Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

DP Number: D417422 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: 22-May-2014 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

Subject: Pyroxasulfone. Acute and Chronic Aggregate Dietary Exposure and Risk 

Assessments for the Amended Section 3 Registration Request for Use of 

Pyroxasulfone on Corn. 

PC Code: 090099 DP Barcode: D417422 

Decision No.: 482174 Registration No.: 63588-91,63588-92 and 63588-93 

Petition No.: 3F8196 Regulatory Action: Section 3 Registration 

Risk Assessment Type: Single Chemical, Dietary Case No.: NA 

TXR No.: NA CAS No.: 447399-55-5 

MRIDNo.: NA 40CFR: 180.659 ~ 

Reviewer: Thurston G. Morton, Chemist ~ '), .. /~ 0 

Risk Assessment Branch IV !Health Effects Division (RABIV/HED; 7509P) 

Through: Mohsen Sahafeyan, Chemis 

And 

Elissa Reaves, PhD, Chief 

RABIV/HED (7509P) 

To: Bethany Benbow 

Herbicide Branch/RD (7505P) 

~-£?-

Page 1 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

Executive Summary 

DP Number: 0417422 

Acute and chronic aggregate dietary food and drinking water exposure and risk assessments for 

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

Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 

food consumption data from the U.S. Department of Agriculture's (USDA's) National Health 

and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary 

analysis is updated to reflect the latest consumption data and to support registration review. 

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

Standard Operating Procedure (SOP). 

Pyroxasulfone is proposed for an amended use on corn. Unrefined acute and chronic aggregate 

(food and water) assessments were conducted using tolerance level residues adjusted for 

metabolites along with 100 % crop treated (CT). 

The resulting aggregate (food and water) acute exposure estimates were less than HED's level of 

concern (<100% acute Population Adjusted Dose (aPAD)) for general U.S. population (1.2% 

aP AD) and all population sub-groups; the most highly exposed population subgroup was All Infants 

<1 year old with 3.6% aPAD at the 951

h percentile. 

The resulting aggregate (food and water) chronic exposure estimates were less than HED's level of 

concern ( < 1 00% cP AD) for general U.S. population ( 19% cP AD) and all population sub-groups; the 

most highly exposed population subgroup was All Infants <1 year old with 48% 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% ofthe 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 EP N 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-12/606l.pdf; or see SOP 99.6 (20-AUG-1999). 

Pyroxasulfone's most recent dietary risk assessment was conducted by T. Morton, D406657, 

1/30/13. 

Page 2 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

II. Residue Information 

DP Number: D417422 

The registrant (K-1 Chemical, U.S.A. Inc.) has submitted a petition to register pyroxasulfone for an 

amended use on corn. The existing tolerances are listed in 40 CFR §180.659. 

Com, grain 0.020 ppm tolerance plus 0.01 ppm for two metabolites not in the tolerance expression 

Soybean, seed 0.06 ppm tolerance plus 0.005 ppm for one metabolite not in the tolerance expression 

Cotton, undelinted seed 0.04 ppm tolerance plus 0.03 ppm for three metabolites not in the expression 

Milk 0.003 ppm tolerance plus 0.002 ppm for two metabolites not in the expression 

Wheat, grain 0.03 ppm tolerance plus 0.02 ppm for two metabolites not in the expression 

Residues of concern are summarized in the table below (G. Kramer, D379930, 7/30/2010): 

Table 1. Compounds to be Included in the Risk Assessment and Tolerance Expression. 

Residues included in Tolerance 

Expression for Compliance 

Matrix Residues included in Risk Assessment Monitoring 

Plants Cereal Grains Pyroxasulfone, Ml, M3, M25 Pyroxasulfone, Ml, M3, M25*** 

Soybeans Pyroxasulfone, Ml, M3, M25, M28** Pyroxasulfone, M1, M3, M25, M28* 

Livestock Pyroxasulfone, M 1, M3 Pyroxasulfone, M1 , M3, M25, M28 

Drinking Water Pyroxasulfone, M I, M3 Not Applicable 

Pyroxasulfone = 3-[[[ 5-( difluoromethoxy )-!-methyl-3-(trifluoromethyl)-1 H-pyrazol-4-yl]methyl]sulfonyl]-4,5-

dihydro-5,5-dimethylisoxazole. 

M 1 = [ 5-( difluoromethoxy)-1-methyl-3-(trifluoromethyl)-lH-pyrazol-4-yl) ]methanesulfonic acid. 

