UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: November 4, 2013 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Flucarbazone-Sodium. Human Health Assessment Scoping Document in 

Support of Registration Review. 

PC Code: 114009 DP Barcode: D411 036 

Decision No.: t/11.55'2. Registration No.: N/A 

Petition No.: N/A Regulatory Action: Registration Review Scoping Document 

Risk Assessment Type: N/A Case No.: 7251 

TXR No.: N/A CAS Nos.: 181274-17-9, 145026-88-6 

MRID No.: N/A 40 CFR: §180.562 I 

~ II ~""\ rcr---;;-t4 { t) FROM: Charles W. Smith III, Branch Chief(.___---::~ •. ,. 

Monique M. Perron, S.D., Toxicologist ~ -I"~ Julie L. Van Alstine, MPH, Environmental Health Scientist far 

Risk Assessment Branch 1 (RAB 1) 

Health Effects Division (HED, 7509P) 

THROUGH: George F. Kramer, Ph.D., Senior Chemist 

RAB 1 /HED (7 509P) 

TO: Jolene Trujillo, Chemical Review Manager 

Risk Management and Implementation Branch V 

Pesticide Re-Evaluation Division (PRD) (7508P) 

Attached is HED's human health risk assessment scoping document for flucarbazone-sodium to 

support Registration Review. 
_________ Flucarb~~~~ ~~l~l_!l Registration ~~ ew Human He~ ~~~ ~~m _!_l.!_~ copi~~}??~ur~ n! ___________ _ 

Executive Summary 

Flucarbazone-sodium [4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] 

sulfonyl]-lH-1 ,2,4-triazole-1-carboxamide, sodium salt) is a selective herbicide registered in the 

U.S. for pre- and post-emergent control ofbroadleaf weeds in wheat, tree nurseries, residential 

turf, golf courses, and sod farms. There are currently six flucarbazone-sodium containing enduse products sold under the following names: Everest 70% Water Dispersible Granular 

Herbicide (66330-49), Everest 70% Water Dispersible Granular Herbicide in W. S. Packets 

(66330-50), ARY-0454-105 SC Herbicide (66330-391), Pre-Pare SC Herbicide (66330-396), 

Raze Herbicide (66330-405), and DuPont Finesse Grass & BroadleafHerbicide (352-718). In 

addition, there are several Special Local Need (SLN) labels, which allow applications to grasses 

grown for seed. 

Flucarbazone-sodium was first registered for use on wheat in 2000 (J. Rowell, et al.; D257851; 

8/31/2000). The most recent human health risk assessment was performed in 2009 for 

registration for use in tree nurseries, on residential turf, on golf courses, and on sod farms (M. 

Clock-Rust, et al. ; D357818; 7/28/2009). There are currently no pending PRIA actions for 

f1 ucarbazone-sodi um. 

HED has evaluated the status of the human health assessments for flucarbazone-sodium to 

determine whether sufficient data are available and whether any updates are needed to support 

Registration Review. HED has considered all available data and human health risk assessments 

for flucarbazone-sodium with respect to its toxicity, exposure, and usage databases, and the most 

updated Agency science policy and risk assessment methodologies to determine the scope of 

work necessary to support Registration Review. 

The toxicity database for flucarbazone-sodium is complete with respect to the 2007 revised 40 

CFR Toxicology Data Requirements. No additional toxicological studies are currently required. 

Flucarbazone-sodium was categorized as having low acute toxicity via the oral, dermal, and 

inhalation routes (Toxicity Category IV). It is a slight eye irritant (Toxicity Category III), nonirritating to the skin and not a dermal sensitizer. The existing toxicity database for flucarbazonesodium indicates that the dog is the most sensitive species with subchronic and chronic effects 

seen in the thyroid (increased thyroxine-binding capacity and decreased thyroxine levels) and 

liver (induction of microsomal liver enzymes, increased liver weights, and histopathological 

findings). In a 90-day rat inhalation toxicity study, eosinophilic globules (nasal cavity) and 

squamous cell metaplasia (larynx) were observed in both sexes. In a 28-day rabbit dermal 

toxicity study, no treatment related effects were seen up to the limit dose. There was no 

evidence of increased quantitative or qualitative susceptibility to offspring in the database for 

flucarbazone-sodium. The Hazard Identification and Assessment Review Committee (HIARC) 

classified flucarbazone-sodium as not likely to be carcinogenic to humans by all routes of 

exposure based upon lack of evidence of carcinogenicity in rats and mice. Further, genotoxicity 

assays indicate that there is no evidence of genotoxicity for flucarbazone-sodium. During 

Registration Review, HED will reevaluate the points of departure (PODs) and uncertainty factors 

(UFs) for the dietary, residential, and occupational exposure assessments. 

Adequate metabolism (crops, livestock, and rotational crops) and magnitude of the residue data 

are available to support the currently registered uses of flucarbazone-sodium. A formal review 

of a submitted magnitude of the residue in field rotational crops study on wheat, mustard greens, 

and turnip (MRID 46083802) will be conducted during Registration Review. Based on the 

results of this review, re-evaluation of the flucarbazone-sodium rotational crop plant-back 

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intervals (PBIs) may be required. Although adequate methods are available for enforcement of 

the currently established tolerances, petition method validations (PMVs) of the plant and 

livestock analytical enforcement methods using Standard Operating Procedures (SOP) ACB-019 

(9/15/2008) need to be completed. 

The dietary exposure database is adequate to support existing registrations; however, a revised 

dietary assessment that utilizes the most recent version of the Dietary Exposure Evaluation 

Model-Food Consumption Intake Database (DEEM-FCID), incorporates any updated estimated 

drinking water concentrations and, incorporates any revised toxicological PODs may be required 

during Registration Review.

