Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 1 of 14 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM

Date: July 12, 2012

SUBJECT: Halosulfuron

- methyl Acute and Chronic Aggregate Dietary (Food and

Drinking Water ) Exposure and Risk Assessments for the Section 3 Registration Action on Proso Millet and Crop Group 17 (Grass, Forage, Fodder, and Hay)

.

PC Code: 128721 DP Barcode: D3 964 59 Decision No.: 4 53868 Registration Nos. : 81880

- 2

, 81880

- 6 and 81880

- 18 Petition No.: 1F7916 Regulatory Action: Section 3 Registration Risk Assessment Type: Dietary Case No.: NA T XR No.: NA CAS No.: 100784

- 20

- 1 MRID Nos.: NA 40 CFR: §180.479



### FROM : Cassi Walls

, Ph.D., Biologist

Risk Assessment Branch 3 Health Effects Division (7509 P)

THROUGH: Doug Doston, Ph.D., Chemist

Kristin Rury, MPH, Biologist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division ( HED; 7509P)

TO: Kable Davis, RM#25

Registration Division (7505P)Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 2 of 14 

### Executive Summary

A cute and chronic aggregate dietary (food and drinking water ) exposure and risk assessments were conducted using the Dietary E xposure Evaluation Model DEEM

FCIDTM, Version 2.03

, which use s food consumption data from the U.S. Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994

- 1996 and 1998

. The analyses were performed to suppor t a Section 3 request for

new use s proso millet and crop group 17 (grass, forage, fodder, and hay)

.

Acute and Chronic Dietary ( Food and Drinking Water) Exposure Results and Characterization

A cute and chronic dietary (food and drinking water) exposure assessment s were conducted for the current uses, proposed use s on proso millet and crop group 17 (grass, forage, fodder, and hay), and drinking water. U nrefined assessment s were conducted. The residue levels us ed in the assessment s for all commodities were the currently established and recommended tolerance levels ( D393948, M. Negussie

, 06/21/2012 )

. The assessment s were conducted using the assumption that 100% of the crop was treated (100%CT)

. Default (DEEM 7.81) processing factors were used unless processing studies were available

.

Estimated concentrations of halosulfuron

- methyl in drinking water from use on rice, which reflected the highest use rate, were provided by the Environmental Fate and Effects Div ision ( EFED ) and incorporated directly into the acute assessment. A Tier 1 drinking water assessment for the use on rice was performed using the FQPA Index Reservoir Screening Tool ( FIRST ) modeling. The acute and chronic estimated drinking
water concentr ation ( EDWC ) of halosulfuron

- methyl is not expected to exceed 59.2 ppb (0.0592 ppm) ( D394244, J. Meléndez, 5/15/2012)

. The acute dietary (food and drinking water) exposure to halosulfuron

- methyl is below HED ’s level of concern for the general U.S. popul ation and all population subgroups. For the general U.S. population, an appropriate dose/endpoint attributable to a single dose was not observed in the reviewed oral toxicity studies. T he acute dietary exposure estimate at the 95 th 

### percentile is <1 % of t he aPAD for females 13

- 49 years old, the only population subgroup of concern.

The chronic dietary (food and drinking water) exposure to halosulfuron

- methyl is below HED ’s level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 2 % of the cPAD for the general U.S. population and 6 % of the cPAD for all infants (<1 year old), the most highly exposed populatio n subgroup.

C ancer Dietary (Food and Drinking Water) Exposure Results and Characterization

H alosulfuron

- methyl is classified as “not likely to be a human carcinogen ;” therefore, quantification of human cancer risk is not required.Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 3 of 14 

### 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 unreasona ble adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non

- cancer chroni c 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 m illion

. References which discuss the acute and chronic risk assessments in more detail are availa ble on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21

- JUN

- 2000, web link: http://www.epa.gov/fedrgstr/EPA

- PEST/20 00/July/Day

- 12/6061.pdf ; or see SOP 99.6 ( 20

- AUG

- 1999 ).

The most recent dietary risk assessment for halosulfuron

- methyl was conducted by Debra Rate ( DP 367059, 03/04/2010 )

.

