UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

W ASHfNGTON, D.C. 20460 

MEMORANDUM 

Date: September 10, 2015 

OFFICE OF 

CHEMICALSAFETYAND 

POLLUTION PREVENTION 

SUBJECT: Prosulfuron. Draft Human Health Risk Assessment in Support of Registration 

Review. 

PC Code: 12903 1 

Decision No.:502173 

Petition No.: NA 

Risk Assessment Type: Single Chemical 

Aggregate 

TXRNo.: NA 

MRJD No.: NA 

DP Barcodc: D426092 

Registration No.: NA 

Regulatory Action: Registration Review 

Case No.: 7235 

CAS No.: 94 125-34-5 

40 CFR: § 180.481 

FROM: Evisabel Craig, PhD, DABT, Risk Assessor/Toxicologist ~- -!f}t.AJf, .J 

Monica Hawkins, PhD, MPH, Environmental Health Scientist 1{~ Yf-VJll 

Julie Yan Alstine, MPH, Environmental Health ScientisWu.. V: ~ 1 -...L • 

Risk Assessment Branch VI · ~ ,7rl./\,, rv ~ 

Health Effects Division (7509P) 

THROUGH: Donna Davis, Branch Chief 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

TO: Wilhelmena Livingston, Risk Manager Reviewer 

Kevin Costello, Branch Chief 

Risk Management and Implementation Branch IV 

Pesticide Re-evaluation Division (7508P) 

Page 1 of32 
Table of Contents 

1.0 Executive sum_mary ................................. .................................................................................. 3 

2.0 l-IED Recommendations ............................... ........................................................................ 4 

2. 1 Tolerance Considerations ..................................................................................................... 4 

2.2 Label Considerations ........................................................................................................... 4 

3.0 Introduction .......................................................................................................................... 4 

3 .1 Chemical Identity and Physical/Chemical Characteristics ............................................... 4 

3.2 Pesticide Use Panern and Anticipated Exposure Pathways ............................................. 5 

3.3 Consideration of Environmental Justice .......................................................................... 5 

4.0 Hazard Identification/Toxicology ............................................ .... ......................................... 6 

4.1 Summary of Toxicological Effects .................................................................................. 6 

4.2 Safety Factor for Infants and Children (FQPA Safety Factor) ......................................... 7 

4.3 Toxicity Endpoint and Point of Departure Selections ...................................................... 7 

4.4 Endocrine Disruptor Screening Program ......................................................................... 9 

5.0 Dietary Exposure and Risk Assessment ............................................................................. I 0 

5.1 Residue Profile ............................................................................................................... I 0 

5.2 Water Residue Profile .................................................................................................... 10 

5.3 Dietary Risk Assessment.. .............................................................................................. 11 

6.0 Residential (Non-Occupational) Exposure/Risk Characteri zation .................................... 12 

6.1 Spray Drift ...................................................................................................................... 12 

7.0 Aggregate Exposure/Risk Characterization ....................................................................... 13 

8.0 Cumulative Exposure/Risk Characterization ..................................................................... 13 

9.0 Occupational Exposure/Risk Characterization .................................................................. 14 

9 .1 Occupational Handler Exposure/Risk Estimates ............................................................... 14 

I 0.0 Public Health and Pesticide Epidemiology Data ............................................................... 17 

11.0 References .................................................................................................................... ..... 17 

Appendix A. Toxicology Profile and Executi ve Summaries .................................................... 27 

Appendix B. Review of Human Research ................................................................................ 27 

Appendix C. Occupational Non-cancer Handler Algorithms ................................................... 27 

Appendix D. Dietary Exposure/Risk Modeling Input and Output ........................................... 27 

Appendix E. Nomenclature and Physical/Chemical Properties ............................................... 27 

Appendix F. Spray Drift Detailed Description ......................................................................... 27 

Appendix G. Submittal of Analytical Reference Standards (860.1650) .................................... 32 

Page 2 of32 
Page 3 of 32

1.0 Executive summary

Prosulfuron is a sulfonylurea herbicide that is used to control pre- and post-emergent broadleaf 

weeds in/on a variety of agricultural crops. It is currently registered for use in/on barley, field 

corn (grown for grain, silage, or seed), grain sorghum (milo), oats, popcorn, proso millet, rye, 

triticale, wheat, and following small grain harvest. This document addresses exposures and risk 

estimates from the registered uses of prosulfuron required during Registration Review. 

There are several end-use product labels registered with prosulfuron as the active ingredient. 

These include water-dispersible granules in water-soluble packet (WSP) formulations. The 

registered products are applied either with aerial or groundboom equipment. The single 

application rate of the registered uses for prosulfuron range from 0.02 to 0.0356 lb ai/A. Based 

on the registered use pattern for prosulfuron, short- and intermediate-term inhalation and dermal 

exposures are anticipated for occupational handlers. In terms of personal protective equipment 

(PPE), the prosulfuron labels require handlers to wear baseline attire (i.e., long sleeved shirt, 

long pants, shoes plus socks) and chemical-resistant gloves. 

The toxicology database for prosulfuron is adequate for risk assessment. Immunotoxicity and 

subchronic inhalation toxicity studies have been waived for prosulfuron by the Hazard and 

Science Policy Council (HASPOC). The last human health risk assessment for prosulfuron was 

completed in 2009 and a human health scoping document was issued in 2012. Since then, no 

new toxicity and/or metabolism data have been received. For this assessment, the toxicological 

endpoints and points of departure (PODs) have been updated to include an incidental oral POD

in order to assess exposure from spray drift. All other endpoints/PODs selected for risk 

assessment remain the same as in the previous assessments. 

The existing residue chemistry database for prosulfuron is complete and adequate for risk 

assessment purposes. No additional residue chemistry data are required at this time. HED has 

conducted acute and chronic dietary exposure and risk assessments for prosulfuron using 

tolerance-level residues in foods and estimated drinking water concentrations (EDWCs) provided 

by the Environmental Fate and Effects Division (EFED). Acute and chronic dietary exposure 

and risk estimates (food and drinking water) are not of concern for the general U.S. population or 

any other population subgroup. Prosulfuron is classified as, “not likely to be carcinogenic to 

humans”; therefore, a cancer dietary assessment was not conducted for prosulfuron. 

There are no proposed or current registrations for products containing prosulfuron that allow 

residential use. Therefore, residential handler and conventional residential post-application 

exposure assessments were not conducted to support Registration Review. A quantitative spray 

drift assessment was conducted. Risk estimates from groundboom and aerial applications are not 

of concern from the field edge for all scenarios considered.

In the case of prosulfuron, aggregate exposure and risk estimates are equivalent to the dietary

(food and water) exposure and risk estimates and are below HED’s level of concern.

The occupational handler exposure and risk estimates based on the highest application rate and 

amount handled scenario indicate that the short- and intermediate-term inhalation MOEs are not 
Page 4 of 32

of concern to HED (i.e., MOEs ≥ 100). The inhalation MOEs ranged from 41,000 to 2,000,000. 

Occupational post-application dermal exposure was not quantitatively assessed since there is no 

dermal hazard for prosulfuron. Based on the Agency's current practices, a quantitative noncancer occupational post-application inhalation exposure assessment was not performed for 

prosulfuron at this time. If new policies or procedures are put into place, the Agency may revisit 

the need for a quantitative occupational post-application inhalation exposure assessment for 

prosulfuron. The restricted entry interval (REI) of 12 hours specified on the registered labels is 

based on the acute toxicity of prosulfuron and is adequate. 

HED has not identified any risk concerns associated with the registered uses of prosulfuron. 

There are no data gaps that would require submission of additional toxicity or exposure data.

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. For a list of data sources, see Appendix B.

2.0 HED Recommendations

2.1 Tolerance Considerations

The existing tolerances for residues of prosulfuron (40 CFR §180.481) are supported by the 

available residue chemistry data. Codex has not established maximum residue limits (MRLs) for 

residues of prosulfuron. Canada has established MRLs for prosulfuron which are harmonized 

with U.S. tolerances. 

HED notes that the tolerance expression for prosulfuron in 40 CFR §180.481 requires revision to 

state the following:

(a) General. Tolerances are established for residues of prosulfuron, including its 

metabolites and degradates, in or on the commodities in the table below. Compliance 

with the tolerance levels specified below is to be determined by measuring only 

prosulfuron (N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-

trifluoropropyl)benzenesulfonamide) in or on the commodity.

2.2 Label Considerations

There are no label recommendations for registered products containing prosulfuron.

3.0 Introduction

3.1 Chemical Identity and Physical/Chemical Characteristics

Prosulfuron, (N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-

trifluoropropyl)benzenesulfonamide), is a colorless, odorless, crystalline solid. The chemical 

properties of prosulfuron do not suggest that there are any particular exposure issues that warrant 

special consideration. The structure and physical/chemical properties of prosulfuron are 

provided in Appendix E.
Page 5 of 32

3.2 Pesticide Use Pattern and Anticipated Exposure Pathways

Table 3.2 provides a summary of the highest application rate of the registered uses for 

prosulfuron.

Table 3.2. Summary of Registered Uses of Prosulfuron.

Application

Equipment Formulation 

Maximum 

Application

Rate REI Use Directions and Limitations

Field Corn (grown for grain, silage, or seed), Grain Sorghum (Milo) 

Aerial,

Groundboom

Waterdispersible 

granule in 

WaterSoluble 

Packets

0.0356 lb ai/A 12 hours

Do not apply this product 

through any type of 

irrigation system. Do not 

apply the product by aerial 

application in New York.