The residential and occupational exposure databases for flucarbazone-sodium are adequate for 

Registration Review. Residential exposure/risk assessments may need to be reassessed during 

Registration Review to address updates to HED’s exposure policies, including updates to the 

SOPs for Residential Pesticide Exposure Assessment (Residential SOPs) and assumptions for 

body weights. Occupational exposure/risk assessments may need to be reassessed during 

Registration Review to address updates to HED’s exposure policies, including updates to default 

exposure data and assumptions for body weights. Residential and occupational exposure/risk 

assessments may also need to be reassessed if changes to the toxicity endpoints or uncertainty 

factors are made during Registration Review.

HED did not identify any data deficiencies for flucarbazone-sodium.

EPA anticipates conducting the following risk assessment updates during Registration Review:

Toxicology: 

o Reevaluation of the toxicity endpoint/dose selection, along with the Food Quality 

Protection Act (FQPA) Safety Factor (SF) may be required.

Residue Chemistry: 

o A formal review of the magnitude of the residue in field rotational crops study on 

wheat, mustard greens, and turnip (MRID 46083802) will be required. Based on 

the results of this review, reevaluation of the flucarbazone-sodium rotational crop

PBIs may be required.

o PMVs of the plant and livestock analytical enforcement methods using SOP 

ACB-019 (9/15/2008) need to be completed.

Dietary Exposure: 

o Revised dietary risk assessment may be necessary to reflect the potential revised 

EDWCs, dietary exposure models, and/or toxicological PODs.

Occupational/Residential Exposure: 

o Revised residential exposure/risk assessments may be necessary to reflect updates 

to HED’s exposure policies, including updates to the Residential SOPs and

assumptions for body weights. Residential exposure/risk assessments may also 

need to be reassessed if changes to the toxicity endpoints or uncertainty factors 

are made during Registration Review.

o Revised occupational exposure/risk assessments may be necessary to reflect 

updates to HED’s exposure policies, including updates to default exposure data 

and assumptions for body weights. Occupational exposure/risk assessments may 

also need to be reassessed if changes to the toxicity endpoints or uncertainty 

factors are made during Registration Review.
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1.0 Introduction

Flucarbazone-sodium [4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] 

sulfonyl]-1H-1,2,4-triazole-1-carboxamide, sodium salt] is a selective herbicide registered in the 

U.S. for pre- and post-emergent control of broadleaf weeds in wheat, tree nurseries, residential 

turf, golf courses, and sod farms. There are currently six flucarbazone-sodium containing enduse products sold under the following names: Everest 70% Water Dispersible Granular 

Herbicide (66330-49), Everest 70% Water Dispersible Granular Herbicide in W. S. Packets

(66330-50), ARY-0454-105 SC Herbicide (66330-391), Pre-Pare SC Herbicide (66330-396), 

Raze Herbicide (66330-405), and DuPont Finesse Grass & Broadleaf Herbicide (352-718). In 

addition, there are several SLN labels, which allow applications to grasses grown for seed. 

Flucarbazone-sodium products are formulated as water-dispersible granulars, water-dispersible

granulars in water-soluble bags, and soluble concentrates. This memo only evaluates the status 

of the human health assessments for flucarbazone-sodium.

Flucarbazone-sodium was first registered for use on wheat in 2000 (J. Rowell, et al.; D257851; 

8/31/2000). The most recent human health risk assessment was performed in 2009 for 

registration for use in tree nurseries, on residential turf, on golf courses, and on sod farms (M. 

Clock-Rust, et al.; D357818; 7/28/2009). There are currently no pending PRIA actions for 

flucarbazone-sodium. 

2.0 Hazard Identification/Toxicology

Radiolabeled flucarbazone was readily absorbed in rats when administered as single or repeated 

oral doses with maximum plasma concentrations achieved within 30 minutes of dosing. Based 

on the amount of radioactivity collected by urinary excretion, the fraction absorbed was 

relatively low (estimated at 15-30%). Less than 1% of the administered dose remained in the 

carcass and tissues at sacrifice with the highest tissue residues in the liver. Excretion primarily 

occurred within 24 hours of dosing via the urine and feces. The major component in urine and 

feces was unchanged parent. 

Flucarbazone-sodium was categorized as having low acute toxicity via the oral, dermal, and 

inhalation routes (Toxicity Category IV). It is a slight eye irritant (Toxicity Category III), nonirritating to the skin and not a dermal sensitizer. The endpoints and PODs from the most recent 

human health risk assessment for flucarbazone (M. Clock-Rust, et al.; D357818; 7/28/2009) can 

be found in Attachment C. 

The existing toxicity database for flucarbazone indicates that the dog is the most sensitive 

species with subchronic and chronic effects seen in the thyroid (increased thyroxine-binding 

capacity and decreased thyroxine levels) and liver (induction of microsomal liver enzymes, 

increased liver weights, and histopathological findings). Other findings indicative of a 

treatment-related effect in dogs included histopathological findings in the stomach, body-weight 

gain decrements and decreased food consumption. 

No treatment-related adverse effects were seen in subchronic oral toxicity studies in mice. In 

rats, immunological changes were observed in both sexes in subchronic dietary studies and in 

males at the one-year interim sacrifice in the combined chronic/carcinogenicity study, but not at 

study termination. Subsequent studies investigating the immunotoxic potential of flucarbazonesodium up to and including the limit dose found the immunotoxic potential to be negative at all 
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dose levels tested. Therefore, the immunological findings in the rat studies are considered to 

represent slight or moderate non-specific toxicity rather than immunotoxicity.

In a 90-day rat inhalation toxicity study, eosinophilic globules (nasal cavity) and squamous cell 

metaplasia (larynx) were observed in both sexes. In a 28-day rabbit dermal toxicity study, no 

treatment related effects were seen up to the limit dose.

