Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128845 DP Barcode D369038

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF 

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE: 19 January 2010

SUBJECT: Thifensulfuron Methyl. Acute and Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk Assessments for the Section 3

Registration Action Associated with Food/Feed Use of the Herbicide on 

Safflower. 

PC Code: 128845 DP Barcode: D369038

Decision Number: 405073 Registration Number: 352-633

Petition Number: 9F7523 Regulatory Action: Amended Section 3

Risk Assessment Type: Single Chemical, Aggregate Case Number: NA

TXR Number: NA CAS Number: 79277-27-3

MRID Number: 47641801 40CFR: §180.439

Chemical Class: Triazinylsulfonylurea Herbicide Trade Name: DuPontTM Harmony® SG

REVIEWER:William T. Drew, Chemist

Risk Assessment Branch 2 (RAB2)

Health Effects Division (HED), 7509P

THROUGH: Debra Rate, PhD, Biologist

Thurston Morton, Chemist

Dietary Exposure Science Advisory Council (DESAC)

HED, 7509P

and

Michael Doherty, PhD, Senior Scientist

RAB2/HED, 7509P

TO: William T. Drew, Chemist and Risk Assessor

RAB2/HED, 7509P

and

Barbara Madden, RM Team 5

Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

Registration Division (RD), 7505P
Dietary Exposure and Risk Assessment

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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 software with the 

Food Commodity Intake Database (DEEM-FCIDTM), Version 2.03, which uses food 

consumption data from the US Department of Agriculture’s Continuing Surveys of Food Intakes 

by Individuals (CSFII), collected from 1994 to 1996, and 1998. These analyses were performed 

to support the Section 3 request for thifensulfuron methyl use on safflower in North Dakota, 

South Dakota, Nebraska, Montana (East of Route 87 or East of I-15), and Wyoming (East of I-25 

or North of I-90). All registered, pending and proposed uses of thifensulfuron methyl, as of the 

date of this memorandum, are included in these assessments. 

According to OPPTS Residue Chemistry Test Guideline 860.1000, Table 1 Feedstuffs 

(June 2008), safflower meal is the only animal feedstuff associated with the current petition. 

Safflower meal may constitute up to 5% of beef cattle diet, 10% of dairy cattle diet, 25% of 

poultry diet, and 5% of swine diet. In consideration of the proposed regional use of 

thifensulfuron methyl on safflower, and the observed residues of <0.050 ppm in safflower meal, 

the potential contribution to the maximum reasonably balanced dietary burdens of livestock is 

negligible. 

Tolerances have been established for thifensulfuron methyl (40CFR §180.439[a]) in 

canola, flax, cotton, soybean, and cereal grain commodities. The residue of concern (ROC), for 

both tolerance enforcement and risk assessment, is the parent compound, thifensulfuron methyl. 

Both the acute and chronic assessments are highly conservative, and assume 100% crop treated 

(%CT), along with tolerance-level residues for all agricultural commodities. The default 

processing factor from DEEM 7.81 was used for corn syrup in the analyses. 

Based on these highly conservative assumptions, the acute dietary risk estimate, at the 

95th percentile of exposure, is less than 1% of the acute population-adjusted dose (aPAD) for the

population subgroup, females 13-49. This is the only subgroup for which an acute dietary

endpoint was identified. 

Chronic dietary risk estimates are less than or equal to 1% of the chronic populationadjusted dose (cPAD) for all population subgroups. Children 3 to 5 years of age are the most 

highly-exposed subgroup, utilizing 1% of the cPAD, while the general US population also 

utilizes 1% of the cPAD. Generally, the Agency is concerned when risk estimates exceed 100% 

of the PAD; therefore, all acute and chronic dietary risk estimates are below HED’s level of 

concern (LOC). 

Thifensulfuron methyl has been classified by the Cancer Assessment Review Committee 

(CARC) as “not likely to be a human carcinogen.” Therefore, cancer risk is not of concern. 

1. 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 (the dose which HED has concluded will result in no unreasonable adverse health effects). 
Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128845 DP Barcode D369038

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This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD), such as the NOAEL or LOAEL, divided by the requisite uncertainty 

and/or safety factors. 