Rye, Oats, Proso Millet, Wheat, Barley, Popcorn, Triticale, Small Grains

Aerial, 

Groundboom

Waterdispersible 

granule in 

WaterSoluble 

Packets

0.02 lb ai/A 12 hours

Do not apply this product 

through any type of 

irrigation system. 

Exposure Pathways

Individuals may be exposed to prosulfuron via their diet (food and drinking water). There are no 

residential uses of prosulfuron. However, there is the potential for non-occupational exposure as 

a result of spray drift. Agricultural workers may be exposed to prosulfuron during mixing, 

loading, and/or applying the herbicide as well as during post-application activities.

3.3 Consideration of Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in the 

preliminary human health risk assessment for prosulfuron, in accordance with U.S. Executive 

Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and 

Low-Income Populations,"

(http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pdf). As a part of 

every pesticide risk assessment, OPP considers a large variety of consumer subgroups according 

to well-established procedures. In line with OPP policy, HED estimates risks to population 

subgroups from pesticide exposures that are based on patterns of that subgroup’s food and water 

consumption, and activities in and around the home that involve pesticide use in a residential 

setting. Extensive data on food consumption patterns are compiled by the USDA under the 

National Health and Nutrition Examination Surveys/What We Eat in America 

(NHANES/WWEIA) and are used in pesticide risk assessments for all registered food uses of a 

pesticide. These data are analyzed and categorized by subgroups based on age and ethnic group. 

Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and 
Page 6 of 32

exposure assessments are performed when conditions or circumstances warrant. Whenever 

appropriate, non-dietary exposures based on home use of pesticide products and associated risks 

for adult applicators and for toddlers, youths, and adults entering or playing on treated areas 

post-application are evaluated. Further considerations are currently in development as OPP has 

committed resources and expertise to the development of specialized software and models that 

consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary 

patterns among specific subgroups. 

4.0 Hazard Identification/Toxicology

The toxicology database for prosulfuron is complete and adequate for risk assessment. 

Immunotoxicity and subchronic inhalation studies are listed as part of the current 40 CFR Part 

158 Toxicology Data Requirements. However, the Hazard and Science Policy Council 

(HASPOC) determined that these studies are not required at this time for prosulfuron (Y. Yang, 

TXR#0056759, 08/15/2013 and E. Craig, TXR#, 0052986, 05/072015). The TOXLINE 

(National Library of Medicine) database literature search did not identify any new toxicological 

information not already considered. The latest risk assessment was conducted in 2009 (B. 

Hanson, D370557, 10/20/2009). For a summary of the acute, subchronic and chronic toxicity 

profile, see Appendix A.

4.1 Summary of Toxicological Effects

The most prevalent effect observed across species and study durations following administration 

of prosulfuron was decreased body weight; observed in subchronic and chronic oral toxicity 

studies in rats and dogs. Additionally, subchronic and chronic oral toxicity studies in dogs

showed decreased hematological parameters and hepatic toxicity. Evidence of neurotoxicity was 

observed in an acute neurotoxicity study but not in the subchronic neurotoxicity study. The 

neurological effects seen in the acute neurotoxicity study were transient, affecting primary 

sensorimotor and gait functions. In a developmental range-finding study in rabbits, ataxia, 

hypoactivity, and neuropathology were observed starting at doses of 150 mg/kg/day. However, 

these potential signs of neurotoxicity were not consistent with findings in the two main 

developmental studies in rabbits where there were no signs of neurotoxicity observed up to 200 

mg/kg/day. Additionally, other repeated dosing studies in the rat, mouse and dog did not show 

evidence of neurotoxicity. There is no evidence that prosulfuron is an immunotoxic chemical. 

In accordance with the 2005 Guidelines for Carcinogen Risk Assessment, prosulfuron is 

classified as “Not Likely to Be Carcinogenic to Humans” based on the lack of evidence of 

carcinogenicity in mice and rats and no concern for mutagenicity. Prosulfuron has low acute 

toxicity by the oral, dermal, and inhalation routes of exposure, it is not considered an eye or skin 

irritant and it is not a skin sensitizer.

There was no evidence from the developmental and reproductive studies of increased 

susceptibility in rat or rabbit fetuses. In the first of two rabbit developmental studies, there were 

no signs of maternal or developmental toxicity. The second rabbit (tested using higher doses than 

the first) and the rat developmental studies showed dose-related increases in small fetuses and 

skeletal effects but these occurred at maternally toxic doses. In the reproductive study in rats, 
Page 7 of 32

decreases in body weights were noted for both the adults of the P0 and P1 generations and for the 

F1 and F2 pups. 

With oral administration in rats, approximately 90% of the administered dose was excreted 

during the first 48 hours. No information regarding absorption was provided in metabolism 

studies. At higher doses a greater proportion of the administered dose was excreted in the feces 

compared to urine. Females usually excreted more of the dose in the urine than males in both 

instances. The major routes of metabolism occurred via hydroxylation at side chains and phenyl 

ring positions, and O-demethylation of the triazyl methoxy group or O-demethylation of the 

methoxy group, and hydroxylation of the triazinyl methyl group. Minor routes of metabolism 

included unsaturation of the trifluoropropyl side chain, hydrolysis of the phenyl-sulfonylurea 

link, and oxidative/hydrolytic cleavage of the triazine ring system. 

4.2 Safety Factor for Infants and Children (FQPA Safety Factor)

The toxicity database of prosulfuron is complete and adequate to assess susceptibility in the 

young. There is no evidence of increased qualitative or quantitative susceptibility and exposure 

estimates are unlikely to underestimate risk.. Although there was evidence of neurotoxicity in the 

acute neurotoxicity study and the range-finding developmental toxicity rabbit study (see Section 

4.1), the selected endpoints are protective of these effects since they were seen at dose levels in 

excess of those where systemic toxicity occurred and at doses at least 15-fold higher than the noobserved adverse effect levels (NOAELs) selected for risk assessment. Concern is also low since 

no neurotoxicity was observed in the rest of the prosulfuron toxicological database, including the 

subchronic neurotoxicity study in rats. . Therefore, the 10-fold FQPA Safety Factor is reduced to 

1x.

4.3 Toxicity Endpoint and Point of Departure Selections

There have been no changes to selected endpoints since the last risk assessment, except the 

subchronic oral toxicity study in dogs was also selected to assess incidental oral exposures. The 

study is appropriate for the route and duration of exposure for incidental oral assessment and 

considered protective of the population of concern given that there was no evidence of offspring 

susceptibility in the toxicological database.

It is recognized that the studies in the toxicological database for prosulfuron, including those 

used for endpoint selection, have not been updated to reflect current policy and may be 

considered conservative. However, the current PODs are protective of the effects observed in 

the prosulfuron database and any updates would not impact the overall findings of the risk 

assessment given the current risk picture for prosulfuron.

Table 4.3.1. Prosulfuron Summary of Toxicological Doses and Endpoints for Use in 

Dietary Human Health Risk Assessments.

Exposure 

Scenario

Point of 

Departure

Uncertainty/

FQPA SFs

Population Adjusted 

Dose for Risk 

Assessment

Study and Toxicological Effects
Page 8 of 32

Exposure 

Scenario

Point of 

Departure

Uncertainty/

FQPA SFs

Population Adjusted 

Dose for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary

(General 

Population 

including 

Infants and 

Children)

(Females 13-49 

years of age)

NOAEL = 10 

mg/kg/day

UFA = 10x

UFH =10x

FQPA SF= 1x

Acute RfD = 0.1 

mg/kg/day

aPAD = 0.1 

mg/kg/day

Acute Neurotoxicity Study – Rat

MIRD 43387703

LOAEL = 250 mg/kg/day, based on 

abnormal gait in females.

Chronic Dietary 

(All 

Populations)

NOAEL= 5.3 

mg/kg/day

UFA = 10x

UFH =10x

FQPA SF= 1x

Chronic RfD = 0.053 

mg/kg/day

cPAD = 0.053 

mg/kg/day

Subchronic Oral Toxicity Study –

Dog

MIRD 42685230

LOAEL = 54 mg/kg/day, based on 

decreased feed efficiency, 

hematological findings and 

hepatotoxicity in both sexes.

Incidental oral 

(short- & 

intermediateterm)

NOAEL= 5.3 

mg/kg/day

UFA = 10x

UFH =10x

FQPA SF= 1x

Residential LOC for 

MOE = 100

Subchronic Oral Toxicity Study –

Dog

MIRD 42685230

LOAEL = 54 mg/kg/day, based on 

decreased feed efficiency, 

hematological findings and 

hepatotoxicity in both sexes.

Dermal 

exposure (all 

durations)

Not required based on the fact that no hazard was identified in the dermal study at dose levels as 

high as the limit dose (1000 mg/kg/day) and there is no evidence of quantitative offspring 

susceptibility

Inhalation 

exposure 

Short- (1-30 

days), 

Intermediate (1-

6 months) and 

Long-Term (> 6 

months)

Oral

NOAEL = 5.3 

mg/kg/day

UFA = 10x

UFH =10x

FQPA SF= 1x

IA = 100%

Residential LOC for 

MOE = 100

Subchronic Oral Toxicity Study –

Dog

MIRD 42685230

LOAEL = 54 mg/kg/day, based on 

decreased feed efficiency, 

hematological findings and 

hepatotoxicity in both sexes.

