Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

PC Code: 128721

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Page 1 of 14 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 **OFFICE OF CHEMICA**  **L SA FETY**  **AND POLLUTION PREVENTION**  

### MEMORANDUM **Date:** 03/11 /2013 **SUBJECT: Halosulfuron**  **- methyl**  **.** Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Artichoke and Can eberry Subgroup 13 - 07A. **PC Code:** 128721 **DP Barcode:** D 405660 **Decision No.:** 465913 **Registration Nos. :**  81880 - 18 and 81880 - 2 **Petition No.:** 2E8050 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary **Case No.:** NA **T XR No.:**  NA **CAS No.:** 100784 - 20 - 1 **MRID No.:** NA **40 CFR:** §180.479 **FROM :**  Meheret Negussie , Chemist

Risk Assessment Branch III Health Effects Division (7509 P) **THROUGH:** Donna Davis , Chemist

Ideliz Negron - Encarnacion Ph.D., Chemist 

### Dietary Exposure Science Advisory Council (DESAC) Health Effects Division ( HED; 7509P) **TO:** Christine Olinger, Branch Chief

Sheila Heal y, Ph.D., To x icologist/Risk Assessor HED/RAB3 (7509P)

and Barbara Madden/S ydne y Jackson (RM Team 03) Risk Integration Minor Use, and Emergency Response Branch Registration Division (7505P)Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### Executive Summary Acute and c hronic aggregate dietary (food and drinking water) exposure and risk assessment s w ere conducted using the Dietary Exposure Evaluation Model software with the Food Commodity

Intake Database (DEEM - FCID) Version 3.16. This software uses 2003 - 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA). The anal ys es were conducted to support a human health risk assessment for the proposed Section 3 reques ts on artichoke and c aneberry

Subgroup 13 - 07A . This memorandum was reviewed b y two peer reviewers of the DESAC, per DESAC SOP 2012.1. Acute and Chronic Dietary ( Food and Drinking Water) Exposure Results and Characterization A cute and chronic dietary (food and drinking water) exposure assessment s were conducted for the current uses, and proposed new use s on artichoke and caneberry Subgroup 13 - 07A . T he assumptions of the dietary assessment s included tolerance - level residues for all commodities and 100 % crop treated (CT) for all crops . DEEM version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities or when processing studies showed no concentration. M odeled estimated drinking water concentrations were included in the assessment There was no indication of an adverse effect attributable to a single dose for the general U.S. population. However, an acute reference dose (aRfD) was establ ished for females 13 - 49 y ears old, and an acute dietary

exposure assessment was only conducted for females 13 - 49 y ears old. The acute dietary

exposure estimate at the 95 th 

### percentile is <1 % of the acute population adjusted dose ( aPAD ) for females 13 - 49 ye ars old . The chronic dietary

(food and drinking water) exposure to halosulfuron - methyl is below HED ’s level of concern (<100% of the chronic population adjusted dose (cPAD)) for the general U.S. population and all population subgroups. The chronic diet ary exposure estimates are 2 .0 % of the cPAD for the general U.S. population and 5.5 % of the cPAD for children 1 - 2 ye ar old, the most highl y exposed population subgroup. C ancer Dietary (Food and Drinking Water) Exposure Results and Characterization H alosulfuron - methyl is classified as “not likel y to be a human carcinogen ;” therefore, quantification of human cancer risk is not required. **I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasona ble adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to theHalosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertaint y or safet y factors. For acute and non - cancer chr onic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one m illion . References which discuss the acute and chronic risk assessments in more detail are ava ilable on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: http://www.epa.gov/fedrgstr/EPA PE ST/2000/July