M3 = 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-lH-pyrazole-4-carboxylic acid. 

M25 = [5-( difluoromethoxy)-3-(trifluoromethyl)-1 H-pyrazol-4-yl)]methanesulfonic acid. 

M28 = 3-[1-carboxy-2-(5,5-dimethyl-4,5-dihydroisoxazol-3-ylthio )ethylamino ]-3-oxopropanoic acid. 

Metabolite C = 3-[ 1-carboxy-2-(5,5-dimethyl-4,5-dihydroisoxazol-3-ylthio )ethenylamino ]-3-oxopropanoic acid. 

*reanalysis of the seed samples showed residues of M28 and therefore M28 needs to be included in both the 

tolerance expression and risk assessment as a residue of concern in soybean seed. M-i is included for soybean 

forage and hay. 

** residues of concern for soybean seed is pyroxasulfone and metabolite M-1, M-3, M-25, & M-28 for risk 

assessment and does not include M-1 for tolerance enforcement purposes. 

***residues of concern for wheat grain, cotton seed, com, field, grain and com, sweet, kernel plus cob with husks 

removed is pyroxasulfone and metabolite M-3. 

III. Percent Crop Treated Information 

The acute and chronic dietary exposure analyses used 100 % crop treated. 

Page 3 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

IV. Drinking Water Data 

DP Number: 0417422 

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

Envirorunental Fate and Effects Division (EFED; Memo, J. Hetrick, 1-June-20 ll; D39022l ). 

EFED conducted a Tier II PRZM GW drinking water assessment from groundwater sources for 

pyroxasulfone. Residues of concern for drinking water for risk assessment purposes were parent, 

Ml , and M3. The estimated drinking water concentrations (EDWCs) for peak concentration 

(used in the acute assessment) and average (used in the chronic assessment) were 0.210 and 

0.174 mg/L (ppm), respectively. 

V. DEEM-FCIDTM Program and Consumption Information 

Pyroxasulfone acute and chronic dietary exposure assessments were conducted using the DEEMFCID, Version 3.16, which incorporates 2003-2008 consumption data from USDA's 

NHANES/WWEIA. 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. 

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 mglkg body weight/day and as a percent of the 

cP AD. 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 surruned to obtain a total daily pesticide exposure for a 

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

Page 4 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

DP Number: D417422 

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 refmement. 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 

The toxicological doses and endpoints for pyroxasulfone for use in the dietary assessment are 

summarized in Table 2. 

Table 2. Toxicological Doses and Endpoints for Pyroxasulfone for Use in Dietary Human Health Risk Assessments 

Exposure/ Point of Uncertainty/ 

Scenario Departure FQPA Safety RID&PAD Study and Toxicological Effects 

Factors 

Acute Dietary NOAEL= 100 UFA= 10 X Acute RID= Developmental neurotoxicity study (DNT) in 

(General mglkg UFH= IO X 1.0 mglkg rats, MRID 47701724. 

Population, FQPA SF=Ix The LOAEL of300 mglkg/day is based on 

including Infants aPAD = 1.0 decreased brain weight in both sexes, reduced 

and Children) mglkg thickness of the hippocampus, corpus callosum 

and cerebellum in PND 21 female offspring. 

Chronic Dietary NOAEL= 2 UFA= 10 X Chronic RID One- year chronic dog study, MRID 47701707 

(All Populations) mg!kg/day UFH=IO X = 0.02 The LOAEL of I 0 mglkg/day is based on 

FQPA SF= lx mg!kg/day impaired hind limb function, ataxia, hind limb 

twitching and tremors; clinical pathology: 

cPAD = 0.02 increased creatine kinase, aspartate 

mglkg/day aminotransferase; axonaVmyelin degeneration of 

the sciatic nerve and spinal cord sections. 

Cancer (all routes) "Not Likely to be Carcinogenic to Humans" at doses that do not cause crystals with subsequent calculi 

formation resulting in cellular damage of the urinary tract. Risk is quantified using a non-linear (i.e., 

RID) approach. 

Point of Departure (POD)= A data pomt or an esttmated point that IS denved 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. UF A = 

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). RID= 

reference dose. MOE = margin of exposure. N/A = not applicable. 

VII. Results/Discussion 

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

100% of the PAD. The following summarizes the DEEM-FCIDTM (ver. 3.16) chronic exposure 

analyses. 