Cancer (oral, 

dermal, 

inhalation)

Prosulfuron is classified as “Not Likely to Be Carcinogenic to Humans” based on the lack of 

evidence of carcinogenicity in mice and rats and no concern for mutagenicity. 

UF = uncertainty factor, FQPA SF = Special FQPA SF, NOAEL = no observed adverse effect level, LOAEL = lowest observed 

adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose. MOE = margin of exposure. 

LOC = level of concern. IA = inhalation absorption factor.

Table 4.3.2. Prosulfuron Summary of Toxicological Doses and Endpoints for Use in 

Occupational Human Health Risk Assessments

Exposure/

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of Concern for 

Risk Assessment Study and Toxicological Effects

Dermal exposure (all 

durations)

Not required based on the fact that no hazard was identified in the dermal study at dose 

levels as high as the limit dose (1000 mg/kg/day).
Page 9 of 32

Exposure/

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of Concern for 

Risk Assessment Study and Toxicological Effects

Inhalation exposure 

Short- (1-30 days), 

Intermediate (1- 6 

months) and LongTerm (> 6 months)

Oral

NOAEL = 5.3 

mg/kg/day

UFA = 10x

UFH =10x

IA = 100%

Occupational LOC for 

MOE = 100

Subchronic Oral Toxicity Study 

– Dog

MIRD 42685230

LOAEL = 54 mg/kg/day, based 

on decreased feed efficiency, 

hematological findings and 

hepatotoxicity in both sexes.

Cancer (oral, 

dermal, inhalation)

Prosulfuron is classified as “Not Likely to Be Carcinogenic to Humans” based on the lack of 

evidence of carcinogenicity in mice and rats and no concern for mutagenicity. 

NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = 

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

population (intraspecies). MOE = margin of exposure. LOC = level of concern. IA = inhalation absorption factor.

4.4 Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for prosulfuron, EPA 

reviewed these data and selected the most sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 

prosulfuron is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 
Page 10 of 32

chemicals identified for EDSP screening was published on June 14, 20131and includes some 

pesticides scheduled for Registration Review and chemicals found in water. Neither of these lists 

should be construed as a list of known or likely endocrine disruptors. For further information on 

the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test 

guidelines and the Tier 1 screening battery, please visit our website.2

5.0 Dietary Exposure and Risk Assessment 

5.1 Residue Profile

The existing residue chemistry database for prosulfuron is complete and adequate for risk 

assessment purposes. The qualitative nature of the residue of prosulfuron in plants is adequately 

understood based on acceptable metabolism studies and the most recently submitted rotational 

crop studies on root and leafy vegetables and small grains. The qualitative nature of the residues 

of prosulfuron in animals is adequately understood based on the available metabolism studies in 

ruminants and poultry. There is no reasonable expectation of residues in livestock commodities 

(40CFR§180.6(a)(3)). Adequate high-performance liquid chromatography (HPLC) methods are 

available for enforcing tolerances for prosulfuron residues in plant commodities. Previous 

residue chemistry deficiencies have been resolved. No additional residue chemistry data are 

required at this time. 

5.2 Water Residue Profile

Screening ground water-sourced drinking water exposure estimates were generated with the 

Pesticide Root Zone Model for GroundWater (PRZM-GW; v.1.07) for use in the sulfonylurea 

(SU) dietary risk assessments. EFED initially provided coarse-screen estimates that should 

exceed the upper-bound chemical-specific EDWCs for any SU; however, for several of the SUs, 

the coarse-screen EDWCs resulted in dietary risks of concern and EFED subsequently generated 

refined-screen EDWCs for these SUs. The application inputs for the refined-screen EDWCs 

represent the maximum application rate pattern for the chemical, considering the maximum 

single application rate first, then the maximum seasonal application rate, using usage data 

provided by BEAD if the labels do not provide a maximum seasonal rate. The modeled sorption 

coefficient is also chemical-specific. All other inputs, including the screening assumptions of 

stability to degradation and application every year, remained the same as for the coarse screen. 

The resulting refined-screen EDWCs from PRZM-GW can be used as a conservative estimate of 

exposure and are summarized in Table 5.2 (G. Orrick, D427429, 08/12/2015). 

The acute and chronic dietary assessments for prosulfuron used the refined-screen maximum 

daily concentration of 15 μg/L (0.015 ppm) and the post-breakthrough mean value of 13 μg/L 

(0.013 ppm), respectively.

 

1 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.

2 http://www.epa.gov/endo/
Page 11 of 32

Table 5.2. PRZM-GW Refined-Screen EDWCs for Sulfonylureas

Sulfonylurea (Use)

PRZM-GW 

Scenario Max. Daily Conc. (μg/L) Post-breakthrough 

Mean (μg/L)

Mean 

Breakthrough Time 

(years)

Chlorsulfuron (non-ag areas) NC cotton 78 52 5.9

Halosulfuron-methyl (fallow) NC cotton 74 53 8.1

Nicosulfuron (rights-of-way) NC cotton 39 26 6.2

Prosulfuron (corn) NC cotton 15 13 12

Rimsulfuron (commercial areas) NC cotton 105 71 6.5

Triasulfuron (rangeland) NC cotton 21 19 16

Tribenuron-methyl (corn) NC cotton 35 23 6.1

Triflusulfuron-methyl (sugarbeet) FL citrus 23 20 9.5

5.3 Dietary Risk Assessment

HED has conducted acute and chronic dietary exposure and risk assessments for prosulfuron 

using tolerance-level residues in foods and EDWCs provided by EFED. Exposure and risk 

estimates were obtained from the Dietary Exposure Evaluation Model using the Food 

Commodity Intake Database (DEEM-FCID; version 3.18). The model uses food consumption 

data from the 2003-2008 National Health and Nutrition Examination Survey/What We Eat in 

America (NHANES/WWEIA) database, coupled with recipe files and residues in foods, to 

derive estimates of dietary exposure and risk. 

Generally, HED is concerned when dietary exposure estimates exceed 100% of the acute or 

chronic population adjusted dose (aPAD and cPAD, respectively). Acute and chronic dietary 

risk estimates (food and drinking water) are not of concern for the general U.S. population or any 

other population subgroup (Table 5.3). At the 95th percentile of exposure, the acute exposure 

estimate utilized <1.0% of the aPAD for the general U.S. population and 2.6% of the aPAD for 

all infants (<1 year old), the most highly-exposed population subgroup. The chronic exposure 

estimate utilized <1.0% of the cPAD for the general U.S. population and 1.4% of the cPAD for 

all infants (<1 year old), the most highly-exposed population subgroup. Because of the very 

conservative assumptions used in the analysis (tolerance-level residues, 100% crop treated, 

upper-bound modeled drinking water estimates), actual exposure and risks are expected to be 

much lower than those shown in Table 5.3. The listings of inputs and outputs to the assessment 

are included in Appendix D. Prosulfuron is classified as, “not likely to be carcinogenic to 

humans”; therefore, a cancer dietary assessment was not conducted for prosulfuron. 

Table 5.3. Summary of Acute and Chronic Dietary Exposure (Food and Drinking Water) and Risk for 

Prosulfuron1.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary Exposure 

(mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD

General U.S. Population 0.000866 <1.0 0.000311 <1.0

All Infants (<1 year old) 0.002641 2.6 0.000756 1.4

Children 1-2 years old 0.001389 1.4 0.000483 <1.0
Page 12 of 32

Table 5.3. Summary of Acute and Chronic Dietary Exposure (Food and Drinking Water) and Risk for 

Prosulfuron1.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary Exposure 

(mg/kg/day)

% aPAD Dietary Exposure 

(mg/kg/day)

% cPAD

Children 3-5 years old 0.001132 1.1 0.000422 <1.0

Children 6-12 years old 0.000863 <1.0 0.000306 <1.0

Youth 13-19 years old 0.000729 <1.0 0.000242 <1.0

Adults 20-49 years old 0.000838 <1.0 0.000305 <1.0

Adults 50-99 years old 0.000742 <1.0 0.000292 <1.0

Females 13-49 years old 0.000853 <1.0 0.000302 <1.0

1 Population with the greatest exposure is in bold. Exposure and risk estimates calculated using DEEM version 3.18.

6.0 Residential (Non-Occupational) Exposure/Risk Characterization

There are no proposed or registered products containing prosulfuron that would result in 

residential exposure. Therefore, a quantitative residential exposure and risk assessment was not 

performed. However, prosulfuron can be applied via ground and aerial equipment, therefore, a 

quantitative assessment was conducted to address any potential indirect exposures to prosulfuron

as a result of spray drift.

6.1 Spray Drift

A detailed description about HED’s spray drift policy and how to evaluate the drift potential and 

associated risks is available in Appendix F. 

6.1.1 Combined Risk Estimates from Lawn Deposition Adjacent to Applications

The spray drift risk estimates are based on an estimated deposited residue concentration as a 

result of the screening level agricultural application scenarios. Prosulfuron is used on field corn, 

popcorn, grain sorghum (milo), wheat, barley, rye, oats, triticale, proso millet, and small grain 

harvest and can be applied via groundboom and aerial equipment. The spray drift assessment 

was conducted using the highest registered application rate of 0.0356 lb ai/acre for use on field 

corn. The recommended drift scenario screening level options are listed below: 

 Groundboom applications are based on the AgDrift® option for high boom height and 

using very fine to fine spray type using the 90th percentile results. 

