UNITED ST A TES ENVIRONMENT AL PROTECTION AGENCY 

WASHrNGTON, D.C. 20460 

MEMORAND UM 

Date: September 15, 2015 

OFFICE OF 

CHEMICAL SAFETY ANO 

POLLUTION PREV ENTION 

SUBJECT: Trifloxysulfuron-Sodium. Draft Human Health Risk Assessment in Support of 

Registration Review. 

PC Code: I 19009 DP Barcode: 0427105 

Decision No.: 503928 Registration No.: NA 

Petition No.: NA Regulatory Action: Registration Rev iew 

Risk Assessment Type: Single Chemical Case No.: 7028 

Aggregate CAS Nos.: 199119-58-9, 290332-10-4, 145099-

TXR No.: NA 2 1-4 

MRID No.: NA 40 CFR: § 180.591 . 

FROM: Karlyn 

Zaida Figueroa, 

Middleton

D

, 

rPH, 

M.S.

In

, Risk 

dustri

Assessorffoxicologist 

al Hygienist ~ ~~ f ~ 

Michael A. Doherty, Ph.D., Chemist i)~ J~ ~ 

Risk Assessment Branch 1I 

Health Effects Division (7509P) 

THROUGH: Christina 

Ris

Health 

k Assessment 

Effects 

Swartz

D

, 

ivision 

B

Branch 

ranch 

(7509P) 

II 

Chief ~ 

TO: Kelly Ballard, Chemical Review Manager 

Neil Anderson, Branch Chief 

Risk Management and Implementation Branch I (RMIB I) 

Pesticide Re-Evaluation Division (7508P) 

As pa11 of registration review, HED has examined the toxicological and exposure databases for 

assessing human health risks associated with trifloxysulfuron-sodium and conducted a new risk 

assessment following current practices and policies. Significant changes relative to the last risk 

assessment (D352260, M. Doherty, 2008) include: 

I) The inhalation toxicity study requirement has been waived. 

2) The exposure assessments have been updated to incorporate new science policies. 

3) A high-end drinking water exposure value was used to assess screening-level dietary 

exposure/risk estimates. 

4) HED considered all the exposure and toxicity information and determined that chemicalspecific DFR and TTR data are not required to refine the exposure assessment. 

Page 1 of 60 
Page 2 of 60

Table of Contents

1.0 Executive Summary........................................................................................................... 3

2.0 HED Recommendations.................................................................................................... 4

2.1 Tolerance Considerations................................................................................................. 4

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

3.0 Introduction........................................................................................................................ 5

3.1 Chemical Identity and Physical/Chemical Characteristics............................................... 5

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

3.3 Consideration of Environmental Justice .......................................................................... 6

4.0 Hazard Identification/Toxicology..................................................................................... 7

4.1 Summary of Toxicological Effects .................................................................................. 7

4.2 Safety Factor for Infants and Children (FQPA Safety Factor)......................................... 8

4.3 Toxicity Endpoint and Point of Departure Selections...................................................... 8

4.4 Endocrine Disruptor Screening Program ....................................................................... 10

5.0 Dietary Exposure and Risk Assessment......................................................................... 11

5.1 Water Residue Profile .................................................................................................... 11

5.2 Food Residue Profile...................................................................................................... 12

5.3 Dietary Exposure and Risk Estimates............................................................................ 12

6.0 Residential (Non-Occupational) Exposure and Risk Assessment ............................... 13

6.1 Residential Handler Exposure/Risk Estimates............................................................... 13

6.2 Residential Post-application Exposure/Risk Estimates.................................................. 16

6.3 Residential Risk Estimates for Use in Aggregate Assessment ...................................... 17

6.4 Spray Drift...................................................................................................................... 18

6.5 Residential Bystander Post-Application Inhalation Exposure ....................................... 19

7.0 Aggregate Exposure/Risk Characterization.................................................................. 19

7.1 Acute and Chronic Aggregate ........................................................................................ 19

7.2 Short-and Intermediate-Term Aggregate Risk Estimates .............................................. 19

8.0 Cumulative Exposure/Risk Characterization ............................................................... 20

9.0 Occupational Exposure/Risk Characterization ............................................................ 21

9.1 Occupational Handler Exposure/Risk Estimates............................................................ 21

9.2 Occupational Post-application Exposure/Risk Estimates .............................................. 24

9.2.1 Occupational Post-application Inhalation Exposure/Risk Estimates...................... 24

9.2.2 Occupational Post-application Dermal Exposure/Risk Estimates.......................... 24

10.0 Public Health and Pesticide Epidemiology Data........................................................... 28

11.0 Literature References...................................................................................................... 28

12.0 References......................................................................................................................... 29

Appendix A. Toxicology Data Requirements and Toxicology Profile ................................... 30

Appendix B. Review of Human Research................................................................................ 34

Appendix C. Occupational Non-cancer Algorithms............................................................. 35

Appendix D. Nomenclature and Physical/Chemical Properties............................................. 37

Appendix E. Residential Handler and Post-application Exposure Algorithms................. 39

Appendix F. Dietary Exposure/Risk Modeling Input and Output..................................... 48
Page 3 of 60

1.0 Executive Summary

Trifloxysulfuron-sodium (N-[(4,6-dimethoxy-2-pyrimidinyl)carbamoyl]-3-(2,2,2-

trifluoroethoxy)-pyridin-2-sulfonamide sodium salt) is a sulfonylurea herbicide currently used on 

numerous agricultural food/feed crops, including almonds, citrus, cotton (picker variety only), 

sugarcane and tomatoes. Non-agricultural uses include sports fields and residential turf grass. It 

acts by inhibiting the plant enzyme acetolactate synthase, resulting in reduced production of 

branched-chain amino acids. 

A human health scoping document was conducted for trifloxysulfuron-sodium in 2013

(D408404, E. Holman); an inhalation toxicity study was identified as a data gap. However, 

HED’s Hazard and Science Policy Council (HASPOC) has since waived the inhalation toxicity 

study requirement (TXR# 0056564). The toxicology database for trifloxysulfuron-sodium is 

considered complete and adequate for risk assessment. The last human health risk assessment 

for trifloxysulfuron-sodium was completed in 2008 (D352260, M. Doherty). Since the last risk 

assessment and scoping document, no new toxicity and/or metabolism data have been received. 

For this assessment, the toxicological endpoints and points of departure (PODs) selected for risk 

assessment remain the same as in the previous assessments. This draft risk assessment includes 

updates to exposure assessments, science policies, and procedures. 

For dietary exposure, HED has conducted a screening-level acute and chronic dietary risk 

assessment for trifloxysulfuron-sodium using tolerance-level residues in foods and a 

sulfonylurea-class-wide screening-level estimate of residues in drinking water. Dietary risk 

estimates range from <1 to 8% of the acute population adjusted dose (aPAD) and from 3 to 11% 

of the chronic population adjusted dose (cPAD) and are not of concern. 

The existing tolerances (40 CFR 180.625) are supported by adequate residue chemistry data. 

There are registered uses for trifloxysulfuron that will result in direct residential exposure from 

treated turf. There were no risks of concerns. Additionally, there is the potential for indirect 

exposure to trifloxysulfuron-sodium related to spray drift. However, a quantitative spray drift 

assessment for trifloxysulfuron-sodium was not conducted because the maximum application 

rate to a crop/target site multiplied by the adjustment factor for drift of 0.26 is less than the 

maximum direct spray residential turf application rate for the trifloxysulfuron-sodium products. 

Therefore, the turf post-application risk estimates are protective for any potential exposures 

related to spray drift for trifloxysulfuron-sodium. 

For trifloxysulfuron, acute and chronic aggregate exposures results from residues in food and 

drinking water alone and are equivalent to the acute and chronic dietary risk assessment. Shortand intermediate-term aggregate risk assessments were conducted for both adults (dermal and 

inhalation exposure) and children (incidental oral exposure). The short-term/intermediate-term 

aggregate risk assessments resulted in an MOE of 2,900 for children and 3,600 for adults (the

level of concern (LOC) =100). Therefore, the estimated short-/intermediate-term aggregate risks

are not of concern. 
Page 4 of 60

No chemical-specific handler exposure data were submitted in support of this draft risk 

assessment; therefore, HED relied on the best available data to assess handler exposure. Default 

assumptions established by HED’s Science Advisory Council for Exposure (ExpoSAC) were 

used for parameters such as body weight and amount handled. All occupational handler 

scenarios for the registered uses resulted in MOEs that are not of concern at baseline attire. The 

lowest MOE of 5,700 is associated with applying a dry flowable formulation using airblast 

equipment to 40 acres. All other MOEs were higher, ranging from 7,200 to 53,000. No 

additional personal protective equipment (PPE) requirements are needed on the registered labels. 

 

Occupational post-application dermal exposure and risk estimates resulted in MOEs that are 

>100 and are not of concern. The restricted entry interval (REI) of 12 hours specified on the 

registered labels is based on the acute toxicity of trifloxysulfuron-sodium and is adequate to 

protect agricultural workers from post-application exposures.

Based on the Agency's current practices, a quantitative non-cancer occupational post-application 

inhalation exposure assessment was not performed for trifloxysulfuron-sodium. 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 trifloxysulfuron-sodium. 

HED has not identified any risk concerns associated with the registered uses of trifloxysulfuronsodium. There are no data gaps that would require submission of additional toxicity, residue 

chemistry, or exposure data.

2.0 HED Recommendations

2.1 Tolerance Considerations

The existing tolerances (40 CFR 180.591) are supported by the available residue chemistry data. 

At this time, there are no Codex or Canadian MRLs; therefore, international harmonization is not 

a consideration for trifloxysulfuron-sodium during registration review. 

HED notes that the tolerance expression for trifloxysulfuron requires revision to the following:

Tolerances are established for residues of trifloxysulfuron, 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 trifloxysulfuron, N-[[(4,6-

dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(2,2,2-trifluoroethoxy)-2-

pyridinesulfonamide.

2.2 Label Considerations

There are no label recommendations associated with trifloxysulfuron-sodium for registered 

products containing that active ingredient.
Page 5 of 60

3.0 Introduction

3.1 Chemical Identity and Physical/Chemical Characteristics

Trifloxysulfuron-sodium is relatively soluble in water at neutral pH, but is significantly less 

soluble under acidic conditions, as would be expected given the compound’s pKa value of 4.76. 

Data were not provided regarding solubility in basic solutions; however, based on the properties 

summarized in Appendix D (Table D.2), solubility under basic conditions is expected to be 

similar to that in neutral aqueous media. This herbicide has a low vapor pressure at 25 °C and 

dissipation via volatilization is not expected under normal conditions.

3.2 Pesticide Use Pattern and Anticipated Exposure Pathways

Trifloxysulfuron-sodium is currently registered for use on numerous agricultural food/feed crops, 

including almonds, citrus, cotton (picker variety only), sugarcane and tomatoes. Nonagricultural uses include sports fields and residential turf grass. The primary registered end-use 

product (EP) is a 75% wettable granule (WG) formulation. Application is via ground and 

handheld application equipment only; aerial applications and chemigation equipment are 

prohibited. 

Based on the use pattern, the duration of exposure for occupational handlers in conjunction with 

the registered uses is expected to be short-term (i.e., 1 to 30 days) and intermediate-term (i.e., 1 

to 6 months); long-term exposures (i.e., greater than 6 months) are not anticipated. The 

statements on registered labels require applicators and other handlers to wear the following

baseline attire: long sleeved shirt, long pants, shoes plus socks. The restricted entry interval 

(REI) on all labels is 12 hours.

Exposure Pathways

Individuals may be exposed to trifloxysulfuron-sodium via their diet (food and drinking water). 

Also, there are registered uses for trifloxysulfuron-sodium that may result in direct non-dietary 

(i.e., residential) exposures, as well as the potential for indirect exposure (incidental oral and 

dermal) to trifloxysulfuron-sodium related to spray drift. Agricultural workers may be exposed

(dermal and inhalation) to trifloxysulfuron-sodium during mixing, loading, and/or applying the 

herbicide as well as during post-application activities. 

Table 3.2. Summary of Directions for Use of Trifloxysulfuron-Sodium.

Applic. Timing, Type, 

and Equip.

Applic. 

Rate 

Max. No. 

Applic. per 

Season

Max. Seasonal 

Applic. Rate 

(lb ai/A)

PHI 

(days)

Use Directions and Limitations

Almond

Postemergence; Ground 

Equip.

0.019 lb 

ai/A

3 0.056 3 For use as a tank mix with glyphosate formulations 

registered for use on almonds. The minimum 

retreatment interval is 30 days. Application to newly 

established groves (<2 years old) is prohibited.

Citrus

Postemergence, Ground 

Equip.

3 0.056 14 For use as a tank mix with glyphosate formulations 

registered for use on citrus. The minimum 
Page 6 of 60

Table 3.2. Summary of Directions for Use of Trifloxysulfuron-Sodium.

Applic. Timing, Type, 

and Equip.

Applic. 

Rate 

Max. No. 

Applic. per 

Season

Max. Seasonal 

Applic. Rate 

(lb ai/A)

PHI 

(days)

Use Directions and Limitations

0.019 lb 

ai/A

retreatment interval is 30 days. Application to newly 

established groves (<2 years old) is prohibited.

Cotton

Early postemergence; 

Ground Equip.

0.005-0.007 

lb ai/A

Not 

specified 

(NS)

0.019 60 Tank mixing with any other herbicides or additives 

(other than surfactant) or with insecticides containing 

malathion, profenofos, or emamectin benzoate is 

prohibited.

Postemergence (≥8 

inches in height to 

layby); Ground Equip.

0.007-0.012 

lb ai/A

NS 0.019 60 The minimum retreatment interval is 14 days. 