There was no evidence of increased quantitative or qualitative susceptibility to offspring in the 

database for flucarbazone. In the rat developmental toxicity study, no effects were seen up to the 

limit dose. In rabbits, developmental effects (decreased fetal body weight and increased 

incidence of delayed ossification) occurred at 500 mg/kg/day while maternal effects (decreased 

food consumption and increased clinical signs) were observed at 300 mg/kg/day. In the rat 

reproductive toxicity study, offspring effects (reduced pup weights, decreased liver weights, 

marbled liver, and air filled stomach) occurred in the presence of parental toxicity. Liver 

weights were decreased in parental males. Decreased uterine weights and increased incidence of 

severe cecal enlargement were observed in parental females. 

In the acute neurotoxicity study in rats, both sexes had transient decreases in motor activity and 

locomotor activity and an increase in the incidence of low levels of activity in the open field at 

the limit dose. In the subchronic neurotoxicity study, body weight, body-weight gain and food 

consumption were reduced in males at the highest dose tested (1482 mg/kg/day) while no 

treatment related effects were observed in females. There were no treatment-related 

histopathological findings in the central or peripheral nervous system in the acute or subchronic 

neurotoxicity studies.

In the combined chronic/carcinogenicity study in rats, adverse effects were observed at 1000 

mg/kg/day (thickened mucosa of the glandular stomach in both sexes; decreased body weight, 

increased food consumption, and vacuolation of squamous epithelium in the forestomach in 

females; inflammatory infiltrates and immunological effects in males). In the mouse 

carcinogenicity study, reduced body weights in both sexes and increased food consumption in 

males were seen at the highest dose tested (2066 and 3212 mg/kg/day in males and females, 

respectively). The HIARC (2000) classified flucarbazone-sodium as not likely to be 

carcinogenic to humans by all routes of exposure based upon lack of evidence of carcinogenicity 

in rats and mice. Further, genotoxicity assays indicate that there is no evidence of genotoxicity 

for flucarbazone-sodium. 

Conclusions: The toxicity database for flucarbazone-sodium is complete with respect to the 

2007 revised 40 CFR Toxicology Data Requirements. No additional toxicological studies are 

currently required. As part of registration review, the endpoints, doses, and safety factors used in 

the most recent risk assessment will be re-evaluated according to current HED policy.

3.0 Residue Chemistry

Flucarbazone-sodium is registered for use on conifers (plantations and nurseries), grasses grown 

for seed, ornamental lawns and turf, and wheat. Tolerances are established in 40 CFR §180.562

for residues in/on the following commodities: wheat forage, grain, hay, and straw; milk; and the 

meat, meat byproducts (except liver), and liver of cattle, goats, hogs, horses, and sheep. 

The nature of the residue in wheat is adequately understood based on the results of two wheat 

metabolism studies (phenyl-labeled and triazolinone-labeled). The metabolism of flucarbazone-
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sodium in wheat was rapid; little or no parent compound was found in any of the raw agricultural 

commodities (RACs). The nature of the residues in livestock is understood based on the results 

of two ruminant metabolism studies (phenyl-labeled and triazolinone-labeled) and two poultry 

metabolism studies (phenyl-labeled and triazolinone-labeled).

The HED Metabolism Assessment Review Committee (MARC) has determined that the residues 

of concern in wheat for risk assessment purposes are flucarbazone-sodium, N-desmethyl 

flucarbazone-sodium, and flucarbazone-sodium sulfonamide and its conjugates and that the 

residues of concern for the wheat tolerance expression are flucarbazone-sodium and N-desmethyl

flucarbazone-sodium. For rotational crops, the MARC determined that the residues of concern 

for risk assessment purposes are flucarbazone-sodium, flucarbazone-sodium sulfonic acid, 

flucarbazone-sodium sulfonamide and its conjugates. For livestock, the residues of concern for 

tolerance enforcement and risk assessment are flucarbazone-sodium and flucarbazone-sodium

sulfonamide and its conjugates. For drinking water, the residues of concern for risk assessment 

purposes are flucarbazone-sodium and flucarbazone-sodium sulfonamide (J. Rowell; D267418;

8/14/2000 and J. Tyler; D271382; 3/12/2001).

In the August 2000 HED risk assessment for the proposed use of flucarbazone-sodium on wheat, 

HED requested additional field accumulation data on flucarbazone-sodium sulfonamide and its 

conjugates. These data were requested because the MARC determined that adequate data were 

not available to rule out flucarbazone-sodium sulfonamide and its conjugates as residues of 

concern in rotational crops (Memo, J. Tyler; D271382; 3/12/2001). Therefore, a 9-month PBI 

was placed on the flucarbazone-sodium labels. A magnitude of the residue in field rotational 

crops study on wheat, mustard greens, and turnip (MRID 46083802) was subsequently submitted 

in 2003. A preliminary review of these data indicates that flucarbazone-sodium, N-desmethyl 

flucarbazone-sodium, and flucarbazone-sodium sulfonamide and its conjugates are all less than 

the LOQ of the analytical method at a PBI of 4 months. During Registration Review, HED will 

formally review the above study and reevaluate the flucarbazone-sodium rotational crop PBIs.

Confined rotational crop studies (phenyl-labeled and triazolinone-labeled) were submitted for 

wheat, kale, and turnips, and were reviewed by HED. Storage stability data for turnip tops (≥228 

days) and kale (≥258 days) from the phenyl-UL14C rotational crop study were not submitted 

(Memo, J. Tyler; D273561; 3/21/2001). Although these data were previously required, HED has 

determined that these data are no longer needed based on a preliminary review of the submitted 

rotational field trial studies (MRID 46083802), which indicated that residues were <LOQ at a 

PBI of 4 months. 

Analytical enforcement methods for plant and livestock commodities are available for enforcing 

tolerances. Both of these methods were forwarded to the Analytical Chemistry Branch (ACB)/ 

Biological and Economics Analysis Division (J. Rowell; D260775; 11/17/1999 and J. Rowell; 

D260776; 11/17/1999) for PMV. HED has not received the results of the PMV. The PMVs of 

the plant and livestock analytical enforcement methods using SOP ACB-019 (9/15/2008) will 

need to be completed during Registration Review. 