 Aerial applications are based on the use of AgDrift® Tier 1 aerial option for a fine to 

medium spray type and a series of other parameters, which will be described in more 

detail below (e.g., wind vector assumed to be 10 mph in a downwind direction for entire 

application/drift event).3

 

3 AgDrift® allows for consideration of even finer spray patterns characterized as very fine to fine. However, this 

spray pattern was not selected as the common screening basis since it is used less commonly for most agriculture. If 

assessors identify this use pattern, then it should be used as the screening criteria and deposition values associated 

with it ae provided in Table 1 below. Justification for including this spray quality should be included in any 

assessment based on specific label directions for its use.
Page 13 of 32

There are no short- or intermediate-term dermal PODs. Only incidental oral risk estimates were 

evaluated. The total applicable LOC is 100, so MOEs <100 would be of concern. Children (1 to 

<2 years old) incidental oral risk estimates from exposure to prosulfuron related to spray drift 

result in no risks of concern at the field edge for either groundboom or for aerial applications 

(Table 6.1.1.). 

6.2 Residential Bystander Post-Application Inhalation Exposure

Volatilization of pesticides may be a source of post-application inhalation exposure to 

individuals nearby pesticide applications. The agency sought expert advice and input on issues 

related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act 

Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on 

March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The 

agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a 

subsequent Volatilization Screening Analysis 

(http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2014-0219). 

During Registration Review, the Agency will utilize this analysis to determine if data (i.e., flux 

studies, route-specific inhalation toxicological studies) or further analysis is required for 

prosulfuron.

7.0 Aggregate Exposure/Risk Characterization

The Food Quality Protection Act of 1996 directs EPA to assess aggregate exposure to pesticide 

chemical residues, including all anticipated dietary exposures and all other exposures for which 

there is reliable information. In the case of prosulfuron, aggregate exposure and risk estimates 

are equivalent to the dietary (food and water) exposure and risk estimates in Section 5, above, 

and are below HED’s level of concern.

8.0 Cumulative Exposure/Risk Characterization

In 2015, EPA’s Office of Pesticide Programs released a guidance document entitled, Pesticide 

Cumulative Risk Assessment: Framework for Screening Analysis 

[http://www.epa.gov/oppfead1/cb/csb_page/updates/2015/framework-for-screeninganalysis.html]. This document provides guidance on how to screen groups of pesticides for 

Table 6.1.1. Children (1 to <2 years old) Incidental Oral Risk Estimates (MOEs) Related to 

Spray Drift Exposure for Flurprimidol.

Crop/Rate 

Group Spray Type/Nozzle Configuration

Application 

Rate

(lb ai/A)

Estimated 

TTRt (ug/cm2)

At Edge

HtM MOE

Field Corn

Aerial Fine to Medium

0.0356 0.00395694

38,000

Groundboom High Boom Very fine to Fine 52,000
Page 14 of 32

cumulative evaluation using a two-step approach beginning with the evaluation of available 

toxicological information and if necessary, followed by a risk-based screening approach. This 

framework supplements the existing guidance documents for establishing common mechanism 

groups (CMGs)[1] and conducting cumulative risk assessments (CRA)[2]. The Agency has 

utilized this framework to evaluate the SUs of which prosulfuron is a member (J. D’Agostino; 

D428798; 9/9/15). Although the SUs share some chemical and toxicological characteristics, the 

toxicological database does not support a testable hypothesis for a common mechanism of 

action. No further mechanistic data are required and no further cumulative evaluation is 

necessary.

9.0 Occupational Exposure/Risk Characterization

9.1 Occupational Handler Exposure/Risk Estimates

Based on current labeling, types of equipment and techniques that can potentially be used, 

occupational exposure associated with handler activities (i.e., mixing, loading, and applying) is 

expected from the registered use on field corn (grown for grain, silage, or seed), popcorn, grain 

sorghum (milo), wheat, barley, rye, oats, triticale, proso millet, and following small grain 

harvest. The quantitative exposure/risk assessment developed for occupational handlers is based 

on the scenarios listed in Table 9.1. Based on the use patterns (i.e., 1 application per season) 

and resistance management practices, occupational exposure from the registered food uses is 

expected to be short-term (1-30 days) and intermediate-term (1-6 months) and in duration. 

Long-term exposures (greater than 6 months) are not anticipated. The registered labels require 

handlers to wear baseline attire and chemical resistant gloves.

Occupational Handler Exposure Data and Assumptions

Application Rate: The highest application rate of the registered uses for prosulfuron is listed in 

Table 3.2.

Unit Exposures: It is the policy of HED to use the best available data to assess handler exposure. 

Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, 

include PHED 1.1, the AHETF database, the Outdoor Residential Exposure Task Force 

(ORETF) database, or other registrant-submitted occupational exposure studies. Some of these 

data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. 

The standard values recommended for use in predicting handler exposure that are used in this 

assessment, known as “unit exposures”, are outlined in the “Occupational Pesticide Handler Unit 

Exposure Surrogate Reference Table4”, which, along with additional information on HED policy 

 

[1] Guidance For Identifying Pesticide Chemicals and Other Substances that have a Common 

Mechanism of Toxicity (USEPA, 1999)

[2] Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common 

Mechanism of Toxicity (USEPA, 2002)

4 Available: http://www.epa.gov/opp00001/science/handler-exposure-table.pdf
Page 15 of 32

on use of surrogate data, including descriptions of the various sources, can be found at the 

Agency website5. 

Area Treated or Amount Handled: The area treated or amount handled is based on HED 

ExpoSAC Policy No. 9.1. Refer to Table 9.1. or these assumptions for each scenario.

Risk Estimate Equations: The algorithms used to estimate non-cancer exposure and dose for 

occupational handlers can be found in Appendix C.

Combining Exposures/Risk Estimates:

The dermal route of exposure does not need to be combined with the assessed inhalation route of 

exposure because there is no identified systemic dermal hazard.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

The short- and intermediate-term inhalation risk estimates for the occupational handlers are 

greater than HED’s LOC (i.e., MOEs ≥ 100) at baseline for all scenarios, with MOEs ranging 

from 41,000 to 2,000,000. Table 9.1 provides the worst-case scenarios for the registered uses for 

prosulfuron.

1 “High-acreage field crops” include field corn. The worst-case scenarios for the registered uses for prosulfuron are listed in this table.

2 “Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation = Baseline except for aerial 

applicator which includes engineering controls (EC).

3 Based on the currently registered labels (See Table 4.1).

4 Exposure Science Advisory Council Policy #9.1.

 

5 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.html

Table 9.1. Occupational Short- and Intermediate-Term Handler Exposure and Risk Estimates for 

Prosulfuron.

Exposure Scenario Crop or Target1

Inhalation 

Unit 

Exposure2

μg/lb ai

(unless 

otherwise 

indicated)

Maximum

Application 

Rate3

Area 

Treated or 

Amount 

Handled 

Daily4

Inhalation

Dose5

mg/kg/day

MOE6

LOC = 100

Mixer/Loader

M/L water dispersible granule in 

water-soluble packet for aerial 

application 

High-acreage field crops 0.24

(EC)

0.0356 lb 

ai/A

1,200 

acres

0.000129 41,000

M/L water-dispersible granule in 

water-soluble packet for 

groundboom application

High-acreage field crops 0.24

(EC)

0.0356 lb 

ai/A

200 

acres

0.0000214 250,000

Applicator

Applying sprays for aerial 

application High-acreage field crops 0.0049(EC)

0.0356 lb 

ai/A

1,200 

acres

0.00000261 2,000,000

Applying sprays for groundboom 

application High-acreage field crops 0.34 0.0356 lb ai/A

200

acres

0.0000303 170,000

Flagger

Flagger High-acreage field crops 0.35 0.0356 lb 

ai/A

350 

acres

0.0000545 97,000
Page 16 of 32

5 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated 

or Amount Handled Daily (A or gal/day) ÷ BW (80 kg).

6 Short- and Intermediate-term Inhalation MOE = Inhalation NOAEL (5.3 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

9.2 Occupational Post-application Exposure/Risk Estimates

9.2.1 Occupational Post-application Inhalation Exposure/Risk Estimates

There are multiple potential sources of post-application inhalation exposure to individuals 

performing post-application activities in previously treated fields. These potential sources 

include volatilization of pesticides and resuspension of dusts and/or particulates that contain 

pesticides. The agency sought expert advice and input on issues related to volatilization of 

pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel 

(SAP) in December 2009, and received the SAP’s final report on March 2, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The agency has 

evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent 

Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA-HQOPP-2014-0219). During Registration Review, the agency will utilize this analysis to determine 

if data (i.e., flux studies, route-specific inhalation toxicological studies) or further analysis is 

required for prosulfuron.

In addition, the Agency is continuing to evaluate the available post-application inhalation 

exposure data generated by the Agricultural Reentry Task Force. Given these two efforts, the 

Agency will continue to identify the need for and, subsequently, the way to incorporate 

occupational post-application inhalation exposure into the Agency's risk assessments.

Although a quantitative occupational post-application inhalation exposure assessment was not 

performed, an inhalation exposure assessment was performed for occupational/commercial 

handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in 

higher exposure than post-application exposure. Therefore, it is expected that these handler 

inhalation exposure estimates would be protective of most occupational post-application 

inhalation exposure scenarios.