I I. Residue Information

Halosulfuron

- methyl Use:

On behalf of Canyon Group L.L.C., Gowan Company has proposed new uses of halosulfuron

- methyl on: proso millet and crop group 17 (grasses, forage, fodder, and hay)

. Permanent tolerances are established under §180.479(a)(1) for residues of halosulfuron

- methyl and its metabolites de termined as 3

- chloro

- 1

- methyl

- 5

- sulfamoylpyrazole

- 4

- carboxylic acid, expressed as halosulfuron

- methyl equivalent s, in/on the meat byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm. Tolerances are established under §180.479(a)(2) for residues of halosulfuron

- methyl in/on a variety of field, fruit, and vegetable crop commodities, at levels ranging from 0.05 to 2.0 ppm.

T he Metabolism Committee has concluded that t he residue of concern for tolerance enforcement and risk assessment in target plan ts, rotational plants

, and livestock is halosulfuron

- methyl (G. J. Herndon, No DP# s , 9/1 6 / 19 93 and 5/21/ 19 96). The enforcement method identifies residues containing 3

- chloro

- 1

- methyl

- 5

- sulfamyolpyrazole

- 4

- carboxylic acid (3

- CSA), and those are expressed in terms of parent. The tolerances account for all residues of concern for risk assessment purposes.

The residue of concern in water is halosulfuron

- methyl. The parent is mobile and persistent.Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 4 of 14 

### Residue Data used for Acute and Chronic Assessments:

T hese acute and chronic assessments are unrefined assessments using tolerance

- level residues and 100% CT for all commodities with proposed and established tolerances

. Additionally, d efault ( DEEM 7.81 ) processing factors were used unless processing studies were available

. The processing factors which were used were 1.5X for field corn syrup, 14.3X for dried tomato, 1.5X for tomato juice, 8.0X for dried apple, and 1.3X for apple juice. For some commodities, processing studies show ed that residues do not concentrate upon processing (i.e. tomato paste, tomato puree, potato flour and potato granules/flakes).

The proposed use of the additional livestock feed items (i.e., millet forage and hay and grass forage and hay) result in the need for increases in the meat byproduct tol erances and establishment of tolerances for fat, meat, and milk ( D393948, M. Negussie

, 06/21/2012).

. A summary of the tolerances and residue values used in the dietary analyses is provided in Table 1.

Table 1 . Tolerance Summary for Halosulfuron

- Methyl. Commodity Recommended Tolerance And Residue Value Used in the Acute and Chronic Analyses

(ppm) Millet, proso, grain 0.01 Cattle, meat byproducts 1 .0 Goat, meat byproducts 1. 0 Horse, meat byproducts 1. 0 Sheep, meat byproducts 1. 0 Cattle, fat 0.05 Cattle, meat 0.05 Goat, fat 0.05 Goat, meat 0.05 Horse, fat 0.05 Horse, meat 0.05
Milk 0.05 Sheep, fat 0.05 Sheep, meat 0.05



### III. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by EFED in the following memorandum: “ Halosulfuron methyl Drinking Water Assessment for Additional Food/Feed Uses on Proso Millet, Pasture and Rangeland Grass Forage, Fodder and Hay (Crop Group 17) ” ( D 394244

, J

. Meléndez, 5/ 15 / 20 12 ) and incorporated directly into this dietary assessment. Water residues were incorporated in the DEEM

-Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 5 of 14 

### FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” Sin ce the application rates associated with the proposed new uses did not exceed the application rate on rice (0.125 lb ai/A), a new drinking water assessment was not required for this dietary analysis.

The Tier I EDWCs for halosulfuron

- methyl are b ased on a maximum annual application rate of 0.125 lb ai/A for rice. The two screening models, FIRST and Screening Concentrations in Ground Water ( SCI

- GROW ) , were used for estimatin g EDWCs of halosulfuron

- methyl. Estimates for halosulfuron

- methyl in surface water based on the FIRST model for rice are 59.2 ppb for acute and chronic concentrations. It should be noted that the drinking water estimate based on rice application is an upper bound estimate. The estimate for halosulfuron

- methyl in groundwater based on the SCI

- GROW model result is 0.065 ppb. Table 2 summarizes the results.

