UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: 05/25/20 15 

SUBJECT: Halosulfuron-Mcthyl. Acute and Chronic Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments for the Section 3 Registration Action on 

Pomc Fruit Group 11 - 10 and Frnit, Small Vine Climbing Subgroup 13-07F. 

PC Code: 128721 

Decision No.: 493338 

Petition No.: 4E8297 

DP Ba rcocle: 0426724 

Registra tion No.: 81880-18 and 81880-2 

Regulatory Action: Section 3 Registration 

Risk Assessment Type: Dietary Case No.: NIA 

TXR No.: NIA CAS No.: I 00784-20-1 

MRID No.: NIA 40 CFR: § 180.479 

FROM: 

THROUG H: 

TO: 

Kristin Rury, Biologist y_Q~ Risk Assessment Branch Jir (RABJ)L) 

Health Effects Division (7509P) 

Doug Dotson, Chemist J. ~~ - tf!J. 11. .... 

SumitraBoseBiswas,Chemist-~ p·PQ>~ 

Dietary Exposure Science Advisory Council (DESAC) 

Kristin Rury, Risk Assessor ; / / / , 

Risk Assessment Branch HI (RABJ) _;t~ Health Effects Division (7509P) -

and 

Sidney Jackson, Risk Manager Reviewer 

Barbara Madden, Risk Manager 

Minor Use and Emergency Response Branch 

Registration Division (7505P) 

Executive Summary 

Page I of 13 
Halosul furon-Methyl Dietary Exposure and Risk Assessment DP Number: D426724 

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 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 analyses 

were conducted in support of a human-health risk assessment for the proposed Section 3 uses of 

halosulfuron-methyl on Pome Fruit Group 11-1 0 and Fruit, Small Vine Climbing Subgroup 13-

07F. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 

20 12. 1. 

Unrefined acute (females 13-49 years old) and chronic dietary (food and drinking water) 

exposure assessments were conducted for the currently registered and proposed new uses on 

Pome Fruit Group 11-10 and fruit, Small Vine Climbing Subgroup 13-07F. There were no 

appropriate toxicological effects attributable to a single exposure (dose) for the general 

population or any other population subgroups except females 13-49 years old; therefore, these 

population subgroups were not included in the acute dietary assessment. The acute (females 13-

49 years old) and chronic dietary assessments included tolerance-level residues for all 

commodities and assumed 100 % crop treated (CT) for all crops. Modeled drinking water 

estimates were provided by the Environmental Fate and Effects Division (EFED). 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. 

Modeled estimated drinking water concentrations were included in the assessment. 

Acute Dietary Exposure 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 established for females 13-49 years 

old. Therefore, an acute dietary exposure assessment was only conducted for females 13-49 

years old. The unrefined acute dietary exposure estimate at the 95111 percentile is < l % of the 

acute population adjusted dose (aPAD) for females 13-49 years old. 

Chronic Dietary Exposure Assessment 

The unrefined 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 dietary exposure estimates 

are 2.1 % of the cPAD for the genera l U.S. population and 5.7% of the cPAD for children 1-2 

years old, the most highly exposed population subgroup. 

Cancer Dietary Exposure Assessment 

Halosulfuron-methyl is classified as " not likely to be a human carcinogen;" therefore, 

quantification of human cancer risk is not required. 

I. Introduction 

Halosulfuron-methyl is a selective herbicide belonging to the sulfonylurea group of herbicides, 

which inhibits the action of acetolacetate synthase enzyme, a speci lie plant enzyme. 

Page 2of13 
Halosul furon-Methyl Dietary Exposure and Risk Assessment DP Number: D426724 

I-Ialosulfuron-methyl is used for the pre- and postemergence control of ann ual broad leaf weeds 

and nutsedges on various agricultural crops, as well as on residential turf grass and ornamentals. 

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 that 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. no observed adverse effect level (NOAEL), lowest observed adverse 

effect level (LOAEL), e.g.) divided by the required uncertainty or safety factors. 

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

exceeds I 00% of the PAD. References that 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," 2 l-JUN-2000, web link: 

http://www.regul ations.gov/# !documentDetail:D=EPA-HQ-OPP-2007-0780-000 I; or see SOP 

99.6 (20-AUG-1999). 

The most recent dietary risk assessment for halosulfuron-methyl was conducted by Meheret 

Negussie (D405660, 03/25/20 13). 