9.2.2 Occupational Post-application Dermal Exposure/Risk Estimates

Occupational post-application dermal exposure was not quantitatively assessed for prosulfuron 

since there is no dermal hazard for prosulfuron. 

Dislodgeable Foliar Residue (DFR): In accordance with the updated Part 158 data requirements 

(2007), one or more DFR studies are required when a pesticide has residential or occupational 

uses that could result in post-application dermal exposure. Since there is no hazard via the 

dermal route of exposure, a non-cancer dermal post-application risk assessment was not 

performed for prosulfuron. Therefore, DFR studies are not needed for prosulfuron at this time. 

If the PODs change, the need for DFR studies may be reevaluated in the future to refine the postapplication assessment.

Restricted Entry Interval
Page 17 of 32

The REI specified on the proposed label is based on the acute toxicity of prosulfuron. 

Prosulfuron is classified as Toxicity Category III via the dermal route and Toxicity Category IV 

for skin irritation potential. It is not a skin sensitizer. Under 40 CFR 156.208 (c) (2) (iii), ai’s 

classified as Acute III or IV for acute dermal, eye irritation and primary skin irritation are 

assigned a 12-hour REI. Therefore, the [156 subpart K] Worker Protection Statement interim 

REI of 12 hours is adequate to protect agricultural workers from post-application exposures to 

prosulfuron. 

10.0 Public Health and Pesticide Epidemiology Data

The OPP Incident Data System (IDS), the Centers for Disease Control and Prevention/National 

Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System 

for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data 

on the active ingredient prosulfuron in 2012 and no incidents of concern were identified (S. 

Recore, D397848, 02/04/2012); therefore additional analysis is not required. Prosulfuron is not 

included in the Agricultural Health Study (AHS), and therefore this study does not provide 

information for this report. The Agency will continue to monitor the incident information and if 

a concern is triggered, additional analysis will be included in the risk assessment.

11.0 References

Open literature references

A literature search was performed for prosulfuron. The search did not reveal information that 

would impact the current risk assessment. 

Internal memos

Author Barcode Date Title

M. Hawkins,

Y. Barnes,

S. Dapson

D396736 4/17/2012 Prosulfuron: Registration Review Scoping Document for Human 

Health Assessments.

S. Recore D397848 2/14/2012 Prosulfuron: Review of Human Incidents

B Hanson D370557 10/20/2009 Prosulfuron. REVISED Human Health Risk Assessment for the 

Proposed Establishment of Permanent Tolerances for Uses in/on 

Cereal Grains (Crop Group 15), Except Rice.

G. Orrick D427429 08/12/2015 Drinking Water Exposure Assessment for the Registration Review 

of 22 Sulfonylurea Herbicides
Page 18 of 32

Appendix A. Toxicology Profile and Executive Summaries

A.1. Toxicology Data Requirements

Table A.1. Prosulfuron Data Requirements

Test Technical

Required Satisfied

870.1100 Acute Oral Toxicity......................................................

870.1200 Acute Dermal Toxicity.................................................

870.1300 Acute Inhalation Toxicity.............................................

870.2400 Primary Eye Irritation...................................................

870.2500 Primary Dermal Irritation .............................................

870.2600 Dermal Sensitization ....................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100 Oral Subchronic (rodent)..............................................

870.3150 Oral Subchronic (nonrodent)........................................

870.3200 21/28-Day Dermal........................................................

870.3250 90-Day Dermal.............................................................

870.3465 90-Day Inhalation.........................................................

yes

yes

yes

no

yes

yes

yes

yes

---

Waived1

870.3700 Developmental Toxicity (rodent) .................................

870.3700 Developmental Toxicity (nonrodent) ...........................

870.3800 Reproduction ................................................................

yes

yes

yes

yes

yes

yes

870.4100a Chronic Toxicity (rodent).............................................

870.4100b Chronic Toxicity (nonrodent).......................................

870.4200a Carcinogenicity (rat).....................................................

870.4200b Carcinogenicity (mouse) ..............................................

870.4300 Chronic Toxicity/Carcinogenicity (rodent) ..................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.5100 Mutagenicity—Gene Mutation - bacterial....................

870.5300 Mutagenicity—Gene Mutation - mammalian...............

870.5375 Mutagenicity—Structural Chromosomal Aberrations..

870.5385 Mutagenicity—Structural Chromosomal Aberrations..

870.5395 Mutagenicity—Other Genotoxic Effects......................

870.5550 Mutagenicity—Other Genotoxic Effects......................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.6100 Acute Delayed Neurotox. (hen)....................................

870.6100 90-Day Neurotoxicity (hen) .........................................

870.6200a Acute Neurotox. Screening Battery (rat)......................

870.6200b 90-Day Neurotoxicity Screening Battery (rat) .............

870.6300 Developmental Neurotoxicity ......................................

no

no

yes

yes

no

---

---

yes

yes

---

870.7485 General Metabolism .....................................................

870.7600 Dermal Penetration.......................................................

870.7800 Immunotoxicity ............................................................

yes

no

yes

yes

---

Waived2

1 Data requirement waived by HASPOC for the inhalation study (E. Craig, TXR# 0052986).

2 Data requirement waived by HASPOC for the immunotoxicity study (Y. Yang, TXR#0056759).
Page 19 of 32

A.2. Toxicity Profiles

Table A.2.2. Prosulfuron Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ Classification 

/Doses

Results

870.3100 90-Day oral 

toxicity- rats

42685232 (1991)

Acceptable/guideline

Dietary levels of 0, 5, 50, 500, 

4,000 or 8,000 ppm

( 0, 0.31, 3.1, 31, 255, or 522 

mg/kg/day for males and 0, 0.32, 

3.4, 35, 268, or 512 mg/kg/day for 

females)

NOAEL = 50 ppm (3.1 mg/kg/day) for males 

and 500 ppm (35 mg/kg/day) for females.

LOAEL = 500 ppm (31 mg/kg/day) for 

males, based on reduced body weight and 

body weight gain (13%); and 4,000 ppm (268 

mg/kg/day) for females, based on reduced 

body weight, body weight gain, food 

consumption, and food efficiency. 

870.3100 90-Day feeding -

mouse

42685234 (1991)

Core minimum

Dietary levels of 0, 15, 500, 1750, 

3500, or 7000 ppm. Mean daily 

doses were 0, 2.0, 69.3, 234, 504, 

969 mg/kg/day for males and 0, 

2.9, 91.3, 293, 606, and 1400 

mg/kg/day for females.

The NOAEL = 15 ppm (2.0 mg/kg/day) for 

males; 500 ppm (91.3 mg/kg/day) for 

females.

LOAEL = 500 ppm (69.3 mg/kg/day) for 

males, based on statistically significant 

decreased albumin and total bilirubin and 

statistically significant increased absolute and 

relative liver (to brain and/or body) weights. 

The LOAEL is 1750 ppm (293 mg/kg/day) 

Table A.2.1. Acute Toxicity of Prosulfuron Technical

Guideline No. Study Type MRID # Results Toxicity Category

870.1100 Acute Oral 42685215 LD50 = 986 mg/kg III

870.1200 Acute Dermal 42685216 LD50 > 2000 mg/kg III

870.1300 Acute Inhalation 42685217 LC50 = 5.467 mg/L IV

870.2400 Primary Eye 

Irritation

42685218 Minimal irritant IV

870.2500 Primary Skin 

Irritation

42685219 Non-irritant IV

870.2600 Dermal 

Sensitization

42685220 Non-sensitizer N/A
Page 20 of 32

Table A.2.2. Prosulfuron Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ Classification 

/Doses

Results

for females, based on statistically significant 

increased relative liver (to brain and body) 

weights, statistically significant increased 

hematocrit and mean corpuscular volume, 

and decreased mean corpuscular hemoglobin 

concentration. 

870.3150 90-Day feeding –

dog.

42685230 (1992)

Acceptable/guideline

via the diet at dose levels of 0, 15, 

150, 1500, or 3000 ppm for 90 

days. The equivalent average 

daily intake of test material was 0, 

0.54, 5.3, 57, or 110 mg/kg/day 

(males) and 0, 0.59, 6.5, 54, or 

120 mg/kg/day (females). 

NOAEL = 150 ppm (5.3 mg/kg/day) for 

males and females

LOAEL = 1500 ppm (54 mg/kg/day) based 

on decreased bodyweight gain and feed 

efficiency as well as hematological and 

hepatic toxicity in both males and females.

870.3200 21-day dermal 

toxicity study -

rabbits

42685235 (1992)

Acceptable/guideline

Doses of 0, 10, 100, 500 or 1,000 

mg/kg/day CGA-152005 

Technical, were applied to the 

clipped backs of Chbb:NZW 

rabbits for 6 hours/day, 7 

days/week, for 3 weeks.

Systemic NOAEL = 1000 mg/kg/day

Systemic LOAEL = Not established.

There was increased absolute and relative 

liver weights in both sexes at 500 and 1000 

mg/kg/day. However, these findings were not 

considered sufficient to establish a systemic 

toxicity LOAEL. The increased liver weights, 

however, were considered indicative of 

dermal absorption of CGA-152005. 

Dermal NOAEL = 1000 mg/kg/day, based on

the absence of any significant dermal or 

systemic effects at the highest dose tested.

Dermal LOAEL = Not determined.

870.3250 90-Day dermal 

toxicity

No study available and not required at this time. 