/Day - 12/6061.pdf ; or see SOP 99.6 ( 20 - AUG - 1999 ). The most recent dietary

risk assessment for halosulfuron - methyl was conducted b y Cassi Walls ( D 3 96459 , 07/12 /201 2 ) . **I I.**  **Residue Information** The Interregional Research Project No. 4 (IR - 4) has proposed new uses of halosulfuron - methyl on artichoke and c aneberry Subgroup 13 - 07A . Permanent tolerances are established under §180.479(a)(1) for residues of halosulfuron - methyl and its metabolites determined as 3 - chloro - 1 - methyl - 5 - sulfamoylpy

razole - 4 - carbox yl ic acid, expressed as halosulfuron - methyl equivalent s , at levels ranging from 0.05 ppm ( milk, fat and meat) to 1.0 ppm ( meat by products ) of cattle, goat, hog, horse, and sheep at 0.1 ppm. Tolerances are established under §180.479(a)(2) for residues of halosulfuron - methyl in/on a variet y of field, fruit, and vegetable crop commodities at levels ranging from 0.05 to 2.0 ppm. T he Metabolism Committee has concluded that the residue of conc ern for tolerance enforcement and risk assessment in target plants and rotational plants is halosulfuron - methyl (G. J. Herndon, No DP# s , 9/1 6 / 19 93 and 5/21/ 19 96). HED previousl y has concluded that the residue of concern in ruminants is halosulfuron - methyl. However, because the approved enforcement method for livestock commodities quantifies the parent compound and metabolites containing the 3 - CSA moiety by converting residues to 3 - CSA, tolerances f

or residues of parent and its metabolites in livestock commodities are determined as 3 - CSA, expressed in halosulfuron - methyl equivalents. The residue of concern in water is halosulfuron - methyl. Residue Data used for Acute and Chronic Assessments: Th ese acute and chronic assessments are unrefined assessments using tolerance - level residues and 100% CT for all commodities . Additionally , DEEM version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities or when processing studies showed no concentration . Based on processing studies, the processing factors for tomato paste, tomato puree, potato flour and potato granules/flakes were reduced to 1 .Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### Table 1 is a summary

of the HED recommende d food tolerances resulting from the proposed uses (D405659, L. Cheng, 11/26/2012). **Table 1 . Tolerance Summary for**  **the New Uses for Halosulfuron**  **- Methyl.**  Commodity Recommended Tolerance s Used in the Ac ute and Chronic Analyses

(ppm) Artichoke 0.05 Caneberry Subgroup 13 - 07A 0.05 

### III. **Drinking Water Data (We didn’t receive the water memo, but**  **EFED communicated**  **(email) that there is no change.** The drinking water residues used in the acute dietary risk assessment were provided b y EFED in the following memorandum: “ Halosulfuron methyl Drinking Water Assessment for Additional Food/Feed Uses on Proso Millet, Pasture and Rangeland Grass Forage, Fodder and Hay (Crop Group 17) ” ( D 394244 , J . Meléndez, 5/ 15 /20 12 ) and incorporated directl y i nto this dietary assessment. Water residues were incorporated in the DEEM - FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” Since the application rates associated with the proposed new uses did not exceed the application rate on rice (0.125 lb ai/A), a new acute drinking water assessment was not required for th e acute dietary assessment (personal communication via email from Jose Melendez to Meheret Neghussie, date) . Monitoring data is not available for halosulfuron - methyl; therefore estimated drinking water concentrations (EDWCs) were derived from models. Acute Tier I EDWCs for halosulfuron - methyl were based on a maximum annual application rate of 0.125 lb ai/A for rice. The two screening models, FIRST and Screening Concentrations in Ground Water ( SCI - GROW ) , were used for estimatin g EDWCs of halosulfuron - methyl. Estimates for halosulfuron - methyl in surface water based on the FIRST model for rice are 59.2 ppb for acute and chronic concentrations . This value was used for the acute dietary assessment only . HED notes that this drinking water value is considered to be highl y conservative and reflects a calculated concentration of residue in a shallow farm p ond based on the maximum application rate on the label. HED considers this value appropriate as a screening level assessment for potential acute exposure and since the calculated concentration does not pose a risk of concern, further refinement is not req uired. The estimate for halosulfuron - methyl in groundwater based on the SCI - GROW model result is 0.065 ppb. Table 2 summarizes the results.Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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Page 5 of 14 **Table 2**  **. Summary of Estimated Surface Water and Groundwater Concentrations fo**  **r Halosulfuron**  **- me**  **thyl. Surface Water Conc., ppb**  **a Groundwater Conc., ppb**  **b** Ac ute 59.2 0.065 Chronic (non - cancer) 59.2 0.065 a From the FIRST model. b From the SCI - GROW model. 