II. Residue Information 

The Interregional Research Project No. 4 (IR-4) has proposed new uses of halosulfuron-methyl 

on Pome Fruit Group 11-10 and Fruit, Small Vine Climbing Subgroup I 3-07F. Permanent 

tolerances arc established under § J 80.479(a)( I) for residues of halosulfuron-methyl and its 

metabolites determined as 3-chloro-l-mcthyl-5-sulfamoylpyrazole-4-carboxylic acid (3-CSA), 

expressed as halosulfuron-methyl equivalents, at levels ranging from 0.05 ppm (milk, fat and 

meat) to 1.0 ppm (meat byproducts) of cattle, goat, hog, horse, and sheep. Tolerances are 

established under § 180.4 79(a)(2) for residues of halosulfuron-mcthyl in/on a variety of field , 

fruit, and vegetable crop commodities at levels ranging from 0.05 to 20 ppm. 

The Health Effects Division (HED) has concluded that the residue of concern for tolerance 

enforcement and risk assessment in target plants and rotational plants is halosulfuron-methyl (G. 

J. Herndon, No DP, 09/ 16/1993 and 05/2 1/ 1996). 

HED previously 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 for 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: 

Page 3of13 
Halosu If uron-Methyl Dietary Exposure and Risk Assessment DP Number: 0426724 

The acute and clu·onic assessments are unrefined assessments using tolerance-level residues and 

I 00% 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 studi es showed no concentration. Based on processing studies, the processing factors 

were reduced to l for tomato paste, tomato puree, potato flour, and potato granules/flakes. 

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, 

and 2010. In general, pesticide residues would not be expected to be found in fish unless the 

pesticide bioaccumulates or has an aquatic use. To determine whether or not residues are present 

in fish, HED now routi nely checks PDP monitoring data regardless of the pesticide's uses and 

physicochemical properties. However, PDP did not analyze catfish samples for halosulfuronmethyl. As a result, residues in fish were not included in the assessment. 

Table 1 is a summary of the HED recommended food tolerances resulting from the proposed 

uses (0426614). 

Table 1- Tolerance Summary for the New Uses for Halosulfuron-Methyl. 

Recommended Tolerances 

Commodity Used in the 

Acute and Chronic Analyses 

(ppm) 

Pornc Fru it Group 11-10 0.05 

Fruit, Small Vine Climbing Subgroup 13-07F 0.05 

Ill. Percent Crop Treated Information 

The acute and chronic dietary exposure assessments assumed that 100% of the proposed and 

registered crops were treated with halosulfuron-methyl ( 100% CT). 

IV. Drinking Water Data 

Tier I estimated surface and ground water estimated drinking water concentrations (EDWCs) 

were evaluated for the proposed new uses of halosulfuron-methyl. The highest EDWCs continue 

to be from the existing use on rice, even with evaluating the proposed and existing uses using the 

Pesticide Root Zone Model - Ground Water (PRZM-GW) (M. Barret, 042 1820, 04/ 15/2015). 

Water residues were incorporated in the DEEM-FCJD into the food categories "water, direct, all 

sources" and "water, indirect, all sources.'· 

The Tier I EDWCs for halosulfuron-methyl are based on a maximum annual application rate of 

0. 125 lb ai/ A for rice. The two screening models, the Food Quality Protection Act (FQPA) 

Index Resevoir Screening Tool (FIRST) and Screening Concentrations in Ground Water (SCIGROW), were used for estimating EDWCs of halosulfuron-methyl. Estimates for halosulfuronmethyl in surface water based on the FIRST model for rice are 59.2 ppb for both acute and 

chronic concentrations. The drinking water estimate based on rice application is an upper bound 

estimate. The estimate for halosulfuron-methyl in groundwater based on the SCI-GROW model 

result is 0.065 ppb. Table 2 summarizes the results. 

Page 4of13 
Halosul furon-Methyl Dietary Exposure and Risk Assessment DP Number: D426724 

Table 2. Summary of Estimated Surface Water and Groundwater Concentrations for 

Halosulfuron-methyl. 

Duration Surface Water Cone., ppb a Groundwater Cone., 

ppbb 

Acute 59.2 0.065 

Chronic (non-cancer) 59.2 0.065 

• From the PIRST model. 

b From the SCI-GROW model. 

The drinking water models and their descriptions are available at the EPA internet site: 

http://www.epa.gov/oppefed I /models/water/. 