Applications are to be directed to minimize contact 

with cotton leaves. Applications may be made alone 

or as a tank mix with glyphosate (to Roundup 

Ready® cotton varieties only), Caparol® 

(prometryn), Dual Magnum® (metolachlor), MSMA, 

Staple® (pyrithiobac-sodium), Cotoran® 

(fluometuron), or Buctril® (bromoxynil, BXN cotton 

varieties only). Tank mixing with insecticides 

containing malathion, profenofos, or emamectin 

benzoate is prohibited.

Sugarcane

Early postemergence; 

Ground Equip.

0.014 lb 

ai/A

3 0.070 100 The minimum retreatment interval is 14 days. 

Applications may be made alone or as a tank mix 

with atrazine or asulam.

Postemergence ; 

Ground Equip.

0.014-0.028 

lb ai/A

3 0.070 100 The minimum retreatment interval is 14 days. 

Applications may be made alone or as a tank mix 

with atrazine or asulam.

Tomato

Preemergence (pretransplant);

Ground Equip.

0.007 lb 

ai/A

1 

(+ 1 postemergence)

0.014 45 Mechanical incorporation of product into the soil is 

to be avoided.

Postemergence;

Over-the-top;

Ground Equip.

0.007-0.014 

lb ai/A

1

(+1 preemergence)

0.014 45 Application is to be made prior to fruit set.

Turf, Ornamentals

Postemergence;

Ground Equip.

0.005 -

0.026 lb 

ai/A 

(0.0004 lb 

ai/gal)

Not 

specified; 3 

implied

0.080 N/A 12-month rotational restriction to anything other than 

turf grasses. Via communication with the petitioner, 

turf uses are to be restricted to golf courses only.

3.3 Consideration of Environmental Justice

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

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

(http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf). As a part of every pesticide risk 
Page 7 of 60

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 Continuing 

Survey of Food Intake by Individuals (CSFII) 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, season of the year, ethnic group, and region of the country. Additionally, OPP is able to 

assess dietary exposure to smaller, specialized subgroups and 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 trifloxysulfuron-sodium is complete and adequate for risk 

assessment. An inhalation toxicity study is not available for trifloxysulfuron, as required in 

accordance with the current Part 158 Guidelines (40 CFR Part 158). However, the Hazard and 

Science Policy Council (HASPOC) determined that the subchronic inhalation toxicity study is 

not required at this time (TXR# 0056564). No new toxicity and/or metabolism data have been 

received since the scoping document and last risk assessment (D352260, M. Doherty). The 

endpoints/PODs selected for risk assessment remain the same as in previous assessments. See 

Appendix A.2 for the trifloxysulfuron-sodium toxicological profile. 

4.1 Summary of Toxicological Effects

Toxicity studies with trifloxysulfuron-sodium indicate that several organs are affected after oral 

exposure. Effects were primarily seen in the kidneys, urinary bladder, liver and lung, on body 

weight/body weight gain, and motor activity. Other effects observed in the toxicological 

database included effects on the testes, thymus, spleen, and lymph nodes. No corroborating 

effects were observed in the immunotoxicity study for the immune related effects observed in the 

database. The majority of toxic effects outlined above were seen after subchronic exposure. 

More pronounced effects were observed in the lung, kidney, and testes after chronic exposure; 

however, increased exposure did not result in treatment-related tumors in these organs (or others) 

and there was no evidence of carcinogenicity in long-term studies with mice and rats. Therefore, 

trifloxysulfuron-sodium is classified as “not likely to be carcinogenic to humans.” There is no 

mutagenicity concern for trifloxysulfuron-sodium. In neurotoxicity studies, effects on motor 

activity, along with neuropathology were seen after acute exposure at doses above the limit dose. 

Effects on motor activity were also observed after subchronic exposure, but at relatively high 

dose levels and in the absence of neuropathology. No systemic effects were observed after 

dermal exposure.
Page 8 of 60

There was no evidence of increased quantitative and qualitative susceptibility in the rat. 

Developmental effects observed in the rat developmental study (decreased weight gain and 

increased skeletal variations) and offspring effects observed in the rat reproduction study 

(decreased pup weight/weight gain, decreased spleen and thymus weight and increased vaginal 

patency) were observed in the presence of comparable maternal toxicity. There was evidence of 

increased quantitative susceptibility in the rabbit developmental study. Heart abnormalities were 

observed in fetuses in the absence of maternal effects. 

Trifloxysulfuron-sodium has low acute toxicity via the oral, inhalation (Toxicity Category IV), 

and dermal (Toxicity Category III) routes of exposure. It is a mild dermal and moderate eye 

irritant, and it is not a skin sensitizer.

Trifloxysulfuron-sodium is rapidly absorbed and excreted. Most of the administered dose (AD) 

was excreted within 24 hours. After 7 days, very little remained in the tissues. Urine was the 

primary route of excretion in males and in females. Unchanged parent in both sexes was 

excreted almost entirely in the urine and only trace amounts were found in the feces. In bile duct 

cannulated rats, nearly all of the AD was excreted within 48 hours. Urine was the primary route 

of excretion in both sexes. The metabolite profiles in urine, bile fluid and feces were all similar.

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

HED has recommended that the required 10X Food Quality Protection Act (FQPA Safety Factor 

(SF) be reduced to 1x for trifloxysulfuron-sodium. The toxicology database is complete, there is 

a clear NOAEL for effects observed in the rabbit developmental study where susceptibility was 

seen, and there are no concerns/residual uncertainties with regard to pre- and/or postnatal 

toxicity. Additionally, the risk assessments are protective since they are based on the effects of 

concern. Furthermore, HED has not underestimated the potential for exposure through dietary 

and residential sources. 

4.3 Toxicity Endpoint and Point of Departure Selections

The endpoints/PODs selected for risk assessment remain the same as in previous assessments. A 

separate children’s dermal risk assessment is not needed (for assessing spray drift) since no 

effects were seen in the dermal toxicity study up to the limit dose and no increased susceptibility 

was observed in the reproduction study. Although increased susceptibility was seen in the 

developmental rabbit study, the effects were noted in fetuses, which is not applicable to this 

population. Therefore, a dermal risk assessment is needed for adults only (to protect for 

pregnant females). It should be noted that the endpoints and points of departure (POD) presented 

in the toxicology profile table (Appendix A) have not been updated to comply with current 

policy. The NOAELs and LOAELS have not been changed. Therefore, the endpoints/PODs 

selected for risk assessment may be conservative. The PODs selected for risk assessment are 

protective of the effects observed in the trifloxysulfuron-sodium toxicology database. A 

summary of toxicological doses and endpoints used in the trifloxysulfuron-sodium human health 

risk assessments is presented below.
Page 9 of 60

Table 4.3a. Toxicological Doses and Endpoints for Trifloxysulfuron-sodium for Use in Dietary and NonOccupational Human Health Risk Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological Effects

Acute 

Dietary 

(General 

population)

NOAEL = 600 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x

Acute RfD =6 

mg/kg/day

aPAD

= 6 mg/kg/day

Acute Neurotoxicity Studies in Rats. 

LOAEL = 2000 mg/kg/day based on 

decreased motor activity on Day 1 

and histopathological lesions in 

nervous system tissues of males and 

females.

Acute 

Dietary

(Females 13-

49 years of 

age)

Developmental 

NOAEL = 50 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x

Acute RfD =0.5 

mg/kg/day

aPAD

= 0.5mg/kg/day

Developmental Toxicity Study in 

Rabbits.

Developmental LOAEL=100 

mg/kg/day based on increased 

incidence of abnormally shaped 

hearts in fetuses.

Chronic 

Dietary (All 

Populations)

NOAEL=23.7 

mg/kg/day 

UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x

Chronic RfD 

=0.237mg/kg/day

cPAD

= 

0.237mg/kg/day

Combined Chronic/CarcinogenicityRat

LOAEL = 99.3 mg/kg/day based on 

increased tubular atrophy in the 

kidneys of females. 

Incidental 

oral-ShortTerm (1-30 

days)

IntermediateTerm (1-6

months

Offspring 

NOAEL = 79 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x

Residential LOC 

for MOE = 100

2-Generation Reproduction Study in 

Rats. Offspring LOAEL = 631/676 

(M/F) mg/kg/day based on decreased 

pup weight and weight gain, 

decreased spleen weight, thymus 

weight and increased vaginal patency.

Children’s 

DermalShort-Term 

(1-30 days) 

IntermediateTerm (1-6 

months

No dermal risk assessment needed for children since no effects were seen in the dermal toxicity 

study up to the limit dose. Also, no increased susceptibility was observed in the reproduction 

study, where offspring effects are applicable to children’s dermal exposure. A dermal risk 

assessment is needed for adults (to protect for pregnant females) since increased susceptibility 

was seen in the developmental rabbit study. The effects in the study were seen in fetuses, which 

is not applicable to this population.

Adult 

DermalShort-Term 

(1-30 days) 

IntermediateTerm (1-6 

months

Oral study 

NOAEL= 50 

mg/kg/day

DAF=30 %*

UFA=10x

UFH=10x

Residential LOC 

for MOE = 100

Developmental Toxicity Study in 

Rabbits. LOAEL = 100 mg/kg/day 

based on increased incidence of 

abnormally shaped hearts in fetuses 

in the absence of maternal toxicity.

Adult 

Inhalation 

Short-Term 

(1-30 days)

IntermediateTerm (1-6 

months

Oral study 

NOAEL= 50 

mg/kg/day

UFA=10x

UFH=10x

Residential LOC 

for MOE = 100

Developmental Toxicity Study in 

Rabbits. LOAEL = 100 mg/kg/day 

based on increased incidence of 

abnormally shaped hearts in fetuses.

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not Likely to be Carcinogenic to Humans”

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). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose 
Page 10 of 60

(a = acute, c = chronic). RfD = reference dose. N/A = not applicable. * DAF=dermal absorption factor (based on 

SAR; however, the DAFs for the SAR chemicals used to estimate absorption for trifloxysulfuron were not based on 

actual dermal penetration data, but on dermal NOAEL/oral LOAEL extrapolations. The DAF estimated for 

trifloxysulfuron remains the same as in previous assessments.

Table 4.3b. Toxicological Doses and Endpoints for Trifloxysulfuron 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

Adult 

DermalShort-Term 

(1-30 days) 

Intermediate

-Term (1-6 

months

Oral study 

NOAEL= 50 

mg/kg/day

DAF=30 %*

UFA=10x

UFH=10x

Occupational 

LOC for MOE 

= 100

Developmental Toxicity Study in 

Rabbits. LOAEL = 100 mg/kg/day 

based on increased incidence of 

abnormally shaped hearts in fetuses in 

the absence of maternal toxicity.

Inhalation 

Short-Term 

(1-30 days)

Intermediate

-Term (1-6 

months

Oral study 

NOAEL= 50 

mg/kg/day

UFA=10x

UFH=10x

Occupational 

LOC for MOE 

= 100

Developmental Toxicity Study in 

Rabbits. LOAEL = 100 mg/kg/day 

based on increased incidence of 

abnormally shaped hearts in fetuses.

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not Likely to be Carcinogenic to Humans”

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.

*DAF=dermal absorption factor (based on SAR, not dermal absorption data). 

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 trifloxysulfuron-sodium,

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), 

trifloxysulfuron-sodium 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 
Page 11 of 60

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 chemicals identified for EDSP screening was published on June 14, 20131 and 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 Water Residue Profile

Screening groundwater-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. Rather than produce chemical-specific estimated drinking water 

concentrations (EDWCs) following the usual assessment procedures, EFED provided coarsescreen estimates that should exceed upper-bound, chemical-specific EDWCs for any SU. This 

was achieved by using model inputs that represent the use pattern of highest exposure from any 

SU, the highest soil mobility of any SU residue of concern, and the highest persistence to any 

route of degradation over time. The resulting coarse-screen EDWCs from PRZM-GW were used 

as conservative estimates of exposure and are summarized in Table 5.1 (D427429, G. Orrick). 

 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 12 of 60

The acute and chronic dietary assessments for trifloxysulfuron-sodium used the coarse-screen 

maximum daily concentration of 751 μg/L (0.751 ppm) and the post-breakthrough mean value of 

492 μg/L (0.492 ppm), respectively. 

Table 5.1. PRZM-GW Coarse-Screen EDWCs for Sulfonylureas1.

Modeled Scenario Kd or KOC

Initial Application 

Dates (days postemergence)

Max. Daily Conc. 

(μg/L)

Mean 

Breakthrough 

Time (yrs)

Postbreakthrough 

Mean (μg/L)

WI corn Kd 7 449 11.5 415

KOC 7 504 6.9 425

DMV corn Kd 7 489 5.3 369

KOC 7 560 3.3 378

FL citrus Kd 7 429 3.2 351

KOC 7 467 2.3 349

FL potato Kd 7 375 2.6 272

KOC 7 407 2.2 275

GA peanut Kd 7 197 5.2 156

KOC 7 206 3.9 158

NC cotton Kd 7 640 8.7 492

Kd 37 641 8.7 491

Kd 67 637 8.7 490

KOC 7 742 5.7 484

KOC 37 751 5.7 483

KOC 67 744 5.7 482 1 Maximum values are bolded.

5.2 Food Residue Profile 

Trifloxysulfuron-sodium is registered for use on almond, citrus fruit (crop group 10), cotton, 

sugarcane, and tomato. Tolerances have been established for residues of trifloxysulfuron in or 

on, almond nutmeats at 0.02 ppm, almond hulls at 0.01 ppm, citrus fruit at 0.03 ppm, undelinted 

cotton seed at 0.05 ppm, cotton gin byproducts at 1.0 ppm, sugarcane at 0.01 ppm, and tomato at 

0.01 ppm. In conducting this assessment, HED has assumed tolerance-level residues in those raw 

agricultural commodities and processed products, and that 100 percent of those crops are treated 

with trifloxysulfuron-sodium.

5.3 Dietary Exposure and Risk Estimates

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 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 population adjusted dose (PAD). 

