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## Page 1 of 13 UNITED STATES ENVIRONMENTA L PROTECTION AGENCY

WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



## MEM ORANDUM Date: 0 9 - 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 T XR No.: None. CAS No.: 365400 - 11 - 9 MRID No.: Non e. 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)

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## Page 2 of 13 Executive Summary Acute and chron ic 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 Survey s of Food Intakes by Individuals (CSFII) from 1994 - 1996 and 1998. No cancer dietary

exposure assessment was performed because p yr asulfotole is not carcinogenic. The anal ys es were performed to support Section 3 requests for use o f py rasulfotole 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 popu lation 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 directl y into the dietary assessment using the acute concentration f or surface water generated b y the FQPA Index Reservoir Screening Tool (FIRST) model. The results of this assessment indicate that the acute dietary exposure estimates (95 th 

## percentile) are below HED’s level of concern [<100% of the acute p opulation - a djust ed d ose (aPAD)] for the general U.S. population (3 % of the aPAD) and all other populations subgroups. The most highly exposed population subgrou

p 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 wa s incorporated directl y into the dietary assessment using the chronic concentration for surface water generated b y 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 highl y exposed population subgroup is children 1 - 2 years old at 16 % of the cPAD. I. Introduction Dietary risk assess ment 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 equi valent to point of departure (Po D, NOAEL , LOAEL, e.g.) divided by the required uncertainty

or safety factors. For acute and non - cancer chronic exposures, HED is con cerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one m illion . References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticide s 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 ).

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## Page 3 of 13 The most recent dietary risk assessment for p yrasulfotole was conducted b y Jennifer Tyler in conjunction with a Section 3 request for the use of py rasulfotole on small cereal grains ( Memo, 6/7/07; D333435 ). II. Resid ue Information Registered and Proposed Py rasulfotole Use s : Tolerances have been established for residues of p yr asulfotole and p yr asulfotole - desmeth yl 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 p yrasulfotole on sorghum and grass grown for seed. The available residue chemistry database supports the establishment of the permanent tolerances for residues of p yr asulf

otole and its metabolite py rasulfotole - desmeth yl 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

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## Page 4 of 13 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 Pou ltry, 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 py rasulfotole and py

rasulfotole - desmeth yl (Memo, J. Tyler et al., 6/ 8/07; D328640). The residues of concern in drinking water for risk assessment purposes are parent onl y . Percent Crop Treated: For the acute and chronic assessments, it was assumed that 100% of the registered and proposed crops have been treated with py rasulfotole. 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 an d 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 separat e 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 e xposure assessment. DEEM TM 

## 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 p yrasulfotole in surface and ground water usin g 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 - ye ar peak acute and 1 - in 10 - ye ar estimated annual mean non - cancer chronic EDWCs for py rasulfotole in surface water to be 6.9 ppb and 4.8 ppb, respectivel y. 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.”

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## Page 5 of 13 Table 2. Summary of Estimated Surface Water and Groundwater EDWCs for Pyrasulfotole. Surface Water Concentration (ppb) a Groundw ater Concentration (ppb) b Acute 6.9 2 .4 Chronic (non - cancer) 4 .8 2 .4 Chronic (cancer) - - a From the Tier I

FIRST model. I

nput parameters are based on aerial sp ray 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 K oc of 20 ml/g OC , and half

- life of 226 days. 

## IV. DEEM - FCIDTM Program and Consumption Information Py rasulfotole acute and chronic dietary exposure assessments were conducted using the D EEM FCIDTM, 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 day s. 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 publicl y 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 anal ys is 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 ye ar 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 food form (e.g., orange or orange juice) on the food commodity r esidue list is multiplied by the average dail y 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 assessm ents, 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., onl y those wh o 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 an al ysis. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment.