870.3465 90-Day 

inhalation 

toxicity

No study available but requirement waived at this time. 

870.3700 Prenatal 

developmental -

rats.

42685237 (1992)

Acceptable/guideline

Sprague Dawley rats received 

either 0, 5, 50, 200 or 400 mg of 

CGA-152005/kg/day by gavage 

(technical, 96% a.i.), from 

gestation days 6 through 15, 

Maternal toxicity NOAEL = 200 mg/kg/day

Maternal toxicity LOAEL = 400 mg/kg/day 

(highest dose level tested), based on 

decreased body weight gain.

Developmental toxicity NOAEL = 200 

mg/kg/day.

Developmental toxicity LOAEL = 400 
Page 21 of 32

Table A.2.2. Prosulfuron Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ Classification 

/Doses

Results

inclusive mg/kg/day based on skeletal findings 

(increase in findings of 14th ribs).

870.3700

Prenatal 

developmental -

rabbits 

Range finding

42685238 (1991)

Supplementary

New Zealand White rabbits 

received 150, 300, 450, or 600 

mg/kg/day by gavage (96% a.i.), 

from gestation days 7 through 19.

Signs of neurotoxicity (ataxia, hypoactivity, 

and neuropathology) were observed starting 

at the lowest dose tested (150 mg/kg/day).

Developmental toxicity was apparent 

(increased incidence of resorptions and 

abortions) starting at doses of 300 mg/kg/day.

870.3700 Prenatal 

developmental -

rabbits 

42685239 (1992)

43159318 (1994)

Supplementary

New Zealand White rabbits 

receive either 0, 1, 10, or 100 mg 

of CGA-152005/kg/day by gavage 

(96% a.i.), from gestation days 7 

through 19, inclusive. 

Maternal toxicity NOAEL = 100 mg/kg/day 

(HDT)

Maternal toxicity LOAEL = not established

Developmental toxicity NOAEL = 100 

mg/kg/day (HDT)

Developmental toxicity LOAEL = not 

established

No effects were noted at the highest dose 

level tested, 100 mg/kg/day, but this should 

not be considered a definitive NOAEL since 

the maternal animals were not adequately 

challenged, and a limit dose was not utilized 

in this study.

870.3700 Prenatal 

developmental -

rabbits 

43953506 (1996)

Acceptable/guideline

New Zealand White rabbits 

received dosages of CGA-152005 

technical (96% a.i.) by gavage at 

dose levels of 0, 20, 100 and 200 

mg/kg/day on gestation days 7 to 

19.

Maternal toxicity NOAEL= 20 mg/kg/day

Maternal toxicity LOAEL = 100 mg/kg/day 

based on increases in abortion, decreases in 

food consumption, and in mean body weight 

gain.

Developmental toxicity NOAEL = 100 

mg/kg/day

Developmental toxicity LOAEL = 200 

mg/kg/day, based on a dose-related increase 

in runts and small fetuses as well as skeletal

effects.

870.3800 Multigeneration 

Reproduction -

rat 

43159319 (1993)

43159320 (1994)

43387707 (1994)

Core minimum

Sprague-Dawley rats received 

either 0, 10, 200, 2000, or 4000 

ppm (0, 0.67, 13.3, 136, and 278 

mg/kg/day for P0 males and 0, 

0.76, 15.3, 152, and~3l1 

Parental toxicity NOAEL = 200 ppm (13.3 

mg/kg/day for males and 15.3 mg/kg/day for 

females). 

Parental toxicity LOAEL = 2000 ppm (136 

mg/kg/day for males and 152 mg/kg/day for 

females), based upon decreased mean body 

weights and body weight gain observed in the 

P0 and P1 generation animals. 

Reproductive toxicity NOAEL = 200 ppm 
Page 22 of 32

Table A.2.2. Prosulfuron Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ Classification 

/Doses

Results

mg/kg/day for P0 females during 

the premating growth periods, 

respectively) of CGA-152005 

(99.1% a.i.) mixed in the feed.

(13.3 mg/kg/day for males and 15.3 

mg/kg/day for females). 

Reproductive toxicity LOAEL = 2000 ppm 

(136 mg/kg/day for males and 152 mg/kg/day 

for females), based upon decreased pup 

weights observed in both the Fl and F2 

offspring.

870.4100 Chronic toxicity 

rodents

Refer to 870.4300 rat chronic feeding/carcinogenicity study below

870.4100 Chronic toxicity 

dogs. 

1-year

43159314 (1993)

43387705 (1994)

Acceptable/guideline

Diet concentrations at 0, 10, 60, 

600 or 1200 ppm (0.3, 2.0, 18.6 or 

41.0 mg/kg/day, males and 0, 0.3, 

1.8, 20.2 or 48.8 mg/kg/day, 

females).mg/kg/day.

NOAEL = 60 ppm (1.8 mg/kg/day, females).

LOAEL = 600 ppm (18.6 mg/kg/day, males), 

based on hematologic and clinical chemistry 

effects (females) and incidence of lipofuscin 

accumulation in liver (both sexes). 

870.4200

Carcinogenicity 

mice. 

18-months

43159316 (1993)

43387706 (1994)

Acceptable/guideline

(Crl:CD-(ICR)BR), mice were 

admin 0, 15, 700, 3500 or 7000 

ppm of CGA-152005 technical in 

the diet. Compound consumption 

was: 0, 1.71, 81.4, 410 and 832 

mg/kg/day in males; 0, 2.11, 100, 

508, and 1062 mg/kg/day in 

females.

Systemic toxicity NOAEL = 700 ppm (81.4 

mg/kg/day in males and 100 mg/kg/day in 

females).

Systemic toxicity LOAEL = 3500 ppm (410 

mg/kg/day in males and 508 mg/kg/day in 

females), based on slightly decreased body 

weight gain in females. 

There appeared to be no increase in the 

incidence of neoplasia in treatment groups 

when compared to controls. 

870.4300 Combined 

chronic feeding 

and 

carcinogenicity 

study - rats

2 - years

42700003 (1992)

43159321 (1994)

Core Minimum

(CrL:CD(SD)BR), rats were 

administered 0,10, 200, 2000 or 

4000 ppm (0.4, 7.9, 79.9 and 

160.9 mg/kg/day for males and 

0.5, 9.2, 95.7 and 205.8 

mg/kg/day for females, 

respectively) of technical CGA152005 (a.i. 99.1%) in the diet. 

Systemic NOAEL = 200 ppm (7.9 

mg/kg/day, males and 9.2 mg/kg/day, 

females). 

Systemic LOAEL = 2000 ppm (79.9 

mg/kg/day, males and 95.7 mg/kg/day, 

females), based on decreased body weight 

and body weight gain during the first months 

to 1 year of the study, decreased food 

consumption (females), hematopoietic 

system effects (males), and possibly 

increased GGT with decreases in liver, 

kidney and adrenal weight (females).

Increases in the incidence of mammary 

adenocarcinomas in females were observed at 

2000 ppm (31.9%; p < 0.5) and 4000 ppm 
Page 23 of 32

Table A.2.2. Prosulfuron Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ Classification 

/Doses

Results

(26.3%; NS) compared to controls (17.5%). 

Mammary gland adenomas were also slightly 

increased at 2000 ppm and 4000 ppm (4.3% 

and 2.5% vs. 0%, controls). Slight increases 

in the incidence of benign testicular 

interstitial cell tumors (significant trend only) 

were also observed at 2000 ppm (8.6%) and 

4000 ppm (5.0%) compared to controls 

(1.6%). 

870.6200 Acute 

neurotoxicity 

screening battery

43387703 (1994)

Core Minimum

Hsd:Sprague-Dawley rats 

received 0, 10, 250, 500 or 1000 

mg/kg/day of CGA-152005 

(technical, 99.1% a.i.) by gavage 

in aqueous 3% corn starch/-0.5% 

Tween 80 (20 ml/kg). 

NOAEL = 10 mg/kg/day.

LOAEL = 250 mg/kg/day, based on reduced 

motor activity and body temperature in males 

and abnormal gait in females.

870.6200 Subchronic 

neurotoxicity 

screening battery 

– 90 day

43387704 (1994)

Core Minimum

Rats were fed diets containing 0, 

10, 200, 2500, 5000 (high dose, 

females only) or 10,000 (high 

dose, males only) ppm 

prosulfuron technical. The 

equivalent average daily test 

material intakes were 0, 0.6, 12.1, 

147 or 628 mg/kg/day, males; 0, 

0.6, 12.5, 157 or 313 mg/kg/day, 

females).

Neurotoxicity NOAEL = 10,000 ppm (males) 

and 5000 ppm (females).

Neurotoxicity LOAEL = not determined

Systemic NOAEL = 200 ppm

Systemic LOAEL = 2500 ppm, based on 

slightly reduced body weight gain in males. 

870.7485 Metabolism and 

pharmacokinetics 

- rat

43159326 (1993)

Acceptable/guideline

Rats were administered [phenyl14C] prosulfuron as a single oral 

dose of 0.5 mg/kg, a single i.v. 

dose of 0.5 mg/kg, a single oral 

dose of 400 mg/kg and a single 

oral dose of [phenyl-14C] 

prosulfuron following 14 days of 

repeated dosing with 0.5 mg/kg of 

nonlabeled compound.

Approximately 90% of the administered dose 

was excreted during the first 48 hours. At 400 

mg/kg, a greater proportion of the 

administered dose was excreted in the feces 

(33-36%) compared to urine (61-71%). 

