Dietary Exposure and Risk Assessment

Thifensulfur on Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 1 of 14 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 A ggregate 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: D 369038 Decision Number: 405073 Registration Numb er : 352
- 633 Petition Number: 9F7523 Regulatory Action: Amended Section 3 Risk Assessment Type: Single Chemical , Aggregate Case Number: NA T XR Number: NA CAS Number: 79277
- 27
- 3 MRID Number: 47641801 40CFR: §180.439 Chemical Class: Triazinylsu lfonylurea 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 Res ponse Branch (RIMUERB) Registration Division (RD), 7505PDietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 2 of 14 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 TM), 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 analy ses were performed to support the Section 3 request for thifensulfuron methy l 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 thif ensulfuron methy l , 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 §180.43 9 [a] ) i n canola, flax, cotton, soy

bean, and cereal grain commodities. The residue of concern ( ROC ) , for both tolerance enforcement and risk assessment , is the parent compound, thifensulfuron methy l
. Both the acute and chronic assessments are highl y conservative, and assume 100% crop treated (%CT) , along with tolerance
- level residues for all agricultural commodities. The d efault processing factor from DEEM 7.81 w as used for corn sy rup in the anal ys es. Based on these highly

conservative assumptions, the acute dietary risk estimate , at the 95 th p ercentile of exposure , is less than 1% of the acute population
- adjusted dose (aPAD) for the population subgroup , female s 13
- 49
. This is the only subgroup for which an acute dietary endpoint was identified. Chronic dietary

risk estimates are less than o r equal to 1 % of the chronic population
adjusted dose (cPAD) for all population subgroups. Children 3 to 5 ye ars of age are the most highl y - exposed subgroup, utilizing 1 % of the cPAD, while the general US population also utilizes 1 % of the cPAD. Generall y, 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 b y the Cancer Assessment Review Committee (C ARC) 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 128 8 4 5 DP Barcode D369038

Page 3 of 14 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 uncertaint y and/ or safet y 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 ris k 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 19 99). The most recent dietary

risk assessment for thifensulfuron methyl was conducted by Douglas Dotson (D 332686 ; 1 2 Dec ember 200 6 ). That assessment appended the previous assessment to include residue est imates in rice and sorghum , supporting the establishment of permanent tolerance s for thifensulfuron meth yl i n th e raw agricultural commodities (RACs), and their associated commodit ies
. This current document includes residue estimates in safflower oil , sup porting the requested Section 3 registration of thifensulfuron methy l 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 t olerances hav e been established for thifensulfuron methyl (40CFR §180.43 9 [a] ) in cereal grains (barley, field corn, oat, rice, sorghum, triticale and wheat), canola, cotton, flax and soy beans
. The ROC, for both tolerance enforcement and risk assessment, is the parent compound, thifensulfuron methyl . Both the acute and chronic assessments are highl y 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 s yrup in the analy ses. The lowest limit of method validation (LLMV) was 0.050 ppm in safflower seeds, meal and refined oil. T hifensulfuron methy l residues were <LLMV in all samples from both the field trial and processing studies. Because thifensulfuron me thy l 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
- bab y food). In consideration of the proposed regional use of thifensulfuron meth yl on s afflower, 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

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 4 of 14 3. Drinking Water Data The thifensulfuron meth yl drinking water residue s u sed in the se dietary risk assessment s w ere provided in Drinking Water Assessments (DWAs) by the Environmental Fate and Effects Division ( EFED ) , and incorporated directl y into th e dietary assessment s . Water residues were incorporated in DEEM
- FCI D TM via entr y 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 utilizatio n of the FQPA Index Reservoir Screening Tool ( FIRST ) model ( D 363089 ; Andrew Shelb y 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 b y utilizing the FIRST model ( D332797; James Breithaupt; 26 October 2006 ). I n order t o be more c onservative, the highest of the acute , and the highest of the chronic EDWCs (among all th e various acute and chronic scenarios modeled) were taken from EFED’s two most re cent DWAs
. The acute and chronic EDWCs used in the respective dietary anal ys es are shown in Tables 1 and 2 (below), respectivel y, along with the other scenarios assessed b y EFED. TABLE 1 Maximum EDWCs for Drinking Water Risk Assessment, Based upon Grou nd Application

of Thifensulfuron Methyl. * Drinking Water Source [M odel Used] Use [Rate Modeled] Scenario Maximum EDWC (ppb) Groundwater [SCIGROW] Safflower [ 0 .0188 lbs ai/A] Ac ute and Chronic 0.0326 Barley, f allow [ 0 .0 56 lbs ai/A] Ac ute and Chronic 0.0972 Surface water [FIRST] Safflower [ 0.0188 lbs ai /A ] Ac ute 1.656 Chronic 0.336 Barley, f allow [ 0.0 56 lbs ai/A] Acute 4.429 Chronic 0.900 * D 363089 ; Andrew

Shelby and Nelson Thurman ; 29 September 2009. TABLE 2 Maximum EDWCs for Drinking Wa ter Risk Assessment, Based upon Aerial Application

of Thifensulfuron Methyl. * Drinking Water Source [M odel Used] Use [Rate Modeled] Scenario Maximum EDWC (ppb) Surface water [FIRST] Soy bean [ 0.032 lbs ai/A] Ac ute 3.9 Chronic 1.5 * D332797; James Breithaupt; 26 October 2006. Th e variou s model s used by EFED in conducting DWAs , and their description s, are available at the EPA web site via the web link , http://www.epa.gov/oppefed1/models/wat er/
. No surface or ground water monitoring data were available for thifensulfuron methy l
.Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 5 of 14 4 . DEEM - FCIDTM Program and Consumption Information T hifensulfuron meth yl acute and chronic dietary exposure asses sments were conducted using DEEM
- FCIDTM ( Versi on 2.03), which incorporates consumption data from USDA’s CSFII, 1994 to 1996 , and 1998. The 1994
- 96, 19 98 data are based on the reported consumption of more than 20,000 individuals over two non
- consecutive survey day s. 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 anal ys is of the 1994
- 96, 19 98 CSFII consumption data, which took into account dietary patterns and survey