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

risk exceeds 100% of the PAD. 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 June 2000), which can be accessed via the web 

link http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf (or see SOP 99.6, 

dated 20 August 1999). 

The most recent dietary risk assessment for thifensulfuron methyl was conducted by

Douglas Dotson (D332686; 12 December 2006). That assessment appended the previous 

assessment to include residue estimates in rice and sorghum, supporting the establishment of

permanent tolerances for thifensulfuron methyl in the raw agricultural commodities (RACs), and 

their associated commodities. This current document includes residue estimates in safflower oil, 

supporting the requested Section 3 registration of thifensulfuron methyl for use on safflower in 

North Dakota, South Dakota, Nebraska, Montana (East of Route 87 or East of I-15), and 

Wyoming (East of I-25 or North of I-90). 

2. Residue Information

The Interregional Research Project Number 4 (IR-4), has submitted a tolerance petition, 

9F7523, proposing the establishment of a tolerance for residues of the herbicide, thifensulfuron 

methyl, in or on safflower seeds (RAC) at 0.05 ppm. Permanent tolerances have been 

established for thifensulfuron methyl (40CFR §180.439[a]) in cereal grains (barley, field corn, 

oat, rice, sorghum, triticale and wheat), canola, cotton, flax and soybeans. The ROC, for both 

tolerance enforcement and risk assessment, is the parent compound, thifensulfuron methyl. Both 

the acute and chronic assessments are highly conservative, and assume 100%CT, along with 

tolerance-level residues for all agricultural commodities. The default processing factor from 

DEEM 7.81 was used for corn syrup in the analyses. 

The lowest limit of method validation (LLMV) was 0.050 ppm in safflower seeds, meal 

and refined oil. Thifensulfuron methyl residues were <LLMV in all samples from both the field 

trial and processing studies. Because thifensulfuron methyl does not concentrate in safflower oil, 

the RAC tolerance (0.05 ppm) was entered into the acute and chronic DEEM input files for 

safflower oil (and safflower oil - baby food). In consideration of the proposed regional use of 

thifensulfuron methyl on safflower, and the observed residues of <0.050 ppm in safflower meal, 

the potential contribution to the maximum reasonably balanced dietary burdens of livestock is

negligible. 
Dietary Exposure and Risk Assessment

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3. Drinking Water Data

The thifensulfuron methyl drinking water residues used in these dietary risk assessments

were provided in Drinking Water Assessments (DWAs) by the Environmental Fate and Effects 

Division (EFED), and incorporated directly into the dietary assessments. Water residues were 

incorporated in DEEM-FCIDTM via entry into the food categories “water, direct, all sources” and 

“water, indirect, all sources.” 

The highest estimated drinking water concentration (EDWC) for acute scenarios was in 

surface water, at 0.0044 ppm. This concentration was derived via utilization of the FQPA Index 

Reservoir Screening Tool (FIRST) model (D363089; Andrew Shelby and Nelson Thurman; 29 

September 2009). The highest EDWC for chronic scenarios was also in surface water, at 0.0015 

ppm. This concentration was also obtained by utilizing the FIRST model (D332797; James 

Breithaupt; 26 October 2006). 

In order to be more conservative, the highest of the acute, and the highest of the chronic 

EDWCs (among all the various acute and chronic scenarios modeled) were taken from EFED’s 

two most recent DWAs. The acute and chronic EDWCs used in the respective dietary analyses 

are shown in Tables 1 and 2 (below), respectively, along with the other scenarios assessed by 

EFED. 

TABLE 1 Maximum EDWCs for Drinking Water Risk Assessment, Based upon Ground Application 

of Thifensulfuron Methyl.* 

Drinking Water Source 

[Model Used]

Use [Rate Modeled] Scenario Maximum EDWC 

(ppb)

Groundwater [SCIGROW] Safflower [0.0188 lbs ai/A] Acute and Chronic 0.0326

Barley, fallow [0.056 lbs ai/A] Acute and Chronic 0.0972

Surface water [FIRST] Safflower [0.0188 lbs ai/A] Acute 1.656

Chronic 0.336

Barley, fallow [0.056 lbs ai/A] Acute 4.429

Chronic 0.900

* D363089; Andrew Shelby and Nelson Thurman; 29 September 2009. 

