### Pyroxasulfone Dietary Ex posure and Risk Ass essment P

C Code: 090099 DP Number: 0 410009 & 

### 410011



### UNITED STATES ENVIRONME NTAL PROT ECTION AGENCY WASHINGTON, D.C. 20460



### MEMORANDUM Date: 24-July-2013 OFFICE OF CHEM IC AL SAFETY AND POLLUTION PREVEN TI ON



### Subject: Pyroxasulfone. Acute and Chronic Aggregate Dietary Ex posure and Risk Assessments for the Sect ion 3 Registration Reques t for Use ofPyroxasu lfone on Wheat and Cotton.
PC Code: 090099 DP Barcode: 0410009 & 

### 0410011 Decision No.: 464491 & 465295 Regi s trat i on No. : 63588-91 , 63588-92 and 63588-93 Petition No.: 2F8026 & 

### 2F8042 Regulatory Action : Section 3 Registration Risk Assessment Type : Single Chemical, Di etary Case No

. : NA TXR No.: NA CAS No

. : 447399-55 -5 MRlD No.: NA 40 CFR: 180.659 , 

# L_ Reviewer: Thurston G. Morton, Chemist 

# a;/./

# -~ (!!" 0 Risk Assessment Branch IV

# /Healt{Effec~~sio~IV IRED; 7509P) 

### Through: Donna Davis, Senior Chemist Ide li z Neg ron- E ncarnacion, Chem i st Di etary Exposure Science Advisory Co And Susan V. Hummel, Senior Chemist RABIV IHED (7509P) 

### To: Thurston G. Morton, Risk Assessor RABIV/HED (7509P) 

### And Michae l Walsh Herbicide Branch/RD (7505P)

Page 1 of 1 1Pyroxasulfone Dietary Exposure and Risk Assessment PC Code: 090099 

### Executive Summary DP Number: 0410009 & 410011



### Pyroxasulfone is proposed for use on wheat and cotton. 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 RED's level of concern (<100% aPAD) for general U.S. population (1.2% aPAD) and all population sub-groups; the most highly exposed population subgroup was All Infants <1 year old with 3.6% aPAD at the 95th percentile. The resulting aggregate (food and water) chronic exposure estimates were less than RED ' s level of concern ( < 100% cP AD) for general U.S. popu l ation ( 19% cP AD) and all popu l ation 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 RED 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, RED is concerned when estimated dietary risk exceeds 100% ofthe PAD. RED 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 E PA/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 had a previous dietary risk assessment conducted 

### (T. Morton, D406657, 1130/13).

Page 2 of IIPyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

Page 3 of 11 

### II. Residue Information The registrant (K

- I Chemical, U.S.A. Inc.) has s ubmitted a petition to register pyroxasulfone for use on wheat and cotton

. DEEM ® 

### residue inputs for so ybean commodities u se d tolerance level residue values adjusted for additional metabolites which are not in the tolerance expression. The existing tolerances are listed in 40 CFR §180.659. Soybean, seed 0.06 ppm plus 0.01 ppm for two metabolites not i n the tolerance expression Corn, grain 0.015 ppm plus 0.01 ppm for two metabolites not in the tolerance expression



### Tole rances for residues of pyroxasulfone r aw agricultural commodities (RACs) will be established as fo llows based on field tr ial data : Cotton, undelinted seed 0.06 ppm plus 0.01 ppm for two metabolites not in the tolerance expression Milk 0.003 ppm plus 0.002 ppm for two metabolites not in the tolerance expression Wheat, grain 0.03 ppm plus 0.02 ppm for two metabolites not in the tolerance 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 Expressi on.

Matrix Residues included in Risk Assessment Residues included in Tolerance Expression for Compliance Monitoring Plants Cereal Grains Pyroxasulfone, M1, M3, M25 Pyroxasulfone, M1, M3, M25 ***

Soybeans Pyroxasulfone, M1, M3, M25, M28 ** Pyroxasulfone, M1, M3, M25 , M28 * Livestock Pyroxasulfone, M1, M3 Pyroxasulfone, M1, M3, M25 , M28 Drinking Water Pyroxasulfone, M1, M3 Not Applicable Pyroxasulfone = 3

- [[[5

- (difluoromethoxy)

- 1

- methyl

- 3

- (trifluoromethyl)

- 1H

- pyrazol

- 4

- yl]methyl]sulfonyl]

- 4,5

- dihydro

- 5,5

- dimethylisoxazole. M1 = [5

- (difluoromethoxy)

- l

- methyl

- 3

- (trifluoromethyl)

- lH

- pyrazol

- 4

- yl)]methanesulfonic acid. M3 = 5

- (difluoromethoxy)

- l

- methyl

- 3

- (trifluoromethyl)

- lH

- pyrazole

- 4

- carboxylic acid. M25 = [5

- (difluoromethoxy)