### Halosulfuron - methyl, like most other sulfonylurea herbicides, is extremel y mobile with a median Koc 

### of 104 g/mL and Kf 

### (Freundlich partition) values ranging from 0.32 to 3.6 in four test soils. Its persistence in soil and water appears to be highly variable. Halosulfuron - methyl has the potential to leach to groundwater, and also presents concerns fo r transport to surface water b y runoff. **IV. DEEM**  **- FCIDTM Program and Consumption Information**  Halosulfuron - methyl acute and chronic dietary exposure assessments w ere conducted using the DEEM - FCID, Version 3.16, which incorporates 2003 - 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups. However, for acute exposure assessment, consumption data are retained as individual consumption events. Based on anal ys is of the 2003 - 2008 WWEIA 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 U.S. population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 y ears old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form (e.g., orange or orange juice) on the foo d commodity residue list is multiplied by the average dail y consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for al l 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. **V. Toxicolog**  **ical Information** The risk assessment team confirmed endpoints that were previously selected and confirmed the reduction to 1X of the FQPA Safet y Factor for all population subgroups (D 358031 , W . Phang , 06 / 30 /200 9 ).Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### Toxicological endpoints for use in dietary exposure risk assessment s are summarized in Table 3 below . **Table 3**  **. Summary of Toxicological Doses and Endpoints for Halosulfuron -**  **me thyl for Use in Dietary**  **Exposure Risk Assessments .**  **Exposure/ Scenario**  **Point of**

**Departure Uncertainty/FQPA** 

**Safet y Factors**  **RfD, PAD,**

**Level of Concern**  **Study and Toxicological Effects** Ac ute Dietary (Females 13 - 49 years of age) NOAEL=

50 mg/kg/day UF A= 10x

UF H = 10x FQPA SF= 1x Ac ute RfD =

0.5 mg/kg/day aPAD =0.5 mg/kg/day **Developm ental Toxicity**  **- Rabbit** 

LOAEL = 150 mg/kg/day based on decreased mean litter size, increased number of resorptions (total and per dam) and increased postimplantation loss. (developmental toxicity) Ac ute Dietary (General Population , including Infants and Children) N/A N/A N/A **No effect seen in the database that is**  **likely the result of a single exposure; therefore, no**  **dose/endpoint selected.**

Chronic Dietary (All Populations) NOAEL=

10 mg/kg/day UF A= 10x

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

= 0.1 mg/kg/day cPAD = 0.1 mg/kg/day **Chronic Toxicity -**  **Dog**

LOAEL = 40 mg/kg/day based on decreased body weight gains in females. Cancer (oral, dermal, inhalation) **Classification: “**  **not likely to be carcinogenic to hum ans**  **”** by the oral route, based on no

evidence of carcinogenicity from studie s in rats and mice . Point of Departure (POD) = A data point or an estimated point that is derived from observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human expos ures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human populat ion (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. N/A = not applicable. 

### V **I .**  **Results/Discussion** As stated above, for acute and chronic dietary assessments, HED is concerned when dietary risk exceeds 1 00% of the PAD. The DEEM - FCID  anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 3 are for the general U.S. Population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ years. Results of Acute Dietary

(Food and Drinking Water) Exposure Anal ys is The acute dietary

(food and drinking water) exposure to halosu lfuron - methyl is below HED’s level of concern. T he acute dietary exposure estimate at the 95 th 

### percentile is <1 % of the aPAD for females 13 - 49 y ears old, the only population subgroup of concern.Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### Results of Chronic Dietary (Food and Drinking Water) Exposure Analy sis The chronic dietary

(food and drinking water) exposure to halosulfuron - methyl is below HED ’s level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are 2 .0 % of the cPAD for the general U.S. population and 5.5 % of the cPAD for children 1 - 2 ye ar old s, the most highl y exposed population subgroup. **Table 3. Summary of Dietary Exposure and Risk for**  **Halosulfuron -**  **methyl.** Population Subgroup Ac ute Dietary (95th Percentile) Chronic Dietary Dietary Exposure (mg/kg/day) % aPAD* Dietary Exposure (mg/kg/day) % cPAD* General U.S. Population

N/A N/A 0.00 2 050 2 .0 All Infants (< 1 year old) 0.00 4871 4.9 **Children 1 -**  **2 years old 0.00**  **5 508**  **5.5** Children 3 - 5 y ears old 0.00 3884 3.9 Children 6 - 12 y ears old 0.00 2 433 2.4 Youth 13 - 19 y ears old 0.001 579 1.6 Adults 20 - 49 y ears old 0.001 7 91 1.8 Adults 50+ years old 0.001 7 37 1.7 Females 13 - 49 y ears old 0.003 733 <1 0.001 7 85 1.8 The population subgroup with the highest estimated exposure/risk is bolded. 