Table 2

. Summary of Estimated Surface Water and Groundwater Concentrations fo r Halosulfuron

- methyl. Surface Water Conc., ppb a Groundwater Conc., ppb b

Acute 59.2 0.065 Chronic (non

- cancer) 59.2 0.065

a From the FIRST model.

b From the SCI

- GROW model.



### Halosulfuron

- methyl, like most other sulfonylurea herbicides, is extremely mobile with a median K oc 

### of 104 g/mL and K f 

### (Freundlich partition) values ranging from 0.32 to 3.6 in four test soils. Its persistence in soil and water appears to be highly variable. Halosulfuron

- methyl has the potential to leach to groundwater, and also presents concerns for transport to surface water by runoff.

The FIRST and SCI

- GROW model s and their description s are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

IV. DEEM

- FCIDTM Program and Consumption Information

Halosulfuron

- methyl acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Da tabase DEEM

- FCIDTM, Version 2.03

, which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (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 itHalosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 6 of 14 

### is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), ch ildren 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 com modity 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 oth er 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 fo r 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 tie rs of analysis. However, for unrefined assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk
assessment.

V. Toxicological Information

The risk assessment team confirmed endpo ints that were previously selected and confirmed the reduction to 1X of the FQPA Safety Factor for all population subgroups (D 358031

, W

. Phang

, 06 / 30 /200 9 ).

H alosulfuron

- methyl is classified as “ not likely to be carcinogenic to humans” based on a lack of evidence of carcinogenicity in male and female mice and rats. Therefore, halosulfuron

- methyl is not expected to pose a cancer risk for humans.

Toxicological endpoints for use in dietary exposure risk assessment s are summarized in Table 3 below

.Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 7 of 14 

### Table 3 . Summary of Toxicolo gi cal Doses and Endpoints for Halosulfuron

- methyl for Use in Dietary Exposure Risk Assessments Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD,

Level of Concern Study and Toxicological Effects

Acute Dietary (Females 13

- 49 years of age) NOAEL=

50 mg/kg/day UF A = 10x

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

0.5 mg/kg/day

aPAD =0.5 mg/kg/day Developmental Toxicity

- Rabbit

LOAEL = 150 mg/kg/day based on decreased mean litter size, increased number of resorptions (total and per dam) and increased postimplantation loss. (developmental toxicity) Acute Dietary (General Population

, including Infants and Children) N/A N/A N/A No appropriate dose/endpoint selected.

Chronic Dietary (All Populations) NOAEL=

10 mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Chronic

RfD = 0.1 mg/kg/day

cPAD = 0.1 mg/kg/day Chronic Toxicity

- Dog

LOAEL = 40 mg/kg/day based on decreased body weight gains in females.

Cancer (oral, dermal, inhalation) Classification: “ not likely to be carcinogenic to humans ” by the oral route, based on no

evidence of carcinogenicity from studies in rats and mice

. 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 obs erved adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (int er species). UF H = potential variation in sensitivity among members of the human population (int ra species). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = ch ronic). RfD = reference dose. N/A = not applicable.



### V I

. Results/Discussion

As stated above, for acute and chronic dietary assessments, HED is concerned when dietary risk ex ceeds 1 00% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 3 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

The acute dietary (food and drinking water) exposure to halosulfuron

- methyl is below HED’s level of concern. T he acute dietary exposure estimate at the 95 th 

### percentile is <1 % of the aPAD for females 13

- 49 years old, the only population subgroup of concern.Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 8 of 14 

### Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The chronic dietary (food and drinking water) exposure to halosulfuron

- methyl is below HED ’s level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 2 % of the cPAD for the general U.S. population and 6 % of the cPAD for all infants (<1 year old), the most highly exposed population subgroup.

Table 3

. Summary of Dietary Exposure and Risk for Halosulfuron

- methyl.

