  SEQ CHAPTER \h \r 1 

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.  

™ 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  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 

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

		Registration Division (RD), 7505P

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-FCID™), 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 population-adjusted 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).  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.  

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-FCID™ 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,  
HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  No surface or ground water
monitoring data were available for thifensulfuron methyl.  

4.	DEEM-FCID™ Program and Consumption Information

	Thifensulfuron methyl acute and chronic dietary exposure assessments
were conducted using DEEM-FCID™ (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

	  SEQ CHAPTER \h \r 1  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 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.    SEQ CHAPTER \h \r 1 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-FCID™
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 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.  

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.  



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
 

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
 



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  



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
 

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
 



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%

 

 

 



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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%

Dietary Exposure and Risk Assessment

Thifensulfuron Methyl			     PC Code 128845		 	       DP Barcode D369038

 PAGE   

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DRAFT – Confidential, Internal, and Deliberative Material

[Chemical Name]	Dietary Exposure and Risk Assessment	DP Number:
[xxxxxxx]

PC Code:  [xxxxxx]		

Dietary Exposure and Risk Assessment

Thifensulfuron Methyl			     PC Code 128845		 	       DP Barcode D369038

Dietary Exposure and Risk Assessment

Thifensulfuron Methyl			     PC Code 128845		 	       DP Barcode D369038