In the case of trifloxysulfuron-sodium, the dietary risk estimates (Table 5.3) and are not of 

concern, ranging from <1 to 8% of the aPAD and from 3 to 11% of the cPAD. 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 risk are expected to be 
Page 13 of 60

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

are included in Appendix F. 

Table 5.3. Summary of dietary exposure and risk estimates for trifloxysulfuron-sodium.

Acute Estimates (95th Percentile) Chronic Estimates

Population Group

Exposure, mg/kg 

bw Risk, % aPAD

Exposure, mg/kg 

bw/day Risk, % cPAD

Total US Population 0.0411 <1 0.0104 4

All Infants (< 1 year old) 0.129 2 0.0266* 11

Children 1-2 years old 0.0631 1 0.0150 6

Children 3-5 years old 0.0517 <1 0.0127 5

Children 6-12 years old 0.0391 <1 0.00911 4

Youth 13-19 years old 0.0342 <1 0.00756 3

Adults 20-49 years old 0.0404 <1 0.0103* 4

Adults 50-99 years old 0.0360 <1 0.0102 4

Female 13-49 years old 0.0410 8 0.0103 4

*used in aggregate assessment.

6.0 Residential (Non-Occupational) Exposure and Risk Assessment

There are existing residential uses that have been reassessed in this document to reflect updates 

to HED’s 2012 Residential SOPs3 along with policy changes for body weight assumptions. The 

revision of residential exposures will impact the human health aggregate risk assessment for 

trifloxysulfuron-sodium.

6.1 Residential Handler Exposure/Risk Estimates

HED uses the term “handlers” to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct tasks related to applications and that 

exposures can vary depending on the specifics of each task. Residential handlers (homeowners) 

are assumed to complete all elements of an application without use of any protective equipment. 

Current uses of trifloxysulfuron-sodium on turf are likely limited to commercial or professional 

applicators only; however, trifloxysulfuron-sodium applied on turf is not a restricted use. Since 

the label language “for commercial applicators only” is not enforceable, there is potential for 

residential handler exposure. Therefore, a quantitative exposure/risk assessment was developed 

for residential handlers based on the scenarios listed on Table 6.1.

Residential Handler Exposure Data and Assumptions

Application Rate: The maximum single application rates are listed in Table 3.3. Refer to 

Section 3.3 for a complete use pattern description.

Unit Exposures and Area Treated or Amount Handled: Unit exposure values and estimates for 

area treated or amount handled were taken from HED’s 2012 Residential SOPs4. 

 3 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html 4 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 14 of 60

Exposure Duration: Residential handler exposure is expected to be short-term in duration. 

Intermediate-term exposures are not likely because of the intermittent nature of applications by 

homeowners. However, as the same endpoint and point of departure were selected for short- and 

intermediate-term durations, short-term exposure and risk estimates are considered to be 

protective of intermediate-term exposure and risk. 

Residential Handler Non-Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate exposure and dose for residential handlers can be found in 

Appendix E and/or the 2012 Residential SOPs5.

Summary of Residential Handler Non-Cancer Exposure and Risk Estimates

The exposure and risk estimates for residential handler exposure are provided in Table 6.1. All 

estimated risks are above HED’s LOC for residential risk (MOE >100) and are not of concern.

 5 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 15 of 60

Table 6.1. Residential Handler Exposure and Risk Estimates for Trifloxysulfuron-sodium.

Scenario Dermal 

Unit 

Exposurea

(mg/lb ai)

Inhalation 

Unit 

Exposurea

(mg/lb ai)

Application 

Rate b

Amount 

Treated c

Dermal 

Dosed 

(mg/kg/day)

Dermal 

MOEe

(mg/kg/day)

Inhalation 

Dosef

(mg/kg/day)

Inhalation 

MOEg

Total MOEh

Mixer/Loader/Applicator (Turf, Ornamentals)

Dry Flowable 

for Backpack 

Sprayer 

Applications

69 1.1 0.0004 lb 

ai/gal

5 gal 0.00056 83,000 0.000032 1,600,000 79,000

Dry Flowable 

for Manuallypressurized 

Handwand 

Applications

69 1.1 0.0004 lb 

ai/gal

5 gal 0.00056 83,000 0.000032 1,600,000 79,000

Dry Flowable 

for Hose-end 

Sprayer 

Applications

13.4 0.022 0.026 lb ai/A 0.5 A 0.00076 66,000 0.0000041 12,000,000 66,000

Dry Flowable 

for Sprinkler 

Can 

Applications

13.4 0.022 0.0000006 lb 

ai/ft2

1,000 ft2 0.000035 1,400,000 0.00000019 260,000,000 1,400,000

a. Based on HED’s 2012 Residential SOPs (http://www.epa.gov/pesticides/science/residential-exposure-sop.html).

b. Application rate based on the registered labels.

c. Based on HED’s 2012 Residential SOPs (http://www.epa.gov/pesticides/science/residential-exposure-sop.html).

d. Dermal Dose = Dermal Unit Exposure (mg/lb ai) * Application Rate * Dermal Absorption Factor (30%) x Acres Treated or Amount Handled / Body Weight (69

kg).

e. Dermal MOE = NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day). LOC=100.

f. Inhalation Dose (mg/kg/day) = Inhalation Unit Exposure (mg/lb ai) * Application Rate * Acres Treated or Amount Handled / Body Weight (69 kg).

g. Inhalation MOE = NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day). LOC=100.

h. Total MOE = NOAEL (mg/kg/day)/ [Dermal Dose + Inhalation Dose (mg/kg/day)]. LOC=100.
Page 16 of 60

6.2 Residential Post-application Exposure/Risk Estimates

There is the potential for post-application exposure for individuals exposed as a result of being in 

an environment that has been previously treated with trifloxysulfuron-sodium.

Post-application exposures are expected for adults and children following use of 

trifloxysulfuron-sodium on residential sites. These exposures include dermal exposure for adults 

and dermal and incidental oral (i.e., hand-to-mouth, objects-to-mouth, and soil ingestion) 

exposure for children. Since dermal risks are not anticipated for children because of the absence 

of dermal toxicity and no concern for susceptibility in this population, the residential postapplication assessment for children is based on incidental oral exposures only. The quantitative 

exposure/risk assessment for residential post-application exposures is based on the scenarios 

presented in Table 6.2. 

Residential Post-application Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the residential 

post-application risk assessment. Each assumption and factor is detailed in the 2012 Residential 

SOPs (Turf SOP).

Lifestages: The lifestages selected for each post-application scenario are based on an analysis 

provided as an Appendix in the 2012 Residential SOPs. While not the only lifestage potentially 

exposed for these post-application scenarios, the lifestage that is included in the quantitative 

assessment is health protective for the exposures and risk estimates for any other potentially 

exposed lifestage. 

Application Rate: The maximum single application rates are listed in Table 3.3. Refer to 

Section 3.3 for a complete use pattern description.

Exposure Duration: Residential post-application exposure is expected to be short-term in 

duration. Intermediate-term exposures are not likely because of the intermittent nature of 

applications by homeowners. However as the same endpoint and point of departure were 

selected for short- and intermediate-term durations, short-term exposure and risk estimates are 

considered to be protective of intermediate-term exposure and risk. 

Turf Transferable Residue (TTR): In accordance with 40CFR158, TTR data are required for all 

residential turf uses that could result in post-application exposure to turf. In the absence of 

chemical-specific TTR data, EPA uses default values. Since the estimated residential turf postapplication exposure for [residential turf/mower/golf course] using default TTR values for 

trifloxysulfuron-sodium is minimal in comparison to the level of concern (i.e., the calculated 

MOE is greater than 10 times higher than the level of concern, MOE = 15,000 compared to the 

LOC of 100); EPA is waiving the 40CFR TTR data requirement. In this instance, it is unlikely 

that chemical-specific TTR data would be needed to further refine exposure assessments or 

would add appreciably to our general understanding of the availability of turf transferable 

pesticide residues for trifloxysulfuron-sodium.

Residential Post-application Non-Cancer Exposure and Risk Equations
Page 17 of 60

The algorithms used to estimate residential post-application exposure and dose can be found in 

Appendix E and/or the 2012 Residential SOPs (Turf SOP).

Summary of Residential Post-application Non-Cancer Exposure and Risk Estimates

The post-application exposure scenarios presented in Table 6.2 are considered protective of all 

existing residential uses. All residential post-application MOEs are above the LOC of 100 and 

are not of concern. 

Table 6.2. Residential Post-application Non-cancer Exposure and Risk Estimates for 

Trifloxysulfuron-sodium.

Lifestage

Post-application Exposure 

Scenario Application Rate1 Dose 

(mg/kg/day)2 MOEs3 Combined MOEs Use Site Route of 

Exposure

Adult

High-Contact 

Lawn 

Activities 

(Turf) Dermal 0.026 lb ai/A

0.00339 15,000

N/A

Mowing Turf 0.000069 720,000

Golfing 0.000266 190,000

Child 

(1<2 years 

old)

Turf

Oral (Hand-toMouth)

0.026 lb ai/A

0.0004 200,000

Oral (Object-to- N/A

Mouth) 0.000012 6,600,000

Oral (Soil 

Ingestion) 0.0000009 90,000,000

1 Based on the registered labels.

2 Dose (mg/kg/day) equations provided in Appendix E.

3 MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day).

6.3 Residential Risk Estimates for Use in Aggregate Assessment

Table 6.3. reflects the residential risk estimates that are recommended for use in the aggregate 

assessment for trifloxysulfuron-sodium:

• The recommended residential exposure for use in the adult aggregate assessment reflects 

dermal and inhalation exposure from applications to treated turf.

• The recommended residential exposure for use in the children 1<2 years old aggregate 

assessment reflects hand-to-mouth exposures from post-application exposure to outdoor 

(turf) applications.

Table 6.3. Recommendations for the Residential Exposures for the Trifloxysulfuron-sodium Aggregate Assessment.

Lifestage Exposure 

Scenario

Dose (mg/kg/day)1 MOE2

Dermal Inhalation Oral Total Dermal Inhalation Oral Total

Adult

Turf

0.00339 0.000032 N/A 0.0034 15,000 1,600,000 N/A 15,000

Child (1<2 

years old) Turf N/A N/A 0.0004 0.0004 N/A N/A 200,000 200,000
Page 18 of 60

1. Dose = the highest dose for each applicable lifestage of all residential scenarios assessed. Total = dermal + 

inhalation + incidental oral (where applicable). See tables 6.1 and 6.2 for specific scenarios.

2. MOE = the MOEs associated with the highest residential doses. 

6.4 Spray Drift

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 indirect 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 is based 

on a premise of compliant applications which, by definition, should not result in direct exposures 

to individuals because of existing label language and other regulatory requirements intended to 

prevent them.6

 Direct exposures would include inhalation of the spray plume or being sprayed 

directly. Rather, the exposures addressed here are thought to occur indirectly through contact 

with impacted areas, such as residential lawns, when compliant applications are conducted. 

Given this premise, 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 indirect 

exposure are the focus of this analysis analogous to how exposures to turf products are 

considered in risk assessment. 

Several trifloxysulfuron-sodium products have existing labels for use on turf, thus it was 

considered whether the risk assessment for that use may be considered protective of any type of 

exposure that would be associated with spray drift. It should be noted that the registered 

residential uses on turf result in exposure greater than potential exposure from spray drift; 

therefore, no new residential assessment needs to be completed. If the maximum application rate 

on crops adjusted by the amount of drift expected is less than or equal to existing turf application 

rates, the existing turf assessment is considered protective of spray drift exposure. The currently 

registered maximum single application rate of trifloxysulfuron-sodium for agricultural crops is 

0.028 lb ai/A. The highest degree of spray drift noted for any application method immediately 

adjacent to a treated field (e.g., Tier 1 output from the aerial application using fine to medium 

spray quality) results in a deposition fraction of 0.26 of the application rate. A quantitative spray 

drift assessment for trifloxysulfuron-sodium is not required because the maximum application 

rate to a crop/target site multiplied by the adjustment factor for drift of 0.26 is less than (0.0073 

lb ai/A) the maximum direct spray residential turf application rate [(0.026 lb ai/A)]7 for any 

trifloxysulfuron-sodium products. The turf post-application MOEs have been previously 

assessed and are based on the revised SOPs for Residential Exposure Assessment (i.e., see above 

in Section 6.2).

 6 This approach is consistent with the requirements of the EPA’s Worker Protection Standard which, 

when included on all labels, precludes direct exposure pathways.

7 Maximum Application rate for Spray Drift Assessment = 0.028 lb ai/A x 0.26 = 0.0073 lb ai/A ≤ 0.026 lb ai/A.
Page 19 of 60

6.5 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 trifloxysulfuron-sodium.

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. 

7.1 Acute and Chronic Aggregate

Acute and chronic aggregate exposure to trifloxysulfuron-sodium results from residues in food 

and drinking water alone. Therefore, the acute and chronic aggregate risk estimates are 

equivalent to the dietary risk estimates discussed in Section 5.3. Acute and chronic aggregate 

risks are not of concern. 

7.2 Short-and Intermediate-Term Aggregate Risk Estimates

Short-and intermediate-term aggregate risk assessments are needed for adults and children. For 

children, aggregate exposure is expected through incidental oral and dermal routes. However, a

dermal endpoint was not selected for children since no effects were seen in the dermal toxicity 

study (up to the limit dose) and there is no concern for increased susceptibility in this population. 

Therefore, a quantitative dermal risk assessment for children was not conducted. For adults, 

aggregate exposure includes the dermal and inhalation routes. 

The incidental oral endpoint is based on decreased pup body weight, spleen and thymus weights, 

as well as increased vaginal patency seen in the rat reproduction study with a NOAEL of 79

mg/kg/day. The adult short- and intermediate-term dermal and inhalation endpoints are based on 

an increased incidence of abnormally shaped hearts in fetuses seen in the rat developmental 

study with a NOAEL of 50 mg/kg/day. 