Population Subgroup Acute Dietary (95th Percentile) Chronic Dietary

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

General U.S. Population

N/A N/A 0.00 210 8 2

All Infants (< 1 year old) 0.005 726 6

Children 1

- 2 years old 0.00 5147 5

Children 3

- 5 years old 0.00 4144 4

Children 6

- 12 years old 0.00 2642 3

Youth 13

- 19 years old 0.001 674 2

Adults 20

- 49 years old 0.001 733 2

Adults 50+ years old 0.001 767 2

Females 13

- 49 years old 0.003 733 <1 0.001 726 2 The population subgroup with the highest estimated exposure/risk is bolded.



### VI I

. Characterization of Inputs/Outputs

An unrefined assessment was conducted. The residue levels used in the assessment for all commodities were the established or recommended tolerance levels. The assessment was conducted using the assumption that 100% of the crop was treated. Default (DEEM 7.81) processing factors were used unless processing studies were available

.

T he assessment could be refined with percent crop treated estimates , anticipated residues, or monitoring data. Since risk estimates are well below HED ’s level of concern, a more highly refined analysis is not needed at this time.

VIII. Conclusions

Acute and chronic dietary exposure assessments were conducted for the proposed uses on proso millet and crop group 17 (grass forage, fodder, and hay) . The analyses were unrefined assessments, using the proposed or established tolerances for all commoditie s ,Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 9 of 14 

### using the assumption of 100% CT, and d efault (DEEM 7.81) processing factors when appropriate

.

For both of the acute and chronic assessments, the general U.S. population and all
p opulation subgroups have risk estimates which are below HED ’s level of concern

. HED is confident that the acute and chronic assessments do not underestimate risk to the general U.S. population or any population subgroup.

IX. List of Attachments

Attachment 1: Acute and Chronic Foo d plus Water Residue Input File Attachment 2: Acute Results File Attachment 3 : Chronic Results FileHalosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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### Attachment 1: Acute and Chronic Food plus Water Residue Input File

Filename: C: \ Documents and Settings \ cwalls \ My Documents \ Cassi \ HED \ Halosulfuron \ New Use 2012 \ acute & chronic 070912.R98 Chemical: halosulfuron

- methyl RfD(Chronic): .1 mg/kg bw/day NOEL(Chronic): 10 mg/kg bw/day RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day Date created/last modified: 07

- 10

- 2012/13:06:19/8 Program ver. 2.03 Comment: Acute is only for Females 13

- 49 yrs

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01030150 1CD Arrowroot, flour 0.050000 1.000 1.000 9E7577 01030151 1CD Arrowroot, flour

- babyfood 0.050000 1.000 1.000 9E7577 01030170 1CD Artichoke, Jerusalem 0.050000 1.000 1.000 9E7577 01030820 1CD Cassava 0.050000 1.000 1.000 9E7577 01030821 1CD Cassava

- babyfood 0.050000 1.000 1.000 9E7577 01031390 1CD Dasheen, corm 0.050000 1.000 1.000 9E7577 01031660 1CD Ginger 0.050000 1.000 1.000 9E7577 01031661 1CD Ginger

- babyfood 0.050000 1.000 1.000 9E7577 01031670 1CD Ginger, drie d 0.050000 1.000 1.000 9E7577 01032960 1C Potato, chips 0.050000 1.000 1.000 9E7577 01032970 1C Potato, dry (granules/ flakes) 0.050000 1.000 1.000 9E7577 01032971 1C Potato, dry (granules/ fl akes)

- b 0.050000 1.000 1.000 9E7577 01032980 1C Potato, flour 0.050000 1.000 1.000 9E7577 01032981 1C Potato, flour

- babyfood 0.050000 1.000 1.000 9E7577 01032990 1C Potato, tuber, w/peel 0.0 50000 1.000 1.000 9E7577 01032991 1C Potato, tuber, w/peel

- babyfood 0.050000 1.000 1.000 9E7577 01033000 1C Potato, tuber, w/o peel 0.050000 1.000 1.000 9E7577 01033001 1C Potato, tuber, w/o peel

- babyfood 0.050000 1.000 1.000 9E7577 01033660 1CD Sweet potato 0.050000 1.000 1.000 9E7577 01033661 1CD Sweet potato

