### UNITED ST A TES ENVIRONMENT AL P R OTECT I ON AGENCY

WAS H rNGTON, D

. C. 20460

MEMORA N D U M



### D ate: September 15, 20 1 5 OFF I CE OF

C H EM I C A L S AF E TY AN O

POLL U T I O N PR E V EN T I O N



### S UBJE C T: Tr ifl ox ys u l furon

- So diu m. Draft Human Hea lt h R isk Assessment in Support of Regist r ation Review

.

P C C od e: I 19009 DP Barcod e: 0427105

D e c i s i o n N o

. : 503928 R e g i s t r a tion N o .: NA

P e tition N o .: NA R eg ul a tory A ct i o n : Registrat i on Rev i ew Ri s k As s e ss me n t T y p e: S i ng l e Che m ical Ca s e No

. : 7028 Agg r egate C A S N o s

. : 199119-58-9

, 290332-10-4, 145099-

TXR No

. : NA 2 1 -4

MRID N o .: NA 40 CF R : § 

### 180.591

.



### FROM: Karlyn Middleton

, M.S.

, Risk Assessorffoxicologist 

# f**~** Zai d a Figueroa, D rPH, In d u st ri a l H yg i enist

# ~**~~** Michael A. Doherty, Ph.D., Chemis t

### i)~**J~ ~**  R i sk Assessment Br anch 1I

Health Effects Division (7509P)



### THRO UG H: Christina Swartz

, Branch Chief

# ~ Ris k Assessment B r anc h II

Health Effects D ivision (7509P)



### TO: Kelly Ballard

, Chemical Review Manager

Ne il Ande r so n
, B r anch C hi ef

Risk Management and I mplementation Branch I (RMIB 

### I)

Pesticide Re-Eva l uatio n Di v i sion (7508P)

As pa 1 1 of registrat i o n r eview, HE D has exam in ed the tox i co l og i cal and exposure databases for assessing human health risks associated with trifloxysulfuron-sodium and cond u cted a n ew r i sk

assessment following curre n t p ractices and po li c i es. Sign i ficant c h anges relative to t h e last r i sk

assessment (D352260

, M. Doherty

, 2008) include:

I) The inhala t ion toxic i ty study requi r eme n t h as been waived. 2) The exposure assessme nt s have been upda t ed to incorporate new science policies. 3) A high-end drinking water exposure va l ue was used to assess sc r eening- l eve l dieta r y

expos u re / r isk est i mates. 4) HED considered all the exposu r e and toxic i ty information and determined that chemica l

specific DFR and TTR data are not requ i red 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 R isk 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 Append ix 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 gras s. It acts by inhibiting the plant enzyme acetolactate synthase, resulting in reduced production of

branched

- chain amino acids.

A human health s coping document was conducted for trifloxysulfuron

- sodium in 2013 ( D408404, E

. Holman ) ; an inhalation toxicity study was identified as a data gap

. Howev er, 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

- s odium 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 asse ssments. 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 a cute population adjusted dose (a PAD ) and from 3 to 11%

of the chronic populat ion 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, t he tur f post

- application risk estimates are protective for any potential exposures related to spray drift for trifloxysulfuron

- sodium.

For trifloxysulfuron

, acute and chronic aggregate exposure s r esults from residues in food and drinking water alone and are equivalent to the acute and chronic dietary risk assessment

. Short

and 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, 9 00 for children and 3, 6 00 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 p ost

- application dermal exposure and risk estimates res ulted 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

- appl ication exposures.

Based on the Agency's current practices, a quantitative non

- cancer occupational post

- application inhalation exposure assessment was not performed for trifloxysulfuron

- s odium . 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

- s odium

.

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

sodium. There are no dat a 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 La bel C onsiderations

There are no label recommendations associated with trifloxysulfuron

- sodium for registered products containing that active ing redient

.

### 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 comp ound’ 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 a gricultural food/feed crops, including almonds, citrus, cotton (picker variety only), sugarcane and tomatoes. Non

agricultural uses include sports fields and residential turf grass. The primary registered end

- use product (EP) is a 75% wettable granule (W G) 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 i ntermediate

- term ( i.e., 1 to 6 months) ; long

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

statement s on registered labels require applicators and other handler s 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, t here 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 trif loxysulfuron

- 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 insecti cides 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 (pre

transplant);

Ground Equip. 0.007 lb

ai/A 1 (+ 1 post

emergence) 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 pre

emergence) 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/eo1 2898.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. Ad ditionally, 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 a ssociated 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 develop ment 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 trifloxysulfur on

- 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 ( D 352260 , M. Doherty ) 

### . The endpoin ts/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 s everal 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 th e 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 w ith 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 i n 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 A D 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 t he 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 no t 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 rabbi t 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) p resented

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 fo r 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 Non

Occupational 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 UF A = 10x

UF H =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 UF A = 10x

UF H =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 UF A = 10x

UF H =10x FQPA SF=1x

Total UF=100x Chronic RfD =0.237mg/kg/day

cPAD

= 0.237mg/kg/day Combined Chronic/Carcinogenicity

Rat LOAEL = 99.3 mg/kg/day based on increased tubular atrophy in the kidneys of females.