For children, post-application incidental oral (i.e., hand to mouth) exposures were combined with 

background exposure from food and water. For adults, dermal and inhalation exposure estimates 

resulting from use on turf were combined with background exposure from food and water. 

The chronic dietary exposure estimates are the background exposure levels that were added 

directly to the residential exposure estimates. Of the adult population subgroups, the Adults 20-49 
Page 20 of 60

years old had the highest dietary exposure estimate. For the population subgroups comprised of 

children, the most highly exposed subgroup was All Infants (< 1 year old). 

The short-term/intermediate-term aggregate risk assessments resulted in an MOE of 2,900 for 

children and 3,600 for adults. The adult and child MOEs are greater than the LOCs of 100. As a 

result, the aggregate dietary and residential risk estimates are not of concern. The aggregate risk 

estimates are given in Table 7.2; the calculations are shown below the table.

Table 7.2 Short-Term and/or Intermediate Term Aggregate Risk Calculations for Trifloxysulfuron.

Population

Short- or Intermediate-Term Scenario

NOAEL 

mg/kg/day LOC1

Max 

Allowable 

Exposure2

mg/kg/day

Average 

Food and 

Water 

Exposure 

mg/kg/day

Residential 

Exposure 

mg/kg/day3

Total 

Exposure 

mg/kg/day4

Aggregate 

MOE (food, 

water, and 

residential)5

Dermal and Inhalation

Adult 50 100 0.5 0.0103 0.0034 0.0137 3,600

Incidental Oral

Child 79 100 0.79 0.0266 0.0004 0.027 2,900 1 Level of Concern (LOC) based on the standard inter- and intra- species uncertainty factors totaling 100X. 2 Maximum Allowable Exposure (mg/kg/day) = NOAEL/LOC. 3 Residential Exposure = Dermal exposure of 0.00339 mg/kg/day based on post-application high contact lawn activities and 

inhalation exposure of 0.000032 based on dry flowable backpack sprayer/pressurized hand wand applications (same exposure 

values) for adults. Incidental oral exposure of 0.0004 mg/kg/day for children (1<2 years old) based on playing on treated turf 

(Table 6.3). 4 Total Exposure = Avg Food & Water Exposure + Residential Exposure. 5 Aggregate MOE = [NOAEL/ (Avg Food & Water Exposure + Residential Exposure)].

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 

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)8 and conducting cumulative risk assessments (CRA)9

. The Agency has utilized 

this framework to evaluate the SUs of which orthosulfamuron 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.

 8 Guidance For Identifying Pesticide Chemicals and Other Substances that have a Common Mechanism of Toxicity 

(USEPA, 1999)

9 Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity 

(USEPA, 2002)
Page 21 of 60

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 handler exposure is expected from the registered uses. The quantitative 

exposure/risk assessment developed for occupational handlers is based on the scenarios listed in

Table 9.1. Based on the use pattern and agricultural practices, occupational exposure from the 

registered food uses is expected to be short-term (1-30 days) and intermediate-term (i.e., 1-6 

months) in duration. Since the same endpoint and point of departure were selected for short- and 

intermediate-term durations, short-term exposure and risk estimates are considered to be 

protective of intermediate-term exposure and risk. Long-term exposures (i.e., more than 6 

months) are not anticipated.

Occupational Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational 

handler risk assessments. Each assumption and factor is detailed below on an individual basis.

Application Rate: The maximum single application rates are listed in Table 3.2. Refer to section 

3.0 for a complete use pattern description.

Body Weight: The female body weight (69 kg) was used for all dermal and inhalation exposure 

scenarios covered in this risk assessment because the endpoints selected were based on 

developmental and/or fetal effects. 

Absorption Factor: Since no inhalation absorption data are available, toxicity by the inhalation 

route is considered to be equivalent to the estimated toxicity by the oral route of exposure. A 

dermal absorption factor (DAF) of 30% was used for the exposure assessment, estimated based 

on structure-activity-relationships with other sulfonylurea pesticides. However, the DAFs 

determined for the structurally related chemicals were not based on actual dermal penetration

data, but on dermal NOAEL/oral LOAEL extrapolations. The DAF estimated for 

trifloxysulfuron remains the same as in previous assessments.

 

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, and the AHETF database. 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 Table10.” HED policy on use of surrogate data, including descriptions of the various 

sources, can be found at the Agency website11. 

Area Treated or Amount Handled: The inputs for area treated or amount handled were based on 

the Science Advisory Council for Exposure Policy 9.1: Standard Values for Daily Acres Treated 

 10 Available: http://www.epa.gov/opp00001/science/handler-exposure-table.pdf 11 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.html
Page 22 of 60

in Agriculture (values are listed in Table 9.1). Application is via ground and handheld 

application equipment only (ground-boom, back pack sprayer and airblast); aerial applications 

and chemigation equipment are prohibited. The acres treated for high acreage crops for 

groundboom applications and orchard/vineyards for airblast applications were used as screening 

for the occupational assessment. 

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: Dermal and inhalation risk estimates were combined in 

this assessment, since the toxicological effects for these exposure routes were similar. Dermal 

and inhalation risk estimates were combined using the following formula:

Total MOE = Point of Departure (mg/kg/day) ÷ [Dermal Dose + Inhalation Dose (mg/kg/day)]

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimate

The exposure scenarios presented in Table 9.1 are considered protective of all existing uses. All 

occupational handler scenarios for the registered uses resulted in total MOEs (dermal+inhalation) 

greater than 100 at baseline level of risk mitigation (i.e., baseline attire with no gloves or 

respirator), and therefore, are not of concern. The lowest total MOE is 5,700 associated with 

total exposure for a dispersible granule formulation being applied using airblast equipment over 

up to 40 acres. All other MOEs were higher and required less level of mitigation, ranging from 

7,200 to 53,000. 

Table 9.1. Short-term Handler Exposure and Risk Estimates for Trifloxysulfuron-sodium.

Exposure Scenario Dermal Unit 

Exposure 

(ug/lb ai)

[Mitigation 

Level]ab

Inhalation 

Unit 

Exposure

(ug/lb ai)

[Mitigation 

Level]ab

Application 

Ratec

Area 

Treated 

or 

Amount 

Handledd

Dermal 

Dosee

Dermal 

MOEf

Inhalation 

Doseg

Inhalation 

MOEh

Tota 

MOE

Mixer/Loader

Dry Flowable 

(Dispersible Granule) 

for Groundboom 

Application

227 

(Baseline)

8.96 (No 

respirator)

0.028 lb ai/A 200 A 0.00552 9,100 0.000728 69,000 8,000

Dry Flowable 

(Dispersible Granule) 

for Airblast 

Application

227 

(Baseline)

8.96 (No 

respirator)

0.028 lb ai/A 40 A 0.00110 45,000 0.000145 340,000 40,00

Applicator

Sprays for 

Groundboom 

Application

78.6 

(Baseline)

0.34 

(Baseline)

0.028 lb ai/A 200 A 0.00191 26,000 0.0000275 1,800,000 26,00

Sprays for Airblast 

Application

1,770 

(Baseline)

4.71 

(Baseline)

0.028 lb ai/A 40 A 0.00861 5,800 0.0000765 650,000 5,700

Mixer/Loader/Applicator

Sprays for Backpack 

Sprayer

13,200 

(Baseline)

140 (No 

respirator)

0.0004

lb ai/gal

40 gal 0.00092 55,000 0.000033 1,500,000 53,00

Sprays Manuallypressurized 

Handwand Sprayer

100,000 

(Baseline)

30 (No 

respirator)

0.0004

lb ai/gal

40 gal 0.00696 7,200 0.0000069 7,200,000 7,200
Page 23 of 60

Table 9.1. Short-term Handler Exposure and Risk Estimates for Trifloxysulfuron-sodium.

Exposure Scenario Dermal Unit 

Exposure 

(ug/lb ai)

[Mitigation 

Level]ab

Inhalation 

Unit 

Exposure

(ug/lb ai)

[Mitigation 

Level]ab

Application 

Ratec

Area 

Treated 

or 

Amount 

Handledd

Dermal 

Dosee

Dermal 

MOEf

Inhalation 

Doseg

Inhalation 

MOEh

Tota 

MOE

Sprays for 

Mechanicallypressurized Handgun

3,500 

(Baseline)

120 (No 

respirator)

0.028 lb ai/A 1,000 gal 0.00609 8,200 0.000696 72,000 7,400

a. Mitigation Level: “baseline” (i.e., single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no 

gloves, and no respirator).

b. Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (February, 2015).

c. Based on the maximum single application rates listed on registered labels (Table 3.2).

d. Based on the Science Advisory Council for Exposure Policy 9.1: Standard Values for Daily Acres Treated in Agriculture.

e. Dermal Dose (mg/kg/day) = [Rate x UE x 0.0001 x Dermal Absorption Factor (30%) x Area Treated or Amount Handled]/BW 

(69 kg). 

f. Dermal MOE = Dermal NOAEL (mg/kg/day)/ Dermal Dose (mg/kg/day). LOC=100.

g. Inhalation Dose (mg/kg/day) = [Rate x UE x 0.0001 x Area Treated or Amount Handled]/BW (69 kg).

h. Inhalation MOE = Inhalation NOAEL (mg/kg/day)/ Inhalation Dose (mg/kg/day). LOC=100.

i. Total MOE = NOAEL (mg/kg/day)/ [Dermal + Inhalation Dose (mg/kg/day)]. LOC=100.
Page 24 of 60

9.2 Occupational Post-application Exposure/Risk Estimates

HED uses the term post-application to describe exposures that occur when individuals are 

present in an environment that has been previously treated with a pesticide (also referred to as reentry exposure). Such exposures may occur when workers enter previously treated areas to 

perform job functions, including activities related to crop production, such as scouting for pests 

or harvesting. Post-application exposure levels vary over time and depend on such things as the 

type of activity, the nature of the crop or target that was treated, the type of pesticide application, 

and the chemical’s degradation properties. In addition, the timing of pesticide applications, 

relative to harvest activities, can greatly reduce the potential for post-application exposure.

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 trifloxysulfuron-sodium.

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 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

A series of assumptions and exposure factors served as the basis for completing the occupational 

post-application dermal risk assessment, including the following:

Exposure Duration: Based on the use pattern and agricultural practices, occupational postapplication exposure from the registered uses is expected to be short-term (i.e., 1-30 days) and 

intermediate-term (i.e., 1-6 months) in duration. Since the same endpoint and point of departure 

were selected for short- and intermediate-term durations, short-term exposure and risk estimates 
Page 25 of 60

are considered to be protective of intermediate-term exposure and risk. Long-term exposures 

(i.e., more than 6 months) are not anticipated.

Transfer Coefficients: It is the policy of HED to use the best available data to assess postapplication exposure. Sources of generic post-application data, used as surrogate data in the 

absence of chemical-specific data, are derived from the Agricultural Reentry Task Force (ARTF) 

exposure monitoring studies, and, as proprietary data, are subject to the data protection 

provisions of FIFRA. The standard values recommended for use in predicting post-application 

exposure that are used in this assessment, known as “transfer coefficients”, are presented in the 

ExpoSAC Policy 312” which, along with additional information about the ARTF data, can be 

found at the Agency website13. Table 9.2.2.1 provides a summary of the anticipated postapplication activities and associated transfer coefficients for the proposed crops/use sites.

Table 9.2.2.1. Anticipated High-contact Post-Application Activities and Dermal Transfer Coefficients.

Proposed Crops

Policy Crop 

Group 

Category

Crop 

Height

Foliage 

Density

Transfer 

Coefficients 

(cm2/hr)

Activities

Almond Tree, “nuts” High Full 580 Scouting

Ornamentals Nursery, Nonbearing plants High Full 1,900 Irrigation (Hand set)

Citrus, Orange Tree, "fruit", 

evergreen High Full 1,400 Hand Harvesting

Sod, Turf Turf, sod Low Full 6,700 Maintenance, Harvesting, Slab, 

Transplanting, Planting

Sugarcane Sugarcane High Full 8,800 Hand Harvesting

Tomato Vegetables, 

fruiting High Full 1,900 Irrigation (Hand set)

Cotton Field, row, 

medium Low Full

900 Harvesting Mechanical 

(Module Builder)

2400 Harvesting Mechanical 

(Picker Operator; Raker)

5050 Harvesting Mechanical (Tramper)

Application Rate: The maximum single application rates are listed in Table 3.2. Refer to section 

3.0 for a complete use pattern description.

Exposure Time: The average occupational workday is assumed to be 8 hours. 

Dislodgeable Foliar Residues: Chemical-specific dislodgeable foliar residue data have not been 

submitted for trifloxysulfuron-sodium during registration review. Therefore, this assessment 

uses HED’s default assumption that 25% of the application is available for transfer on day 0 

following the application and the residues dissipate at a rate of 10% each following day.

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

occupational post-application workers can be found in Appendix C.

 12 Available: http://www.epa.gov/pesticides/science/exposac_policy3.pdf 13 Available: http://www.epa.gov/pesticides/science/post-app-exposure-data.html
Page 26 of 60

Occupational Post-application Non-Cancer Dermal Risk Estimates

Agricultural Crops

A summary of the post-application exposure and risk estimates for the registered uses is provided 

in Table 9.2.2.2. Only risk estimates for the highest contact activity for each crop and the 

highest application rates are shown below. Post-application dermal exposure and risk estimates 

for the scenarios shown below resulted in MOEs greater than 100 and are not of concern on day 

0 (i.e., 12 hours following application). All other scenarios involving lower contact activities 

would have higher MOEs and are also not of concern.