Page 5 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

DP Number: 0417422 

Acute and chronic aggregate (food+ water) analyses were performed using DEEM-FCIDTM 

estimating the dietary exposure of the U.S. population and various population subgroups. The 

results are summarized in Table 2. 

The resulting aggregate (food and water) acute exposure estimates were less than HED's level of 

concern (<100% acute Population Adjusted Dose (aPAD)) for general U.S. population (1.2% 

aP AD) and all population sub-groups; the most highly exposed population subgroup was All Infants 

<1 year old with 3.6% aPAD at the 951

h percentile. 

The resulting aggregate (food and water) chronic exposure estimates were less than HED's level of 

concern ( < 1 00% cP AD) for general U.S. population (19% cP AD) and all population sub-groups; the 

most highly exposed population subgroup was All Infants <1 year old with 48% cPAD. 

Table 2. R esults o f Acute and Cb ronic D E I . ~ p ietary xposure Ana ys1s or •yroxasu I~ on e (Food and Water) 

Acute Dietary Chronic Dietary (95th Percentile) 

Population Subgroup Dietary Dietary 

Exposure o/oaPAD Exposure o/ocPAD 

(mg/kglday) (mglkg/day) 

General U.S. Population 0.011740 1.2 0.003822 19 

All Infants(< 1 year old) 0.036394 3.6 0.009679 48 

Children 1-2 years old 0.018442 1.8 0.005829 29 

Children 3-5 years old 0.015013 1.5 0.004898 25 

Children 6-12 years old 0.011445 l.l 0.003509 18 

Youth 13-19 years old 0.009849 1.0 0.002843 14 

Adults 20-49 years old 0.011476 1.2 0.003774 19 

Adults 50-99 years old 0.010239 1.0 0.003700 19 

Females 13-49 years old 0.011621 1.2 0.003757 19 

VIII. Characterization of Inputs/Outputs 

HED has conducted a conservative assessment for the amended use of pyroxasulfone on com. 

Tolerance level residues along with 100% CT were used in the acute and chronic dietary 

exposure assessments. In addition, DEEM default processing factor of 1.5x was used for com 

syrup. Residues do not warrant the need for further refinement at this time. 

Page 6 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

IX. Conclusions 

DP Number: 0417422 

Unrefined acute and chronic aggregate (food+ water) dietary risk assessments were conducted 

for pyroxasulfone using the DEEM-FCIDTM (ver. 3.16) model using tolerance level residues, 

DEEMTM default processing factor, and 100% CT. The resulting acute aggregate exposure 

estimate was less than HED's level of concern. For the general U.S. population and all 

population subgroups in the acute analysis all dietary exposure estimates were 9l% aP AD). The 

resulting chronic aggregate exposure estimate was less than HED's level of concern. For the 

general U.S. population, the cP AD was 19% while the most highly-exposed population 

subgroups in the chronic analysis was All Infants <1 year old ( 48% cP AD). 

X. Attachments 

List of Attachments: 

Attachment 1: Residue Information. 

Attachment 2: Acute Results. 

Attachment 3: Chronic Results. 

cc with all attachments: T. Morton (RABIV) 

RDI: M. Sahafeyan and K. Rury- DESAC (20-May-2014); E. Reaves (20-May-2014) 

Petition Number(s): 3F8196 

DP#: 417422 

PC Code: 090099 . 

T. Morton:S10838:PY1 :(703)305-6691 

Page 7 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

Attachment 1: Residue Information. 

Acute Analysis 

DP Number: 0417422 

Filename: C:\Documents and Settings\tmorton\My Documents\MyFiles\DEEM Files\090099 

Pyroxasulfone\Amended Corn 3F8196\090099ACUTEFOODANDWATER .R08 

Chemical : Pyroxasulfone 

RfD(Chronic): .02 mg/kg bw/day NOEL (Ch ronic) : 0 mg/kg bw/day 

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day 

Date created/last modified: 11-13-2013/12:22:57 Program ver. 3.16, 03-08-d 

EPA Crop 

Code Grp Commodit y Name 

Def Res 

(ppm) 