Incidental

oral

- Short

Term (1

- 30 days)

Intermediate

Term (1

- 6

months Offspring

NOAEL = 79 mg/kg/day UF A = 10x

UF H =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 spl een weight, thymus weight and increased vaginal patency.

Children’s

Dermal

Short

- Term (1

- 30 days)

Intermediate

Term (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

w as seen in the developmental rabbit study. The effects in the study were seen in fetuses, which is not applicable to this population.

Adult

Dermal

Short

- Term (1

- 30 days)

Intermediate

Term (1

- 6

months Oral study

NOAEL= 50 mg/kg/day

DAF=30 %* UF A =10x

UF H =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)

Intermediate

Term (1

- 6

months Oral study

NOAEL= 50 mg/kg/day UF A =10x

UF H =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 (or al, 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. UF A = extrapolation from animal to human (interspecies). UF H = 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 d ose. 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 extrapolation s. 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

Dermal

Short

- Term (1

- 30 days)

Intermediate

- Term (1

- 6

months Oral study

NOAEL= 50 mg/kg/day

DAF=30 %* UF A =10x

UF H =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 UF A =10x

UF H =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. UF A = extrapolation from animal to human (interspecies). UF H = 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 Pr ogram

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, sex ual 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 FFDC A 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

det erminations. 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 an y 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 Febr uary 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, 2013 1 

### and inclu des 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 proced ures, 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 estima tes 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 ass essment procedures, EFED provided coarse

screen 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://w ww.epa.gov/endo/

### Page 12 of 60 The acut e 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 Sulfonylureas 1

.

Modeled Scenario K d or K OC Initial Application Dates (days post

emergence) Max. Daily Conc. (μg/L) Mean Breakthrough

Time (yrs) Post

breakthrough Mean (μg/L)

WI corn K d 7 449 11.5 415

K OC 7 504 6.9 425

DMV corn K d 7 489 5.3 369

K OC 7 560 3.3 378

FL citrus K d 7 429 3.2 351

K OC 7 467 2.3 349

FL potato K d 7 375 2.6 272

K OC 7 407 2.2 275

GA peanut K d 7 197 5.2 156

K OC 7 206 3.9 158

NC cotton K d 7 640 8.7 492

K d 37 641 8.7 491

K d 67 637 8.7 490

K OC 7 742 5.7 484

K OC 37 751 5.7 483

K OC 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 es timates 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 f oods, 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 exposur e 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 asses sment are included in Appendix F

.

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

- sodium.

Acute Estimates (95 th 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 SOPs 3 

### 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. Resid ential 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, trif loxysulfuron

- 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 develo ped

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 d escription.

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 SOPs 4



### .

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 expos ure 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 i n Appendix E and/or the 2012 Residential SOPs 5



### .

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 Exposure a (mg/lb ai) Inhalation

Unit Exposure a (mg/lb ai) Application

Rate b Amount

Treated c Dermal

Dose d (mg/kg/day) Dermal

MOE e (mg/kg/day) Inhalation

Dose f (mg/kg/day) Inhalation

MOE g Total MOE h

Mixer/Loader/Applicator ( Turf , Ornamentals) Dry Flowable for Backpack Sprayer Applications 69 1.1 0.0004 lb ai/gal 5 gal 0.0005 6 83 ,000 0.0000 32 1, 6 00,000 79 ,000

Dry Flowable for Manually

pressurized

Handwand Applications 69 1.1 0.0004 lb ai/gal 5 gal 0.0005 6 83 ,000 0.0000 32 1, 6 00,000 79 ,000

Dry Flowable

for Hose

- end Sprayer Applications 13.4 0.022 0.026 lb ai/A 0.5 A 0.000 76 66 ,000 0.00000 41 1 2 ,000,000 6 6,000

Dry Flowable for Sprinkler

Can Applications 13.4 0.022 0.0000006 lb

ai/ft 2 1,000 ft 2 0.00003 5 1, 4 00,000 0.0000001 9 26 0,000,000 1, 4 00,000

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 ex posed 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 inc lude 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 post

application 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

pres ented 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

- a pplication 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 e stimated residential turf post

application 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 unlikel y 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