In accordance with 40CFR158, DFR and TTR data are required for all occupational (e.g., crop, 

nursery, greenhouse use sites, sod farms, golf courses, parks, and recreational areas) uses that 

could result in post-application exposure to foliage or treated turf/sod. In the absence of 

chemical-specific DFR and TTR data, EPA uses default values. 

Since the highest estimated occupational post-application exposure using default DFR values for 

trifloxysulfuron-sodium is minimal in comparison to the level of concern (i.e., the calculated 

MOE is greater than 2 times higher than the level of concern, MOE = 2,100 compared to the 

LOC of 100); EPA is waiving the 40CFR DFR data requirement. In this instance, it is unlikely 

that chemical-specific DFR data would be needed to further refine exposure assessments or 

would add appreciably to our overall understanding of the availability of dislodgeable foliar 

pesticide residues for trifloxysulfuron-sodium. 

Furthermore, since the estimated occupational post-application exposure for sod farms using 

default TTR values for trifloxysulfuron-sodium is minimal in comparison to the level of concern 

(i.e., the calculated MOE is greater than 10 times higher than the level of concern, MOE = 2,700

compared to the LOC of 100); EPA is waiving the 40CFR TTR data requirement. In this 

instance, it is unlikely that TTR data would be needed to further refine exposure assessments or 

would add appreciably to our overall understanding of the availability of turf transferable 

pesticide residues for trifloxysulfuron-sodium. 

Cotton

A summary of the post-application dermal exposure and risk estimates from use of 

trifloxysulfuron-sodium on cotton during harvesting activities is provided in Table 9.2.2.3. Postapplication dermal exposure and risk estimates resulted in MOEs greater than 100 and are not of 

concern. 

Table 9.2.2.2. Occupational Post-application Non-Cancer Exposure and Risk Estimates for 

Trifloxysulfuron-sodium.

Crop/Site Activities Transfer Coefficient 

(cm2/hr) DFR1 Dermal Dose (mg/kg/day)2 MOE3

Short- and Intermediate-term

Almonds Scouting 580 0.08 0.002 32,000

Ornamentals Irrigation (Hand set) 1,900 0.08 0.005 9,600

Citrus, Orange Hand Harvesting 1,400 0.08 0.004 13,000
Page 27 of 60

Table 9.2.2.2. Occupational Post-application Non-Cancer Exposure and Risk Estimates for 

Trifloxysulfuron-sodium.

Crop/Site Activities Transfer Coefficient 

(cm2/hr) DFR1 Dermal Dose (mg/kg/day)2 MOE3

Short- and Intermediate-term

Sod, Turf

Maintenance, 

Harvesting, Slab, 

Transplanting, 

Planting

6,700 0.08 0.018 2,700

Sugarcane Hand Harvesting 8,800 0.08 0.024 2,100

Tomato Irrigation (Hand set) 1,900 0.08 0.005 9,600

1. DFR (default approach) = Application Rate × F × (1-D)t × 4.54E8 μg/lb × 2.47E-8 acre/cm2; where F = 0.25 and D = 

0.10 per day.

2. Daily Dermal Dose = [DFR (μg/cm2) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × Dermal Absorption (30%)] ÷

BW (69 kg).

3. MOE = Dermal NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day); LOC=100. 

Table 9.2.2.3. Post-Application Exposure and Risk Estimates for use of Trifloxysulfuron-sodium on Cotton during 

Harvesting Activities.

Crop

Proposed 

Maximum 

Seasonal 

Application 

Rate

(lb ai/A)

Activity

TC1

(g 

cotton/hr)

Days After 

Treatment

Residue 

from Cotton 

Field Trial 2

(mg ai/g 

cotton)

Daily Dose 

(mg/kg/d)3

Dermal 

MOE4

Short- and Intermediate-term

Cotton 0.019

Harvesting 

Mechanical 

(Module Builder)

900

60 0.001

0.031 1,600

Harvesting 

Mechanical 

(Picker Operator; 

Raker)

2,400 0.083 600

Harvesting 

Mechanical 

(Tramper)

5,050 0.176 280

1. Transfer Coefficients from HED Policy No. 3.0., Non-Foliar Transfer Coefficient Table, March 2012 (p 122). 

2. Tolerance value for trifloxysulfuron-sodium in cotton gin byproducts adjusted to Max. Seasonal Application Rate (mg ai/g 

cotton) = (1.0 mg ai/kg cotton) (0.001 kg/g) ((0.019 lb ai/A)/(0.019 lb ai/A)) = 0.001 mg ai/g cotton.

3. Dermal Dose (mg/kg/day) = [Cotton Field Trial Residue Value adjusted (mg ai/g cotton) x TC (g cotton/hr) x 8 hrs/day x DAF 

(30%)]/ BW (69 kg).

4. Dermal MOE = NOAEL (mg/kg/day)/Dermal Dose (mg/kg/day); LOC = 100.

Restricted Entry Interval

The REI specified on the proposed label is based on the acute toxicity of trifloxysulfuronsodium. Trifloxysulfuron-sodium is classified as Toxicity Category III via the dermal route and 

Toxicity Category IV for skin irritation potential. It is not a skin sensitizer. Short- and 

intermediate-term post-application risk estimates were not a concern on day 0 (i.e., 12 hours 

following application) for all post-application activities. 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 

trifloxysulfuron-sodium. 
Page 28 of 60

10.0 Public Health and Pesticide Epidemiology Data

For this evaluation, the OPP Incident Data System (IDS) was utilized for pesticide incident data 

on the active ingredient trifloxysulfuron-sodium (D408567, S. Recore). The purpose of the 

database search is to identify potential patterns in the frequency and severity of the health effects 

attributed to trifloxysulfuron-sodium exposure. IDS records incidents resulting in higher severity 

outcomes in more detail, in a module called the Main IDS module. This system stores incident 

data for death, major and moderate incidents, and it includes more details about the location, date 

and nature of the incident. Main IDS incidents involving only one pesticide are considered to 

provide more certain information about the potential effects of exposure from the pesticide. The

less severe human incidents (minor, unknown, or no effects outcomes) are reported by registrants 

as counts called aggregate summaries and are recorded in a separate module called Aggregate 

IDS. 

In addition, findings from the AHS were reviewed. The Agricultural Health Study (AHS) is a 

high quality, prospective epidemiology study evaluating the link between pesticide use and 

various health outcomes including cancer. Trifloxysulfuron-sodium is not included in the AHS, 

and therefore this study does not provide information for this report.

In Aggregate IDS, from January 1, 2007 to December 11, 2012, there were 3 reported incidents 

involving trifloxysulfuron-sodium. These incidents were classified as minor severity.

For the Main IDS, from January 1, 2007 to December 11, 2012, there were no incidents reported 

in the database involving trifloxysulfuron-sodium. 

The National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event 

Notification System for Occupational Risk-Pesticides (SENSOR) database was also consulted 

for pesticide incident data on the active ingredient trifloxysulfuron-sodium. The NIOSH 

SENSOR database covers 11 states from 1998-2009, although reporting varies from state to 

state. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: 

reports from local Poison Control Centers, state Department of Labor workers’ compensation 

claims when reported by physicians, reports from State Departments of Agriculture, and 

physician reports to state Departments of Health. Although both occupational and nonoccupational incidents are included in the database, SENSOR focuses on occupational pesticide 

incidents, and is of particular value in providing that information. A state SENSOR contact 

specialist attempts to follow-up with cases and obtains medical records to verify symptoms, 

circumstances surrounding the exposure, severity, and outcome. Using standardized protocol 

and case definitions derived from poison center reporting, SENSOR coordinators at State 

Departments of Health enter the incident interview description provided by the case, medical 

report, physician and patient into the SENSOR data system. The SENSOR data system is 

accessible to participating states and EPA. A query of SENSOR-Pesticides 1998-2009 finds no 

reported cases for trifloxysulfuron-sodium.

11.0 Literature References

A literature search was performed for trifloxysulfuron-sodium. The search did not reveal 

information that would impact the current risk assessment. 
Page 29 of 60

12.0 References

Author Barcode Date Title

L. Hansen,

E. Holman,

M. Lloyd

D408404 5/08/2013 Trifloxysulfuron-Sodium: Human Health Assessment 

Scoping Document in Support of Registration Review

S.Recore D408567 2/05/2013 Trifloxysulfuron-Sodium: Review of Human Incidents

M. Doherty,

K. Bailey,

S. Wang

D352260 11/12/2008 Trifloxysulfuron-Sodium: Human Health Risk 

Assessment for the Requested Use on Sports Fields and 

Residential Turfgrass.

S. Wang D353060 08/22/08 Trifloxysulfuron-Sodium: Occupational and Residential 

Exposure/Risk Assessment of Trifloxysulfuron-Sodium 

for Section 3 Registration of a New Use on Turf 

S. Wang D284482 09/20/03 Occupational and Residential Exposure/Risk Assessment 

for a New Active Ingredient, Trifloxysulfuron, on Cotton, 

Sugarcane, Citrus, Almonds, Tomatoes, and Turfgrass. S.

Wang. 9/20/03. DP Barcode D284482.

M. Doherty D284104 09/24/03 Human Health Risk Assessment for the Section 3 

Registration of Trifloxysulfuron-sodium on Almond, 

Citrus, Cotton, Sugarcane, Tomato, and Turf. PP# 

1F06280.

G. Orrick D427429 8/12/2015 Drinking Water Exposure Assessment for the 

Registration Review of 22 Sulfonylurea Herbicides 
Page 30 of 60

Appendix A. Toxicology Data Requirements and Toxicology Profile 

A.1. Toxicology Data Requirements: The toxicology requirements (40 CFR 158.340) for 

trifloxysulfuron-sodium are presented below. 

Table A.1 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 21/28-Day Inhalation....................................................

yes

yes

yes

no

no

yes

yes

yes

---

Not required*

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

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

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

yes

yes

yes

yes

yes

yes

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

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

870.4200a Oncogenicity (rat).........................................................

870.4200b Oncogenicity (mouse) ..................................................

870.4300 Chronic/Oncogenicity ..................................................

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..

870.5395 Mutagenicity—Micronucleus.......................................

870.5395 Mutagenicity—Unscheduled DNA Synthesis..............

yes

yes

yes

yes

No

yes

yes

yes

yes

yes

870.6100a Acute Delayed Neurotoxicity (hen)..............................

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

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

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

870.6300 Develop. Neurotoxicity ................................................

no

no

yes

yes

no

---

---

yes

yes

---

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

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

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

yes

no

yes

yes

---

yes

* The Hazard and Science Policy Council (HASPOC) determined that the subchronic inhalation toxicity study is not 

required (TXR 0056564).
Page 31 of 60

A.2. Toxicity Profiles

Table A.2-1. Acute Toxicity Profile - Trifloxysulfuron-sodium

Test 

Material

GDLN Study Type MRID Results Tox

Category

Technical 870.1100 Acute Oral - rat 45371922 LD50 > 5000 mg/kg IV

Technical 870.1100 Acute Oral - mouse 45371923 LD50 > 5000 mg/kg IV

Technical 870.1200 Acute Dermal - rat 45371925 LD50 > 2000 mg/kg III

Technical 870.1300 Acute Inhalation 45371927 LC50 (M & F): > 5.03 mg/L IV

Technical 870.2400 Primary Eye Irritation 45371929 Moderate irritation to the eye III

Technical 870.2500 Primary Dermal 

Irritation

45371931 Mild irritation to the skin IV

Technical 870.2600 Dermal Sensitization 

(Buehler)

45371933 Negative N/A

Technical 870.2600 Dermal Sensitization 

(Maximization)

45371934 Negative N/A

Table A.2-2. Toxicity Profile of Trifloxysulfuron-sodium Technical Grade Active Ingredient*

Guideline 

No.

Study Type Results

870.3100 90-Day oral toxicity 

rodents (rats)

MRIDs 45372002, 

45372025, 45372026, 

45372029, 45372032, 

45372034

NOAEL: 507/549 mg/kg/day (M/F)

LOAEL: 1052/1128 mg/kg/day (M/F): M = decreased body 

weight, decreased body weight gain, equivocal increased testicular 

atrophy at end of recovery phase; F = decreased body weight, 

decreased body weight gain, equivocal slightly increased 

histopathology in liver (single cell necrosis, focal necrosis, 

inflammation, hepatocellular hypertrophy).

870.3100 90-Day oral toxicity 

rodents (mice)

MRID 45372032

NOAEL: 1023/1507 mg/kg/day (M/F)

LOAEL: >1023/>1507 mg/kg/day (M/F): M = not attained; F = 

not attained

870.3150 90-Day oral toxicity in 

nonrodents (dogs)

MRIDs 45372031, 

45372003,45372028

NOAEL:19.8/19.6 mg/kg/day (M/F)

LOAEL: 164.2/167.3 mg/kg/day (M/F): M = decreased body 

weight gain (20%), slight hematological effects, clinical chemistry 

changes suggesting hepatotoxicity, decreased thymus weight, 

thymic atrophy, increased glycogen in liver, hemorrhage in 

mesenteric lymph nodes; F = decreased body weight gain (44%), 

anemia with extramedullary hematopoiesis in liver/spleen and 

myeloid hyperplasia in bone marrow, clinical chemistry changes 

suggesting hepatotoxicity, decrease thymus weight, thymic 

atrophy and hyaline tubular change in kidney.

870.3200 21/28-Day dermal 

toxicity (rats)

MRID 45372004

NOAEL: 1000/100 mg/kg/day (M/F)

LOAEL: >1000/1000 mg/kg/day (M/F): M = not attained; F = 

decreased body weight gain.

No dermal irritation M/F.

870.3700 Prenatal 

developmental in 

rodents (rats)

MRIDs 45372006, 

45372024

Maternal NOAEL: 300 mg/kg/day

Maternal LOAEL: 1000 mg/kg/day based on decreased food 

consumption during treatment, decreased body weight gain during 

post-treatment.