V. DEEM-FCID Program and Consumption Information 

Halosulfuron-methyl acute and chronic di etary exposure assessments were conducted using the 

DEEM-FCID, Version 3. 16, which incorporates 2003-2008 consumption data from USDA's 

N HANES/WW ETA. The data are based on the reported consumption of more than 20,000 

individuals over two non-consecuti ve survey days. Foods "as consumed" (e.g., apple pie) are 

linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; 

or wheat flour - cooked; fresh or N/S, baked) using publicly avai lable 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 

analysis 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 year old), children 

1-2, children 3-5, children 6-1 2, youth 13-19, adults 20-49, females 13-49, and adults 50-99 

years old. 

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

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

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is perfom1ed for each population subgroup. 

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

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

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or "matched" in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who repor1ed eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

Page 5of13 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment DP Number: D426724 

exposure and risk are reported for analyses performed at all levels of refinement. However, for 

deterministic assessments, any signifi cant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment. 

VI. Toxicological Information 

The risk assessment team confirmed endpoints that were previously selected, and confirmed the 

reduction to IX of the FQPA Safety Factor for all population subgroups (W. Phang, 0358031 , 

06/30/2009). 

Toxicological endpoints for use in dietary exposure risk assessments are summarized in Table 3 

below. 

Table 3. Summary of Toxicological Doses and Endpoints for Halosulfuron-metbyl for Use in 

Dietary Exposure Risk Assessments. 

Exposure/ Point of Uncertainty/FQPA RID, PAD, 

Level of Study and Toxicological Effects Scenario Departure Safety Factors Concern 

Acute RID Developmental Toxicity - Rabbit 

Acute = 0.5 LOA EL = 150 mg/kg/day based on 

Dietary NOA EL= UFt.= IOx mg/kg/day decreased mean I itter size, 

(Females so UF11= I Ox increased number of resorptions 

13-49 years mg/kg/day FQPA SF= Ix 

aPAD =0.5 (total and per dam) and increased 

of age) mg/kg/day postimplantation loss. 

(developmenta l toxicity) 

Acute 

Dietary No adverse effect attributable to a single dose was identified; therefore, no dose/endpoint was 

(General selected for this exposure scenario. [Although the acute neurotoxicity listed in the Toxicity 

Population, Profile (Appendix A) showed a death occurred in this study, the death was not considered to 

including be treatment related and occurred at I 000 mg/kg/day where no compound related effect was 

In fants and seen] 

Children) 

Chronic 

RfD = 0.1 Chronic Toxicity - Dog Chronic NOAEL= UFA=IOx mg/kg/day 

Dietary (All 10 UFH= IOx LOAEL = 40 mg/kg/day based on 

Populations) mg/kg/clay FQPA SF= Ix cPAD = decreased body weight gains in 

0.1 fema les. 

mg/kg/day 

Cancer 

(oral, Classification: " not likely to be carcinogenic to humans" by the oral route, based 

dermal, on no evidence of carcinogenicity from studies in rats and mice. 

inhalation) 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to 

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

NOA EL = no observed adverse effect level. LOA EL = lowest observed adverse effect level. ur = uncertainty factor. ur A= 

extrapolation from animal to human (interspecies). UF11 = potential variation in sensitivity among members of the human 

population (intraspecics). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RID = 

reference dose. NIA = not applicable. 

Page 6of13 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment DP Number: 0 426724 

VII. Results/Discussion 

As slated above, for acute and chro nic assessments, HED is concerned when dietary risk exceeds 

100% of the PA D. The DEEM-FCID analyses estimate the dietary exposure and risk of the U.S. 

population and vari ous population subgroups. The resu lts reported in Table 4 are for the general 

U.S. Population, all infants(< ! year old), children l-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years. 

Results of the Acute Dietary (rood and Drinkina Water) Exposure Assessment 

There was no indication of an adverse effect attributable to a single dose for the general U.S. 

population. However, an aRfD was established for females I 3-49 years old, and an acute dietary 

exposure assessment was only conducted for fema les 13-49 years old. The unrefined acute 

dietary exposure estimate at the 95111 percentile is < 1 % of the aPAD for females 13-49 years old. 

Results of the Chronic Dietary (Food and Drinking Water) Exposure Assessment 

The unrefined chronic dietary (food and drinking water) exposure to halosulfuron-methyl is 

below I-IED's level of concern (< 100% of the cPAD) for the genera l U.S. population and all 

population subgroups. The chronic dietary exposure estimates are 2. 1 % of the cPAD for the 

general U.S. population and 5.7% of the cPAD for children 1-2 year old, the most highly 

exposed population subgroup. 