Conclusions: The qualitative nature of flucarbazone-sodium residues is adequately understood. 

The residue chemistry database is sufficient to support the current registrations for flucarbazonesodium. During Registration Review, HED will formally review the magnitude of the residue in 

field rotational crops study on wheat, mustard greens, and turnip, and reevaluate the 

flucarbazone-sodium rotational crop PBIs. In addition, review of the plant and livestock 
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analytical enforcement methods using SOP ACB-019 (9/15/2008) will need to be completed 

during Registration Review.

4.0 Dietary Exposure

The most recent acute and chronic dietary exposure and risk assessments for flucarbazonesodium were performed in conjunction with the 2009 risk assessment for use of flucarbazonesodium on turf, tree nurseries, Christmas tree farms, golf courses, and other non-food use sites (J. 

Van Alstine; D366918; 7/28/2009 and M. Clock-Rust et al.; D357818; 7/28/2009). Tolerances 

were not recommended for the uses proposed in 2009; however, an updated dietary assessment 

was required since the dietary exposure model had been updated since the previous assessment in 

2000 (J. Rowell; D267413; 8/17/2000). 

The most recent (2009) acute and chronic dietary exposure and risk assessments were performed 

using the DEEM-FCID model (ver. 2.03), which uses food consumption data from the United 

States Department of Agriculture Continuing Surveys of Food Intakes by Individuals (1994-1996 

and 1998). A cancer analysis was not conducted because flucarbazone-sodium was classified as 

“not likely to be carcinogenic to humans.”

The acute and chronic assessments utilized anticipated residues (ARs) for wheat, tolerance-level 

residues for all remaining commodities, and DEEM (ver. 7.81) default processing factors. Both 

the acute and chronic assessments assumed 100% crop treated (CT) for all commodities. The 

Environmental Fate and Effects Division (EFED) provided estimated drinking water residues for 

the assessment. The degradates of flucarbazone-sodium are resistant to aerobic metabolism in 

soil; therefore, a value for the concentration of total flucarbazone-sodium residues in the soil 

pore water of the top 1-foot of soil immediately postapplication was estimated. This estimate 

resulted in the highest concentration of total flucarbazone-sodium residues in water (50 ppb) and 

was incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and 

“water, indirect, all sources” for the acute and chronic assessments. 

The acute and chronic dietary exposure and risk estimates were below HED’s level of concern.

The acute dietary analysis was only conducted for females 13-49 years old as no acute dietary 

endpoint was selected for the general population. At the 95th percentile, the acute dietary risk

estimate for females 13-49 years old accounted for <1% of the acute population-adjusted dose 

(aPAD). The chronic dietary risk estimates are <1% of the chronic population-adjusted dose 

(cPAD) for the general U.S. population, and 1% of the cPAD for infants <1 year, the mostly 

highly exposed population subgroup.

Conclusions: The most recent acute and chronic dietary risk estimates were below HED’s level 

of concern for the general U.S. population and all population subgroups examined. As part of 

Registration Review, a new dietary exposure and risk assessment may be required, utilizing the 

most recent version of DEEM-FCID. A new dietary exposure and risk assessment should also 

incorporate any updated estimated drinking water concentrations and any revised toxicological 

PODs.

5.0 Residential Exposure

Residential handler and postapplication exposures are expected based on the registered turf uses 

of flucarbazone-sodium. Attachment 4 provides a summary of the residential use pattern. The 

application rates range from 0.0088 – 0.027 lb ai/A.
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Residential Handlers

There is the potential for dermal and inhalation exposure to residential handlers from the 

currently registered use pattern of flucarbazone-sodium. In all past risk assessments, no

chemical-specific data were available with which to assess potential exposure to pesticide 

handlers; therefore, residential handler assessments were based primarily on surrogate unit 

exposures from the Pesticide Handlers Exposure Database (PHED) and the Outdoor Residential 

Exposure Task Force (ORETF). Previous risk calculations were based on the maximum 

application rates and assumed maximum area treated per day or gallons handled. Residential 

handlers were assumed to be wearing shorts and a short-sleeve shirt.

The most recent human health risk assessment in 2009 included a residential handler assessment 

for homeowner application of flucarbazone-sodium to turf (M. Clock-Rust, et al.; D357818; 

7/28/2009). None of the application scenarios resulted in risks of concern as the margins of 

exposure (MOEs) ranged from 26,000 to 130,000).

Residential Postapplication

There is the potential for postapplication dermal exposure to adults and children as well as 

incidental oral exposure to children following applications of flucarbazone-sodium to residential 

turf. There is also the potential for postapplication dermal exposure to adults and children 

following applications of flucarbazone-sodium to golf courses.

The 2009 human health risk assessment included residential postapplication assessments for both 

the residential turf and golf course scenarios. None of the adult postapplication dermal scenarios 

resulted in risks of concern (MOEs for golfing = 320,000 and MOEs for residential turf = 

22,000). None of the children postapplication dermal scenarios (MOEs for residential turf = 

13,000) or children postapplication incidental oral scenarios (MOEs for hand-to-mouth = 84,000; 

object-to-mouth = 330,000; and soil ingestion 26,000,000) resulted in risks of concern.

