Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

PC Code: 128721

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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: D396459

Decision No.: 453868 Registration Nos.: 81880-2, 81880-6 and 81880-18

Petition No.: 1F7916 Regulatory Action: Section 3 Registration

Risk Assessment Type: Dietary Case No.: NA

TXR 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 (7509P)

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 Risk Assessment DP Number: 396459

PC Code: 128721

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Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk 

assessments were conducted using the Dietary Exposure Evaluation Model DEEMFCIDTM, Version 2.03, which uses 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 support a Section 3 request for 

new uses proso millet and crop group 17 (grass, forage, fodder, and hay).

 

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

Characterization

Acute and chronic dietary (food and drinking water) exposure assessments were

conducted for the current uses, proposed uses on proso millet and crop group 17 (grass, 

forage, fodder, and hay), and drinking water. Unrefined assessments were conducted. 

The residue levels used in the assessments for all commodities were the currently 

established and recommended tolerance levels (D393948, M. Negussie, 06/21/2012). 

The assessments 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 Division (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 concentration (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. population 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. The acute dietary exposure 

estimate at the 95th percentile is <1% of the 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 

population subgroup.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Halosulfuron-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 Risk Assessment DP Number: 396459

PC Code: 128721

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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 the point of departure (POD, NOAEL, LOAEL, e.g.) divided 

by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary 

risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk 

exceeds one in one million. References which discuss the acute and chronic risk 

assessments in more detail are available on the EPA/pesticides web site: “Available 

Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, 

web link: http://www.epa.gov/fedrgstr/EPA-PEST/2000/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 (DP367059, 03/04/2010).

II. 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 determined as 3-chloro-1-methyl-5-

sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalents,

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. 

The Metabolism Committee has concluded that the residue of concern for tolerance 

enforcement and risk assessment in target plants, rotational plants, and livestock is 

halosulfuron-methyl (G. J. Herndon, No DP#s, 9/16/1993 and 5/21/1996). 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 Risk Assessment DP Number: 396459

PC Code: 128721

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Residue Data used for Acute and Chronic Assessments:

These acute and chronic assessments are unrefined assessments using tolerance-level 

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

Additionally, default (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 showed 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 tolerances 

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)” (D394244, J. Meléndez, 5/15/2012) and incorporated 

directly into this dietary assessment. Water residues were incorporated in the DEEM-
Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

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

sources.” Since 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 based 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 estimating 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 for 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 Koc of 104 g/mL and Kf (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 models and their descriptions 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 

Database 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 it 
Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

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is most appropriate to report risk for the following population subgroups: the general U.S. 

population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-

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

For chronic dietary exposure assessment, an estimate of the residue level in each food or 

food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied 

by the average daily consumption estimate for that food/food form to produce a residue 

intake estimate. The resulting residue intake estimate for each food/food form is summed 

with the residue intake estimates for all other food/food forms on the commodity residue 

list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg 

body weight/day and as a percent of the cPAD. This procedure is performed for each 

population subgroup.

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

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

can be multiplied by a residue point estimate and summed to obtain a total daily pesticide 

exposure for a deterministic exposure assessment, or “matched” in multiple random 

pairings with residue values and then summed in a probabilistic assessment. The 

resulting distribution of exposures is expressed as a percentage of the aPAD on both a 

user (i.e., only those who reported eating relevant commodities/food forms) and a percapita (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 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 endpoints that were previously selected and 

confirmed the reduction to 1X of the FQPA Safety Factor for all population subgroups

(D358031, W. Phang, 06/30/2009). 

Halosulfuron-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 assessments are summarized in 

Table 3 below. 
Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

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Table 3. Summary of Toxicological 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

UFA= 10x

UFH= 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

UFA= 10x

UFH= 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 observed adverse effect level. LOAEL = lowest 

observed adverse effect level. UF = uncertainty factor. UFA = 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). 

RfD = reference dose. N/A = not applicable.

VI. Results/Discussion

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

dietary risk exceeds 100% 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. The acute dietary exposure estimate at the 95th percentile is 

<1% of the aPAD for females 13-49 years old, the only population subgroup of concern.
Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

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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

0.002108 2

All Infants (< 1 year old) 0.005726 6

Children 1-2 years old 0.005147 5

Children 3-5 years old 0.004144 4

Children 6-12 years old 0.002642 3

Youth 13-19 years old 0.001674 2

Adults 20-49 years old 0.001733 2

Adults 50+ years old 0.001767 2

Females 13-49 years old 0.003733 <1 0.001726 2

The population subgroup with the highest estimated exposure/risk is bolded.

VII. 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. 

The 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 commodities,
Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

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using the assumption of 100% CT, and default (DEEM 7.81) processing factors when 

appropriate. 

For both of the acute and chronic assessments, the general U.S. population and all 

population 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 Food plus Water Residue Input File

Attachment 2: Acute Results File

Attachment 3: Chronic Results File
Halosulfuron-methyl Dietary Exposure and Risk Assessment DP Number: 396459

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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, dried 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/ flakes)-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 0.050000 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 9E7577

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 4B 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 6B 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, succulent 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, navy, 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 0.050000 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 6C 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 9E7577
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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, dried-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 

08003760 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, puree-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 1.000 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 9E7577

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

11000110 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 Blueberry-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 Pistachio 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 6F4661
Halosulfuron-methyl Dietary Exposure and Risk 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 1.000 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 1.000000 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, kidney 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 1.000 
Halosulfuron-methyl Dietary Exposure and Risk 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"

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

Summary 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 5192 
Halosulfuron-methyl Dietary Exposure and Risk 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 season) 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%

Males 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%

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