### VI **I .**  **Characterization of Inputs/Outputs** The acute and chronic assessments are considered to be highl y conservative and health protective . The residue levels used in the assessment s for all commodities were the established or recommended tolerance levels. The assessment s w ere conducted using the assumption that 100% of the crop was treated. Default (DEEM 7.81) processing factors were used unless processing studies were available (t omato and potato) and modeled estimated drinking water concentrations were included in the assessments . The se assessment s could be refined , which would likely significantl y decrease the estimated risk, with percent crop treated estimates , anticipated re sidues, or monitoring data. Since risk estimates are well below HED ’s level of concern, a more highl y refined anal ys is is not needed at this time.Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### VI **II .**  **Conclusions** Acute and chronic dietary exposure assessments were conducted for the proposed uses on artichoke and can e berry

subgroup 13 - 07A . The analy ses were unrefined assessments, using tolerances for all commodities , the assumption of 100% CT, d efault (DEEM 7.81) processing factors when appropriate , and modeled water numbers . For both of the acute and chronic assessments, assessments for all populations of concern have risk estimates which are below HED ’s level of concern . HED is confident that the acute and chronic assessments do not underestimate risk to the general U.S. population or an y population subgroup. **IX. List of Attachments**  Attachment 1: Acute and Chronic Foo d plus Water Residue Input File Attachment 2: Acute Results File Attachment 3 : Chronic Results FileHalosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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### Attachment 1: Acute **and Chronic Food plus Water**  **Residue Input File .**  Filename: C: \ Documents and Settings \ MNEGUSSI \ My Documents \ DEEM Version 3.16 \ Halosulfuron methyl \ ACUTE & CHRONIC 022713.R08 Chemical: halosulfuron - methyl RfD(Chronic): .1 mg/kg bw/day NOEL(Chronic): 10 mg/kg bw/day RfD(Acute): .5 mg/kg bw/day NOEL(Acute): 50 mg/kg bw/day Date created/last modified: 02 - 27 - 2013/14:16:43 Program ver. 3.16, 03 - 08 - d Comment: Acute is only for Females 13 - 49 yrs; New Uses Artichoke and Caneberry sugroup 13 - 07A