TABLE 2 Maximum EDWCs for Drinking Water Risk Assessment, Based upon Aerial Application 

of Thifensulfuron Methyl.* 

Drinking Water Source 

[Model Used]

Use [Rate Modeled] Scenario Maximum EDWC 

(ppb)

Surface water [FIRST] Soybean [0.032 lbs ai/A] Acute 3.9

Chronic 1.5

* D332797; James Breithaupt; 26 October 2006. 

The various models used by EFED in conducting DWAs, and their descriptions, are

available at the EPA website via the web link, http://www.epa.gov/oppefed1/models/water/. No 

surface or ground water monitoring data were available for thifensulfuron methyl. 
Dietary Exposure and Risk Assessment

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4. DEEM-FCIDTM Program and Consumption Information

Thifensulfuron methyl acute and chronic dietary exposure assessments were conducted 

using DEEM-FCIDTM (Version 2.03), which incorporates consumption data from USDA’s 

CSFII, 1994 to 1996, and 1998. The 1994-96, 1998 data are based on the reported consumption 

of more than 20,000 individuals over two non-consecutive survey days. Foods “as consumed” 

(such as apple pie) are linked to EPA-defined food commodities (such as apples, peeled fruit -

cooked, fresh/unspecified, or baked; or wheat flour - cooked, fresh/unspecified, or 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 US population, and 

within population subgroups, but for acute exposure assessment, they are retained as individual 

consumption events (which is why it is appropriate to add residue values together for the acute 

assessment, while separate exposure estimates are summed for the chronic assessment). Based 

on analysis of the 1994-96, 1998 CSFII consumption data, which took into account dietary

patterns and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general US 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 (such as orange or orange juice) on the food commodity residue list is multiplied by

the average daily consumption estimate for that food/food form. The resulting residue 

consumption estimate for each food/food form is summed with the residue consumption 

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 (those who reported eating relevant 

commodities/food forms) and a per-capita (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 levels of refinement of the analysis. However, for analyses which are largely

unrefined, significant differences in user versus per capita exposure and risk are identified, and 

noted in the risk assessment. 

5. Toxicological Information

For detailed information, please refer to the human health risk assessment conducted for 

thifensulfuron methyl’s use on safflower (D361902; William T. Drew; 29 January 2010). The 

database adequately characterizes thifensulfuron methyl as having low acute oral, dermal and 
Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128845 DP Barcode D369038

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inhalation toxicity. It has low (Category IV) acute toxicity via the oral route. By inhalation and 

dermal routes of exposure in the rat, there was relatively low (Category III) acute toxicity. There 

was moderate eye irritation (Category III), and slight dermal irritation (Category IV). It is not a 

dermal sensitizer. 

The risk assessment team evaluated the toxicology database for thifensulfuron methyl,

and selected doses and endpoints for acute and chronic dietary exposure risk assessments. The 

acute and chronic dietary reference doses and PADs are summarized in Table 3 (below). The 

risk assessment team also evaluated the potential for increased susceptibility of infants and 

children from exposure to thifensulfuron methyl. The team concluded that the FQPA Safety 

Factor should be reduced to 1X, as there are no residual uncertainties for pre- or post-natal 

toxicity. 

Thifensulfuron methyl was classified as not likely to be a human carcinogen, based on 

the lack of evidence of carcinogenicity in both the rat and the mouse. Therefore, cancer dietary

risk is not of concern. 

TABLE 3 Summary of Thifensulfuron Methyl Toxicological Doses and Endpoints for Use in Dietary 

Exposure and Risk Assessments. 

Exposure/

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

LOC for Risk 

Assessment

Study and Toxicological Effects

Acute dietary

(females 13-49 

only)

NOAEL = 

159

mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1

aRfD = 1.59 

mg/kg/day

aPAD = 1.59 

mg/kg/day

Developmental oral toxicity in rats. 

LOAEL = 725 mg/kg/day, based on 

decreased mean body weight, and 

increased incidence of small renal 

papillae. 