Table 4. Summary of Dietary (Food a nd Drinking Water) Exposure and Risk for 

Ha losulfuron-Methyl. 

Acute Dietary Chronic Dietary (9Sth Percentile) 

Population Subgroup Dietary Dietary 

Exposure % aPAD* Exposure % cPAD* 

(me/k.2/day) (mg/kg/day) 

General U.S. Population 0.002091 2.1 

All Infants (< I year old) 0.004987 5.0 

Children 1-2 yea rs old* 0.005740 5.7 

Children 3-5 years old 

NIA NIA 

0.004025 4.0 

Children 6-12 years old 0.002488 2.5 

Youth 13- 19 years old 0.00 I 597 1.6 

Adults 20-49 years old 0.0018 17 1.8 

Adults 50-99 years old 0.001767 1.8 

Females 13-49 years old 0.004 139 < I 0.001812 1.8 

*The subpopulat1011(s) w11h the highest nsk estimates. The highest risk estimate is bolded. 

VIII. Characterization of Inputs/O utputs 

The acute and chronic assessments are considered to be unrefined and highly conservative. The 

residue levels used in the assessments for all commoditi es were the established or recommended 

tolerance levels. The assessments were conducted using the assumption that 100% of the crop 

was treated. Default (DEEM 7.8 1) processing factors were used unless processing studies were 

Page 7of13 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment DP Number: 0426724 

available (tomato and potato) and modeled estimated drinking water concentrations were 

included in the assessments. 

These assessments could be refined, which would likely significantly decrease the estimated risk, 

with percent crop treated estimates, anticipated residues, or monitoring data. Since risk estimates 

are well below HED's level of concern, a more highly refined analysis is not needed at this time. 

IX. Conclusions 

Acute and chronic dietary exposure assessments were conducted for the proposed uses on Pome 

Fruit Group 11 - 10 and Fruit, Small Vine Climbing Subgroup I 3-07F. The analyses were 

unrefined assessments. 

For both of the acute and chronic assessments, assessments for all populations of concern have 

risk estimates that are below HED's level of concern. HED is confident that the acute and 

chronic assessments do not underestimate risk to the general U.S. population or any population 

subgroup. 

X. List of Attachments 

Acute and Chronic Residue Input file 

Acute Results file 

• Chronic Results File 

Page 8 of 13 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment DP Number: D426724 

Attachment 1: Acute and Chronic Residue Input File 

Filename: C:\Users\KRURY\Documents \My Work Files\Halosulfuron\Pome fruit and Small Vine 

Climbing\Dietary\ACUTE & CHRONIC 042415.R08 

Chemical: halosulfuron-methyl 

RfD(Chronicl: .1 mg/kg bw/day NOEL(Chronic): 10 mg/kg bw/day 

RfD(Acutel: .s mg/kg bw/day NOEL(Acute): SO mg/kg bw/day 

Date created/last modified: 04-24 -2 015/12:57:10 Program ver. 3.16, 03-08 -d 

Comment: Acute is only for Females 13 -49 yrs; Ne w Uses Artichoke a n d Caneberry s u group 13 -

07A 

EPA Crop 

Code Grp Commodity Name 

Def Res 

(ppm) 

0103015000 lCD 

0103015001 lCD 

0103017000 lCD 

0103082000 lCD 

0103082001 lCD 

0103139000 lCD 

0103166000 lCD 

0103166001 lCD 

0103167000 lCD 

0103296000 lC 

0103297000 lC 

0103297001 lC 

0103298000 lC 

0103298001 lC 

0103299000 lC 

0103299001 lC 

0103300000 lC 

0103300001 lC 

0103366000 lCD 

0103366001 lCD 

0103371000 lCD 

0103387000 lCD 

0 103406000 lCD 

0103407000 lCD 

0402322000 4B 

0600347000 6 

0600349000 6 

0600349001 6 

0600350000 6 

0600350001 6 

0601043000 6A 

0601043001 6A 

0601257000 6A 

0601349500 6AB 

0602031000 6B 

0602033000 6B 

0602037000 6B 

0602255000 6B 

0602255001 6B 

0602259000 6B 

0603030000 6C 

0603032000 6C 

0603034000 6C 

0603035000 6C 

0603036000 6C 

0603038000 6C 

0603039000 6C 

0603040000 6C 

0603041000 6C 

0603042000 6C 

0603098000 6C 

0603098001 6C 

Arrowroot, flour 

Arrowroot, flour-babyfood 

Artichoke, Jerusalem 

Cassava 

Cassava-baby food 

Dasheen, corm 

Ginger 

Ginger-baby food 

Ginger, dried 

Potato, chips 

Potato, dry (granules/ flakes) 