- Can cer 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 Rate 1 

### Dose (mg/kg/day) 2 

### MOEs 3 

### Combined

MOEs Use Site Route of Exposure

Adult High

- Contact

Lawn

Activities

(Turf) Dermal 0.026 lb ai/A 0.003 39 1 5 ,000

N/A

Mowing Turf 0.0000 6 9 72 0,000 Golfing 0.0002 66 19 0,000

Child (1<2 years old) Turf Oral (Hand

- to

Mouth)

0.026 lb ai/A 0.0004 200,000

N/A Oral (Object

- to

- Mouth) 0.00001 2 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 a pplications 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 MOE 2

Dermal Inhalation Oral Total Dermal Inhalation Oral Total

Adult Turf 0.003 39 0.000032 N/A 0.003 4 1 5 ,000 1,600,000 N/A 1 5 ,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. Spray s that are released and do not deposit in the application area end up off

target 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., chi ldren 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 ap proach 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 regu latory 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 resid ential 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

exposur e 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

residenti al 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 degr ee 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 quantitativ e 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 ap plication 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 ra te for Spray Drift Ass essment = 0. 028 lb ai/A x 0.26 = 0.0073 lb ai/A ≤ 0. 026 lb ai/A.

### Page 19 of 60 6.5 Residenti al 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 volatiliza tion 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

a gency 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 di rects 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 r esults 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
risk s are not of c oncern

.

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 see n in the rat reproduction study with a NOAEL of 79 mg/kg/day

. The adult short

- and intermediate

- term dermal and inhalation endpoint s are based on an increased incidence of abnormally shaped hearts in fetuses seen in the rat developmental study with a NOAE L 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 i nhalation 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 2 0 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, 9 00 for

children and 3, 6 00 for adult s . 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 LOC 1 Max

Allowable Exposure 2 mg/kg/day Average

Food and

Water Exposure mg/kg/day Residential Exposure mg/kg/day 3 Total Exposure mg/kg/day 4 Aggregate MOE (food, water, and residential) 5

Dermal and Inhalation

Adult 50 100 0.5 0.0103 0.003 4 0.013 7 3, 6 00

Incidental Oral

Child 79 100 0.79 0.0266 0.0004 0.027 2

, 9 00

1 L evel of C oncern (LOC) based on the standard inter

- and intra

- species uncertainty factors totaling 100 X.

2 Maximum Allowable Exposure (mg/kg/day) = NOAEL/LOC

. 3 Residential Exposure = D ermal exposure of 0.003 39 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 y ea rs 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 Exposur e/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

- screening

analysis.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 availa ble 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 h ypothesis 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 Pe sticide 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 depar ture 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 ora l route of exposure. A dermal absorption factor (DAF) of 30% was us ed 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 protect ion 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 Table 10 

### .” HE D policy on use of surrogate data, including descriptions of the various sources, can be found at the Agency website 11



### .

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 equi pment 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., b aseline 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

Rate c Area

Treated

or Amount

Handled d Dermal

Dose e Dermal

MOE f Inhalation

Dose g Inhalation

MOE h Tota

MOE

Mixer/Loader Dry Flowable (Dispersible Granule)

for Groundboom Application 227 (Baseline) 8.96 (No respirator) 0.028 lb ai/A 200 A 0.00 552 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 0.001 1 0 4 5 ,000 0.00014 5 3 4 0,000 4 0 ,00

Applicator Sprays for

Groundboom Application 78.6 (Baseline) 0.34 (Baseline) 0.028 lb ai/A 200 A 0.001 91 26 ,000 0.00002 75 1

, 8 00,000 26 ,00

Sprays for Airblast Application 1,770 (Baseline) 4.71 (Baseline) 0.028 lb ai/A 40 A 0.00 861 5,800 0.0000 765 650 ,000 5,700

Mixer/Loader/Applicator Sprays for Backpack Sprayer 13,200 (Baseline) 140 (No respirator) 0.0004 lb ai/gal 40 gal 0.000 92 55 ,000 0.0000 33 1, 5 00,000 53 ,00

Sprays Manually

pressurized Handwand Sprayer 100,000 (Baseline) 30 (No respirator) 0.0004 lb ai/gal 40 gal 0.006 96 7,200 0.000006 9 7

, 2 00,000 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

Rate c Area

Treated

or Amount

Handled d Dermal

Dose e Dermal

MOE f Inhalation

Dose g Inhalation

MOE h Tota

MOE

Sprays for Mechanically

pressurized Handgun 3,500 (Baseline) 120 (No respirator) 0.028 lb ai/A 1,000 gal 0.00 609 8,200 0.0006 96 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 max imum 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 Absor ption 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 re

entry exposure). Such exposures may occur when workers enter previously treated areas to perform job fun ctions, 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 ty pe 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

- applicatio n 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 pestic ides 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

Vola tilization 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.