- babyfood 0.050000 1.000 1.000 9E7577 01033710 1CD Tanier, corm 0.050000 1.000 1.000 9E75 77 01033870 1CD Turmeric 0.050000 1.000 1.000 9E7577 01034060 1CD Yam, true 0.050000 1.000 1.000 9E7577 01034070 1CD Yam bean 0.050000 1.000 1.000 9E7577 04023220 4 B Rhubarb 0.050000 1.000 1.000 9E7577 06003470 6 Soybean, seed 0.050000 1.000 1.000 8F7424 06003480 6 Soybean, flour 0.050000 1.000 1.000 06003481 6 Soybean, flour

- babyfood 0.050000 1.000 1.000 06003490 6 Soybean, soy milk 0.050000 1.000 1.000 06003491 6 Soybean, soy milk

- babyfood or in 0.050000 1.000 1.000 06003500 6 Soybean, oil 0.050000 1.000 1.000 8F7424 06003501 6 Soybean, oil

- babyfood 0.050000 1.000 1.000 06010430 6A Bean, snap, succulent 0.050000 1.000 1.000 06010431 6A Bean, snap, succulent

- babyfood 0.050000 1.000 1.000 06020310 6 B Bean, broad, succulent 0.050000 1.000 1.000 9E7577 06020330 6B Bean, cowpea, succulent 0.050000 1.000 1.000 9E7577 06020370 6B Bean, lima, succulent 0.050000 1.000 1.000 9E7577 06022550 6B Pea, succ ulent 0.050000 1.000 1.000 9E7577 06022551 6B Pea, succulent

- babyfood 0.050000 1.000 1.000 9E7577 06022590 6B Pea, pigeon, succulent 0.050000 1.000 1.000 9E7577 06030300 6C Bean, black, seed 0.050000 1.000 1.000 06030320 6C Bean, broad, seed 0.050000 1.000 1.000 06030340 6C Bean, cowpea, seed 0.050000 1.000 1.000 06030350 6C Bean, great northern, seed 0.050000 1.000 1.000 06030360 6C Bean, kidney, seed 0.050000 1.000 1.000 06030380 6C Bean, lima, seed 0.050000 1.000 1.000 06030390 6C Bean, mung, seed 0.050000 1.000 1.000 06030400 6C Bean, nav y, seed 0.050000 1.000 1.000 06030410 6C Bean, pink, seed 0.050000 1.000 1.000 06030420 6C Bean, pinto, seed 0.050000 1.000 1.000 06030980 6C Chickpea, seed 0.050 000 1.000 1.000 06030981 6C Chickpea, seed

- babyfood 0.050000 1.000 1.000 06030990 6C Chickpea, flour 0.050000 1.000 1.000 06031820 6C Guar, seed 0.050000 1.000 1.000 06031821 6 C Guar, seed

- babyfood 0.050000 1.000 1.000 08001480 8 Eggplant 0.050000 1.000 1.000 08002340 8 Okra 0.050000 1.000 1.000 9E7577Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

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Page 11 of 14 08002700 8 Pepper, bell 0.050000 1.000 1.000 08002701 8 Pepper, bell

- babyfood 0.050000 1.000 1.000 08002710 8 Pepper, bell, dried 0.050000 1.000 1.000 08002711 8 Pepper, bell, dri ed

- babyfood 0.050000 1.000 1.000 08002720 8 Pepper, nonbell 0.050000 1.000 1.000 08002721 8 Pepper, nonbell

- babyfood 0.050000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.050000 1. 000 1.000 08003740 8 Tomatillo 0.050000 1.000 1.000 0F6169 08003750 8 Tomato 0.050000 1.000 1.000 0F6169 08003751 8 Tomato

- babyfood 0.050000 1.000 1.000 080037 60 8 Tomato, paste 0.050000 1.000 1.000 0F6169 08003761 8 Tomato, paste

- babyfood 0.050000 1.000 1.000 08003770 8 Tomato, puree 0.050000 1.000 1.000 0F6169 08003771 8 Tomato, pur ee
- babyfood 0.050000 1.000 1.000 08003780 8 Tomato, dried 0.050000 14.300 1.000 0F6169 08003781 8 Tomato, dried