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## Page 6 of 13 V. Toxicological Information A summary

of the toxicological doses and endpoints selec ted for dietary exposure a ssessment is provided in Tabl e 3 . Table 3 . Summary of Toxicological Doses and Endpoints for Pyrasulfotole for Use in Dietary Human Health Risk Assess me nts. Exposure Scenario Point of

Departure Uncertainty/F

QPA Safety Factors Rf

D, PAD, Level of Concern for Risk Assessment Study and Relevant Toxicological Effects Acute Dietary (All populations) NOAEL = 3.8

mg/kg/day UF A = 10X

UF H = 10X UF FQPA = 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 UF A = 10X

UF H = 10X UF FQPA = 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 re tinal 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, UF A = extrapolation from animal to human (interspecies), UF H = potential variation in sensitivity among members of th e human population (intraspecies), UF FQPA = 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 anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Tabl e 4 are for the general U.S. Population, all infants (<1 year old), children 1 - 2, ch ildren 3 - 5, children 6 - 12, youth 13 - 19, females 13 - 49, adults 20 - 49, and a dults 50+ years . Results of Acute Dietary

(Food and Drinking Water) Exposure Anal ys is : 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 directl y in the dietary asses sments 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 (95 th 

## percentile) are below HED’s level of concern (<100% of the aPAD) for the gene ral 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 Analy sis : The chronic dietary expo sure 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

assessm ent using the chronic concentration for surface water generated by the FIRST model. The results of the

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## Page 7 of 13 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 Dietary 1 Chronic Di etary 2 Dietary Exposure (m g/kg/day) % aPAD Dietary Exposure (m g/kg/day) % cPAD U.S. Population (total) 0.00 131 5 3 0.000 43 3 4 All Infants (< 1 year old) 0.00 25 49 7 0.000 82 9 8 Children 1 - 2 years old 0.00 3 428 9 0.00 15 67 16 Children 3 - 5 years old 0.00 22 8 8 6 0.00 11 50 12 Children 6 - 12 years old 0.00 14 80 4 0.000 69 9 7 Youth 13 - 19 years old 0.000 8 78 2 0.000 3 52 4 Adults 20 - 49 years old 0.000 69 5 2 0.000 29 8 3 Adults 50+ years old 0.000 61 6 2 0.000 300 3 Females 13 - 49 years old 0.000 69 8 2 0.000 29 5 3 1 Acute di etary 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/Outpu ts These analy ses 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 c onsumption. 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 anal ys is to ensure minimal degradation of residues. In actual p ractice, 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 analy ses could be made through the use of monitoring data, %CT data, and additional empirical processing factors. Since risk e stimates are not of concern to HED, a more highl y refined analysis is not needed at this time. VIII . List of Attachments Attachment 1. Residue File for Acute DEEM - FCIDTM Anal ys is

– All Populations. Attachment 2. Acute DEEM - FCIDTM Anal ys is

– All Populatio ns. Attachment 3: Residue File for Chronic DEEM - FCIDTM Anal ys is. Attachment 4: Chronic DEEM - FCIDTM Anal ys is. 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

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## Page 8 of 13 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 1.00 0 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 2100048 0 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, sk in 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 0.02000 0 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 sol ids 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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## Page 9 of 13 25002910 M Pork, skin 0.020000 1.000 1.000 25002920 M Pork, meat byproducts 0.050000 1.000 1.000 2500 2921 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 0.02 0000 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 1.00 0 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 150040 11 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

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## 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."

========================================= ====================================== 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 17.1 4 583 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 1 1.18 894 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

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rasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 PC Code: 000692

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## Page 11 of 13 Attachment 3: Residue File for Ch ronic 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 byprod ucts - 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 Chic ken, 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 40000 971 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, kid ney 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 0.020 000 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 - bab yfood 0.020000 1.000 1.000

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rasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 PC Code: 000692

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## 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 P ork, 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 15 003280 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 - babyfoo d 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 1.00 0 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 Tritic ale, 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 5000384 1 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 Whe at, bran 0.020000 1.000 1.000

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rasulfotole Dietary Exposure and Risk Assessment DP Number: D375390 PC Code: 000692

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## 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 - 9 8 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.

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

------------------------------------------------------------------------------- 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 y rs 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 0.00 0334 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 2 0+ 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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