0600347000 6 

0600349000 6 

0600349001 6 

0600350000 6 

0600350001 6 

0601349500 6AB 

0603348000 6C 

0603348001 6C 

1 50012 0000 15 

1500120001 15 

1500121000 15 

1500121001 15 

1500122000 15 

1500123000 15 

1500123001 15 

1500124000 15 

1500124001 15 

1500125000 15 

1500125001 15 

1500126000 15 

1500127000 15 

1500127001 15 

1500381000 15 

1500381001 15 

1500401000 15 

1500401001 15 

1500402000 15 

1500402001 15 

1 500403000 1 5 

1500404000 15 

2003128000 20C 

2003128001 20C 

3600222000 36 

3600222001 36 

3600223000 36 

3600223001 36 

3600224 000 36 

3600224001 36 

3600225001 36 

8601000000 86A 

8602000000 86B 

Soybea n, seed 

Soybean, soy mil k 

Soybean, soy milk-babyfood or in 

Soybean, oil 

Soybean, oil-babyfood 

Soybean, vegetable 

Soybean, flour 

Soybean, flour-babyfood 

Corn, f ield, flour 

Corn, field, flour- baby food 

Corn, field, meal 

Corn, field, meal- babyfood 

Corn, field, bran 

Corn, field, starch 

Corn, field, starch- babyfood 

Corn, field, syrup 

Corn , field, syrup- babyfood 

Corn, field, o il 

Corn, field, oil-babyfood 

Corn, pop 

Corn, sweet 

Corn, sweet-babyfood 

Tr iticale, flour 

Triticale, flour -babyfood 

Wheat, grain 

Wheat, grain-babyfood 

Wheat, flour 

Wheat, flour-babyf ood 

Wheat, germ 

Wheat, bran 

Cottonseed, oil 

Cottonseed, oil-babyfood 

Milk, fat 

Milk, fat-baby food/infant formu 

Milk, nonfat solids 

Milk, nonfat solids- baby food/in 

Mi lk, wa ter 

Milk, water-babyf ood/infant form 

Milk, sugar (lactos e)-baby food/ 

water, direct, all sources 

Water, indirect, all sources 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.050000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0.050000 

0.050000 

0.070000 

0.070000 

0.005000 

0.005000 

0.005000 

0.005000 

0 .005000 

0.005000 

0.005000 

0.210000 

0.210000 

Page 8 of 12 

Adj.Factors 

#1 #2 

l. 000 

l. 000 

1 .000 

1.000 

l. 000 

1. 000 

1.000 

1.000 

1 .000 

1. 000 

l. 000 

1.000 

1.000 

1.000 

1.000 

1 . 500 

1.500 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

l. 000 

1.000 

l. 000 

l. 000 

l. 000 

1.000 

l. 000 

1.000 

1. 000 

1.000 

1.000 

1 .000 

l. 000 

l. 000 

1.000 

l. 000 

1 .000 

1.000 

l. 000 

l. 000 

1.000 

1. 000 

l. 000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1 .000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 .000 

1.000 

1.000 

1.000 

l. 000 

l. 000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1 . 000 

1.000 

l. 000 

1.000 

1 .000 

1.000 

comment 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

Chronic Analysis 

DPNumber: 0417422 

Filename: C:\Documents and Settings\ tmorton\ My nocuments\ MyFiles\DEEM Files\090099 

Pyroxasulfone\Amended Corn 3F8196\090099CHRONICFOODANDWATER.R08 

Chemical: Pyroxasulfone 

RfD(Chronic) : .02 mg/ kg bw/ day NOEL(Chronic): 0 mg/kg bw/ day 

RfD(Acute): 1 mg/kg bw/ day NOEL(Acute): 0 mg/ kg bw/ day 

Date created/last modified: 11-13-2013/12:23:19 Program ver. 3.16, 03 - 08 - d 

EPA Crop 

Code Grp Commodity Name 

Def Res 

(ppm) 