- 3

- (trifluoromethyl)

- 1H

- 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 se ed 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

- 1 is included for soybean forage and hay. ** residues of concern for soybean seed i s 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, corn, field, grain and corn, sweet, kernel plus cob with husks remov ed is pyroxasulfone and metabolite M

- 3.Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

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### III. Drinking Water Data The drinking water estimates used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED; Memo, J. Hetrick , 1

- June

- 20 1 1 ; D 3 90221 ). EFED conduct ed a Tier II PRZM GW drinking water assessment from ground water sources for the proposed new active ingredient

. Residues of concern for drinking water for risk assessment purposes were parent, M1, and M3. The estimated drinking water residues for peak co ncentration (used in the acute assessment) and average (used in the chronic assessment) were 0. 210 and 0. 1 74 m g/L (pp m ) , respectively. IV. DEEM - FCID  Program and Consumption Information Pyroxasulfone acute and chronic dietary exposure assessments wer e conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM

FCIDTM, Version 3.16, which incorporates consumption data from USDA’s National Health and Nutrition Examination Survey, What We Eat in America, (NH ANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The data are based on the reported consumption of more than 20,000 individuals over two non

- consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA

- defined food c ommodities (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 a re 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 2003

- 2008 WWEIA consumption data, which took into account dietary pattern s 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 chronic dietary exposure assessment, an estimate of the residue level in each food or food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estima te 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 a verage 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 ind ividual

- 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 pa irings 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 eatingPyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

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### relevant commodities/food forms) and a per

- capi ta (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. V. Toxicological Information The toxicological doses and endpoints for pyroxasulfone for use in the dietary assessment are summarized in Table 2.

T able 2. Toxicological Doses and Endpoints for Pyroxasulfone for Use in Dietary Human Health Risk Assessments Exposure/ Scenario Point of

Departure Uncertainty/

FQPA Safety Factors RfD & PAD Study and Toxicological Effects Acute Dietary (General Populati on, including Infants and Children) NOAEL= 100

mg/kg UF A = 10 x

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

1.0 mg/kg aPAD = 1.0 mg/kg Developmental neurotoxicity study (DNT) in

rats, MRID 47701724. The LOAEL of 300 mg/kg/day is based on decreased brain weight in bo th sexes, reduced thickness of the hippocampus, corpus callosum and cerebellum in PND 21 female offspring. Chronic Dietary (All Populations) NOAEL= 2

mg/kg/day UF A = 10 x

UF H =10 x FQPA SF=1x Chronic RfD

= 0.02 mg/kg/day cPAD = 0.02 mg/kg/day One

- year c hronic dog study, MRID 47701707

The LOAEL of 10 mg/kg/day is based on impaired hind limb function, ataxia, hind limb twitching and tremors; clinical pathology: increased creatine kinase, aspartate aminotransferase; axonal/myelin degeneration of the sciati c 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., RfD) approach. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human po pulation (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

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### VI. Results/Discussion As state d above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The following summari z es the DEEM

- FCID  (ver. 3.16 ) chronic exposure analyses. Acute and c hronic aggregate (food + water) analys e s w ere performed usin g DEEM

- FCID  estimating the dietary exposure of the U.S. population and various population subgroups. The results are summarized in Table 2

. The resulting acute food and water exposure estimates were less than HED’s level of concern (

- <100% a PAD) for t he general U.S. population and all population sub

- groups . The resulting chronic food and water exposure estimates were less than HED’s level of concern ( <100% c PAD) for the general U.S. population and all population sub

- groups ; All Infants <1 yr old ha d the highest dietary exposure at 48 % cPAD

. Table 2 . Results of Acute and Chronic Dietary Exposure Analysis for Pyroxasulfone (Food and Water)

Population Subgroup Acute Dietary (95th Percentile) Chronic Dietary Dietary Exposure (mg/kg/day) % aPAD Di etary Exposure (mg/kg/day) % cPAD General U.S. Population 0.0 11 7 43 1

. 2 0.00 3 812 1 9 All Infants (< 1 year old) 0.0 36 358 3.6 0.0 09 6 60 48 Children 1

- 2 years old 0.0 1 8 433 1. 8 0.00 5 808 2 9 Children 3

- 5 years old 0.0 1 4 9 87 1

. 5 0.00 4 8 76 2 4 Children 6

- 12 years old 0.0 11 420 1 .1 0.00 3 4 92 1 8 Youth 13

- 19 years old 0.00 9 830 1.0 0.00 2 8 31 1 4 Adults 20

- 49 years old 0.0 1 1 46 8 1

. 2 0.00 3 7 65 1 9 Adults 50

- 99 years old 0.0 10 2 23 1.0 0.00 3 6 95 1 9 Females 13

- 49 years old 0.0 1 1 6 18 1

. 2 0.00 3 74 9 1 9Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

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### VII. Characterizatio n of Inputs/Outputs HED has conducted a highly conservative, health protective assessment for the new proposed use of pyroxasulfone on wheat and cotton