Developmental NOAEL: 300 mg/kg/day

Developmental LOAEL: 1000 mg/kg/day based on slight 

decrease in fetal weight, increased skeletal anomalies, increased 

poor/absent skeletal ossification.
Page 32 of 60

Table A.2-2. Toxicity Profile of Trifloxysulfuron-sodium Technical Grade Active Ingredient*

Guideline 

No.

Study Type Results

870.3700 Prenatal 

developmental in 

nonrodents (rabbit)

MRIDs 45372005, 

45372027

Maternal NOAEL: 100 mg/kg/day

Maternal LOAEL: 250 mg/kg/day based on increased mortality, 

increased vaginal/anal bleeding.

Developmental NOAEL: 50 mg/kg/day 

Developmental LOAEL: 100 mg/kg/day based on abnormally 

shaped heart (one fetus at 100 mg/kg/day and 3 fetuses from 2 

litters at 250 mg/kg/day).

870.3800 Reproduction and 

fertility effects (rat)

MRIDs 45372007, 

45372023

Parental systemic NOAEL:78.8/83.5 mg/kg/day (M/F)

Parental systemic LOAEL: 631/676 mg/kg/day (M/F) based on 

decreased body weight and gain as well as decreased food 

consumption.

Offspring systemic NOAEL:78.8/83.5 mg/kg/day (M/F)

Offspring systemic LOAEL: 631/676 mg/kg/day (M/F):

decreased pup weight and weight gain, decreased spleen weight, 

thymus weight and increased vaginal patency.

Reproductive NOAEL:968/1030 mg/kg/day (M/F)

Reproductive LOAEL:>968/1030 (M/F)

870.4100 Chronic toxicity dogs

MRID 45372008

NOAEL: 51.1/45.3 mg/kg/day (M/F)

LOAEL: 123/121 mg/kg/day (M/F): M = gray-white foci in 

lungs, fibrous thickening of lung pleura, equivocal decreased body 

weight gain; F = equivocal increased incidence and severity of 

chronic urinary bladder inflammation. 

870.4200 Carcinogenicity mice

MRIDs 45372009, 

45372030

NOAEL:854/112 mg/kg/day (M/F)

LOAEL: >854/818 mg/kg/day (M/F): M = not determined; F = 

decreased body weight, body weight gain, and food consumption. 

Negative for carcinogenicity in M and F.

870.4300 Chronic 

feeding/Carcinogenicit

y rats

MRID 453720 I 0

NOAEL: 82.6/23.7 mg/kg/day (M/F)

LOAEL: 429/99.3 mg/kg/day (M/F): M = decreased body weight 

and gains, decreased food consumption and increased Leydig cell 

hyperplasia in testes; F = increased tubular atrophy in kidneys. At 

500 mg/kg/day decreased body weight, body weight gain, food 

consumption and increased tubular atrophy in kidneys. Negative 

for carcinogenicity in M and F.

870.5100 Gene Mutation 

bacterial reverse 

mutation assay (S. 

typhimurium/E. coli)

MRID 45372011

Negative without and with S-9 activation.

870.5300 In vitro mammalian 

cell forward gene 

mutation assay (CHO 

cells/HGPRT locus)

MRID 45372013

Negative without and with S-9 activation.

870.5375 In vitro mammalian 

cytogenetics assay in 

CHO cells

MRID 453720]4

Negative without and with S-9 activation.

870.5395 Cytogenetics -

mammalian 

Negative at single oral doses up to 5000 mg/kg.
Page 33 of 60

Table A.2-2. Toxicity Profile of Trifloxysulfuron-sodium Technical Grade Active Ingredient*

Guideline 

No.

Study Type Results

erythrocyte 

micronucleus test in 

the mouse

MRID 45372015

870.5500 In vitro unscheduled 

DNA synthesis 

(primary rat 

hepatocytes)

MRID 45372016

Negative response up to 250 μg/mL. Cytotoxicity at ≥15.63 

μg/mL.

870.6200 Acute neurotoxicity 

screening battery (rat)

MRIDs 45372033, 

45372022,45372018, 

45372020, 43572021

NOAEL:<2000 mg/kg/day (M/F)

LOAEL: 2000 mg/kg/day (M/F): M&F = decreased motor 

activity on day 1, histopathological lesions in nervous system 

tissues. 

870.6200 Subchronic 

neurotoxicity 

screening battery (rat)

MRIDs 45372017, 

45372021, 45372022, 

45372018

NOAEL:112/553 mg/kg/day (M/F)

LOAEL: 472/1128 mg/kg/day (M/F): M = decreased body 

weight, body weight gain and food consumption; F = decreased 

body weight.

870.7485 Metabolism and 

pharmacokinetics (rat)

MRID 4537]919

Rapidly absorbed and excreted. Most (>87%) of the administered 

dose (AD) was excreted within 24 hours. After 7 days, very little 

(≤0.3% of AD) remained in the tissues. Urine was the primary 

route of excretion in males (50-61% of AD) and in females (70-

80% of AD). Unchanged parent in males (11-20% of AD) and in 

females (37-47% of AD) was excreted almost entirely in the urine 

and only trace amounts were found in the feces. With the 

exception of the parent, the metabolite profile was similar between 

the urine and feces. The 2 primary metabolites in both urine and 

feces were Metabolite J (desmethyl parent, up to 26% of AD) and 

Metabolite K (5'hydroxy-pyrimidine of parent, up to 19% of AD). 

Other metabolites were Metabolites X, N, F, A and D, each up to 

8.2% of the AD in males and up to 4.7% of the AD in females. 

Several minor metabolites were also identified as Metabolite Q, 

Metabolite P, guanidine, CGA-382997 and CGA-368732 (each 

≤4.4% of the AD).

870.7485 Biliary Metabolism 

(rat)

MRID 45709101

In bile duct cannulated rats, absorption was 84-88% of the 

Administered Dose (AD) at 48 hours. Nearly all of the AD was 

excreted within 48 hours. Excretion in urine ranged from 58-76%, 

in bile from 5-27%, and in feces was about 6% of the AD. There 

was no evidence for an enterohepatic circulation. 

Biotransformation was similar to that in the conventional rat 

metabolism study. The metabolite profiles in urine, bile fluid and 

feces were all similar.

870.7800 Immunotoxicity (rat)

MRID 48857701

NOAEL= 4000 ppm (equivalent to 1066.6 mg/kg bw/day). 

LOAEL is not determined.

*The toxicity profile table has not been updated to the current version. 
Page 34 of 60

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 are subject to ethics review 

pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics 

requirements. For certain studies that 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:

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

http://www.epa.gov/pesticides/science/post-app-exposure-data.html.
Page 35 of 60

Appendix C. Occupational Non-cancer Algorithms

Occupational Non-cancer Handler Algorithms

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

E=UE * AR * A * 0.001 mg/ug

where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

AR = maximum application rate according to registered labels (lb ai/A), and

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

The daily doses are calculated using the following formula:

ADD= 

E * AF

BW

where:

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

E = exposure (mg ai/day),

AF = absorption factor (dermal 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/or inhalation doses 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:

MOE= 

POD

ADD

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 36 of 60

Occupational Non-cancer Post-application Algorithms

Potential daily exposures for occupational post-application workers are calculated using the 

following formulas:

DFRt=AR * F* (1-D)t

* �4.54E8 ug

lb� * �2.47E-8

A

cm2�

where:

DFRt = dislodgeable foliage residue on day "t" (μg/cm2

),

AR = application rate (lb ai/acre),

F = fraction of ai retained on foliage or 25% (unitless),

D = fraction of residue that dissipates daily or 10% (unitless), and

t = number of days after application day (days).

E=TC * DFR t

* ET * 0.001 mg

ug

where:

E = exposure (mg ai/day),

TC = transfer coefficient (cm2/hr),

DFRt = dislodgeable foliar residue on day “t” (μg/cm2), and

ET = exposure time (hours/day).

The daily doses are calculated using the following formula:

ADD= 

E * AF

BW

where:

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

E = exposure (mg ai/day),

AF = absorption factor (dermal), and

BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each 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 dose received by occupational post-application workers is compared to the 

appropriate POD (i.e., NOAEL) to assess the risk to occupational post-application workers. All 

MOE values are calculated using the following formula:

MOE= 

POD

ADD

where:
Page 37 of 60

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).

Appendix D. Nomenclature and Physical/Chemical Properties

TABLE D.1. Test Compound Nomenclature

Compound

Trifloxysulfuron-sodium

Chemical Structure

Common name Trifloxysulfuron-sodium

Company experimental name CGA-362622

IUPAC name Sodium (4,6-dimethoxypyrimidin-2-yl)({[3-(2,2,2-trifluoroethoxy)pyridin-2-

yl]sulfonyl}carbamoyl)azanide

CAS name N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(2,2,2-trifluoroethoxy)-2-

pyridinesulfonamide sodium salt

CAS Registry Number 199119-58-9 (sodium salt); 290332-10-4 (sodium salt monohydrate);

145099-21-4 (free sulfonylurea)

End-use product/EP Trifloxysulfuron 75% a.i., wettable granule formulation

Chemical Class Sulfonylurea

Known Impurities of Concern None

TABLE D.2. Physicochemical Properties

Parameter Value Reference

Molecular Weight Monosodium salt: 459 Daltons

Free acid: 437 Daltons

–

Melting point/range 173-175 C MRIDs 45371904 and 45371910

pH 7.85 (saturated solution) MRID 45371905

Density 1.63 g/cm3 at 21 C MRID 45371905

Water solubility (20 C) 63 mg/L at pH 5.06

5016 mg/L at pH 7.04

23.7 g/L at pH 7.71

38 g/L at pH 7.85

MRIDs 45371904 and 45371910
Page 38 of 60

TABLE D.2. Physicochemical Properties

Parameter Value Reference

Solvent solubility (temperature not specified) methanol 39 g/L

ethanol 5.6 g/L

isopropanol 0.8 g/L

acetonitrile 5 g/L

acetone 12.4 g/L

ethyl acetate 595 mg/L

MRIDs 45371904 and 45371910

Vapor pressure (25 C) <1 x 10-7 Pa MRIDs 45371904 and 45371910

Dissociation constant, pKa 4.76 (acidic) MRID 45371905

Octanol/water partition coefficient, logPOW

(25 C)

1.4 at pH 5.0

-0.42 at pH 7.0

-1.6 at pH 9.1

MRIDs 45371904 and 45371910

UV/visible absorption spectrum not provided —
Page 39 of 60

Appendix E. Residential Handler and Post-application Exposure Algorithms

Handler Dermal and Inhalation Exposure Algorithms

Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers, for a given 

formulation-application method combination, is estimated by multiplying the formulationapplication method-specific unit exposure by an estimate of the amount of active ingredient 

handled in a day, using the equation below:

E = UE * AR * A

where:

E = exposure (mg/day);

UE = unit exposure (mg/lb ai);

AR = application rate (e.g., lb ai/ft2, lb ai/gal or lb ai/A); and

A = area treated or amount handled (e.g., ft2

/day, gal/day or A/day).

Dermal and/or inhalation absorbed doses normalized to body weight are calculated as:

D = E *AF / BW

where:

D = dose (mg/kg-day);

E = exposure (mg/day);

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

BW = body weight (kg).

Post-application Dermal Exposure Algorithm – Physical Activities on Turf

Exposure resulting from contacting previously treated turf while performing physical activities is 

calculated as shown below. Residential post-application exposure assessment must include 

calculation of exposure on the day of application. Therefore, though an assessment can present 

exposures for any day “t” following the application, it must include “day 0” exposure.

E = TTRt * CF1 * TC * ET

where:

E = exposure (mg/day);

TTRt = turf transferable residue on day t (μg/cm2

);

CF1 = weight unit conversion factor (0.001 mg/μg);

TC = transfer coefficient (cm2

/hr); and

ET = exposure time (hr/day).
Page 40 of 60

If chemical-specific TTR data are available, then surface residues from the day of application 

should be used (assume that individuals could be exposed to residues immediately after 

application). However, if data are not available, then TTRt can be calculated using the following 

formula:

TTRt= AR * F * (1-FD)t * CF2 * CF3

where:

TTRt = turf transferable residue on day t (μg/cm2);

AR = application rate (lbs ai/ft2 or lb ai/acre);

F = fraction of ai as transferable residue following application (unitless);

FD = fraction of residue that dissipates daily (unitless);

t = post-application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 108 μg/lb); and

CF3 = area unit conversion factor (1.08 x 10-3 ft2/ cm2 or 2.47 x 10-8 acre/cm2).

Dermal absorbed doses are calculated as:

BW

E AF D* =

where:

D = dose (mg/kg-day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table E.1 Turf (Physical Activities) -- Inputs for Residential Post-application Dermal Exposure.

Algorithm Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) 0.026 lb ai/A

F

Fraction of AR as TTR 

following application (if 

chemical-specific data is 

unavailable)

L/WP/WDG 0.01

Granules 0.002

FD

Daily residue dissipation 

(if chemical-specific data 

is unavailable)

(fraction)

L/WP/WDG 0.1

Granules 0.1

TC

Transfer 

Coefficient 

(cm2

/hr)

L/WP/WDG

Adults 180,000

Children 1 < 2 years old 49,000

Granules

Adults 200,000

Children 1 < 2 years old 54,000

ET Exposure Time

(hours per day)

Adults 1.5

Children 1 < 2 years old 1.5

BW Body Weight

(kg)

Adults 80

Children 1 < 2 years old 11

L/WP/WDG = Liquids/Wettable Powders/Water-dispersible Granules
Page 41 of 60

Post-application Hand-to-Mouth Exposure Algorithm– Physical Activities on Turf

Exposure from hand-to-mouth activity is calculated as follows (based on the algorithm utilized in 

the SHEDS-Multimedia model):

E = [HR * (FM * SAH) * (ET * N_Replen) * (1- (1- SE)

(Freq_HtM/N-Replen))]

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm2);

FM = fraction hand surface area mouthed / event (fraction/event);

SAH = typical surface area of one hand (cm2);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SE = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_HtM = number of hand-to-mouth contacts events per hour (events/hour).

and

SA * 2

Fai *DE

HR

H

hands =

where:

HR = hand residue loading (mg/cm2);

Faihands = fraction ai on hands compared to total surface residue from dermal transfer coefficient 

study (unitless);

DE = dermal exposure (mg); and

SAH = typical surface area of one hand (cm2).