0600347000 6 

0600349000 6 

0600349001 6 

0600350000 6 

0600350001 6 

0601349500 6AB 

0603348000 6C 

0603348001 6C 

1500120000 15 

1500120001 15 

1500121000 15 

1500121001 15 

1500122000 1 5 

1 500123000 15 

1500123001 15 

1500124000 15 

1500124001 15 

1500125000 15 

1500125001 15 

1500126000 15 

1500127000 15 

1500127001 15 

1500381000 15 

1500381001 15 

1500401000 15 

1500401001 15 

1500402000 15 

1500402001 15 

1500403000 15 

1500404000 15 

2003128000 20C 

2003128001 20C 

3600222000 36 

3600222001 36 

3600223000 36 

3600223001 36 

3600224000 36 

3600224001 36 

3600225001 36 

8601000000 86A 

8602000000 86B 

Soybean, seed 

Soybean, soy milk 

Soybean, soy mil k-babyfood or in 

Soybean, oil 

Soybean, oil- babyfood 

Soybean, vegetable 

Soybean, flour 

Soybean, flour-babyfood 

Corn, fiel d, flour 

Corn, field, flour-babyfood 

Corn, field, meal 

Corn, field, meal-babyfood 

Corn, field, bran 

Corn, field, starch 

Corn, field, starch- babyfood 

Corn, field, syrup 

Corn, field, syrup- babyfood 

Corn, field, oil 

Corn, field, oil-babyfood 

Corn, pop 

Corn, sweet 

Corn, sweet-babyfood 

Triticale, flour 

Triticale, flour- babyfood 

Wheat, grain 

Wheat, grain- babyfood 

Wheat, flour 

Wheat, flour-babyfood 

Wheat, germ 

Wheat, bran 

Cottonseed, oil 

Cottonseed, oil-babyfood 

Milk, fat 

Milk, fat-baby food/infant formu 

Mi l k, nonfat solids 

Milk, nonfat solids-baby food/in 

Milk, water 

Milk, water-babyfood/infant form 

Milk , sugar (lactose)-baby food/ 

Water, direct, all sources 

water, indirect, all sources 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.065000 

0.030000 

0 . 030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.030000 

0.070000 

0.070000 

0.00 5000 

0.005000 

0.005000 

0.005000 

0.005000 

0.005000 

0.005000 

0.174000 

0.174000 

Page 9 of 12 

Adj.Factors 

#1 #2 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1 .000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.500 

1.500 

1.000 

1.000 

1.000 

1 .000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1.000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1. 000 

1.000 

1. 000 

1. 000 

1. 000 

1.000 

1. 000 

Comment 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

Attachment 2:Acute Results 

DP Number: 0417422 

U. S. EPA 

DEEM-FCI D ACUTE Anal ysis for PYROXASULFONE 

Residue file: 090099ACUTEFOODANDWATER.R08 

Analysis Date: 11-13- 2013 / 12:25:41 Residue 

Ver. 3.16, 03-08-d 

NHANES 2003 - 2008 2- Day 

Adjustment factor #2 NOT used. 

file dated: 11-13-2013/12: 22:57 

RAC/ FF intake summed over 24 hours 

Run Comment: "" 

Summary calculations--per capita : 

95th Percentile 99th Percentile 99.9th Percentile 

Exposure t aRfD Exposure t aRfD Exposure % aRfD 

---------- -------- ---------- -------- ---------- -------- Total us Popul ation: 

0 . 011740 1.17 0.019301 1. 93 0.036509 3 . 65 

All Infant s: 

0.036394 3.64 0.048855 4.89 0. 071962 7.20 

Children 1 - 2: 

0.018442 1. 84 0.027605 2.76 0.065857 6.59 

Children 3-5: 

0.015013 1. so 0.022803 2.28 0.035980 3 .60 

Children 6-12: 

0.011445 1. 14 0.018232 1. 82 0.028366 2. 84 

Youth 13-19: 

0.009849 0.98 0.015965 1.60 0.023981 2.-40 

Adults 20-49: 

0.011476 1.15 0.016892 1. 69 0.024560 2.46 

Adults 50-99: 

0.010239 1. 02 0.015445 1.54 0 . 024112 2.41 

Female 1 3-4 9: 

0.011621 1.16 0.01 691 6 1.69 0.023872 2.39 

FOOD ONLY 

U.S. EPA 

DEEM- FCID ACUTE Analysis for PYROXASULFONE 

Residue f ile: 090099ACUTEFOOD ONLY . R08 

Ver. 3.16, 03 - 08-d 

NHANES 2003 - 2008 2 - Day 

Adjustment factor #2 used. 

Anal ysis Date: 02-18-2014/14:15:48 Residue file dated: 02-18-2014/14:13 : 26 

RAC/FF intake summed over 24 hours 

Run Comment: "" 

Summary c a lculations--per capita: 

95t h Percent i l e 99th Percentile 99.9th Percentile 

Exposure t aRfD Exposure t aRfD Exposure % aRfD 

---------- --- - ---- ---------- -------- ---------- -------- Total us Population: 

0 . 000584 0 . 06 0.000 916 0.09 0.001649 O.H 

All Inf ant s: 

0 .000893 0 .09 0.001284 0.13 0.003000 0.30 

Children 1 - 2: 

0.001146 0.11 0.001901 0.19 0.005656 0.57 

Children 3 - 5: 