- babyfood 0.050000 14.300 1.000 08003790 8 Tomato, juice 0 .050000 1.500 1.000 0F6169 09010750 9A Cantaloupe 0.100000 1.000 1.000 0E6206 09010800 9A Casaba 0.100000 1.000 1.000 0E6206 09011870 9A Honeydew melon 0.100000 1.0 00 1.000 0E6206 09013990 9A Watermelon 0.100000 1.000 1.000 09014000 9A Watermelon, juice 0.100000 1.000 1.000 09020210 9B Balsam pear 0.500000 1.000 1.000 09020880 9B Chayote, fruit 0.500000 1.000 1.000 09021020 9B Chinese waxgourd 0.500000 1.000 1.000 09021350 9B Cucumber 0.500000 1.000 1.000 0E6085 09023080 9B Pumpkin 0.500000 1.000 1.000 0E6085 09023090 9B Pumpkin, seed 0.500000 1.000 1.000 09023560 9B Squash, summer 0.500000 1.000 1.000 0E6085 09023561 9B Squash, summer

- babyfood 0.500000 1.000 1.000 09023570 9B Squash, winter 0.500000 1.000 1.000 0E6085 09023571 9B Squash, winter

- babyfood 0.500000 1.000 1.000 11000070 11 Apple, fruit with peel 0.050000 1. 000 1.000 9E7577 11000080 11 Apple, peeled fruit 0.050000 1.000 1.000 9E7577 11000081 11 Apple, peeled fruit

- babyfood 0.050000 1.000 1.000 9E7577 11000090 11 Apple, dried 0.050000 8.000 1.000 9 E7577 11000091 11 Apple, dried

- babyfood 0.050000 8.000 1.000 9E7577 11000100 11 Apple, juice 0.050000 1.300 1.000 9E7577 11000101 11 Apple, juice

- babyfood 0.050000 1.300 1.000 9E7577 1100011 0 11 Apple, sauce 0.050000 1.000 1.000 9E7577 11000111 11 Apple, sauce

- babyfood 0.050000 1.000 1.000 9E7577 13020570 13B Blueberry 0.050000 1.000 1.000 9E7577 13020571 13B Bluebe rry
- babyfood 0.050000 1.000 1.000 9E7577 13021360 13B Currant 0.050000 1.000 1.000 9E7577 13021370 13B Currant, dried 0.050000 1.000 1.000 9E7577 13021490 13B Elderberry 0.050000 1.000 1.000 9E7577 13021740 13B Gooseberry 0.050000 1.000 1.000 9E7577 13021910 13B Huckleberry 0.050000 1.000 1.000 9E7577 14000030 14 Almond 0.050000 1.000 1.000 8F4937 14000031 14 Almond

- babyfood 0.050000 1.000 1.000 14000040 14 Almond, oil 0.050000 1.000 1.000 8F4937 14000041 14 Almond, oil

- babyfood 0.050000 1.000 1.000 14000590 14 Brazil nut 0.050000 1.000 1.000 8F4937 14000680 14 Butternut 0.050000 1.000 1.000 14000810 14 Cashew 0.050000 1.000 1.000 8F4937 14000920 14 Chestnut 0.050000 1.000 1.000 8F4937 14001550 14 Filbert 0.050000 1.000 1.000 8F4937 14001560 14 Filbert, oil 0.050000 1.000 1.000 14001850 14 Hickory nut 0.050000 1.000 1.000 14002130 14 Macadamia nut 0.050000 1.000 1.000 8F4937 14002690 14 Pecan 0.050000 1.000 1.000 8F4937 14002820 14 Pista chio 0.050000 1.000 1.000 8F4937 14003910 14 Walnut 0.050000 1.000 1.000 8F4937 15001200 15 Corn, field, flour 0.050000 1.000 1.000 6F4661 15001201 15 Corn, field, flour

- babyfood 0.050000 1.000 1.000 15001210 15 Corn, field, meal 0.050000 1.000 1.000 6F4661 15001211 15 Corn, field, meal

- babyfood 0.050000 1.000 1.000 15001220 15 Corn, field, bran 0.050000 1.000 1.000 6F4661 15001230 15 Corn, field, starch 0.050000 1.000 1.000 6F4661 15001231 15 Corn, field, starch