Dose, normalized to body weight, is calculated as:

BW

E D =

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).
Page 42 of 60

Table E.2. Turf (Physical Activities) – Inputs for Residential Post-application Incidental Oral Hand-toMouth Exposure. 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

Faihands

Fraction of ai on hands 

from dermal transfer 

coefficient study

(unitless)

Liquid formulations 0.06

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SAH

Typical surface area of one hand (cm2), children 1 < 

2 years old 150

AR Application rate

(mass active ingredient per unit area) 0.026 lb ai/A

HR Residue available on the hands (mg/cm2) Calculated via (DE * Faihands)/SAH

FM

Fraction hand surface area mouthed

(fraction/event) 0.127

N_Replen Replenishment intervals per hour

(intervals/hr) 4

ET Exposure time 

(hrs/day) 1.5

SE Saliva extraction factor

(unitless) 0.48

Freq_HtM Hand-to-mouth events per hour

(events/hr) 13.9

BW Body Weight

(kg)

Children 1 < 2 years 

old 11

Post-application Object-to-Mouth Exposure Algorithm– Physical Activities on Turf

Exposure from object-to-mouth activity is calculated as follows (based on the algorithm utilized 

in SHEDS-Multimedia):

E = [OR* CF1 * SAMO * (ET * N_Replen) * (1- (1- SEO)

(Freq_OtM/N_Replen))]

where:

E = exposure (mg/day);

OR = chemical residue loading on the object on day “t” (ug/cm2

);

CF1 = weight unit conversion factor (0.001 mg/μg);

SAMO = area of the object surface that is mouthed (cm2

/event);

ET = exposure time (hr/day);

N_Replen = number of replenishment intervals per hour (intervals/hour);

SEO = saliva extraction factor (i.e., mouthing removal efficiency); and

Freq_OtM = number of object-to-mouth contact events per hour (events/hour).

and

OR = AR * FO * CF2 * CF3

where:
Page 43 of 60

OR = chemical residue loading on the object (μg/cm2);

AR = application rate (lbs ai/ft2 or lb ai/acre);

FO = fraction of residue available on the object (unitless);

CF2 = weight unit conversion factor (4.54 x 108 μg/lb); and

CF3 = area unit conversion factor (1.08 x 10-3 ft2/cm2 or 2.47 x 10-8 acre/cm2).

Dose, normalized to body weight, is calculated as:

BW

E D =

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table E.3 Turf (Physical Activities) – Inputs for Residential Post-application Object-to-Mouth 

Exposure. 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

AR Application rate (to turf)

(mass active ingredient per unit area) 0.026 lb ai/A

FO Fraction of AR as OR following application 1 0.01

SAMO

Surface area of object mouthed 

(cm2/event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SEO

Saliva extraction factor

(fraction) 0.48

ET Exposure time 

(hours per day) 1.5

Freq_OtM Object-to-mouth events per hour (events/hr) 8.8

BW Body Weight (kg) Children 1 < 2 years old 11 1 This SOP assumes that all of the residue on the turf could be transferred to the object (e.g., object residue is 

equal to turf transferable residue).

Post-application Incidental Soil Ingestion Exposure Algorithm– Physical Activities on Turf

Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1

where:

E = exposure (mg/day);

SRt = soil residue on day "t" (μg/g);

SIgR = ingestion rate of soil (mg/day); and

CF1 = weight unit conversion factor (1 x 10-6 g/μg).

and
Page 44 of 60

SRt = AR * FS * (1-FD)

t * CF2 * CF3 * CF4

where:

SRt = soil residue on day "t" (μg/g);

AR = application rate (lbs ai/ft2 or lb ai/acre);

FS = fraction of ai available in uppermost cm of soil (fraction/cm);

FD = fraction of residue that dissipates daily (unitless);

T = post-application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 108 μg/lb);

CF3 = area unit conversion factor (1.08 x 10-3 ft2/cm2 or 2.47 x 10-8 acre/cm2); and

CF4 = soil volume to weight unit conversion factor (0.67 cm3

/g soil).

Dose, normalized to body weight, are calculated as:

BW

E D =

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table E.4 Turf (Physical Activities) – Inputs for Residential Post-application Incidental Soil Ingestion 

Exposure. 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) 0.026 lb ai/A

FS Fraction of AR available in uppermost 1 cm of soil

(unitless) 1

FD

Daily residue dissipation

(fraction) 0.1

SIgR Soil ingestion rate (mg/day) 50

BW Body weight (kg) Children 1 < 2 years old 11

Post-application Dermal Exposure Algorithm – Mowing

Exposure resulting from contacting previously treated turf while mowing is calculated as 

follows:

E = TTRt * CF1 * TC * ET

where:
Page 45 of 60

E = exposure (mg/day);

TTRt = turf transferable residue on day "t" (μg/cm2);

CF1 = weight unit conversion factor (0.001 mg/μg);

TC = transfer coefficient (cm2

/hr); and

ET = exposure time (hr/day).

and

TTRt = AR * FAR * (1-FD)

t * CF2 * CF3

where:

TTRt = turf transferable residue on day "t" (μg/cm2);

AR = application rate (lbs ai/ft2 or lb ai/acre);

FAR = fraction of ai retained on turf (unitless);

FD = fraction of residue that dissipates daily (unitless);

t = post-application day on which exposure is being assessed;

CF2= weight unit conversion factor (4.54 x 108 μg/lb); and

CF3 = area unit conversion factor (1.08 x 10-3 ft2

/cm2 or 2.47 x 10-8 acre/cm2).

Absorbed dose, normalized to body weight, are calculated as:

BW

E AF D

* =

where:

D = dose (mg/kg-day);

E = exposure (mg/day); 

AF = absorption factor (dermal); and

BW = body weight (kg).

Table E.5 Turf (Mowing) – Inputs for Residential Post-application Dermal Exposure. 

Algorithm Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

mass active ingredient per unit area 0.026 lb ai/A

FAR

Fraction of AR as 

TTR following 

application

L/WP/WDG 0.01

Granules 0.002

FD

Daily residue 

dissipation

L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient

(cm2

/hr)

Adult 5,500

Children 11 < 16 years 

old 4,500

ET Exposure time 

(hours per day) 1

BW Body Weight 

(kg)

Adults 80

Children 11 < 16 years 

old 57

L/WP/WDG = liquid/wettable powder/water dispersible granule
Page 46 of 60

Post-application Dermal Exposure Algorithm – Golfing

Exposure resulting from contacting previously treated turf while golfing is calculated as follows:

E = TTRt * CF1 * TC * ET

where:

E = exposure (mg/day); 

TTRt = turf transferable residue on day "t" (μg/cm2);

CF1 = weight unit conversion factor (0.001 mg/μg);

TC = transfer coefficient (cm2/hr); and

ET = exposure time (hr/day).

and

TTRt = AR * F * (1-FD)

t * CF2 * CF3

where:

TTRt = turf transferable residue on day "t" (μg/cm2

);

AR = application rate (lbs ai/ft2 or lb ai/acre);

F = fraction of ai retained on turf (unitless);’

FD = fraction of residue that dissipates daily (unitless);

t = post-application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 108 μg/lb); and

CF3 = area unit conversion factor (1.08 x 10-3 ft2

/cm2 or 2.47 x 10-8 acre/cm2).

Absorbed dose, normalized to body weight, is calculated as:

BW

E AF D* =

where:

D = dose (mg/kg-day);

E = exposure (mg/day); 

AF = absorption factor (dermal); and

BW = body weight (kg).

Table E.6 Turf (Golfing) – Inputs for Residential Post-application Dermal Exposure. 

Algorithm 

Notation

Exposure Factor

(units)

Point Estimate(s)

AR Application rate

(mass active ingredient per unit area)

0.026 lb ai/A

F L/WP/WDG 0.01
Page 47 of 60

Fraction of AR as TTR 

following application

Granules 0.002

FD Daily residue dissipation L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient

(cm2/hr)

Adult 5,300

Children 11 < 16 years old 4,400

Children 6 < 11 years old 2,900

ET Exposure time

(hours per day)

Pesticides used on greens, tees, 

and fairways 

4

Pesticides used only on greens 

and tees

1

BW Body Weight

(kg)

Adults 80

Children 11 < 16 years old 57

Children 6 < 11 years old 32

NA = not applicable

L/WP/WDG = liquid/wettable powder/water dispersible granule
Page 48 of 60

Appendix F. Dietary Exposure/Risk Modeling Input and Output

Filename: Trifloxysulfuron.R08

Chemical: Trifloxysulfuron

RfD(Chronic): .237 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 6 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 04-08-2015/11:18:30 Program ver. 3.16, 03-08-d

Comment: Acute for females 13-49 is 0.5 mg/day

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

0801375000 8A Tomato 0.010000 1.000 1.000 

0801375001 8A Tomato-babyfood 0.010000 1.000 1.000 

0801376000 8A Tomato, paste 0.010000 1.000 1.000 

0801376001 8A Tomato, paste-babyfood 0.010000 1.000 1.000 

0801377000 8A Tomato, puree 0.010000 1.000 1.000 

0801377001 8A Tomato, puree-babyfood 0.010000 1.000 1.000 

0801378000 8A Tomato, dried 0.010000 14.300 1.000 

0801378001 8A Tomato, dried-babyfood 0.010000 14.300 1.000 

0801379000 8A Tomato, juice 0.010000 1.000 1.000 

1001106000 10A Citron 0.030000 1.000 1.000 

1001107000 10A Citrus hybrids 0.030000 1.000 1.000 

1001108000 10A Citrus, oil 0.030000 1.000 1.000 

1001240000 10A Orange 0.030000 1.000 1.000 

1001241000 10A Orange, juice 0.030000 1.000 1.000 

1001241001 10A Orange, juice-babyfood 0.030000 1.000 1.000 

1001242000 10A Orange, peel 0.030000 1.000 1.000 

1001369000 10A Tangerine 0.030000 1.000 1.000 

1001370000 10A Tangerine, juice 0.030000 1.000 1.000 

1002197000 10B Kumquat 0.030000 1.000 1.000 

1002199000 10B Lemon 0.030000 1.000 1.000 

1002200000 10B Lemon, juice 0.030000 1.000 1.000 

1002200001 10B Lemon, juice-babyfood 0.030000 1.000 1.000 

1002201000 10B Lemon, peel 0.030000 1.000 1.000 

1002206000 10B Lime 0.030000 1.000 1.000 

1002207000 10B Lime, juice 0.030000 1.000 1.000 

1002207001 10B Lime, juice-babyfood 0.030000 1.000 1.000 

1003180000 10C Grapefruit 0.030000 1.000 1.000 

1003181000 10C Grapefruit, juice 0.030000 1.000 1.000 

1003307000 10C Pummelo 0.030000 1.000 1.000 

1400003000 14 Almond 0.020000 1.000 1.000 

1400003001 14 Almond-babyfood 0.020000 1.000 1.000 

1400004000 14 Almond, oil 0.020000 1.000 1.000 

1400004001 14 Almond, oil-babyfood 0.020000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.050000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.050000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.751000 1.000 0.655 Fact. 2 = 492 / 751 

(chronic/acute H2O)

8602000000 86B Water, indirect, all sources 0.751000 1.000 0.655 Fact. 2 = 492 / 751 

(chronic/acute H2O)

9500362000 O Sugarcane, sugar 0.010000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.010000 1.000 1.000 

9500363000 O Sugarcane, molasses 0.010000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 0.010000 1.000 1.000 
Page 49 of 60

US EPA Ver. 3.16, 03-08-d

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

Residue file name: C:\Users\mdoherty\OneDrive - Environmental Protection Agency (EPA) 1\Chemistry 

Reviews\!DEEM Runs\2015 SU Assessments\Trifloxysulfuron.R08

 Adjustment factor #2 used.