0.001003 0.10 0.001433 0.14 0.003222 0.32 

Children 6 - 12: 

0 . 000731 0 . 07 0.000995 0. 1 0 0.002088 0.21 

Youth 13 - 19: 

0. 000471 0 . 05 0.000660 0.07 0. 001126 0.11 

Adults 20 - 49: 

0.000361 0.04 0.000 545 0.05 0.000867 0.09 

Adults 50 - 99: 

0. 000271 0.03 0.000413 0.04 0.000959 0.10 

Female 13-49: 

0.00 0352 0 . 04 0.000528 0.05 0.000812 0.08 

Page 10 of 12 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

Attachment 3:Chronic Results 

DP Number: 0417422 

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

0~2M-FCIO Chronic anal ysis for PY~OXASULFONE "NHANES 2003 - 2008 2-day 

Residue file name: C:\Documents and Settings\tmorton\My Documents\MyFiles\DEEM Files\090099 

Pyroxasulfone\Amended Corn 3F8196\090099CHRONICFOODANDWATER. R08 

Adjustment factor #2 used . 

Analysis Date 01-15-2014/12 :45:48 Residue file dated: 01 - 15-2014/12 :44 :39 

Reference dose (RfD, Chronic) = .02 mg/kg bw/day 

Total exposure by population subgroup 

Total Exposure 

Population 

Subgroup 

Total us Population 

Hispanic 

Non-Hisp-White 

Non- Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1 - 6 

Children 7-12 

Ma l e 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1 - 2 

Children 3 - 5 

Children 6-12 

Youth 13 - 1 9 

Adults 20 -4 9 

Adults 50-99 

Femal e 13 - 49 

mg/kg 

body wt/day 

0.003822 

0.003680 

0.003922 

0.003 17 9 

0.004384 

0.003404 

0.012482 

0.003585 

0.005167 

0 . 003334 

0. 002710 

0.002974 

0.003528 

0.003943 

0.003627 

0.009679 

0.003760 

0.005829 

0.004898 

0.003509 

0.002843 

0.003 774 

0.003700 

0.003757 

Page ll of 12 

Percent of 

Rfd 

19.1% 

18 .4% 

19 . 6% 

15 . 9% 

21.9% 

17 .0% 

62.4% 

17.9% 

25.8% 

16 . 7% 

13.5% 

14.9% 

17 .6% 

1 9.7% 

18 . 1% 

48.4% 

18.8% 

29 . 1% 

24 .5% 

17.5% 

14.2% 

18.9% 

18.5% 

18.8% 
Pyroxasulfone Dietary Exposure and Risk Assessment 

PC Code: 090099 

FOOD ONLY 

DPNumber: 0417422 

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

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

Residue file name: C:\Documents and Settings\tmorton\My Documents\MyPiles\ DEEM Piles\090099 

Pyroxasulfone\Amended Corn 3F8196\090099CHRONICFOOD ONLY.R08 

Adj ustment factor #2 used. 

Analysis Date 02- 18-2014/14:14:37 Residue fi l e dated: 02 -18-2014/14:13:54 

Reference dose (RfD, Chronic) = .02 mg/kg bw/day 

Total exposure by population subgroup 

Total Exposure 

Population 

Subgroup 

Total us Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non- Nursing Infants 

Female 13+ PREG 

Children 1 - 6 

Children 7 -12 

Male 13 -19 

Female 13 - 19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1 -2 

Children 3-5 

Chil dren 6 - 12 

Youth 13-19 

Adults 20 - 49 

Adults 50-99 

Female 13-49 

mg/kg 

body wt/day 

0.000179 

0.000202 

0.000175 

0.000173 

0.000185 

0 .000108 

0 . 000364 

0 .000154 

0.000500 

0.000296 

0.000205 

0 .000168 

0.000134 

0.000117 

0.000104 

0.000285 

0.000135 

0 .000 574 

0.000470 

0.000316 

0 . 000186 

0 . 000139 

0.00010 7 

0. 000135 

Page 12 of 12 

Percent of 

Rfd 

0 .9% 

1. 0% 

0.9% 

0.9% 

0.9% 

0.5% 

1. 8% 

0.8% 

2.5% 

1.5% 

1. 0% 

0.8% 

0. 7% 

0.6% 

0 .5% 

1. 4% 

0.7% 

2.9% 

2.4% 

1. 6% 

0.9% 

0 . 7% 

0.5% 

0.7%