Females usually excreted more of the dose in 

the urine (79-91%) than males (66-79%). The 

parent compound represented 8-27% of the 

total activity in the urine of females and 5-

9% in males, whereas in the feces there was 

10-16% of the parent compound in females 

and 5-6% in males. Fifteen urinary 

metabolites were determined and 13 similar 

metabolites were confirmed in feces. Tissue 

levels were low. No measurable amount of 

radioactivity was found in most tissues 168 

hours post-dosing in animals at 0.5 mg/kg. 
Page 24 of 32

Table A.2.2. Prosulfuron Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ Classification 

/Doses

Results

The major routes of metabolism occurred via 

hydroxylation at side chains and phenyl ring 

of the trifluoropropyl side chain, hydrolysis 

of the phenyl-sulfonylurea link and 

oxidative/hydrolytic cleavage of the triazine 

ring system. The major metabolite (47% to 

60% of urinary radioactivity at 0.5 mg/kg) 

was formed by hydroxylation of the triazinyl 

methyl group. At the 0.5 mg/kg level, 

metabolism was not affected by route of 

administration.

870.7485 Metabolism and 

pharmacokinetics 

- rat

43159322 (1992)

43159323 (1993)

Acceptable/guideline

Rats were administered [triazine4-14C] prosulfuron as a single 

oral dose of 0.5 mg/kg, a single 

i.v. dose of 0.5 mg/kg, a single 

oral dose of 400 mg/kg and a 

single oral dose of [triazine-4-

14C] prosulfuron following 14 

days of repeated dosing with 0.5 

mg/kg of nonradiolabeled 

compound.

Approximately 90% of the administered dose 

was excreted within 48 hours post-dosing. 

Tissue radioactivity was low, less than 0.91% 

of the administered dose. The metabolite 

profile for each sex was similar regardless of 

the route of administration. However, 

females tended to excrete more radioactivity 

in the urine and less in the feces than males. 

The metabolites in the greatest concentration 

in the urine were #2 (hydroxylation of 

triazinyl methyl group) and #11 (parent 

compound) along with #1 (O-demethylated 

methoxy group) and #3 (hydroxylation of 

trifluoropropyl group). Females excreted 

more parent compound than males. Males 

excreted more of the hydroxylated 

metabolites and more metabolites with a 

double bond on the trifluoropropyl group. 

Urinary metabolite #3 was greater at 400 

mg/kg than 0.5 mg/kg, especially in males. It 

is believed that O-demethylation of the 

methoxy group and hydroxylation of the 

triazinyl methyl group are the primary 

metabolic pathways; while hydroxylation at 

various sites of the trifluoropropylbenzene 

moiety is a slower process that increases in 

importance as the primary pathways 

approach saturation.

870.7800 Immunotoxicity No study available but requirement waived at this time.
Page 25 of 32

Appendix B. Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. These data, which include studies from 

PHED 1.1 and the AHETF database are (1) subject to ethics review pursuant to 40 CFR 26, (2) 

have received that review, and (3) are compliant with applicable ethics requirements. For certain 

studies, the ethics review may have included review by the Human Studies Review Board. 

Descriptions of data sources, as well as guidance on their use, can be found at the Agency 

website6. 

 

6 http://www.epa.gov/pesticides/science/handler-exposure-data.html and 

http://www.epa.gov/pesticides/science/post-app-exposure-data.html
Page 26 of 32

Appendix C. Occupational Non-cancer Handler Algorithms

Occupational Non-cancer Handler Algorithms

Potential daily exposures for occupational handlers are calculated using the following formulas:

where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

AR = maximum application rate according to proposed label (lb ai A or lb ai/gal), and

A = area treated or amount handled (e.g., A/day, gal/day).

The daily doses are calculated using the following formula:

where:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day),

E = exposure (mg ai/day),

AF = absorption factor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each application handler scenario are 

calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to 

the daily dose of concern. The daily dermal and inhalation dose received by occupational 

handlers are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational 

handlers for each exposure route. All MOE values are calculated using the following formula:

where:

MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).
Page 27 of 32

Appendix D. Dietary Exposure/Risk Modeling Input and Output

DEEM-FCID Acute Inputs File

Filename: C:\Users\jlangsda\Documents\Chemicals\SUs\Prosulfuron\Dietary 

Assessment\129031A.R08

Chemical: Prosulfuron

RfD(Chronic): .053 mg/kg bw/day NOEL(Chronic): 5.3 mg/kg bw/day

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

Date created/last modified: 05-08-2015/15:00:26 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1500025000 15 Barley, pearled barley 0.010000 1.000 1.000 5F4469

1500025001 15 Barley, pearled barley-babyfood 0.010000 1.000 1.000 5F4469

1500026000 15 Barley, flour 0.010000 1.000 1.000 5F4469

1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.000 5F4469

1500027000 15 Barley, bran 0.010000 1.000 1.000 5F4469

1500065000 15 Buckwheat 0.010000 1.000 1.000 5F4469

1500066000 15 Buckwheat, flour 0.010000 1.000 1.000 5F4469

1500120000 15 Corn, field, flour 0.010000 1.000 1.000 5F4469

1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.000 5F4469

1500121000 15 Corn, field, meal 0.010000 1.000 1.000 5F4469

1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.000 5F4469

1500122000 15 Corn, field, bran 0.010000 1.000 1.000 5F4469

1500123000 15 Corn, field, starch 0.010000 1.000 1.000 5F4469

1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.000 5F4469

1500124000 15 Corn, field, syrup 0.010000 1.500 1.000 5F4469

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 1.000 5F4469

1500125000 15 Corn, field, oil 0.010000 1.000 1.000 5F4469

1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.000 5F4469

1500126000 15 Corn, pop 0.010000 1.000 1.000 5F4469

1500127000 15 Corn, sweet 0.010000 1.000 1.000 5F4469

1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1.000 5F4469

1500226000 15 Millet, grain 0.010000 1.000 1.000 5F4469

1500231000 15 Oat, bran 0.010000 1.000 1.000 5F4469

1500232000 15 Oat, flour 0.010000 1.000 1.000 5F4469

1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.000 5F4469

1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 5F4469

1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1.000 1.000 5F4469

1500328000 15 Rye, grain 0.010000 1.000 1.000 5F4469

1500329000 15 Rye, flour 0.010000 1.000 1.000 5F4469

1500344000 15 Sorghum, grain 0.010000 1.000 1.000 5F4469

1500345000 15 Sorghum, syrup 0.010000 1.000 1.000 5F4469

1500381000 15 Triticale, flour 0.010000 1.000 1.000 5F4469

1500381001 15 Triticale, flour-babyfood 0.010000 1.000 1.000 5F4469

1500401000 15 Wheat, grain 0.010000 1.000 1.000 5F4469

1500401001 15 Wheat, grain-babyfood 0.010000 1.000 1.000 5F4469

1500402000 15 Wheat, flour 0.010000 1.000 1.000 5F4469

1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.000 5F4469

1500403000 15 Wheat, germ 0.010000 1.000 1.000 5F4469

1500404000 15 Wheat, bran 0.010000 1.000 1.000 5F4469

1500405000 15 Wild rice 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.015000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.015000 1.000 1.000 

DEEM-FCID Acute Results File

US EPA Ver. 3.18, 03-08-d

DEEM-FCID ACUTE Analysis for PROSULFURON NHANES 2003-2008 2-Day

Residue file: 129031A.R08 Adjustment factor #2 used.

Analysis Date: 05-08-2015/15:02:46 Residue file dated: 05-08-2015/15:00:26
Page 28 of 32

NOEL (Acute) = 10.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

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

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

Total US Population:

 0.000866 0.87 11551 0.001425 1.43 7017 0.002646 2.65 3779 

All Infants:

 0.002641 2.64 3786 0.003503 3.50 2854 0.005117 5.12 1954 

Children 1-2:

 0.001389 1.39 7197 0.002172 2.17 4604 0.004799 4.80 2083 

Children 3-5:

 0.001132 1.13 8835 0.001675 1.68 5970 0.002625 2.62 3809 

Children 6-12:

 0.000863 0.86 11587 0.001358 1.36 7366 0.002169 2.17 4609 

Youth 13-19:

 0.000729 0.73 13721 0.001172 1.17 8534 0.001727 1.73 5789 

Adults 20-49:

 0.000838 0.84 11939 0.001222 1.22 8185 0.001770 1.77 5648 

Adults 50-99:

 0.000742 0.74 13485 0.001127 1.13 8872 0.001714 1.71 5833 

Female 13-49:

 0.000853 0.85 11724 0.001223 1.22 8178 0.001721 1.72 5810 

DEEM-FCID Chronic Inputs File

Filename: C:\Users\jlangsda\Documents\Chemicals\SUs\Prosulfuron\Dietary 

Assessment\129031C.R08

Chemical: Prosulfuron

RfD(Chronic): .053 mg/kg bw/day NOEL(Chronic): 5.3 mg/kg bw/day

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

Date created/last modified: 05-07-2015/16:21:26 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1500025000 15 Barley, pearled barley 0.010000 1.000 1.000 5F4469