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 w ill 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 ser ved 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 post

application 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 considere d 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 post

application 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 3 12 

### ” which, along with additional information about the ARTF data, can be found at the Agency website 13 

### . Table 9.2.2.1 provides a summary of the anticipated post

application 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

(cm 2 /hr ) Activities

Almond Tree, “nuts” High Full 580 Scouting

Ornamentals Nursery, Non

bearing 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

- specifi c dislodgeable foliar residue data have not been submitted for trifloxysulfuron

- sodium during registration review. T herefore, t his assessment uses HED’s default assumption that 25% of the application is available for transfer on day 0 following the applic ation 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 an d 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 scenari os 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 recre ational 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 d efault 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 re quirement. 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 trif loxysulfuron

- 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. Post

application 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 (cm 2 /hr) DFR 1 Dermal Dose (mg/kg/day) 2 MOE 3

Short

- and Intermediate

- term

Almonds Scouting 580 0.08 0.00 2 3 2 ,000

Ornamentals Irrigation (Hand set) 1,900 0.08 0.00 5 9,600

Citrus, Orange Hand Harvesting 1,400 0.08 0.00 4 1 3 ,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 (cm 2 /hr) DFR 1 Dermal Dose (mg/kg/day) 2 MOE 3

Short

- and Intermediate

- term

Sod, Turf Maintenance, Harvesting, Slab,

Transplanting, Planting 6,700 0.08 0.01 8 2,700

Sugarcane Hand Harvesting 8,800 0.08 0.02 4 2, 1 00

Tomato Irrigation (Hand set) 1,900 0.08 0.00 5 9,600

1. DFR (default approach) = Application Rate × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

- 8 acre/cm 2 ; where F = 0.25 and D = 0.10 per day.

2. Daily Dermal Dose = [DFR (μg/cm 2 ) × 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 TC 1 (g cotton/hr) Days After

Treatment Residue

from Cotton

Field Trial 2 (mg ai/g cotton) Daily Dose (mg/kg/d) 3 Dermal

MOE 4

Short

- and Intermediate

- term

Cotton 0.019 Harvesting

Mechanical (Module Builder) 900

60 0. 00 1 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 cot ton) (0.001 kg/g) ((0.0 1 9 lb ai/A)/(0.0 1 9 lb ai/A)) = 0.00 1 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 trifloxysulfuron

sodium. 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, e ye 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 s earch 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

I DS.

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

- sodi um 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 cl assified 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 Ev ent 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 varie s 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 St ate Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non

occupational 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 LD 50 > 5000 mg/kg IV

Technical 870.1100 Acute Oral

- mouse 45371923 LD 50 > 5000 mg/kg IV

Technical 870.1200 Acute Dermal

- rat 45371925 LD 50 > 2000 mg/kg III

Technical 870.1300 Acute Inhalation 45371927 LC 50 (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 : 102 3/1507 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 = dec reased 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 (4 4%), 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 der mal 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)

MRID s 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

decr ease 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)

MRID s 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)

MRID s 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 :>968/10 30 (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

MRID s 45372009,

45372030 NOAEL :854/112 mg/kg/day (M/F)

LOAEL : >854/818 mg/kg/day (M/F): M = not determin ed; F = decreased body weight, b ody 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 incr eased 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)

MRID s 45372033, 45372022,45372018,

4 5372020, 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)

MRID s 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 a nd 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

Metaboli te 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,

Metabolit e 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 h ours. 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 ch emical. 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. Descript ions 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 usi ng 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 Occupa tional Non

- cancer Post

- application Algorithms

Potential daily exposures for occupational post

- application workers are calculated using the following formulas:

DFR t 

### =AR * F* (1

- D) t 

### * � 4.54E8 ug

lb � * � 2.47E

- 8 A

cm 2 

### �

where:

DFR t 

### = dislodgeable foliage residue on day "t" (μg/cm 2 

### ),

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 (cm 2 

### /hr),

DFR t 

### = dislodgeable foliar residue on day “t” (μg/cm 2 

### ), 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

o f 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 a bsorbed in a given scenario (mg ai/kg/day).