Potato, dry (granules/ flakes)-b 

Potato, flour 

Potato, flour-babyfood 

Potato, tuber, w/peel 

Potato, tuber, w/peel-babyfood 

Potato, tuber, w/o peel 

Potato, tuber, w/o peel-babyfood 

Sweet potato 

Sweet potato-babyfood 

Tanier, corm 

Turmeric 

Yam, true 

Yam bean 

Rhubarb 

Soybean, seed 

Soybean, soy milk 

Soybea n, soy milk- babyfood or in 

Soybean, oil 

Soybean, oil-babyfood 

Bean, snap, succulent 

Bean, snap, succulent - babyfood 

Pea, edible podded, succulent 

Soybean, vegetable 

Bean, broad , succulent 

Bean, cowpea , succulent 

Bean, lima , succulent 

Pea, succulent 

Pea, succulent-babyfood 

Pea , pigeon, succulent 

Bean, black, seed 

Bean, 

Bean, 

Bean, 

Bean, 

Bean, 

broad, seed 

cowpea, seed 

great northern, 

kidney, seed 

lima , seed 

Bean, mung, seed 

Bea n, navy, seed 

Bean, pink, seed 

Bean, pinto, seed 

Chickpea, seed 

Chickpea, seed-babyfood 

seed 

Page 9of 13 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0.050000 

0 . 050000 

0.050000 

0.050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

Adj . Factors 

Ill 112 

1.000 

1.000 

1.000 

1.000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1 .000 

1 .000 

1.000 

1. 000 

1. 000 

1.000 

1.000 

1.000 

1 . 000 

1 .000 

1 . 000 

1. 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1 .000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1 . 000 

1. 000 

1. 000 

1.000 

1. 000 

1 . 000 

1 . 000 

1.000 

1. 000 

1 . 000 

1. 000 

1.000 

1 . 000 

1. 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1.000 

1. 000 

1. 000 

1. 000 

1 . 000 

1 . 000 

1. 000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1.000 

1 . 000 

1. 000 

1 . 000 

1.000 

1 . 000 

1.000 

1. 000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1 .000 

1.000 1.000 

1 . 000 1.000 

1. 000 1. 000 

1.000 1.000 

1. 000 1. 000 

1. 000 1. 000 

Comment 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7 577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