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

---------- ---- ------------------------------- ------ ---- ------ ------ ------- 0103015000 1CD Arrowroot, flour 0.050000 1.000 1.000 9E7577 0103015001 1CD Arrowroot, flour - babyfood 0.050000 1.000 1.000 9E7577 0103017000 1CD Artichoke, Jerusalem 0.050000 1.000 1.000 9E7577 0103082000 1CD Cassava 0.050000 1.000 1.000 9E7577 0103082001 1CD Cassava - babyfood 0.050000 1.000 1.000 9E7577 0103139000 1CD Dasheen, corm 0.050000 1.000 1.000 9E7577 0103166000 1CD Ginger 0.050000 1.000 1.000 9E7577 0103166001 1CD Ginger - babyfood 0.050000 1.000 1.000 9E7577 0103167000 1CD Ginger, dried 0.050000 1.000 1.000 9E7577 0103296000 1C Potato, chips 0.050000 1.000 1.000 9E7577 0103297000 1C Potato, dry (granules/ flakes) 0.050000 1.000 1.000 9E7577 0103297001 1C Potato, dry (granules/ flakes) - b 0.050000 1.000 1.000 9E7577 0103298000 1C Potato, flour 0.050000 1.000 1.000 9E7577 0103298001 1C Potato, flour - babyfood 0.050000 1.000 1.000 9E7577 0103299000 1C Potato, tuber, w/peel 0.050000 1.000 1.000 9E7577 010329 9001 1C Potato, tuber, w/peel - babyfood 0.050000 1.000 1.000 9E7577 0103300000 1C Potato, tuber, w/o peel 0.050000 1.000 1.000 9E7577 0103300001 1C Potato, tuber, w/o peel - babyfood 0.050000 1.000 1.000 9E7577 0103366000 1C D Sweet potato 0.050000 1.000 1.000 9E7577 0103366001 1CD Sweet potato - babyfood 0.050000 1.000 1.000 9E7577 0103371000 1CD Tanier, corm 0.050000 1.000 1.000 9E7577 0103387000 1CD Turm eric 0.050000 1.000 1.000 9E7577 0103406000 1CD Yam, true 0.050000 1.000 1.000 9E7577 0103407000 1CD Yam bean 0.050000 1.000 1.000 9E7577 0402322000 4B Rhubarb 0.050000 1.000 1.000 9E7577 0600347000 6 Soybean, seed 0.050000 1.000 1.000 8F7424 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk - babyfo od or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 8F7424 0600350001 6 Soybean, oil - babyfood 0.050000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.050000 1.000 1.000 0601043001 6A Bean, snap, succulent - babyfood 0.050000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.050000 1.000 1.000 9E7577 0602033000 6B Bean, cowpea, succulent 0.050000 1.000 1.000 9E 7577 0602037000 6B Bean, lima, succulent 0.050000 1.000 1.000 9E7577 0602255000 6B Pea, succulent 0.050000 1.000 1.000 9E7577 0602255001 6B Pea, succulent - babyfood 0.050000 1.000 1.000 9E7577 0602259000 6B Pea, pigeon, succulent 0.050000 1.000 1.000 9E7577 0603030000 6C Bean, black, seed 0.050000 1.000 1.000 0603032000 6C Bean, broad, seed 0.050000 1.000 1.000 0603034000 6C Bea n, cowpea, seed 0.050000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.050000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.050000 1.000 1.000 0603038000 6C Bean, lima, seed 0.050000 1.000 1.000 0603039000 6C Bean, mung, seed 0.050000 1.000 1.000 0603040000 6C Bean, navy, seed 0.050000 1.000 1.000 0603041000 6C Bean, pink, seed 0.050000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.050000 1.000 1.000 0603098000 6C Chickpea, seed 0.050000 1.000 1.000 0603098001 6C Chickpea, seed - babyfood 0.050000 1.000 1.000Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