- babyfood 0.050000 1.000 1.000 15001240 15 Corn, field, syrup 0.050000 1.500 1.000 6F 4661Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

______________________________________________________________________________________

Page 12 of 14 15001241 15 Corn, field, syrup

- babyfood 0.050000 1.500 1.000 15001250 15 Corn, field, oil 0.050000 1.000 1.000 6F4661 15001251 15 Corn, field, oil

- babyfood 0.050000 1.000 1.000 15001260 15 Corn, pop 0.050000 1.000 1.000 6F4661 15001270 15 Corn, sweet 0.050000 1.000 1.000 6F4661 15001271 15 Corn, sweet

- babyfood 0.050000 1.000 1.000 15002260 15 Millet, grain 0.010000 1.000 1.000 15003230 15 Rice, white 0.050000 1.000 1.000 8F4937 15003231 15 Rice, white

- babyfood 0.050000 1.000 1.000 15003240 15 Rice, brown 0.050000 1.00 0 1.000 8F4937 15003241 15 Rice, brown

- babyfood 0.050000 1.000 1.000 15003250 15 Rice, flour 0.050000 1.000 1.000 8F4937 15003251 15 Rice, flour

- babyfood 0.050000 1.000 1.000 15003260 15 Rice, bran 0.050000 1.000 1.000 8F4937 15003261 15 Rice, bran

- babyfood 0.050000 1.000 1.000 15003440 15 Sorghum, grain 0.050000 1.000 1.000 15003450 15 Sorghum, syrup 0.050000 1.000 1.000 15004050 15 Wild rice 0.050000 1.000 1.000 8F4937 21000440 M Beef, meat 0.050000 1.000 1.000 21000441 M Beef, meat

- babyfood 0.050000 1.000 1.000 21000450 M Beef, meat, dried 0.050000 1.900 1.000 21000460 M Beef, meat byproducts 1.000000 1.000 1.000 21000461 M Beef, meat byproducts

- babyfood 1.00000 0 1.000 1.000 21000470 M Beef, fat 0.050000 1.000 1.000 21000471 M Beef,fat

- babyfood 0.050000 1.000 1.000 21000480 M Beef, kidney 1.000000 1.000 1.000 21000490 M Beef, liver 1.000000 1.000 1.000 21000491 M Beef, liver

- babyfood 1.000000 1.000 1.000 23001690 M Goat, meat 0.050000 1.000 1.000 23001700 M Goat, meat byproducts 1.000000 1.000 1.000 23001710 M Goat, fat 0.050000 1.000 1.000 23001720 M Goat, kidney 1.000000 1.000 1.000 23001730 M Goat, liver 1.000000 1.000 1.000 24001890 M Horse, meat 0.050000 1.000 1.000 25002920 M Pork, meat byproducts 0.100000 1.000 1.000 3F4193 25002921 M Pork, meat byproducts

- babyfood 0.100000 1.000 1.000 25002940 M Pork, kidn ey 0.100000 1.000 1.000 3F4193 25002950 M Pork, liver 0.100000 1.000 1.000 3F4193 26003390 M Sheep, meat 0.050000 1.000 1.000 26003391 M Sheep, meat

- babyfood 0.050000 1.000 1.000 26003400 M Sheep, meat byproducts 1.000000 1.000 1.000 26003410 M Sheep, fat 0.050000 1.000 1.000 26003411 M Sheep, fat

- babyfood 0.050000 1.000 1.000 26003420 M Sheep, kidney 1.000000 1.000 1.000 26003430 M Sheep, liver 1.000000 1.000 1.000 27002220 D Milk, fat 0.050000 1.000 1.000 27002221 D Milk, fat

- baby food/infant for 0.050000 1.000 1.000 27012230 D Milk, nonfat solids 0.050000 1.000 1.000 27012231 D Milk, nonfat solids

- baby food/in 0.050000 1.000 1.000 27022240 D Milk, water 0.050000 1.000 1.000 27022241 D Milk, water

- babyfood/infant form 0.050000 1.000 1.000 27032251 D Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000 86010000 O Water, direct, all sources 0.059200 1. 000 1.000 DP#358