8F7424 

8F742 4 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 

9E7577 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment 

0603099000 6C 

06031B2000 6C 

06031B2001 6C 

060334BOOO 6C 

060334B001 6C 

OS01374000 SA 

OS01375000 SA 

OB01375001 SA 

OB01376000 SA 

OB01376001 SA 

OS01377000 SA 

OS01377001 BA 

OS0137SOOO BA 

OS0137S001 SA 

OS01379000 SA 

OS013SOOOO SA 

0802148000 SBC 

OB02234000 BBC 

OS02270000 BB 

0802270001 BB 

OB02271000 SB 

OB02271001 BB 

OB02272000 SBC 

OS02272001 SBC 

OS02273000 SBC 

0901075000 9A 

09011B7000 9A 

0901399000 9A 

0901400000 9A 

0902021000 9B 

09020SSOOO 9B 

0902102000 9B 

0902135000 9B 

090230SOOO 9B 

0902309000 9B 

0902356000 9B 

0902356001 9B 

0902357000 9B 

0902357001 9B 

1100007000 11 

llOOOOSOOO 11 

llOOOOBOOl 11 

1100009000 11 

1100009001 11 

1100010000 11 

1100010001 11 

1100011000 11 

1100011001 11 

1100129000 11 

1100173500 11 

1100210000 11 

1100266000 11 

1100266001 11 

1100267000 11 

Chickpea, flour 

Guar, seed 

Guar, seed-babyfood 

Soybean, flour 

Soybean, flour-babyfood 

Tomatillo 

Tomato 

Tomato -baby food 

Tomato, past e 

Tomato, paste-babyfood 

Tomato, puree 

Tomato, puree-babyfood 

Tomato, dried 

Tomato, dried-babyfood 

Tomato, juice 

Tomato, Tree 

Eggplant 

Okra 

Pepper , bell 

Pepper, bell- babyfood 

Pepper, bell, dried 

Pepper, bell, dried-babyfood 

Pepper, nonbell 

Pepper, nonbell-babyfood 

Pepper, nonbell, dried 

Cantaloupe 

Honeydew melon 

Watermelon 

Watermelon , juice 

Balsam pear 

Chayote, fruit 

Chinese waxgourd 

Cucumber 

Pumpkin 

Pumpkin, seed 

Squash, summer 

Squash, summer-babyfood 

Squash, winter 

Squash, winter-babyfood 

Apple, fruit with peel 

Apple, peeled fruit 

Apple, peeled fruit-babyfood 

Apple, dried 

Apple , dried-babyfood 

Apple, juice 

Apple, juice-babyfood 

Apple, sauce 

Apple, sauce - babyfood 

Crabapple 

Goji berry 

Loquat 

Pear 

Pear-baby food 

Pear, dried 

ll0026BOOO 11 Pear, juice 

1100268001 11 Pear, juice-babyfood 

1100310000 ll Quince 

1301055000 13A Blackberry 

Full comment: OPll 0405659 

1301056000 13A Blackberry, juice 

Full comment: OPll 0405659 

1301056001 13A Blackberry, juice-babyfood 

Full comment: OPll 0405659 

130105BOOO l3A Boysenberry 

Full commen t : OPll 0405659 

1301208000 13A Loganberry 

Full comment: DPll 0405659 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.100000 