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Page 10 of 14 0603099000 6C C hickpea, flour 0.050000 1.000 1.000 0603182000 6C Guar, seed 0.050000 1.000 1.000 0603182001 6C Guar, seed - babyfood 0.050000 1.000 1.000 0603348000 6C Soybean, flour 0.050000 1.000 1.000 0603348001 6C Soybean, flour - babyfood 0.050000 1.000 1.000 0801374000 8A Tomatillo 0.050000 1.000 1.000 0F6169 0801375000 8A Tomato 0.050000 1.000 1.000 0F6169 0801375001 8A Tomato - babyfood 0.050000 1.000 1.000 0801376000 8A Tomato, paste 0.050000 1.000 1.000 0F6169 0801376001 8A Tomato, paste - babyfood 0.050000 1.000 1.000 0801377000 8A Tomato, puree 0.050000 1.000 1.000 0F6169 0801377001 8A Tomato, puree - babyfood 0.050000 1.000 1.000 0801378000 8A Tomato, dried 0.050000 14.300 1.000 0F6169 0801378001 8A Tomato, dried - babyfood 0.050000 14.300 1.000 0801379000 8A Tomato, juice 0.050000 1.500 1.000 0F6169 0802148000 8BC Eggplant 0.050000 1.000 1.000 0802234000 8BC Okra 0.050000 1.000 1.000 9E7577 0802270000 8B Pepper, bell 0.050000 1.000 1.000 0802270001 8B Pepper, bell - babyfood 0.050000 1.000 1.000 0802271000 8B Pepper, bell, dried 0.050000 1.000 1.000 0802271001 8B Pepper, bell, dried - babyfood 0.050000 1.000 1.000 0802272000 8BC Pepper, nonbell 0.050000 1.000 1.000 0802272001 8BC Pepper, nonbell - babyfood 0.050000 1.000 1.00 0 0802273000 8BC Pepper, nonbell, dried 0.050000 1.000 1.000 0901075000 9A Cantaloupe 0.100000 1.000 1.000 0E6206 0901187000 9A Honeydew melon 0.100000 1.000 1.000 0E6206 090139900 0 9A Watermelon 0.100000 1.000 1.000 0901400000 9A Watermelon, juice 0.100000 1.000 1.000 0902021000 9B Balsam pear 0.500000 1.000 1.000 0902088000 9B Chayote, fruit 0.500000 1.000 1.000 0902102000 9B Chinese waxgourd 0.500000 1.000 1.000 0902135000 9B Cucumber 0.500000 1.000 1.000 0E6085 0902308000 9B Pumpkin 0. 500000 1.000 1.000 0E6085 0902309000 9B Pumpkin, seed 0.500000 1.000 1.000 0902356000 9B Squash, summer 0.500000 1.000 1.000 0E6085 0902356001 9B Squash, summer - babyfood 0.500000 1.00 0 1.000 0902357000 9B Squash, winter 0.500000 1.000 1.000 0E6085 0902357001 9B Squash, winter - babyfood 0.500000 1.000 1.000 1100007000 11 Apple, fruit with peel 0.050000 1.000 1.000 9E7577 11 00008000 11 Apple, peeled fruit 0.050000 1.000 1.000 9E7577 1100008001 11 Apple, peeled fruit - babyfood 0.050000 1.000 1.000 9E7577 1100009000 11 Apple, dried 0.050000 8.000 1.000 9E7577 110000900 1 11 Apple, dried - babyfood 0.050000 8.000 1.000 9E7577 1100010000 11 Apple, juice 0.050000 1.300 1.000 9E7577 1100010001 11 Apple, juice - babyfood 0.050000 1.300 1.000 9E7577 1100011000 11 Apple, sauce 0.050000 1.000 1.000 9E7577 1100011001 11 Apple, sauce - babyfood 0.050000 1.000 1.000 9E7577 1301055000 13A Blackberry 0.050000 1.000 1.000 DP# D4

Full commen t: DP# D405659 1301056000 13A Blackberry, juice 0.050000 1.000 1.000 DP# D4

Full comment: DP# D405659 1301056001 13A Blackberry, juice - babyfood 0.050000 1.000 1.000 DP# D4

Full comment: DP# D405659 1301058000 13A Boysenberry 0.050000 1.000 1.000 DP# D4

Full comment: DP# D405659 1301208000 13A Loganberry 0.050000 1.000 1.000 DP# D4

Full comment: DP# D405659 1301320000 13 A Raspberry 0.050000 1.000 1.000 DP# D4

Full comment: DP# D405659 1301321000 13A Raspberry, juice 0.050000 1.000 1.000 DP# D4

Full comment: DP# D405659 1302057000 13B Blueberry 0.050000 1.000 1.000 9E7577 1302057001 13B Blueberry - babyfood 0.050000 1.000 1.000 9E7577 1302136000 13B Currant 0.050000 1.000 1.000 9E7577 1302137000 13B Currant, dried 0.050000 1.000 1.000 9E7577 1302149000 13B Elderberry 0.050000 1.000 1.000 9E7577 1302174000 13B Gooseberry 0.050000 1.000 1.000 9E7577Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