In accordance with the updated Part 158 data requirements (2007), a turf transferrable residue 

(TTR) study is required when a pesticide has occupational (e.g., sod farms, golf courses) or 

residential turf uses that could result in postapplication dermal exposure. HED analyzed all 

available TTR data and selected new liquid and granular default values for the fraction of the 

application rate available for transfer after a turf application (FAR). These values are based on an 

analysis of 59 TTR studies that used the Modified California Roller Method (36 studies using 

liquids, 11 studies using wettable powders/water-dispersible granules, and 12 studies using 

granulars). These default values are 1% for formulations applied as liquids and 0.2% for 

granular formulations. Of the analyzed liquid TTR studies, the maximum FAR value seen was 

6.1% or 6.1 times higher than the default residue transfer value. Therefore, HED has decided 

that a calculated MOE of approximately 10 times higher than the level of concern (e.g., an MOE 

> 1,000 if the LOC = 100) using the default residue transfer values would provide an adequate 

margin of safety for any potentially higher residues seen in a chemical-specific TTR study. This 

policy is described in Guidance for Requiring/Waiving Turf Transferrable Residue (TTR) and 

Dislodgeable Foliar Residue (DFR) Studies (J. Housenger; 12/12/12). A TTR study is not 

required at this time for flucarbazone-sodium since estimated residential postapplication MOEs 

are greater than 1,000.

Spray Drift and Volatilization

Residential exposures resulting from off-site transport (e.g., spray drift or volatilization) may 

occur as a result of applications of flucarbazone-sodium. The Agency is in the process of 
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evaluating these types of exposures and may, as appropriate, develop policies and procedures to 

identify the need for and, subsequently, the way to incorporate these postapplication exposures 

into the Agency's risk assessments. The need for spray drift and volatilization risk assessment 

for flucarbazone-sodium will be examined during Registration Review.

Conclusions: All of the most recent residential risk estimates (handler and postapplication) were 

below HED’s level of concern. The residential exposure database for flucarbazone-sodium is

adequate for Registration Review. Residential exposure/risk assessments for flucarbazonesodium may need to be reassessed during Registration Review to address updates to HED’s 

exposure policies, including updates to the Residential SOPs and assumptions for body weights. 

Residential exposure/risk assessments may also need to be reassessed if changes to the toxicity 

endpoints or uncertainty factors are made during Registration Review. In addition, the need for 

spray drift and volatilization risk assessments for flucarbazone-sodium will be examined during 

Registration Review.

6.0 Aggregate Risk Assessment

The most recent aggregate risk assessment was performed in conjunction with the 2009 human 

health risk assessment conducted by HED (M. Clock-Rust, et al.; D357818; 7/28/2009). In that 

assessment HED determined that acute, short-term, and chronic aggregate risk assessments were 

appropriate. The acute and chronic aggregate risk estimates were equivalent to the acute and 

chronic dietary risk assessments. The acute and chronic dietary risk estimates for the general 

population and all population subgroups did not result in risks of concern (see Section 4.0).

For the short-term aggregate assessment, HED combined the residential adult and children turf 

exposures with background chronic dietary exposures. HED concluded that the combined 

residues of flucarbazone-sodium from food, drinking water, and residential exposures do not 

result in short-term aggregate risks of concern (MOEs ranged from 1,700 to 7,700).

Conclusions: All of the most recent aggregate risk estimates were below HED’s level of 

concern. The aggregate risk assessments for flucarbazone-sodium may need to be reassessed

during Registration Review if dietary or residential exposure estimates are updated, or if changes 

to the toxicity endpoints or uncertainty factors are made during Registration Review.

7.0 Occupational Exposure

Occupational handler and postapplication exposures are expected based on the registered uses of 

flucarbazone-sodium. Attachment 5 provides a summary of the occupational use pattern. The 

current registrations allow several SLN registrations. The application rates range from 0.013 –

0.027 ai/A, and applications can be made either pre- or post-emergence.

Occupational Handlers

There is the potential for dermal and inhalation exposure to occupational handlers from the 

currently registered uses of flucarbazone-sodium. In all past risk assessments, no chemicalspecific data were available with which to assess potential exposure to pesticide handlers; 

therefore, occupational handler assessments were based primarily on surrogate unit exposures 

from PHED and ORETF. Previous risk calculations were based on the maximum application 

rates and assumed maximum area treated per day or gallons handled. Occupational handler 

exposure and risk were calculated at baseline (long pants, a long-sleeved shirt, no chemical-
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resistant gloves, and no respirator) and with personal protective equipment (PPE) when 

necessary (e.g., chemical-resistant gloves, respirators, and engineering controls). 

The occupational handler assessment for the wheat uses of flucarbazone-sodium was included in 

the 2000 human health risk assessment (J. Rowell, et al.; D257851; 8/31/2000). In addition, the 

most recent human health risk assessment in 2009 included an occupational handler assessment 

for application of flucarbazone-sodium to tree nurseries, residential turf, golf courses, and sod 

farms (M. Clock-Rust, et al.; D357818; 7/28/2009). None of the application scenarios for the 

registered uses resulted in risks of concern (MOEs ranged from 3,700 to 130,000).

Occupational Postapplication

There is the potential for postapplication dermal exposure to workers following applications of 

flucarbazone-sodium from the currently registered uses of flucarbazone-sodium. The 

occupational postapplication assessment for the wheat uses of flucarbazone-sodium was included 

in the 2000 human health risk assessment (J. Rowell, et al.; D257851; 8/31/2000) while the most 

recent human health risk assessment in 2009 included an occupational postapplication 

assessment for application of flucarbazone-sodium to tree nurseries, turf, golf courses, and sod 

farms (M. Clock-Rust, et al.; D357818; 7/28/2009). None of the application scenarios for the 

registered uses resulted in risks of concern (MOEs ranged from 2,400 to 160,000). All current 

flucarbazone-sodium labels have a 12-hour restricted entry interval (REI). 

In accordance with the updated Part 158 data requirements (2007), one or more DFR studies are 

required when a pesticide has occupational uses that could result in postapplication dermal 

exposure. HED analyzed a number of DFR studies and selected a new default value for the 

fraction of the application rate available to be dislodged after a foliar application (FAR). This 

default value is 25%. Of the analyzed DFR studies, the maximum FAR value seen was 89% or 

3.6 times higher than the default residue transfer value. Therefore, HED has decided that a 

calculated MOE of approximately 4 times higher than the level of concern (e.g., an MOE > 400 

if the LOC = 100) using the default dislodged residue values would provide an adequate margin 

of safety for any potentially higher residues seen in a chemical-specific DFR study. This policy 

is described in Guidance for Requiring/Waiving Turf Transferrable Residue (TTR) and 

Dislodgeable Foliar Residue (DFR) Studies (Memo, J. Housenger, 12/12/12). A DFR study is 

not required at this time for flucarbazone-sodium since estimated occupational postapplication 

MOEs are greater than 400.