Chronic dietary

(all populations)

NOAEL = 

4.3

mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1

cRfD = 0.043 

mg/kg/day

cPAD = 0.043 

mg/kg/day

Carcinogenicity oral toxicity in mice. 

LOAEL = 128 mg/kg/day, based on 

decreased body weight and body 

weight gain. 

Cancer (oral) Not likely to be a human carcinogen, based on the lack of evidence of carcinogenicity in rats 

and mice.

Point of Departure (POD) = a data point or estimated point derived from observed dose-response data, which is used 

to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. UF = Uncertainty Factor. UFA = extrapolation from animal to human (interspecies). UFH = potential 

variation in sensitivity among members of the human population (intraspecies). UFDB = database uncertainty factor

to account for the absence of key data (such as the lack of a critical study). FQPA SF = FQPA Safety Factor. 

NOAEL = No Observed Adverse Effect Level. LOAEL = Lowest Observed Adverse Effect Level. PAD = 

Population Adjusted Dose (a = acute, c = chronic). RfD = Reference Dose. MOE = Margin Of Exposure. LOC = 

Level Of Concern. 

6. Results/Discussion

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

risk exceeds 100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of 

the US population, and various population subgroups. The results of the acute analysis are 

summarized in Table 4 (below) for females 13-49, the only subgroup for which an acute dietary
Dietary Exposure and Risk Assessment

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endpoint was identified. As shown in Table 4, the risk estimate associated with acute dietary

exposure to thifensulfuron methyl is below HED’s LOC. The acute dietary risk estimate at the 

95th percentile of exposure is less than 1% of the aPAD for females 13-49. 

TABLE 4 Summary of Acute Dietary Exposure and Risk Estimates for Thifensulfuron Methyl. 

Population Subgroup

[Years of Age]

DEEM Acute Dietary Analysis (95th Percentile)

aPAD (mg/kg/day) Exposure Estimate 

(mg/kg/day)

% aPAD

General US Population NA* NA NA

All Infants [< 1]

Children [1-2]

Children [3-5]

Children [6-12]

Youths [13-19]

Adults [20-49]

Adults [50+]

Females [13-49] 1.59 0.000544 <1

* NA = Not Applicable. 

The results of the chronic analysis are summarized in Table 5 (below) for the general US 

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. Chronic dietary risk estimates are less than or 

equal to 1% of the cPAD for all population subgroups, as shown in Table 5. Children 3 to 5

years of age are the most highly-exposed subgroup. 

TABLE 5 Summary of Chronic Dietary Exposure and Risk Estimates for Thifensulfuron Methyl. 

Population Subgroup*

[Years of Age]

DEEM Chronic Dietary Analysis

cPAD (mg/kg/day) Exposure Estimate

(mg/kg/day)

% cPAD

General US Population 0.043 0.000284 1

All Infants [<1] 0.000487 1

Children [1-2] 0.000602 1

Children [3-5] 0.000621 1

Children [6-12] 0.000447 1

Youth [13-19] 0.000310 1

Adults [20-49] 0.000239 1

Adults [50+] 0.000175 <1

Females [13-49] 0.000226 1

* Values for the population subgroup with the highest risk are in bold type. 

All acute and chronic dietary risk estimates are below HED’s LOC. 
Dietary Exposure and Risk Assessment

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7. Characterization of Inputs/Outputs

This assessment is based on tolerance-level residues in all agricultural commodities, and 

assumes that all crops with existing or proposed tolerances are treated (100%CT). These 

assumptions result in highly conservative, health-protective estimates of dietary exposure and 

risk. 

8. Conclusions

There are no dietary exposure considerations that would preclude the establishment of a 

permanent tolerance for residues of thifensulfuron methyl in/on safflower seeds. 

9. List of Attachments

Attachment 1. Thifensulfuron Methyl Residues Used for Acute Dietary Exposure Estimates. 

Attachment 2. Summary of the Acute Dietary Exposure and Risk Estimates for Thifensulfuron

Methyl. 

Attachment 3. Thifensulfuron Methyl Residues Used for Chronic Dietary Exposure Estimates. 