PC Code: 128721

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Page 11 of 14 1302191000 13B Huckleberry 0.050000 1.000 1.000 9E7577 1400003000 14 Almond 0.050000 1.000 1.000 8F4937 1400003001 14 Almond - babyfood 0.050000 1.000 1.000 1400004000 14 Almond, oil 0.0 50000 1.000 1.000 8F4937 1400004001 14 Almond, oil - babyfood 0.050000 1.000 1.000 1400059000 14 Brazil nut 0.050000 1.000 1.000 8F4937 1400068000 14 Butternut 0.050000 1.000 1.000 1400081000 14 Cashew 0.050000 1.000 1.000 8F4937 1400092000 14 Chestnut 0.050000 1.000 1.000 8F4937 1400155000 14 Hazelnut 0.050000 1.000 1.000 8F4937 1400156000 14 Hazelnut, oil 0.050000 1.000 1.000 1400185000 14 Hickory nut 0.050000 1.000 1.000 1400213000 14 Macadamia nut 0.050000 1.000 1.000 8F4937 1400269000 14 Pecan 0.050000 1.000 1.000 8F4937 1400282000 14 Pistachio 0.050000 1.000 1.000 8F4937 1400391000 14 Walnut 0.050000 1.000 1.000 8F4937 1500120000 15 Corn, field, flour 0.050000 1.000 1.000 6F4661 1500120001 15 Corn, field, flour - babyfood 0.050000 1.000 1.000 1500121000 15 Corn, field, meal 0 .050000 1.000 1.000 6F4661 1500121001 15 Corn, field, meal - babyfood 0.050000 1.000 1.000 1500122000 15 Corn, field, bran 0.050000 1.000 1.000 6F4661 1500123000 15 Corn, field, starch 0.050000 1.0 00 1.000 6F4661 1500123001 15 Corn, field, starch - babyfood 0.050000 1.000 1.000 1500124000 15 Corn, field, syrup 0.050000 1.500 1.000 6F4661 1500124001 15 Corn, field, syrup - babyfood 0.050000 1.500 1.000 1 500125000 15 Corn, field, oil 0.050000 1.000 1.000 6F4661 1500125001 15 Corn, field, oil - babyfood 0.050000 1.000 1.000 1500126000 15 Corn, pop 0.050000 1.000 1.000 6F4661 1500127000 15 Corn, sweet 0.050000 1.000 1.000 6F4661 1500127001 15 Corn, sweet - babyfood 0.050000 1.000 1.000 1500226000 15 Millet, grain 0.010000 1.000 1.000 1500323000 15 Rice, white 0.050000 1.000 1.000 8F4937 1500323001 15 Rice, white - babyfood 0.050000 1.000 1.000 1500324000 15 Rice, brown 0.050000 1.000 1.000 8F4937 1500324001 15 Rice, brown - babyfood 0.050000 1.000 1.000 1500325000 15 Rice, flour 0.050000 1.000 1.000 8F4937 1500325001 15 Rice, flour - babyfood 0.050000 1.000 1.000 1500326000 15 Rice, bran 0.050000 1.000 1.000 8F4937 1500326001 15 Rice, bran - babyfood 0.050000 1.000 1.000 1500344000 15 Sorghum, grain 0.050000 1.000 1.000 1500345000 15 Sorghum, syrup 0.050000 1.000 1.000 1500 405000 15 Wild rice 0.050000 1.000 1.000 8F4937 2003128000 20C Cottonseed, oil 0.050000 1.000 1.000 8F4937 2003128001 20C Cottonseed, oil - babyfood 0.050000 1.000 1.000 3100044000 31 B eef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat - babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.900 1.000 3100046000 31 Beef, meat byproducts 1.000000 1.000 1.000 3100046001 31 Beef, meat byproducts - babyfood 1.000000 1.000 1.000 3100047000 31 Beef, fat 0.050000 1.000 1.000 3100047001 31 Beef, fat - babyfood 0.050000 1.000 1.000 3100048000 31 Beef, kidney 1.000000 1.000 1.000 3100049000 31 Beef, liver 1.000000 1.000 1.000 3100049001 31 Beef, liver - babyfood 1.000000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 1.000000 1.000 1.000 3200171000 32 Goat, fat 0.050000 1.000 1.000 3200172000 32 Goat, kidney 1.000000 1.000 1.000 3200173000 32 Goat, liver 1.000000 1.000 1.000 3300189000 33 Horse, meat 0.050000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.100000 1.0 00 1.000 3F4193 3400292001 34 Pork, meat byproducts - babyfood 0.100000 1.000 1.000 3400294000 34 Pork, kidney 0.100000 1.000 1.000 3F4193 3400295000 34 Pork, liver 0.100000 1.000 1.000 3F 4193 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat - babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 1.000000 1.000 1.000Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