Conclusions: The most recent occupational risk estimates (handler and postapplication) were 

below HED’s level of concern. The occupational exposure database is adequate to support the 

Registration Review process for flucarbazone-sodium. Occupational exposure/risk assessments 

for flucarbazone-sodium may need to be reassessed during Registration Review to address 

updates to HED’s exposure policies, including updates to default exposure data used for handler 

scenarios, postapplication transfer coefficients, transferable residue assumptions, and 

assumptions for body weights. Occupational exposure/risk assessments may also need to be 

reassessed if changes to the toxicity endpoints or uncertainty factors are made during 

Registration Review.
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8.0 Public Health and Pesticide Epidemiology Data

An updated review of flucarbazone-sodium incident reports was recently prepared by HED 

(Recore and Evans, D414420, 08/29/2013). For this evaluation, both the OPP Incident Data 

System (IDS) and the Centers for Disease Control and Prevention/National Institute for 

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

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

the active ingredient flucarbazone-sodium. Flucarbazone-sodium is not included in the

Agricultural Health Study (AHS) and therefore no information from AHS was included in this 

report.

No flucarbazone-sodium incidents were found in the IDS or SENSOR databases. Therefore, 

there does not appear to be a concern for flucarbazone-sodium at this time that would warrant 

further investigation. The Agency will continue to monitor the incident information and if a 

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

9.0 Tolerance Assessment and International Harmonization

U.S. permanent tolerances (listed in 40 CFR §180.562) and maximum residue limits (MRLs) are 

summarized in Attachment D. Codex and Mexico do not have residue definitions or established 

MRLs for flucarbazone-sodium; however, Mexico does adopt U.S. tolerances for export 

purposes. The U.S. and Canadian residue definitions are not harmonized. HED is 

recommending revising the tolerance expression for flucarbazone-sodium. The revised 

expression will not be harmonized with Canada as the Canadian residue definition is for 

flucarbazone-sodium only and the U.S. tolerance expression includes additional residues of 

concern for plant and livestock commodities. 

Many of the U.S. tolerance levels for flucarbazone-sodium are harmonized with the Canadian 

MRLs; however, there are also tolerances and MRLs that are not harmonized. In particular, the 

Canadian MRLs are lower for milk and the liver of cattle, goats, hogs, horse, and sheep. There 

are Canadian MRLs for eggs and the meat and meat byproducts of poultry; however, there are no 

corresponding U.S. tolerances since HED determined that there is no reasonable expectation of 

finite residues in poultry (40 CFR §180.6(a)(3)). Tolerance harmonization may be reexamined 

during Registration Review. 

The current tolerance expressions for plant and livestock commodities as listed in the 40 CFR 

§180.562 have not been updated to reflect current HED policies. The revised tolerance 

expression for flucarbazone-sodium [40 CFR §180.562(a)(1)] for plant commodities should be 

updated as follows: 

“Tolerances are established for residues of flucarbazone-sodium, 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 the sum 

of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2-

(trifluoromethoxy)phenyl]sulfonyl]-1H-1,2,4-triazole-1-carboxamide, sodium salt and its 

metabolite N-desmethyl flucarbazone-sodium (4,5-dihydro-3-methoxy-5-oxo-N-

[[2(trifluoromethoxy)phenyl]sulfonyl]-1H-1,2,4-triazole-1-carboxamide), calculated as 

the stoichiometric equivalent of flucarbazone-sodium, in or on the commodity.”
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The revised tolerance expression for flucarbazone-sodium [40 CFR §180.562(a)(2)] for livestock 

commodities should be updated as follows: 

“Tolerances are established for residues of flucarbazone-sodium [5-dihydro-3-methoxy4-methyl-5-oxo-N-[[2-(trifluoromethoxy)phenyl]sulfonyl]-1H-1,2,4-triazole-1-

carboxamide, sodium salt], 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 those flucarbazone-sodium residues convertible to 2-

(trifluoromethoxy)benzene sulfonamide, expressed as the stoichiometric equivalent of 

flucarbazone-sodium, in or on the commodity.”

 

10.0 Environmental Justice

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

most recent flucarbazone-sodium 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.hss.energy.gov/nuclearsafety/env/guidance/justice/eo12898.pdf). The OPP 

typically considers the highest potential exposures from the legal use of a pesticide when 

conducting human health risk assessments, including, but not limited to, people who obtain 

drinking water from sources near agricultural areas, the variability of diets within the U.S., and 

people who may be exposed when harvesting crops. Should these highest exposures indicate 

potential risks of concern, OPP further refines the risk assessments to ensure that the risk 

estimates are based on the best available information.

11.0 Cumulative 

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a 

common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as 

to flucarbazone-sodium and any other substances. For the purposes of this assessment, therefore, 

EPA has not assumed that flucarbazone-sodium has a common mechanism of toxicity with other 

substances. For information regarding EPA’s efforts to determine which chemicals have a 

common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the 

policy statements released by EPA’s Office of Pesticide Programs concerning common 

mechanism determinations and procedures for cumulating effects from substances found to have 

a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.