respondents, HE D concluded that it is most appropriate to report risk for the following population subgroups: the general US population, all infants (<1 y ear old), children 1
- 2, children 3
- 5, children 6
- 12, y outh 13
- 19, adults 20
- 49, females 13
- 49, and adults 50+ y ears o ld. 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 dail y 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 consumpti on 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 pr obabilistic 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 wel l 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 analy sis. However, for analyses which are largely unrefined , significant differences in user v ersu s per capita exp osure 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 meth yl ’s use on safflower ( D3 61 90 2 ; William T . Dr ew ; 29 January 2010 ). The database adequately

characterizes thifensulfuron methy l as having low acute oral, dermal andDietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 6 of 14 inhalation toxicity
. It has low (Category I V) acute toxicity

via the oral route. By

inhalation and dermal routes o f exposure in the rat, there was relatively low (Category

III) acute toxicity
. There was moderate ey e irritation (Category III) , and slight dermal irritation (Category I V). It is not a dermal sensitizer. The risk assessment team evaluated the toxicolo gy 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 evalu ated the potential for increased susceptibility of infants and children from exposure to thifensulfuron meth yl . The team concluded that the FQPA Safet y Factor should be reduced to 1X, as there are no residual uncertainties for pre
- or post - natal toxicity
. Thifensulfuron meth yl was classified as not likel y to be a human carcinogen , based on the lack of evidence of carcinogenicit y in both the rat and the mouse
. T herefore, 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 L O C for Risk

Assessment Study and Toxicological Effects Ac ute d ietary ( females 13
- 49 only) NOAEL =

159 mg/kg/day UF A = 10X

UF H = 10 X FQPA SF = 1 aRfD = 1.59

mg/kg/day aPAD = 1.59 mg/kg/day Developmental o ral t oxicity in r ats.

LOAEL = 725 mg/kg/day, based on decreased mean body weight , and increased incidence of small renal papillae. Chronic d ietary (a ll populations ) NOAEL =

4.3 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1 cRfD = 0.043

mg/kg/day cPAD = 0.043 mg/kg/day Carcinogenicity o ral t oxicity 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 extrapolati on to determine risk associated with lower environmentally relevant human exposures. UF = Uncertainty Factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the huma n population (intraspecies). UF DB = 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 = Low est Observed Adverse Eff ect 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 anal ys es estimate the dietary exposure of the US population , and various population subgroups. The results of the acute anal ys i s are summarized in Table 4 (below) for females 13
- 49, the only subgroup for wh ich an acute dietaryDietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 7 of 14 endpoint was identified . As shown in Table 4 , the risk estimate associated with acute dietary exposure to thifensulfuron methy l is below HED’s LOC
. T he acute dietary risk estimate at the 95 th 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 (95 th Percentile) aPAD (m g/kg/day) Exposure Estimate (m g/kg/day) % a PAD General US Population NA * NA NA All Infants [< 1] Children [1
- 2] Children [3
- 5] Children [6
- 12] Youths [13
- 19] Ad ults [20
- 49] Ad ults [50+] Fem ales [13
- 49] 1.59 0.000544 <1 * NA = Not Applicable
. The results of the chr onic anal ys is are summarized in Table 5 (below) for the general US p opulation, all infants (<1 y ear old), children 1
- 2, children 3
- 5, children 6
- 12, y outh 13
- 19, females 13
- 49, adults 20
- 49, and adults 50+ years. Chronic dietary risk estimates are less th an or equal to 1 % of the cPAD for all population subgroups , as shown in Table 5 . Children 3 to 5 ye ars of age are the most highl y - 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 (m g/kg/day) Exposure Estimate (m g/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 Ad ults [20
- 49] 0.000239 1 Ad ults [50+] 0.000175 <1 Fem ales [13
- 49] 0.000226 1 * Values for the population subgroup with the highest risk are in bold ty pe . All acute and chronic dietary risk estimates are belo w HED’s LOC.Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 8 of 14 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 i n 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 methy l in/on sa fflower seeds
. 9 . List of Attachments Attachment 1. Thifensulfuron M eth yl Residues Used for Acute Dietary Exposure Estimates. Attachment 2
. Summary

of the Acute Dietary

Exposure and Risk Estimates for Thifensulfuron M ethyl
. Attachment 3
. Thifen sulfuron M eth yl Residues Used for Chronic Dietary Exposure Estimates. Attachment 4
. Summary

of the Chronic Dietary

Exposure and Risk Estimates for Thifensulfuron M ethyl
.Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 9 of 14 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 Comm ent 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 0.05 0000 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
- babyfo od 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 1.00 0 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 1 5003260 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
- bab yfood 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 1.0 00 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 Soybe an, soy milk
- babyfood or in 0.100000 1.000 1.000Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 DP Barcode D369038

Page 10 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 .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 150040 20 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 1.000Dietary Exposure and Risk Assessment

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Page 11 of 14 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 c apita): 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 0.00186 5 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 Y outh 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 0.0005 64 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 144884Dietary Exposure and Risk Assessment

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Page 12 of 14 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 Commo dity 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 15 001200 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
- b abyfood 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 1.00 0 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 1500233 0 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 0.05000 0 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 1.000Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 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 1.000Dietary Exposure and Risk Assessment

Thifensulfuron Methyl PC Code 128 8 4 5 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. Pop ulation (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% So uthern 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%