PC Code: 128721

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Page 12 of 14 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3500341001 35 Sheep, fat - babyfood 0.050000 1.000 1.000 3500342000 35 Sheep, kidney 1.000000 1.000 1.000 3500343000 35 Sheep, li ver 1.000000 1.000 1.000 3600222000 36 Milk, fat 0.050000 1.000 1.000 3600222001 36 Milk, fat - baby food/infant formu 0.050000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.050000 1.000 1.000 3600223001 36 Milk, nonfat solids - baby food/in 0.050000 1.000 1.000 3600224000 36 Milk, water 0.050000 1.000 1.000 3600224001 36 Milk, water - babyfood/infant form 0.050000 1.000 1.000 3600225001 36 Milk, sugar (lactose) - baby food/ 0.050000 1.000 1.000 8601000000 86A Water, direct, all sources 0.059200 1.000 1.000 DP#358

Full comment: DP#358032 8602000000 86B Water, indirect, all sources 0.05920 0 1.000 1.000 9500016000 O Artichoke, globe 0.050000 1.000 1.000 9500019000 O Asparagus 0.800000 1.000 1.000 1F6229 9500362000 O Sugarcane, sugar 0.050000 1.000 1.000 6F4661 9500362001 O Sugarcane, sugar - babyfood 0.050000 1.000 1.000 9500363000 O Sugarcane, molasses 0.050000 1.000 1.000 6F4661 9500363001 O Sugarcane, molasses - babyfood 0.050000 1.000 1.000Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

PC Code: 128721

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Page 13 of 14 

### Attachment 2: Acute Results File **.** U.S. EPA Ver. 3.16, 03 - 08 - d DEEM - FCID ACUTE Analysis for HALOSULFURON - METHYL NHANES 2003 - 2008 2 - Day Residue file: ACUTE & CHRONIC 022713.R08 Adjustment factor #2 NOT used. Analysis Date: 02 - 27 - 2013/14:18:43 Residue file dated: 02 - 27 - 2013/14:16:43 NOEL (Acute) = 50.000000 mg/kg body - wt/day RAC/FF intake summed over 24 hours Run Comment: "Acute is only for Females 13 - 49 yr s; New Uses Artichoke and Cane berry sugroup 13 - 07A"

=============================================================================== Summary calculations -- per capita:

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

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Female 13 - 49: 0.004091 0.82 12221 0.005756 1.15 8686 0.008278 1.66 6040Halosulfuron - methyl Dietary Exposure and Risk Assessment DP Number: 405660

PC Code: 128721

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Page 1 4 of 14 

### Attachment 3: Chronic Results **File .**  U.S. EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for HALOSULFURON - METHYL NHANES 2003 - 2008 2 - day Residue file name: C: \ Documents and Settings \ MNEGUSSI \ My Documents \ DEEM Version 3.16 \ Halosulfuron - methyl \ ACUTE & CHRONIC 022713.R08 Adjustment factor #2 NOT used. Analysis Date 02 - 27 - 2013/14: 29:21 Residue file dated: 02 - 27 - 2013/14:16:43 Reference dose (RfD, Chronic) = .1 mg/kg bw/day COMMENT 1: Acute is only for Females 13 - 49 yrs; New Uses Artichoke and Caneberry sugroup 13 - 07A

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

------------------------------------------------------------------------------- Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.002050 2.0% Hispanic 0.002153 2.2% Non - Hisp - White 0.002066 2.1% Non - Hisp - Blac k 0.001733 1.7% Non - Hisp - Other 0.002316 2.3% Nursing Infants 0.002051 2.1% Non - Nursing Infants 0.0 06130 6.1% Female 13+ PREG 0.001882 1.9% Children 1 - 6 0.004358 4.4% Children 7 - 12 0.002285 2.3% Male 13 - 19 0.001591 1.6% Female 13 - 19/NP 0.001566 1.6% Male 20+ 0.001700 1.7% Female 20+/NP 0.001826 1.8% Seniors 55+ 0.001718 1.7% All Infants 0.004871 4.9% Female 13 - 50 0.001784 1.8% C hildren 1 - 2 0.005508 5.5% Children 3 - 5 0.003884 3.9% Children 6 - 12 0.002433 2.4% Youth 13 - 19 0.001579 1.6% Adults 20 - 49 0.001791 1.8% Adults 50 - 99 0.001737 1.7% Female 13 - 49 0.001785 1.8%