. T olerance level residues along with 100 % CT were used in the acute and chronic dietary exposure asse ssments
. In addition, DEEM default processing factor of 1.5x was used for corn syrup. Residues do not warrant the need for further refinement at this time. VIII. Conclusions Unrefined acute and chronic aggregate (food + water) dietary risk assessme nt s w ere conducted for pyroxasulfone using the DEEM

- FCID  (ver. 3.16 ) model using tolerance level residues , DEEM  default processing factor , and 100 % CT

. The resulting acute aggregate exposure estimate w as less than HED’s level of concern. For the gener al U.S. population and all population subgroups in the acute analys i s all dietary exposure estimates were ≤ 4 % a PAD). The resulting chronic aggregate exposure estimate w as less than HED’s level of concern. For the general U.S. population, the cPAD w as 1 9 % while the mo st highly

- exposed population subgroups in the chronic analys i s w as All Infants <1 year old ( 4 8 % cPAD).

IX. Attachments List of Attachments: Attachment 1 : Residue Information

. Attachment 2 : Acute Results

. Attachment 3 : Chronic Results

.

cc with all attachments: T. Morton (RABIV) RDI: Donna Davis and Ideliz Negrón

- Encarnación

- DESAC ( 2 4

- July

- 20 1 3 ) ; S. Hummel ( 24

- J uly

- 20 1 3 ) Petition Number(s): 2F80 26 & 2F8042 DP #: 4 10009 PC Code: 0 9 0 099 T. Morton:S10 838 :PY1:(703)305

- 6691Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

Page 8 of 11 

### Attachment 1 : Residue Information.

Acute Analysis

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFile s \ DEEM Files \ 090099 Pyroxasulfone \ Wheat Cotton \ 090099ACUTEFOODANDWATER.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: 03

- 14

- 2013 /07:24:53 Program ver. 3.16, 03

- 08

- d

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 0600347000 6 Soybean, seed 0.065000 1.000 1.000 0600349000 6 Soybean, soy milk 0.065000 1.0 00 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.065000 1.000 1.000 0600350000 6 Soybean, oil 0.065000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.065000 1.000 1.000 0601349500 6A B Soybean, vegetable 0.065000 1.000 1.000 0603348000 6C Soybean, flour 0.065000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.065000 1.000 1.000 1500120000 15 Corn, field, flour 0.025000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.025000 1.000 1.000 1500121000 15 Corn, field, meal 0.025000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.025000 1 .000 1.000 1500122000 15 Corn, field, bran 0.025000 1.000 1.000 1500123000 15 Corn, field, starch 0.025000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.025000 1.000 1.000 1500124000 15 Corn, field, syrup 0.025000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.025000 1.500 1.000 1500125000 15 Corn, field, oil 0.025000 1.000 1.000 1500125001 15 Corn, field, oil

- bab yfood 0.025000 1.000 1.000 1500126000 15 Corn, pop 0.025000 1.000 1.000 1500127000 15 Corn, sweet 0.028000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.028000 1.000 1.000 1500381000 15 Triticale, flour 0.050000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.050000 1.000 1.000 1500401000 15 Wheat, grain 0.050000 1.000 1.000 150040100 1 15 Wheat, grain

- babyfood 0.050000 1.000 1.000 1500402000 15 Wheat, flour 0.050000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.050000 1.000 1.000 1500403000 15 Wheat, germ 0.050000 1.000 1.000 1500404000 15 Wheat, bran 0.050000 1.000 1.000 2003128000 20C Cottonseed, oil 0.070000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.070000 1.000 1.000 3600222000 36 Milk, fat 0.005000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.005000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.005000 1.000 1.000 3600223 001 36 Milk, nonfat solids

- baby food/in 0.005000 1.000 1.000 3600224000 36 Milk, water 0.005000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.005000 1.000 1.000 3600225001 36 Milk, sugar (lac tose)

- baby food/ 0.005000 1.000 1.000 8601000000 86A Water, direct, all sources 0.210000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.210000 1.000 1.000Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

Page 9 of 11 

### Chronic Analysis

Filename: C: \ Documents and Sett ings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 090099 Pyroxasulfone \ Wheat Cotton \ 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: 03