0.100000 

0 . 100000 

0 .100000 

0 . 500000 

0 .500000 

0 .500000 

0 . 500000 

0 . 500000 

0 . 500000 

0 .500000 

0 .500000 

0.500000 

0 . 500000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

Page 10 of 13 

1.000 

l. 000 

1 . 000 

l. 000 

l. 000 

1.000 

1. 000 

l. 000 

l. 000 

1.000 

1.000 

l. 000 

14. 300 

14. 300 

l. 500 

1.000 

1.000 

l. 000 

1.000 

1.000 

1.000 

1.000 

l. 000 

1.000 

l. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

l. 000 

1.000 

l. 000 

l. 000 

1.000 

l. 000 

1.000 

l. 000 

1.000 

1.000 

1.000 

1 . 000 

S.000 

S.000 

1.300 

l. 300 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

6 . 250 

l. 000 

1.000 

1.000 

1.000 

l. 000 

1.000 

l. 000 

1.000 

DP Number: D426724 

1.000 

1.000 

l. 000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

l. 000 

l. 000 

1.000 

1 . 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

l. 000 

1.000 

1.000 

l. 000 

1.000 

1.000 

1 . 000 

l.000 

1.000 

1 . 000 

1. 000 

1. 000 

1 . 000 

1.000 

1.000 

1 . 000 

l. 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1.000 

1 . 000 

1 . 000 

1.000 

1 . 000 

l. 000 

OF6169 

OF6169 

OF6169 

OF6169 

OF6169 

OF6169 

9£7577 

OE6085 

OE60B5 

OE6085 

OE6085 

9E7577 

9E7577 

9E7577 

9£7577 

9£7577 

9£7577 

9£7577 

9£7577 

9E7577 

4E8297 

4EB297 

4ES297 

4ES297 

4ES297 

4ES297 

4EB297 

4ES297 

4EB297 

OPll 04 

OPll 04 

OPll 04 

OPll 04 

OPll 04 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment 

1301320000 13A Raspberry 

Full comment: OPU 0405659 

1301321000 13A Raspberry, juice 

Full comment: OPU 0405659 

1302057000 13B 

1302057001 13B 

1302136000 13B 

1302137000 13B 

1302149000 13B 

1302174000 13B 

1302191000 13B 

1304175000 130 

1304176000 130 

1304176001 130 

1304179000 130 

1400003000 14 

1400003001 14 

14 00004 000 14 

1400004001 14 

1400059000 14 

1400068000 14 

1400081000 14 

1400092000 14 

1400155000 14 

1400156000 14 

1400185000 14 

1400213000 14 

1400269000 14 

1400282000 14 

1400391000 14 

1500120000 15 

1500120001 15 

1500121000 15 

1500121001 15 

1500122000 15 

1500123000 15 

1500123001 15 

1500124000 15 

1500124001 15 

1500125000 15 

1500125001 15 

1500126000 15 

1500127000 15 

1500127001 15 

1500226000 15 

1500323000 15 

1500323001 15 

1500324000 15 

1500324001 15 

1500325000 15 

1500325001 15 

1500326000 15 

1500326001 15 

1500344000 15 

1500345000 15 

1500405000 15 

2003128000 20C 

2003128001 20C 

3100044000 31 

3100044001 31 

3100045000 31 

3100046000 31 

3100046001 31 

3100047000 31 

3100047001 31 

3100048000 31 

3100049000 31 

Blueberry 

Blueberry-baby food 

currant 

cur rant, dried 

Elderberry 

Gooseberry 

Huckleberry 

Grape 

Grape, juice 

Grape, juice-babyfood 

Grape, wine and sherry 

Almond 

Almond -babyfood 

Almond, oil 

Almond , oil-babyfood 

Brazil nut 

Butternut 

Cashew 

Chestnut 

Hazelnut 

Hazelnut, oil 

Hickory nut 

Macadamia nut 

Pecan 

Pistachio 

Walnut 

Corn, field, flour 

Corn, field, flour- babyfood 

Corn, field, meal 

Corn, field, meal-babyfood 

Corn, field, bran 

Corn, field, starch 

Corn, field , starch-babyfood 

Corn, field, syrup 

Corn, field, syrup-babyfood 

Corn, field, oil 

Corn, field, oil-babyf ood 

Corn, pop 

Corn, sweet 

Corn, sweet-babyfood 

Millet, grain 

Rice, white 

Rice, white-babyfood 

Rice, brown 

Rice, brown-babyfood 

Rice, flour 

Rice, flour-babyfood 

Rice , bran 

Rice , bran-babyfood 

Sorghum, grain 

Sorghum, syrup 

Wild rice 

Cottonseed, oil 

Cottonseed, oil-babyfood 

Beef, meat 

Beef, meat -babyfood 

Beef, meat, dried 

Beef, meat byproduc t s 

Bee f , meat byproducts-babyfood 

Beef, fat 

Beef, fat-babyfood 

Beef, kidney 

Beef, liver 

0 . 050000 

0.050000 

0.050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0.050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0 . 010000 

0.050000 

0 . 050000 

0 . 050000 

0.050000 

0 . 050000 

0.050000 

0 . 050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

0 . 050000 

0.050000 

0.050000 

0 . 050000 

0 . 050000 

1 . 000000 

1 . 000000 

0 . 050000 

0 . 050000 

1 . 000000 

1.000000 

Page 11 of 13 

DP Number: D426724 

1.000 1.000 OP# 04 

1.000 1 . 000 OPU 04 

1.000 

1 . 000 

1 . 000 

1 . 000 

1 . 000 

1 .000 

1.000 

1.000 

1.200 

1.200 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1. 000 

1 . 000 

1.000 

1.000 

1 . 000 

1.000 

1 . 000 

1. 000 

1.000 

1 . 000 

1.000 

1.000 

1 . 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

9E7577 

9E7577 

9£7577 

9E7577 

9E757 7 

9E7577 

9E7577 

4E8297 

4E8297 

4E8297 

4E8297 

8F4937 

8 F4937 

8F4937 

8F4937 

8F4937 

8F4937 

8 F4937 

1 . 000 1.000 8F4937 

1.000 1 . 000 8F4937 

1.000 1 . 000 8F4937 

1.000 1.000 6F4661 

1.000 1.000 

1 . 000 1.000 6F4661 

1. 000 1. 000 

1.000 1.000 6F4661 

1 . 000 1. 000 6F4661 

1.000 1.000 

1.500 1.000 6F4661 

1.500 1.000 

1.000 1.000 6F4661 

1.000 1.000 

1 . 000 

1. 000 

1 .000 

1 . 000 

1.000 

1.000 

1.000 

1 . 000 

1 . 000 

1 . 000 

1 .000 

1.000 

1.000 

1.000 

1.000 

1.000 

1 . 000 

1. 000 

1 . 000 

1 . 900 

1 . 000 

1 . 000 

1.000 

1.000 

1 . 000 

1. 000 

1.000 

1. 000 

1. 000 

1.000 

1. 000 

1.000 

1.000 

1.000 

1. 000 

1.000 

1.000 

1. 000 

1. 000 

1 . 000 

1.000 

1.000 

1.000 

1.000 

1. 000 

1. 000 

1.000 

1. 000 

1 . 000 

1.000 

1. 000 

1. 000 

6F4661 

6F4661 

8F4937 

8F4937 

8F4937 

8F4937 

8F4937 

8F4937 
Halosulfuron-Methyl Dietary Exposure and Risk Assessment DP Number: 0426724 