Analysis Date 04-08-2015/11:48:32 Residue file dated: 04-08-2015/11:18:30

Reference dose (RfD, Chronic) = .237 mg/kg bw/day

COMMENT 1: Acute for females 13-49 is 0.5 mg/day

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.010353 4.4%

Hispanic 0.009911 4.2%

Non-Hisp-White 0.010640 4.5%

Non-Hisp-Black 0.008561 3.6%

Non-Hisp-Other 0.011928 5.0%

Nursing Infants 0.009336 3.9%

Non-Nursing Infants 0.034293 14.5%

Female 13+ PREG 0.009765 4.1%

Children 1-6 0.013347 5.6%

Children 7-12 0.008658 3.7%

Male 13-19 0.007134 3.0%

Female 13-19/NP 0.007978 3.4%

Male 20+ 0.009636 4.1%

Female 20+/NP 0.010857 4.6%

Seniors 55+ 0.009998 4.2%

All Infants 0.026588 11.2%

Female 13-50 0.010291 4.3%

Children 1-2 0.015034 6.3%

Children 3-5 0.012672 5.3%

Children 6-12 0.009106 3.8%

Youth 13-19 0.007560 3.2%

Adults 20-49 0.010316 4.4%

Adults 50-99 0.010199 4.3%

Female 13-49 0.010279 4.3%

-------------------------------------------------------------------------------
Page 50 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population:

 0.041062 0.68 0.067522 1.13 0.128636 2.14 

All Infants:

 0.128571 2.14 0.173767 2.90 0.256016 4.27 

Children 1-2:

 0.063074 1.05 0.096587 1.61 0.233457 3.89 

Children 3-5:

 0.051722 0.86 0.078725 1.31 0.126255 2.10 

Children 6-12:

 0.039145 0.65 0.064162 1.07 0.098893 1.65 

Youth 13-19:

 0.034193 0.57 0.056306 0.94 0.084884 1.41 

Adults 20-49:

 0.040398 0.67 0.059987 1.00 0.087093 1.45 

Adults 50-99:

 0.036019 0.60 0.054385 0.91 0.085726 1.43 

Female 13-49:

 0.041010 8.20 0.060124 12.02 0.084493 16.90 
Page 51 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Summary calculations--users:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population:

 0.041105 0.69 0.067575 1.13 0.128745 2.15 

All Infants:

 0.134344 2.24 0.190219 3.17 0.256613 4.28 

Children 1-2:

 0.063090 1.05 0.096591 1.61 0.233462 3.89 

Children 3-5:

 0.051722 0.86 0.078725 1.31 0.126255 2.10 

Children 6-12:

 0.039149 0.65 0.064164 1.07 0.098894 1.65 

Youth 13-19:

 0.034198 0.57 0.056307 0.94 0.084884 1.41 

Adults 20-49:

 0.040401 0.67 0.059989 1.00 0.087094 1.45 

Adults 50-99:

 0.036024 0.60 0.054388 0.91 0.085728 1.43 

Female 13-49:

 0.041014 8.20 0.060125 12.03 0.084494 16.90 
Page 52 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Reference Dose (aRfD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Total US Population Daily Exposure Analysis /a

------------------- (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.015777 0.015828

 Standard Deviation 0.014377 0.014372

 Standard Error of mean 0.000065 0.000065

 Percent of aRfD 0.26 0.26

 Percent of Person-Days that are User-Days = 99.68%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aRfD Percentile Exposure % aRfD 

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

 10.00 0.002490 0.04 90.00 0.031674 0.53

 20.00 0.005236 0.09 95.00 0.041105 0.69

 30.00 0.007649 0.13 97.50 0.051808 0.86

 40.00 0.010032 0.17 99.00 0.067575 1.13

 50.00 0.012627 0.21 99.50 0.082498 1.37

 60.00 0.015568 0.26 99.75 0.097767 1.63

 70.00 0.018978 0.32 99.90 0.128745 2.15

 80.00 0.023510 0.39

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aRfD Percentile Exposure % aRfD 

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

 10.00 0.002387 0.04 90.00 0.031628 0.53

 20.00 0.005168 0.09 95.00 0.041062 0.68

 30.00 0.007587 0.13 97.50 0.051762 0.86

 40.00 0.009986 0.17 99.00 0.067522 1.13

 50.00 0.012587 0.21 99.50 0.082342 1.37

 60.00 0.015521 0.26 99.75 0.097674 1.63

 70.00 0.018943 0.32 99.90 0.128636 2.14

 80.00 0.023474 0.39

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

a/ Analysis based on all two-day participant records in NHANES 2003-2008 2-Day

 with 2 days of valid drinking water records.
Page 53 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

All Infants Daily Exposure Analysis 

----------- (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.040585 0.050789

 Standard Deviation 0.045110 0.045037

 Standard Error of mean 0.000903 0.000999

 Percent of aPAD 0.68 0.85

 Percent of Person-Days that are User-Days = 79.91%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.002586 0.04 90.00 0.111925 1.87

 20.00 0.007382 0.12 95.00 0.134344 2.24

 30.00 0.014779 0.25 97.50 0.150058 2.50

 40.00 0.025914 0.43 99.00 0.190219 3.17

 50.00 0.043279 0.72 99.50 0.200298 3.34

 60.00 0.059011 0.98 99.75 0.234448 3.91

 70.00 0.070763 1.18 99.90 0.256613 4.28

 80.00 0.088840 1.48

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.000000 0.00 90.00 0.103623 1.73

 20.00 0.000000 0.00 95.00 0.128571 2.14

 30.00 0.004138 0.07 97.50 0.146751 2.45

 40.00 0.010554 0.18 99.00 0.173767 2.90

 50.00 0.022648 0.38 99.50 0.199192 3.32

 60.00 0.043186 0.72 99.75 0.230915 3.85

 70.00 0.062715 1.05 99.90 0.256016 4.27

 80.00 0.078798 1.31
Page 54 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Children 1-2 Daily Exposure Analysis 

------------ (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.022868 0.022886

 Standard Deviation 0.022350 0.022350

 Standard Error of mean 0.000408 0.000409

 Percent of aPAD 0.38 0.38

 Percent of Person-Days that are User-Days = 99.92%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.002414 0.04 90.00 0.048685 0.81

 20.00 0.006550 0.11 95.00 0.063090 1.05

 30.00 0.010060 0.17 97.50 0.078365 1.31

 40.00 0.013593 0.23 99.00 0.096591 1.61

 50.00 0.017223 0.29 99.50 0.133511 2.23

 60.00 0.021482 0.36 99.75 0.144754 2.41

 70.00 0.026836 0.45 99.90 0.233462 3.89

 80.00 0.035287 0.59

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.002371 0.04 90.00 0.048673 0.81

 20.00 0.006523 0.11 95.00 0.063074 1.05

 30.00 0.010044 0.17 97.50 0.078343 1.31

 40.00 0.013576 0.23 99.00 0.096587 1.61

 50.00 0.017210 0.29 99.50 0.133503 2.23

 60.00 0.021471 0.36 99.75 0.144730 2.41

 70.00 0.026827 0.45 99.90 0.233457 3.89

 80.00 0.035268 0.59
Page 55 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Children 3-5 Daily Exposure Analysis

------------ (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.019257 0.019257

 Standard Deviation 0.017391 0.017391

 Standard Error of mean 0.000328 0.000328

 Percent of aPAD 0.32 0.32

 Percent of Person-Days that are User-Days = 100.00%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.001958 0.03 90.00 0.040578 0.68

 20.00 0.006079 0.10 95.00 0.051722 0.86

 30.00 0.008917 0.15 97.50 0.061873 1.03

 40.00 0.011993 0.20 99.00 0.078725 1.31

 50.00 0.015312 0.26 99.50 0.092892 1.55

 60.00 0.018932 0.32 99.75 0.103337 1.72

 70.00 0.023132 0.39 99.90 0.126255 2.10

 80.00 0.029475 0.49

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.001958 0.03 90.00 0.040578 0.68

 20.00 0.006079 0.10 95.00 0.051722 0.86

 30.00 0.008917 0.15 97.50 0.061873 1.03

 40.00 0.011993 0.20 99.00 0.078725 1.31

 50.00 0.015312 0.26 99.50 0.092892 1.55

 60.00 0.018932 0.32 99.75 0.103337 1.72

 70.00 0.023132 0.39 99.90 0.126255 2.10

 80.00 0.029475 0.49
Page 56 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Children 6-12 Daily Exposure Analysis 

------------- (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.013857 0.013860

 Standard Deviation 0.013193 0.013192

 Standard Error of mean 0.000163 0.000163

 Percent of aPAD 0.23 0.23

 Percent of Person-Days that are User-Days = 99.98%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.001418 0.02 90.00 0.028697 0.48

 20.00 0.003864 0.06 95.00 0.039149 0.65

 30.00 0.005933 0.10 97.50 0.049627 0.83

 40.00 0.008200 0.14 99.00 0.064164 1.07

 50.00 0.010595 0.18 99.50 0.076261 1.27

 60.00 0.013366 0.22 99.75 0.087487 1.46

 70.00 0.016917 0.28 99.90 0.098894 1.65

 80.00 0.021430 0.36

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.001412 0.02 90.00 0.028696 0.48

 20.00 0.003859 0.06 95.00 0.039145 0.65

 30.00 0.005930 0.10 97.50 0.049624 0.83

 40.00 0.008197 0.14 99.00 0.064162 1.07

 50.00 0.010592 0.18 99.50 0.076260 1.27

 60.00 0.013364 0.22 99.75 0.087482 1.46

 70.00 0.016915 0.28 99.90 0.098893 1.65

 80.00 0.021429 0.36
Page 57 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Youth 13-19 Daily Exposure Analysis 

----------- (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.011516 0.011518

 Standard Deviation 0.011752 0.011752

 Standard Error of mean 0.000127 0.000127

 Percent of aPAD 0.19 0.19

 Percent of Person-Days that are User-Days = 99.98%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.000477 0.01 90.00 0.025094 0.42

 20.00 0.002757 0.05 95.00 0.034198 0.57

 30.00 0.004594 0.08 97.50 0.044083 0.73

 40.00 0.006302 0.11 99.00 0.056307 0.94

 50.00 0.008284 0.14 99.50 0.067405 1.12

 60.00 0.010763 0.18 99.75 0.078826 1.31

 70.00 0.013688 0.23 99.90 0.084884 1.41

 80.00 0.017934 0.30

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.000474 0.01 90.00 0.025091 0.42

 20.00 0.002752 0.05 95.00 0.034193 0.57

 30.00 0.004592 0.08 97.50 0.044081 0.73

 40.00 0.006300 0.11 99.00 0.056306 0.94

 50.00 0.008281 0.14 99.50 0.067399 1.12

 60.00 0.010760 0.18 99.75 0.078826 1.31

 70.00 0.013684 0.23 99.90 0.084884 1.41

 80.00 0.017933 0.30
Page 58 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Adults 20-49 Daily Exposure Analysis 

------------ (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.015728 0.015732

 Standard Deviation 0.012902 0.012901

 Standard Error of mean 0.000113 0.000113

 Percent of aPAD 0.26 0.26

 Percent of Person-Days that are User-Days = 99.97%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.002338 0.04 90.00 0.032065 0.53

 20.00 0.005269 0.09 95.00 0.040401 0.67

 30.00 0.007788 0.13 97.50 0.048772 0.81

 40.00 0.010279 0.17 99.00 0.059989 1.00

 50.00 0.012968 0.22 99.50 0.068484 1.14

 60.00 0.015962 0.27 99.75 0.076056 1.27

 70.00 0.019440 0.32 99.90 0.087094 1.45

 80.00 0.024006 0.40

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.002331 0.04 90.00 0.032062 0.53

 20.00 0.005264 0.09 95.00 0.040398 0.67

 30.00 0.007782 0.13 97.50 0.048770 0.81

 40.00 0.010275 0.17 99.00 0.059987 1.00

 50.00 0.012963 0.22 99.50 0.068478 1.14

 60.00 0.015959 0.27 99.75 0.076053 1.27

 70.00 0.019437 0.32 99.90 0.087093 1.45

 80.00 0.024002 0.40
Page 59 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 6.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Adults 50-99 Daily Exposure Analysis 

------------ (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.015549 0.015555

 Standard Deviation 0.011128 0.011126

 Standard Error of mean 0.000099 0.000099

 Percent of aPAD 0.26 0.26

 Percent of Person-Days that are User-Days = 99.96%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.004167 0.07 90.00 0.028910 0.48

 20.00 0.006644 0.11 95.00 0.036024 0.60

 30.00 0.008846 0.15 97.50 0.043021 0.72

 40.00 0.011020 0.18 99.00 0.054388 0.91

 50.00 0.013337 0.22 99.50 0.062640 1.04

 60.00 0.015983 0.27 99.75 0.071559 1.19

 70.00 0.018863 0.31 99.90 0.085728 1.43

 80.00 0.022789 0.38

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.004158 0.07 90.00 0.028907 0.48

 20.00 0.006637 0.11 95.00 0.036019 0.60

 30.00 0.008841 0.15 97.50 0.043015 0.72

 40.00 0.011016 0.18 99.00 0.054385 0.91

 50.00 0.013333 0.22 99.50 0.062636 1.04

 60.00 0.015978 0.27 99.75 0.071553 1.19

 70.00 0.018859 0.31 99.90 0.085726 1.43

 80.00 0.022786 0.38
Page 60 of 60

US EPA Ver. 3.18, 03-08-d

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

Residue file: Trifloxysulfuron.R08 Adjustment factor #2 NOT used.

Analysis Date: 04-08-2015/11:57:08 Residue file dated: 04-08-2015/11:18:30

Acute Pop Adjusted Dose (aPAD) = 0.500000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: "Acute for females 13-49 is 0.5 mg/day"

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

Female 13-49 Daily Exposure Analysis 

------------ (mg/kg body-weight/day) 

 per Capita per User 

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

 Mean 0.015671 0.015674

 Standard Deviation 0.013166 0.013166

 Standard Error of mean 0.000123 0.000124

 Percent of aPAD 3.13 3.13

 Percent of Person-Days that are User-Days = 99.98%

 Estimated percentile of user-days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.001987 0.40 90.00 0.032713 6.54

 20.00 0.004903 0.98 95.00 0.041014 8.20

 30.00 0.007329 1.47 97.50 0.049542 9.91

 40.00 0.010000 2.00 99.00 0.060125 12.03

 50.00 0.012841 2.57 99.50 0.066986 13.40

 60.00 0.015862 3.17 99.75 0.072630 14.53

 70.00 0.019495 3.90 99.90 0.084494 16.90

 80.00 0.024258 4.85

 Estimated percentile of per-capita days falling below calculated exposure

 in mg/kg body-wt/day with Percent of aPAD

Percentile Exposure % aPAD Percentile Exposure % aPAD 

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

 10.00 0.001980 0.40 90.00 0.032711 6.54

 20.00 0.004899 0.98 95.00 0.041010 8.20

 30.00 0.007325 1.47 97.50 0.049540 9.91

 40.00 0.009997 2.00 99.00 0.060124 12.02

 50.00 0.012838 2.57 99.50 0.066985 13.40

 60.00 0.015859 3.17 99.75 0.072598 14.52

 70.00 0.019492 3.90 99.90 0.084493 16.90

 80.00 0.024257 4.85