- 14

- 2013/07:18:53 Program ver. 3.16, 03

- 08

- d

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 0600347000 6 Soybean, seed 0.065000 1.000 1.000 0600349000 6 Soybean, soy mi lk 0.065000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.065000 1.000 1.000 0600350000 6 Soybean, oil 0.065000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.065 000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.065000 1.000 1.000 0603348000 6C Soybean, flour 0.065000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.065000 1.000 1.000 1500 120000 15 Corn, field, flour 0.025000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.025000 1.000 1.000 1500121000 15 Corn, field, meal 0.025000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.025000 1.000 1.000 1500122000 15 Corn, field, bran 0.025000 1.000 1.000 1500123000 15 Corn, field, starch 0.025000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.0 25000 1.000 1.000 1500124000 15 Corn, field, syrup 0.025000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.025000 1.500 1.000 1500125000 15 Corn, field, oil 0.025000 1.000 1.000 15 00125001 15 Corn, field, oil

- babyfood 0.025000 1.000 1.000 1500126000 15 Corn, pop 0.025000 1.000 1.000 1500127000 15 Corn, sweet 0.028000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.028000 1.000 1.000 1500381000 15 Triticale, flour 0.030000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.030000 1.000 1.000 1500401000 15 Wheat, grain 0 .030000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.030000 1.000 1.000 1500402000 15 Wheat, flour 0.030000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.030000 1.000 1.000 1500403000 15 Wheat, germ 0.030000 1.000 1.000 1500404000 15 Wheat, bran 0.030000 1.000 1.000 2003128000 20C Cottonseed, oil 0.070000 1.000 1.000 2003128001 20C Cottonsee d, oil

- babyfood 0.070000 1.000 1.000 3600222000 36 Milk, fat 0.005000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.005000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.005000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.005000 1.000 1.000 3600224000 36 Milk, water 0.005000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.005000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.005000 1.000 1.000 8601000000 86A Water, direct, all sources 0.174000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.174000 1.000 1.000Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

Page 10 of 11 

### Atta chment 2 : Acute Results

U.S. EPA Ver. 3.16, 03

- 08

- d DEEM
- FCID ACUTE Analysis for PYROXASULFONE NHANES 2003

- 2008 2

- Day Residue file: 090099ACUTEFOODANDWATER.R08 Adjustment factor #2 NOT used. Analysis Date: 03

- 14

- 2013/07:30:41 Residue file dated: 03

- 14

- 2013/07:27:15 RAC/FF intake summed over 24 hours Run Comment: ""

=============================================================================== Summary calculations

-- per capita: 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population : 0.011743 1.17 0.019265 1.93 0.036508 3.65 All Infants: 0.036358 3.64 0.048893 4.89 0.071891 7.19 Children 1

- 2: 0.018433 1.84 0.027559 2.76 0.0 65743 6.57 Children 3

- 5: 0.014987 1.50 0.022753 2.28 0.035901 3.59 Children 6

- 12: 0.011420 1.14 0.018189 1.82 0.028351 2.84 Youth 13

- 19: 0.009830 0.9 8 0.015964 1.60 0.023950 2.39 Adults 20

- 49: 0.011468 1.15 0.016873 1.69 0.024610 2.46 Adults 50

- 99: 0.010223 1.02 0.015436 1.54 0.024097 2.41 Female 13

- 49: 0.011618 1.16 0.016903 1.69 0.023846 2.38Pyroxasulfone Dieta ry Exposure and Risk Assessment DP Number: D 410009 & 410011

PC Code: 090099

Page 11 of 11 Attachment 3 : Chronic Results U.S. EPA Ver. 3.16, 03

- 08

- d DEEM
- FCID Chronic analysis for PYROXASULFONE NHANES 2 003

- 2008 2

- day Residue file name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 090099 Pyroxasulfone \ Wheat Cotton \ 090099CHRONICFOODANDWATER.R08 Adjustment factor #2 NOT used. Analysis Dat e 03

- 14

- 2013/07:28:29 Residue file dated: 03

- 14

- 2013/07:25:48 Reference dose (RfD, Chronic) = .02 mg/kg bw/day

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

--- ---------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.003812 19.1% Hispanic 0.003668 18.3% Non
- Hisp

- White 0.003913 19.6% Non
- Hisp

- Black 0.003168 15.8% Non
- Hisp

- Other 0.004376 21.9% Nursing Infants 0.003396 17.0% Non
- Nursing Infants 0.012457 62.3% Female 13+ PREG 0.003576 17.9% Children 1

- 6 0.005145 25.7% Children 7

- 12 0.003317 16.6% Male 13

- 19 0.002696 13.5% Female 13

- 19 /NP 0.002964 14.8% Male 20+ 0.003520 17.6% Female 20+/NP 0.003937 19.7% Seniors 55+ 0. 003622 18.1% All Infants 0.009660 48.3% Female 13

- 50 0.003752 18.8% Children 1

- 2 0.005808 29.0% Children 3

- 5 0.004876 24.4% Children 6

- 12 0.003492 17.5% Youth 13

- 19 0.002831 14.2% Adults 20

- 49 0.003765 18.8% Adults 50

- 99 0.003695 18.5% Female 13

- 49 0.003749 18.7%

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