Attachment 4. Summary of the Chronic Dietary Exposure and Risk Estimates for Thifensulfuron

Methyl. 
Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128845 DP Barcode D369038

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Attachment 1. Thifensulfuron Methyl Residues Used for Acute Dietary Exposure

Estimates.

Filename: C:\Documents and Settings\wdrew\My 

Documents\ThifensulfuronMethylDEEM102809AcuteInput.R98

Chemical: Thifensulfuron methyl

RfD(Chronic): .043 mg/kg bw/day NOEL(Chronic): 4.3 mg/kg bw/day

RfD(Acute): 1.59 mg/kg bw/day NOEL(Acute): 159 mg/kg bw/day

Date created/last modified: 10-23-2009/14:00:23/8 Program ver. 2.03

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

15000250 15 Barley, pearled barley 0.050000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.050000 1.000 1.000 

15000260 15 Barley, flour 0.050000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.050000 1.000 1.000 

15000270 15 Barley, bran 0.050000 1.000 1.000 

15001200 15 Corn, field, flour 0.050000 1.000 1.000 

15001201 15 Corn, field, flour-babyfood 0.050000 1.000 1.000 

15001210 15 Corn, field, meal 0.050000 1.000 1.000 

15001211 15 Corn, field, meal-babyfood 0.050000 1.000 1.000 

15001220 15 Corn, field, bran 0.050000 1.000 1.000 

15001230 15 Corn, field, starch 0.050000 1.000 1.000 

15001231 15 Corn, field, starch-babyfood 0.050000 1.000 1.000 

15001240 15 Corn, field, syrup 0.050000 1.500 1.000 

15001241 15 Corn, field, syrup-babyfood 0.050000 1.500 1.000 

15001250 15 Corn, field, oil 0.050000 1.000 1.000 

15001251 15 Corn, field, oil-babyfood 0.050000 1.000 1.000 

95001280 O Cottonseed, oil 0.020000 1.000 1.000 

95001281 O Cottonseed, oil-babyfood 0.020000 1.000 1.000 

20001630 20 Flaxseed, oil 0.020000 1.000 1.000 

15002310 15 Oat, bran 0.050000 1.000 1.000 

15002320 15 Oat, flour 0.050000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.050000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.050000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.050000 1.000 1.000 

20003190 20 Rapeseed, oil 0.020000 1.000 1.000 

20003191 20 Rapeseed, oil-babyfood 0.020000 1.000 1.000 

15003230 15 Rice, white 0.050000 1.000 1.000 

15003231 15 Rice, white-babyfood 0.050000 1.000 1.000 

15003240 15 Rice, brown 0.050000 1.000 1.000 

15003241 15 Rice, brown-babyfood 0.050000 1.000 1.000 

15003250 15 Rice, flour 0.050000 1.000 1.000 

15003251 15 Rice, flour-babyfood 0.050000 1.000 1.000 

15003260 15 Rice, bran 0.050000 1.000 1.000 

15003261 15 Rice, bran-babyfood 0.050000 1.000 1.000 

20003300 20 Safflower, oil 0.050000 1.000 1.000 

20003301 20 Safflower, oil-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 

06003470 6 Soybean, seed 0.100000 1.000 1.000 

06003480 6 Soybean, flour 0.100000 1.000 1.000 

06003481 6 Soybean, flour-babyfood 0.100000 1.000 1.000 

06003490 6 Soybean, soy milk 0.100000 1.000 1.000 

06003491 6 Soybean, soy milk-babyfood or in 0.100000 1.000 1.000 
Dietary Exposure and Risk Assessment

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06003500 6 Soybean, oil 0.100000 1.000 1.000 

06003501 6 Soybean, oil-babyfood 0.100000 1.000 1.000 

86010000 O Water, direct, all sources 0.004429 1.000 1.000 

86020000 O Water, indirect, all sources 0.004429 1.000 1.000 

15004010 15 Wheat, grain 0.050000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.050000 1.000 1.000 

15004020 15 Wheat, flour 0.050000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.050000 1.000 1.000 

15004030 15 Wheat, germ 0.050000 1.000 1.000 

15004040 15 Wheat, bran 0.050000 1.000 1.000 

15004050 15 Wild rice 0.050000 1.000 1.000 
Dietary Exposure and Risk Assessment

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Attachment 2. Summary of the Acute Dietary Exposure and Risk Estimates for 

Thifensulfuron Methyl. 

