 

60003010 P Poultry, other, meat 0.020000 1.000 1.000 

60003020 P Poultry, other, liver 0.200000 1.000 1.000 

60003030 P Poultry, other, meat byproducts 0.200000 1.000 1.000 

60003040 P Poultry, other, fat 0.030000 1.000 1.000 

60003050 P Poultry, other, skin 0.030000 1.000 1.000 

29003120 M Rabbit, meat 0.020000 1.000 1.000 

15003280 15 Rye, grain 0.020000 1.000 1.000 

15003290 15 Rye, flour 0.020000 1.000 1.000 

26003390 M Sheep, meat 0.020000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.020000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.700000 1.000 1.000 

26003410 M Sheep, fat 0.030000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.030000 1.000 1.000 

26003420 M Sheep, kidney 0.700000 1.000 1.000 

26003430 M Sheep, liver 3.000000 1.000 1.000 

15003440 15 Sorghum, grain 0.700000 1.000 1.000 

15003810 15 Triticale, flour 0.020000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 0.020000 1.000 1.000 

50003820 P Turkey, meat 0.020000 1.000 1.000 

50003821 P Turkey, meat-babyfood 0.020000 1.000 1.000 

50003830 P Turkey, liver 0.200000 1.000 1.000 

50003831 P Turkey, liver-babyfood 0.200000 1.000 1.000 

50003840 P Turkey, meat byproducts 0.200000 1.000 1.000 

50003841 P Turkey, meat byproducts-babyfood 0.200000 1.000 1.000 

50003850 P Turkey, fat 0.030000 1.000 1.000 

50003851 P Turkey, fat-babyfood 0.030000 1.000 1.000 

50003860 P Turkey, skin 0.030000 1.000 1.000 

50003861 P Turkey, skin-babyfood 0.030000 1.000 1.000 

86010000 O Water, direct, all sources 0.004800 1.000 1.000 4.8 pp

 Full comment: 4.8 ppb surface water EDWC

86020000 O Water, indirect, all sources 0.004800 1.000 1.000 4.8 pp

 Full comment: 4.8 ppb surface water EDWC

15004010 15 Wheat, grain 0.020000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.020000 1.000 1.000 

15004020 15 Wheat, flour 0.020000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.020000 1.000 1.000 

15004030 15 Wheat, germ 0.020000 1.000 1.000 

15004040 15 Wheat, bran 0.020000 1.000 1.000 
Pyrasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 

PC Code: 000692

___________________________________________________________________________________________

Page 13 of 13

Attachment 4: Chronic DEEM-FCIDTM Analysis.

U.S. Environmental Protection Agency Ver. 2.00

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

Residue file name: C:\Documents and Settings\gkramer\My 

Documents\Gk\##Temp\000692c.R98

 Adjustment factor #2 used.

Analysis Date 10-06-2010/13:25:39 Residue file dated: 10-06-2010/11:14:49/8

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

COMMENT 1: Proposed use on grain sorghum and grass grown for seed. FQPA safety 

factor=1x; therefore, aRfD=aPAD and cRfD=cPAD.

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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 

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

U.S. Population (total) 0.000433 4.3%

U.S. Population (spring season) 0.000426 4.3%

U.S. Population (summer season) 0.000434 4.3%

U.S. Population (autumn season) 0.000444 4.4%

U.S. Population (winter season) 0.000426 4.3%

Northeast region 0.000426 4.3%

Midwest region 0.000454 4.5%

Southern region 0.000401 4.0%

Western region 0.000467 4.7%

Hispanics 0.000518 5.2%

Non-hispanic whites 0.000417 4.2%

Non-hispanic blacks 0.000442 4.4%

Non-hisp/non-white/non-black 0.000468 4.7%

All infants (< 1 year) 0.000829 8.3%

Nursing infants 0.000281 2.8%

Non-nursing infants 0.001037 10.4%

Children 1-6 yrs 0.001259 12.6%

Children 7-12 yrs 0.000650 6.5%

Females 13-19 (not preg or nursing) 0.000309 3.1%

Females 20+ (not preg or nursing) 0.000291 2.9%

Females 13-50 yrs 0.000334 3.3%

Females 13+ (preg/not nursing) 0.000370 3.7%

Females 13+ (nursing) 0.000417 4.2%

Males 13-19 yrs 0.000392 3.9%

Males 20+ yrs 0.000304 3.0%

Seniors 55+ 0.000302 3.0%

Children 1-2 yrs 0.001567 15.7%

Children 3-5 yrs 0.001150 11.5%

Children 6-12 yrs 0.000699 7.0%

Youth 13-19 yrs 0.000352 3.5%

Adults 20-49 yrs 0.000298 3.0%

Adults 50+ yrs 0.000300 3.0%

Females 13-49 yrs 0.000295 3.0%

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