3100049001 31 Beef, liver-babyfood l.000000 l.000 l . 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 1.000 1.000 3F4193 

3400 292001 34 Pork, meat byproducts-babyf ood 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 3F4193 

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 . 000 

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 

35003 43000 35 Sheep, liver 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#l358 

Full comment: DPll358032 

8602000000 868 Water, indirect, all sources 0 . 059200 1.000 1. 000 

9500016000 0 Artichoke, globe 0 . 050000 1. 000 1 . 000 

9500019000 0 Asparagus 0.800000 1. 000 1. 000 1F6229 

9500177000 0 Grape, leaves 0 . 050000 1.000 1.000 4E8297 

9500178000 0 Grape, raisi n 0 . 050000 4.300 1 . 000 4E8297 

9500362000 0 Sugarcane, sugar 0 . 050000 1. 000 1.000 6F4661 

9500362001 0 Sugarcane, sugar-baby food 0 . 050000 1 . 000 1.000 

9500363000 0 Sugarcane, molasses 0.050000 1. 000 1.000 6F4661 

9500363001 0 sugarcane, molasses-babyfood 0.050000 1. 000 1.000 

Page 12of 13 
Halosulfuron-Mcthyl Dietary Exposure and Risk Assessment DP Number: D426724 

Attachment 2 : Acute Results 

U.S. EPA 

DEEM-FCID ACUTE Analysis for HALOSULFURON-METHYL 

Residue file: ACUTE & CHRONIC 042415.R08 

Ver. 3.16, 03-08-d 

NHANES 2003-2008 2-Day 

Adjustment factor tt2 NOT used . 

Analysis Date: 04-24-2015/13 :04:11 Residue file dated: 04-24-2015/12 :57:10 

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 yrs; New Uses Artichoke and Cane 

berry sugroup 13-07A" 

======================= ================================ =~:=•================== = 

Summary calculations--per capita: 

9Sth Percentile---- 99th Percentile---- ---99 . 9th Percentile----

Exposure % aRfD MOE Exposure % aRf D MOE Exposure % aRfD MOE 

Female 13-49 : 

0.004139 0.83 12079 0 . 005818 1.16 8594 0.008261 1. 6S 6052 

Attachment 3: Chronic Results 

U.S . EPA Ver. 3.16, 03-08-d 

DEEM-FCID Chronic analysis for HALOSULFURON-METHYL 

Residue file name: C:\Users\KRURY\Documents\My Work 

Vine Climbing\Dietary\ACUTE & CHRONIC 04241S.R08 

NHANES 2003 - 2008 2-day 

Files\Halosulfuron\Pome fruit and Small 

Adjustment factor ff2 NOT used. 

Analysis Date 04-24-201S/l2 :S7:44 Residue file dated: 04-24-201S/12 :57:10 

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

COMMENT 1: Acute is only for Females 13-49 yrs; New Uses Artichoke and Caneberry sugroup 

13-07A 

=============2============================================n==~•==z============= 

Population 

Subgroup 

Total US Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children l-6 

Children 7-12 

Male 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors SS+ 

All Infants 

Female 13-SO 

Children 1-2 

Children 3-S 

Children 6-12 

Youth 13-19 

Adults 20-49 

Adulcs S0-99 

Female 13-49 

Total exposure by population subgroup 

Tocal Exposure 

mg/kg 

body wt/day 

0 .002091 

0 .002190 

0.002108 

0.001774 

0.002361 

0.002106 

0 . 006273 

0.001907 

0.004527 

0.002330 

0.001609 

0.001585 

0.00172S 

0 . 001856 

0 . 001750 

0 . 004987 

0.001810 

O.OOS740 

0 . 004025 

0 . 002488 

0 . 001597 

0.001817 

0.001767 

0 . 001812 

Page 13of 13 

Percent of 

Rfd 

2 .1% 

2 . 2% 

2 .1% 

1. 8% 

2 .4% 

2 .1% 

6 .3% 

1.9% 

4 . 5\ 

2 . 3% 

1.6% 

1 . 6% 

1 . 7\ 

l.9% 

l.8% 

S.O\ 

1. 8% 

5.7% 

4.0% 

2.5% 

1.6% 

1. 8% 

1. 8% 

1. 8%