Full comment: DP#358032 86020000 O Water, indirect, all sources 0.059200 1.000 1.000 95000190 O Asparagus 0.800000 1.000 1.000 1F6229 95001280 O Cottonseed, oil 0.050000 1.000 1.000 8F4937 95001281 O Cottonseed, oil

- babyfood 0.050000 1.000 1.000 95003620 O Sugarcane, sugar 0.050000 1.000 1.000 6F4661 95003621 O Sugarcane, sugar

- babyfood 0.050000 1.000 1.000 95003630 O Sugarcane, molasses 0.050000 1.000 1.000 6F4661 95003631 O Sugarcane, molasses

- babyfood 0.050000 1.000 1.000Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

______________________________________________________________________________________

Page 13 of 14 

### Attachment 2: Acute Results File

U.S. Environmental Protection Agency Ver. 2.02
DEEM

- FCID ACUTE Analysis for HALOSULFURON

- METHYL (1994

- 98 data) Residue file: acute & chronic 070912.R98 Adjustment factor #2 NOT used. Analysis Date: 07

- 10

- 2012/13:10:21 Residue file dated: 07

- 10

- 2012/13:06:19/8 NOEL (Acute) = 50.000000 mg/kg body

- wt/day Daily totals for food and foodform consumption used. Run Comment: "Acute is only for Females 13

- 49 yrs"

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

Summa ry calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ----- ----- ------- -------- Females 13

- 49 yrs: 0.003733 0.75 13394 0.005704 1.14 8765 0.009630 1.93 5192Halosulfuron

- methyl Dietary Exposure and R isk Assessment DP Number: 396459

PC Code: 128721

______________________________________________________________________________________

Page 14 of 14 

### Attachment 3: Chronic Results File

U.S. Environmental Protection Agency Ver. 2.00
DEEM

- FCID Chronic analysis for HALOSULFURON

- METHYL (1994

- 98 data) Residue file name: C: \ Documents and Settings \ cwalls \ My Documents \ Cassi \ HED \ Halosulfuron \ New Use 2012 \ acute & chronic 070912.R98 Adjustment factor #2 NOT used. Analysis Date 07

- 10

- 2012/13:07:50 Residue file dated: 07

- 10

- 2012/13:06:19/8 Reference dose (RfD, Chronic) = .1 mg/kg bw/day COMMENT 1: Acute is only for Females 13

- 49 yrs

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

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

Total Exposure

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

-------------------------------------- ------------- --------------- U.S. Population (total) 0.002108 2.1%

U.S. Population (spring season) 0.002096 2.1% U.S. Population (summer se ason) 0.002244 2.2% U.S. Population (autumn season) 0.002065 2.1% U.S. Population (winter season) 0.002022 2.0%

Northeast region 0.002000 2.0% Midwest region 0.002150 2.1% Southern region 0.001987 2.0% Western region 0.002353 2.4%

Hispanics 0.002428 2.4%
Non

- hispanic whites 0.002054 2.1%
Non

- hispanic blacks 0.001993 2.0%
Non

- hisp/non

- white/non

- black 0.002557 2.6%

All infants (< 1 year) 0.005726 5.7% Nursing infants 0.002264 2.3%
Non

- nursing infants 0.007040 7.0% Children 1

- 6 yrs 0.004371 4.4% Children 7

- 12 yrs 0.002489 2.5%

Females 13

- 19 (not preg or nursing) 0.001547 1.5% Females 20+ (not preg or nursing) 0.001779 1.8% Females 13

- 50 yrs 0.001848 1.8% Females 13+ (preg/not nursing) 0.001961 2.0% Females 13+ (nursing) 0.002460 2.5%

Mal es 13

- 19 yrs 0.001789 1.8% Males 20+ yrs 0.001697 1.7% Seniors 55+ 0.001772 1.8%

Children 1

- 2 yrs 0.005147 5.1% Children 3

- 5 yrs 0.004144 4.1% Children 6

- 12 yrs 0.002642 2.6% Youth 13

- 19 yrs 0.001674 1 .7% Adults 20

- 49 yrs 0.001733 1.7% Adults 50+ yrs 0.001767 1.8% Females 13

- 49 yrs 0.001726 1.7%

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