12.0 Endocrine Disruption

As required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal 

Food, Drug, and Cosmetic Act (FFDCA), EPA reviews numerous studies to assess potential 

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

subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, 

developmental, reproductive, and general or systemic toxicity. These studies include endpoints 

which may be susceptible to endocrine influence, including effects on endocrine target organ 

histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, 

reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates 

acute tests and chronic studies that assess growth, developmental and reproductive effects in 

different taxonomic groups. As part of its most recent registration decision, EPA reviewed these 

data and selected the most sensitive endpoints for relevant risk assessment scenarios from the 
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existing hazard database. However, as required by FFDCA section 408(p), flucarbazone-sodium

is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

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

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

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

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

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

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

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

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

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

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

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

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

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

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Flucarbazonesodium is not among the group of 58 pesticide active ingredients on the initial list to be screened 

under the EDSP. Accordingly, as part of Registration Review, EPA will issue future EDSP 

orders/data call-ins, requiring the submission of EDSP screening assays for flucarbazonesodium. For further information on the status of the EDSP, the policies and procedures, the list 

of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website: http://www.epa.gov/endo/.

13.0 Human Studies

Past flucarbazone-sodium risk assessments rely in part on data from studies in which adult 

human subjects were intentionally exposed to a pesticide to determine their dermal and 

inhalation exposure. Many such studies, involving exposure to many different pesticides, 

comprise generic pesticide exposure databases such as PHED, the ORETF Database, and the 

Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting 

these multi-pesticide generic exposure databases, and has found no clear and convincing 

evidence that the conduct of any of them was either fundamentally unethical or significantly 

deficient relative to the ethical standards prevailing at the time the research was conducted. All 

applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 

CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on 

these studies.

14.0 Risk Assessment Updates and Data Deficiencies

HED did not identify any data deficiencies for flucarbazone-sodium.

EPA anticipates conducting the following risk assessment updates during Registration Review:

Toxicology: 

o Reevaluation of the toxicity endpoint/dose selection, along with the FQPA SF 

may be required.

Residue Chemistry: 

o A formal review of the magnitude of the residue in field rotational crops study on 

wheat, mustard greens, and turnip (MRID 46083802) will be required. Based on 
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the results of this review, reevaluation of the flucarbazone-sodium rotational crop

PBIs may be required.

o PMVs of the plant and livestock analytical enforcement methods using SOP 

ACB-019 (9/15/2008) need to be completed.

Dietary Exposure: 

o Revised dietary risk assessment may be necessary to reflect the potential revised 

EDWCs, dietary exposure models, and/or toxicological PODs.

Occupational/Residential Exposure: 

o Revised residential exposure/risk assessments may be necessary to reflect updates 

to HED’s exposure policies, including updates to the Residential SOPs and

assumptions for body weights. Residential exposure/risk assessments may also 

need to be reassessed if changes to the toxicity endpoints or uncertainty factors 

are made during Registration Review.

o Revised occupational exposure/risk assessments may be necessary to reflect 

updates to HED’s exposure policies, including updates to default exposure data 

and assumptions for body weights. Occupational exposure/risk assessments may 

also need to be reassessed if changes to the toxicity endpoints or uncertainty 

factors are made during Registration Review.

15.0 References

Table 1: Flucarbazone-Sodium Memoranda Relevant to Registration Review.

Author Barcode Date Title

J. Rowell D260775 11/17/1999

PP# 9F06011. New Chemical- Flucarbazone-Sodium in/on Wheat. Request 

for Petition Method Validation. MRID#s 448448-41 and 448448-25. 

Barcode D260775. Chemical # 114009. Case 292030. Submission 

S565287.

J. Rowell D260776 11/17/1999

PP# 9F06011. New Chemical- Flucarbazone-Sodium in/on Cattle Tissue 

and Milk. Request for Petition Method Validation. MRID#s 448448-28 and 

448448-19. Barcode D260776. Chemical # 114009. Case 292030. 

Submission S565287.

J. Rowell, et al. D267417 7/20/2000

Flucarbazone-Sodium. Issues to be Presented to the Health Effects Division 

(HED) Metabolism Assessment Review Committee (MARC) Meeting on 

7/27/00. Barcode D267417. Chemical 114009. Case 292030. Submission 

S565287.

J. Rowell D267418 8/14/2000

Flucarbazone-Sodium. Results of the Health Effects Division (HED) 

Metabolism Assessment Review Committee (MARC) Meeting of 7/27/00. 

Barcode D267418. Chemical 114009. Case 292030. Submission S565287.

J. Rowell D267413 8/17/2000

Flucarbazone-Sodium - Acute and Chronic Dietary Exposure Analyses. 

PP#: 9F06011. Chemical: 114009. DP Barcode: D267413. Case: 292030. 

Submission: S565287.

J. Rowell, et al. D267412 8/23/2000

PP# 9F06011. Flucarbazone-Sodium in/on Wheat and Livestock 

Commodities. Review of Analytical Methodology and Residue Data. 

MRID#s 448488-19 thru -21, 448488-23 thru -28, and 448488-34 thru -41. 

Chemical# 114009. DP Barcode D267412. Case# 292030. Submission# 

S565287.

J. Rowell, et al. D257851 8/31/2000

PP# 9F06011. Flucarbazone-Sodium in/on Wheat and Livestock

Commodities. Health Effects Division (HED) Risk Assessment. PC Code:

114009. DP Barcode: D257851. Case: 292030. Submission: S565287.

J. Rowell D267415 12/1/2000 Letter to FDA.

J. Tyler, et al. D272091 1/23/2001

ID# 003125-00533. Flucarbazone-Sodium. Issues to be Presented to the 

Health Effects Division (HED) Metabolism Assessment Review Committee 

(MARC) Meeting on 1/30/01. Barcode D272091. Chemical 114009. Case 

065974. Submission S589907.
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J. Tyler D271382 3/12/2001

Flucarbazone-Sodium. Results of the Health Effects Division (HED) 

Metabolism Assessment Review Committee (MARC) Meeting of 1/31/01. 

Barcode D271382. Chemical 114009. Case 065974. Submission S589907.