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID ACUTE Analysis for THIFENSULFURON METHYL (1994-98 data)

Residue file: ThifensulfuronMethylDEEM102809AcuteInput.R98

Adjustment factor #2 NOT used.

Analysis Date: 10-28-2009/14:17:09 Residue file dated: 10-28-2009/14:03:14/8

NOEL (Acute) = 159.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

U.S. Population:

 0.000790 0.05 201329 0.001202 0.08 132237 0.002047 0.13 77661 

All infants:

 0.001815 0.11 87615 0.002571 0.16 61845 0.003896 0.25 40812 

Children 1-2 yrs:

 0.001369 0.09 116148 0.001865 0.12 85250 0.004932 0.31 32238 

Children 3-5 yrs:

 0.001265 0.08 125643 0.001766 0.11 90038 0.003927 0.25 40492 

Children 6-12 yrs:

 0.000933 0.06 170425 0.001240 0.08 128245 0.002007 0.13 79203 

Youth 13-19 yrs:

 0.000703 0.04 226112 0.000948 0.06 167751 0.001585 0.10 100314 

Adults 20-49 yrs:

 0.000585 0.04 271798 0.000816 0.05 194939 0.001211 0.08 131305 

Adults 50+ yrs:

 0.000427 0.03 372470 0.000564 0.04 282102 0.000898 0.06 176978 

Females 13-49 yrs:

 0.000544 0.03 292158 0.000745 0.05 213285 0.001097 0.07 144884 
Dietary Exposure and Risk Assessment

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Attachment 3. Thifensulfuron Methyl Residues Used for Chronic Dietary Exposure 

Estimates.

Filename: C:\Documents and Settings\wdrew\My 

Documents\ThifensulfuronMethylDEEM102309ChronicInput.R98

Chemical: Thifensulfuron methyl

RfD(Chronic): .043 mg/kg bw/day NOEL(Chronic): 4.3 mg/kg bw/day

RfD(Acute): 1.59 mg/kg bw/day NOEL(Acute): 159 mg/kg bw/day

Date created/last modified: 10-23-2009/13:57:26/8 Program ver. 2.03

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

15000250 15 Barley, pearled barley 0.050000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 0.050000 1.000 1.000 

15000260 15 Barley, flour 0.050000 1.000 1.000 

15000261 15 Barley, flour-babyfood 0.050000 1.000 1.000 

15000270 15 Barley, bran 0.050000 1.000 1.000 

15001200 15 Corn, field, flour 0.050000 1.000 1.000 

15001201 15 Corn, field, flour-babyfood 0.050000 1.000 1.000 

15001210 15 Corn, field, meal 0.050000 1.000 1.000 

15001211 15 Corn, field, meal-babyfood 0.050000 1.000 1.000 

15001220 15 Corn, field, bran 0.050000 1.000 1.000 

15001230 15 Corn, field, starch 0.050000 1.000 1.000 

15001231 15 Corn, field, starch-babyfood 0.050000 1.000 1.000 

15001240 15 Corn, field, syrup 0.050000 1.500 1.000 

15001241 15 Corn, field, syrup-babyfood 0.050000 1.500 1.000 

15001250 15 Corn, field, oil 0.050000 1.000 1.000 

15001251 15 Corn, field, oil-babyfood 0.050000 1.000 1.000 

95001280 O Cottonseed, oil 0.020000 1.000 1.000 

95001281 O Cottonseed, oil-babyfood 0.020000 1.000 1.000 

20001630 20 Flaxseed, oil 0.020000 1.000 1.000 

15002310 15 Oat, bran 0.050000 1.000 1.000 

15002320 15 Oat, flour 0.050000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.050000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.050000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.050000 1.000 1.000 