1500025001 15 Barley, pearled barley-babyfood 0.010000 1.000 1.000 5F4469

1500026000 15 Barley, flour 0.010000 1.000 1.000 5F4469

1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.000 5F4469

1500027000 15 Barley, bran 0.010000 1.000 1.000 5F4469

1500065000 15 Buckwheat 0.010000 1.000 1.000 5F4469

1500066000 15 Buckwheat, flour 0.010000 1.000 1.000 5F4469

1500120000 15 Corn, field, flour 0.010000 1.000 1.000 5F4469

1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.000 5F4469

1500121000 15 Corn, field, meal 0.010000 1.000 1.000 5F4469

1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.000 5F4469

1500122000 15 Corn, field, bran 0.010000 1.000 1.000 5F4469

1500123000 15 Corn, field, starch 0.010000 1.000 1.000 5F4469

1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.000 5F4469

1500124000 15 Corn, field, syrup 0.010000 1.500 1.000 5F4469

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 1.000 5F4469

1500125000 15 Corn, field, oil 0.010000 1.000 1.000 5F4469

1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.000 5F4469

1500126000 15 Corn, pop 0.010000 1.000 1.000 5F4469

1500127000 15 Corn, sweet 0.010000 1.000 1.000 5F4469

1500127001 15 Corn, sweet-babyfood 0.010000 1.000 1.000 5F4469

1500226000 15 Millet, grain 0.010000 1.000 1.000 5F4469

1500231000 15 Oat, bran 0.010000 1.000 1.000 5F4469

1500232000 15 Oat, flour 0.010000 1.000 1.000 5F4469

1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.000 5F4469

1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 5F4469
Page 29 of 32

1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1.000 1.000 5F4469

1500328000 15 Rye, grain 0.010000 1.000 1.000 5F4469

1500329000 15 Rye, flour 0.010000 1.000 1.000 5F4469

1500344000 15 Sorghum, grain 0.010000 1.000 1.000 5F4469

1500345000 15 Sorghum, syrup 0.010000 1.000 1.000 5F4469

1500381000 15 Triticale, flour 0.010000 1.000 1.000 5F4469

1500381001 15 Triticale, flour-babyfood 0.010000 1.000 1.000 5F4469

1500401000 15 Wheat, grain 0.010000 1.000 1.000 5F4469

1500401001 15 Wheat, grain-babyfood 0.010000 1.000 1.000 5F4469

1500402000 15 Wheat, flour 0.010000 1.000 1.000 5F4469

1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.000 5F4469

1500403000 15 Wheat, germ 0.010000 1.000 1.000 5F4469

1500404000 15 Wheat, bran 0.010000 1.000 1.000 5F4469

1500405000 15 Wild rice 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.013000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.013000 1.000 1.000 

DEEM-FCID Chronic Results File

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for PROSULFURON NHANES 2003-2008 2-day

Residue file name: C:\Users\jlangsda\Documents\Chemicals\SUs\Prosulfuron\Dietary 

Assessment\129031C.R08

 Adjustment factor #2 used.

Analysis Date 05-08-2015/14:36:23 Residue file dated: 05-07-2015/16:21:26

Reference dose (RfD, Chronic) = .053 mg/kg bw/day

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000311 0.6%

Hispanic 0.000303 0.6%

Non-Hisp-White 0.000318 0.6%

Non-Hisp-Black 0.000264 0.5%

Non-Hisp-Other 0.000350 0.7%

Nursing Infants 0.000272 0.5%

Non-Nursing Infants 0.000973 1.8%

Female 13+ PREG 0.000289 0.5%

Children 1-6 0.000439 0.8%

Children 7-12 0.000291 0.5%

Male 13-19 0.000236 0.4%

Female 13-19/NP 0.000248 0.5%

Male 20+ 0.000287 0.5%

Female 20+/NP 0.000312 0.6%

Seniors 55+ 0.000286 0.5%

All Infants 0.000756 1.4%

Female 13-50 0.000302 0.6%

Children 1-2 0.000483 0.9%

Children 3-5 0.000422 0.8%

Children 6-12 0.000306 0.6%

Youth 13-19 0.000242 0.5%

Adults 20-49 0.000305 0.6%

Adults 50-99 0.000292 0.6%

Female 13-49 0.000302 0.6%

-------------------------------------------------------------------------------
Page 30 of 32

Appendix E. Nomenclature and Physical/Chemical Properties

Table E1. Prosulfuron Nomenclature.

Compound

Common name Prosulfuron 

IUPAC name 1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-

phenylsulfonyl]-urea

CAS name N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-

trifluoropropyl)benzenesulfonamide

CAS registry number 94125-34-5

Table E2. Physicochemical Properties of the Technical Grade Prosulfuron

Parameter Value Reference

Melting point/range 155°C MSDS

pH Not Applicable

Bulk density (g ml-1)/Specific gravity 1.45

Water solubility (g/L) at 25 oC 4.0 at pH 6.8

Solvent solubility (g/L) at room 

temperature

Acetone: 160 (purity: 95.1 %)

Toluene : 6.1

Dichloromethane : 180

Ethyl acetate : 56

n-Hexane : 0.006

Ethanol : 8.4

n-octanol :1.4

Vapor pressure < 3.5x10-6 Pa at 25 °C

Dissociation constant, pKa pKa = 3.76

Octanol/water partition coefficient

(log Pow)

pH5 : 1.5 at 25°C

UV/visible absorption L mol-1cm-1ε = 21645 l x mol-1x cm-1at λ max = 227.5 nm

shoulder at 250 nm

No absorption >290 nm
Page 31 of 32

Appendix F. Spray Drift Detailed Description

Off-target movement of pesticides can occur via many types of pathways and it is governed by a 

variety of factors. Sprays that are released and do not deposit in the application area end up offtarget and can lead to exposures to those it may directly contact. They can also deposit on 

surfaces where contact with residues can eventually lead to exposures (e.g., children playing on 

lawns where residues have deposited next to treated fields). The potential risk estimates from 

these residues can be calculated using drift modeling coupled with methods employed for 

residential risk assessments for turf products.

The approach to be used for quantitatively incorporating spray drift into risk assessment include 

assessing exposures for children (1 to 2 years old) and adults who have contact with turf where 

residues are assumed to have deposited via spray drift thus resulting in an exposure scenario. 

Aside from the predicted residues available for transfer, the routes of exposure and assessment 

methodology is analogous to how exposures to turf products are considered in risk assessment. 

In order to evaluate the drift potential and associated risks, an approach based on drift modeling 

coupled with techniques used to evaluate residential uses of pesticides was utilized. Essentially, 

a residential turf assessment based on exposure to deposited residues has been completed to 

address drift from the agricultural applications of flufenpyr-ethyl. In the spray drift scenario, the 

deposited residue value was determined based on the amount of spray drift that may occur at 

varying distances from the edge of the treated field using the AgDrift® (v2.1.1) model. 

Exposures were considered for 50 feet wide lawns where the nearest side of the property was 

directly adjoining the treated field (at field edge) and at varied distances up to 300 feet 

downwind of a treated field. Once the deposited residue values were determined, the remainder 

of the spray drift assessment was based on the algorithms and input values specified in the 

recently revised (2012) Standard Operating Procedures For Residential Risk Assessment 

(SOPs). 

 

A screening approach was developed for situations where specific label guidance for 

application parameters is not available.7,8 AgDrift® is appropriate for use only when applications 

are made by aircraft, airblast sprayers, and groundboom sprayers. When AgDrift® was

developed, a series of screening values (i.e., the Tier 1 option) were incorporated into the model 

and represent each equipment type and use under varied conditions. The screening options 

specifically recommended in this methodology were selected because they are plausible and 

represent a reasonable upper bound level of drift for common application methods in agriculture. 

In all cases, each scenario is to be evaluated unless it is not plausible based on the anticipated use 

pattern (e.g., herbicides are not typically applied to tree canopies) or specific label prohibitions 

(e.g., aerial applications are not allowed). Section 6.1.1 provides the screening level drift related 

risk estimates. These drift estimates represent plausible options based on the available pesticide 

labels. 

 

7http://www.agdrift.com/ 

8 Note that for many cases the scenarios outlined in the screening approach represent actual use practice so risk assessors should 

be aware and characterize these appropriately.
Page 32 of 32

Appendix G. Submittal of Analytical Reference Standards (860.1650)

Analytical reference standards for prosulfuron are currently available in EPA’s National 

Pesticide Standards Repository (NPSR) and have an expiration date of 02/28/2019 (email 

communication between G. Verdin and J. Van Alstine, 05/07/2015). The registrant is required to 

maintain reasonable amounts of the reference standards for prosulfuron in the NPSR as long as 

tolerances remain published in 40 CFR §180.481. When necessary, new reference standards, or 

updated certificates of analysis (COAs), should be sent to the Analytical Chemistry Branch 

(ACB), which is located at Fort Meade, MD. It should be sent to the attention of either Theresa 

Cole or Thuy Nguyen at the address listed below, along with a letter of transmittal. Please note 

that the full 9-digit ZIP Code is required, or the mail will be returned to the registrant. 

USEPA

National Pesticide Standards Repository

Analytical Chemistry Branch/BEAD/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350

The letter of transmittal should include the assay of the standard, name of the analytical method 

used, a statement of principal impurities, purification procedures employed, storage 

requirements, and special precautions for safe handling. Replacement of standards, or updated 

COAs, may be required periodically if supplies are exhausted, if the standards expire, or if 

decomposition occurs during storage. Material Safety Data Sheets (MSDSs) must accompany all 

analytical standards as specified by the Occupational Safety and Health Administration (OSHA) 

in 29CFR §1910.1200.