A ppendix 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 S odium (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/cm 3 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, logP OW (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 formulation

application 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/ft 2 

### , lb ai/gal or lb ai/A); and A = area treated or amount handled (e.g., ft 2 

### /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 = dos e (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/cm 2 

### ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm 2 

### /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 availabl e, then TTR t 

### can be calculated using the following

formula:

TTR t 

### = AR * F * (1

- FD) t 

### * CF2 * CF3

where:

TTRt = turf transferable residue on day t (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F = fraction of ai as transferable residue follow ing 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 10 8 

### μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### / cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ).

Dermal absorbed doses are calculated as:

BW AF E 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

F D Daily residue dissipation (if chemical

- specific data is unavailable) (fraction) L/WP/WDG 0.1

Granules 0.1

TC Transfer

Coefficient

(cm 2 /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 * ( F M 

### * SA H 

### ) * (ET * N_Replen) * (1

- (1

- SE ) (Freq_HtM/N

- Replen) 

### )]

where:

E = exposure (mg/day); HR = hand residue loading (mg/cm 2 

### ); FM = fraction hand surface area mouthed / event (fraction/event); SAH = typical surface area of one hand (cm 2 

### );

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

2 * SA DE * Fai HR

H hands



### =



### where:

HR = hand residue loading (mg/cm 2 

### );

Fai hands 

### = fraction ai on hands compared to total surface residue from dermal transfer coefficient study (unitless); DE = dermal exposure (mg); and

SA H 

### = typical surface area of one hand (cm 2 

### ).

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

- to

Mouth Exposure. Algorithm

Notation Exposure Factor (units) Point Estimate(s)

Fai hands Fraction of ai on hands

from dermal transfer

coefficient study (unitless) Liquid formulations 0.06

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SA H Typical surface area of one hand (cm 2 ), 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/cm 2 ) Calculated via (DE * Fai hands )/SA H

F M 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 * SAM O 

### * (ET * N_Replen) * (1

- (1

- SE O 

### ) (Freq_OtM/N_Replen) 

### )]

where:

E = exposure (mg/day); OR = chemical residue loading on the object on day “t” (ug/cm 2 

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

SAM O 

### = area of the object surface tha t is mouthed (cm 2 

### /event); ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (intervals/hour);

SE O 

### = 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 * F O 

### * CF2 * CF3

where:

### Page 43 of 60 OR = chemical residue loading on the object (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F O 

### = fraction of residue available on the object (unitless); CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ).

Dose, normalized to body weight, is calculated as:

BW

E D =



### where:

D = dose (mg/kg

- day);

E = exposure (mg/day); a nd

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

F O Fraction of AR as OR following application 1 0.01

SAM O Surface area of object mouthed (cm 2 /event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SE O 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

- F D 

### ) t 

### * CF2 * CF3 * CF4

where:

SR t 

### = soil residue on day "t" (μg/g); AR = application rate (lbs ai/ft 2 

### or lb ai/acre); FS = fraction of ai available in uppermost cm of soil (fraction/cm);

F D 

### = 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 10 8 

### μg/lb); CF3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ); and CF4 = soil volume to weight unit conversion factor (0.67 cm 3 

### /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

F D 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);

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm 2 

### /hr); and ET = exposure time (hr/day).

and

TTRt = AR * F AR 

### * (1

- F D 

### ) t 

### * CF2 * CF3

where :

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F AR 

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

F D 

### = 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 10 8 

### μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ).

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

BW

AF E 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

F AR Fraction of AR as TTR following

application L/WP/WDG 0.01

Granules 0.002

F D Daily residue dissipation L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient (cm 2 /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);

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm 2 

### /hr); and ET = exposure time (hr/day).

and

TTRt = AR * F * (1

- F D 

### ) t 

### * CF2 * CF3

where :

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

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

F D 

### = 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 10 8 

### μg/lb); and

CF3 = area unit conversion fac tor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ).

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

BW

AF E 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

F D Daily residue dissipation L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient (cm 2 /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 hy brids 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 1.00 0 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 Almon d

- 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 Su garcane, 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 TR IFLOXYSULFURON 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 99.9t h 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

RA C/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 0.0 84494 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/da y"

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

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 99.5 0 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 d ays 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 2 003

- 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: Triflo xysulfuron.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

Stan dard 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 1.8 7

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 99.7 5 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 Analys is 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

Stan dard 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 99.7 5 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

St andard 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 us er

- 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 P ercentile 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

Acu te 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 0.0138 57 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 99.7 5 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 o f 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 0.0 02752 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

Perc ent 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 expo sure

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 99.9 0 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: Trifl oxysulfuron.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 0.00 6644 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/da y) 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 bod y

- 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 99.9 0 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