20003190 20 Rapeseed, oil 0.020000 1.000 1.000 

20003191 20 Rapeseed, oil-babyfood 0.020000 1.000 1.000 

15003230 15 Rice, white 0.050000 1.000 1.000 

15003231 15 Rice, white-babyfood 0.050000 1.000 1.000 

15003240 15 Rice, brown 0.050000 1.000 1.000 

15003241 15 Rice, brown-babyfood 0.050000 1.000 1.000 

15003250 15 Rice, flour 0.050000 1.000 1.000 

15003251 15 Rice, flour-babyfood 0.050000 1.000 1.000 

15003260 15 Rice, bran 0.050000 1.000 1.000 

15003261 15 Rice, bran-babyfood 0.050000 1.000 1.000 

20003300 20 Safflower, oil 0.050000 1.000 1.000 

20003301 20 Safflower, oil-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 

06003470 6 Soybean, seed 0.100000 1.000 1.000 

06003480 6 Soybean, flour 0.100000 1.000 1.000 

06003481 6 Soybean, flour-babyfood 0.100000 1.000 1.000 

06003490 6 Soybean, soy milk 0.100000 1.000 1.000 

06003491 6 Soybean, soy milk-babyfood or in 0.100000 1.000 1.000 
Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128845 DP Barcode D369038

Page 13 of 14

06003500 6 Soybean, oil 0.100000 1.000 1.000 

06003501 6 Soybean, oil-babyfood 0.100000 1.000 1.000 

86010000 O Water, direct, all sources 0.001500 1.000 1.000 

86020000 O Water, indirect, all sources 0.001500 1.000 1.000 

15004010 15 Wheat, grain 0.050000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 0.050000 1.000 1.000 

15004020 15 Wheat, flour 0.050000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 0.050000 1.000 1.000 

15004030 15 Wheat, germ 0.050000 1.000 1.000 

15004040 15 Wheat, bran 0.050000 1.000 1.000 

15004050 15 Wild rice 0.050000 1.000 1.000 
Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128845 DP Barcode D369038

Page 14 of 14

Attachment 4. Summary of the Chronic Dietary Exposure and Risk Estimates for 

Thifensulfuron Methyl. 

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for THIFENSULFURON METHYL (1994-98 data)

Residue file name: C:\Documents and Settings\wdrew\My 

Documents\ThifensulfuronMethylDEEM102309ChronicInput.R98

 Adjustment factor #2 NOT used.

Analysis Date 10-23-2009/14:03:18 Residue file dated: 10-23-2009/13:57:26/8

Reference dose (RfD, Chronic) = .043 mg/kg bw/day

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.000284 0.7%

U.S. Population (spring season) 0.000288 0.7%

U.S. Population (summer season) 0.000288 0.7%

U.S. Population (autumn season) 0.000280 0.7%

U.S. Population (winter season) 0.000281 0.7%

Northeast region 0.000273 0.6%

Midwest region 0.000296 0.7%

Southern region 0.000274 0.6%

Western region 0.000298 0.7%

Hispanics 0.000308 0.7%

Non-hispanic whites 0.000276 0.6%

Non-hispanic blacks 0.000291 0.7%

Non-hisp/non-white/non-black 0.000335 0.8%

All infants (< 1 year) 0.000487 1.1%

Nursing infants 0.000185 0.4%

Non-nursing infants 0.000602 1.4%

Children 1-6 yrs 0.000602 1.4%

Children 7-12 yrs 0.000429 1.0%

Females 13-19 (not preg or nursing) 0.000270 0.6%

Females 20+ (not preg or nursing) 0.000196 0.5%

Females 13-50 yrs 0.000239 0.6%

Females 13+ (preg/not nursing) 0.000244 0.6%

Females 13+ (nursing) 0.000261 0.6%

Males 13-19 yrs 0.000348 0.8%

Males 20+ yrs 0.000236 0.5%

Seniors 55+ 0.000170 0.4%

Children 1-2 yrs 0.000602 1.4%

Children 3-5 yrs 0.000621 1.4%

Children 6-12 yrs 0.000447 1.0%

Youth 13-19 yrs 0.000310 0.7%

Adults 20-49 yrs 0.000239 0.6%

Adults 50+ yrs 0.000175 0.4%

Females 13-49 yrs 0.000226 0.5%