J. Tyler D273561 3/21/2001

ID#: 003125-00533. Flucarbazone-Sodium in/on Wheat and Livestock 

Commodities. Review of Amendment Submitted in Response to HED’s 

Memo Dated 8/23/00. MRID#s None. Chemical 114009. DP Barcode 

D273561. Case 065974. Submission S589907.

J. Van Alstine D366918 7/28/2009

Flucarbazone-Sodium: Acute and Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk Assessment for the Section 3 

Registration Action of an Outdoor Non-Food Use.

M. Clock-Rust, 

et al. D357818 7/28/2009

Flucarbazone-Sodium. Human health Risk Assessment for Application to 

Turf, Tree Nurseries, and Christmas Tree Farms, Golf Courses and Other 

Non-food Use Sites. 

Recore and 

Evans D414420 08/29/2013 Flucarbazone-sodium: Tier I Review of Human Incidents
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Attachments: 

Attachment A: Flucarbazone-sodium Chemical Identity Table

Attachment B: Flucarbazone-sodium Acute, Subchronic, and Chronic Toxicity Profile

Attachment C: Flucarbazone-sodium Endpoint Selection Tables

Attachment D: Summary of Residential Registered Flucarbazone-sodium Uses

Attachment E: Summary of Occupational Registered Flucarbazone-sodium Uses

Attachment F: Flucarbazone-sodium International Residue Limit Status Sheet
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Attachment A: Flucarbazone-sodium Chemical Identity.

Table A1.1. Flucarbazone-sodium Nomenclature.

Chemical Structure

Common name Flucarbazone-sodium

Company name Not applicable

Chemical class Triazolone herbicide

IUPAC name sodium 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-{[2-

(trifluoromethoxy)phenyl]sulfonyl}-1H-1,2,4-triazole-1-carboximidate

CAS name 4,5-Dihydro-3-methoxy-4-methyl-5-oxo-N-((2-

(trifluoromethoxy)phenyl)sulfonyl)-1H-1,2,4-triazole-1-carboxamide sodium salt

CAS # 181274-17-9

Table A1.2. Physicochemical Properties of the Technical Grade Test Compound: Flucarbazone-sodium.

Parameter Value Reference

Molecular weight 418.29g/mol

Refer to M. Clock-Rust et al., D357818, 

7/28/2009

Melting point/range 200°C (under decomposition)

pH 7.97 (1% solution in water at 22.7 °C)

Density 1.59 g/mL at 20 C

Vapor pressure <1x10-9 mmHg at 20 C

Solubility in Water 44g/L in neutral, acidic, and alkaline 

conditions at 20 C

Dissociation Constant 1.9 for free acid
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Attachment B: Flucarbazone-sodium Acute, Subchronic, and Chronic Toxicity Profile 

B.1. Toxicology Data Requirements

The study requirements (40 CFR 158.340) for flucarbazone-sodium are presented below. Use of 

the new guideline numbers does not imply that the new (1998) guideline protocols were used.

Study

Technical

Required Satisfied

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

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

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

870.2400 Acute Eye Irritation .......................................................

870.2500 Acute Dermal Irritation .................................................

870.2600 Skin Sensitization ..........................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100 90-Day Oral Toxicity (rodent).......................................

870.3150 90-Day Oral Toxicity (nonrodent).................................

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

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

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

yes

yes

yes

no

yes

yes

yes

yes

--

yes

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

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

870.3800 Reproduction and Fertility Effects.................................

yes

yes

yes

yes

yes

yes

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

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

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

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

870.4300 Combined Chronic Toxicity/Carcinogenicity................

yes

yes

yes

yes

yes

yes1

yes

yes1

yes

yes

870.5100 Mutagenicity—Bacterial Reverse Mutation Test ..........

870.5300 Mutagenicity—Mammalian Cell Gene Mutation Test ..

870.5xxx Mutagenicity— Structural Chromosomal Aberrations..

870.5xxx Mutagenicity—Other Genotoxic Effects.......................

yes

yes

yes

yes

yes

yes

yes

yes

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

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

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

yes

yes

no

yes

yes

--

870.7485 Metabolism and Pharmacokinetics................................

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

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

yes

no

yes

yes

--

yes

1 The combined chronic toxicity/carcinogenicity study satisfies the requirement of the study.
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B.2. Acute Toxicity Profile – Flucarbazone-sodium

Guideline No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute oral (rat) 44848716

LD50 > 5000 mg/kg 

(M)

LD50 > 5000 mg/kg 

(F)

IV

870.1200 Acute dermal (rat) 44848717 LD50 > 5000 mg/kg 

(M & F) IV

870.1300 Acute inhalation (rat) 44848718 LC50 > 5.13 mg/L IV

870.2400 Acute eye irritation (rabbit) 44848719 Slight irritation, 

cleared by 72 hours III

870.2500 Acute dermal irritation (rabbit) 44848719 No erythema after 

24 hours IV

870.2600 Skin sensitization (guinea pig) 44848720 Not a sensitizer NA
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B.3. Subchronic, Chronic, and Other Toxicity Profile – Flucarbazone-sodium

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

Classification/Doses Results

870.3100

90-Day Oral 

Toxicity in Rodents 

(rat)

44848732 (1996)

Acceptable/nonguideline

0, 100, 250, 2500, or 

10,000 ppm

M: 0, 10.3, 27, 266, or 

1134 mg/kg/day

F:0, 10.8, 25, 251, or 1150 

mg/kg/day 

NOAEL = 27 mg/kg/day in males and 25 

mg/kg/day in females.

LOAEL = 266 mg/kg/day in males and 251 

mg/kg/day in females based on immunological 

changes in both sexes.

870.3100

90-Day Oral 

Toxicity in Rodents 

(rat)

44848727, 44848728 

(1998)

Acceptable/guideline

0, 250, 1000, 4000 or 

20,000 ppm

M: 0, 17.6, 73.5, 287, or 

1,669 mg/kg/day 

F: 0, 21.4, 102, 358, or 

2314 mg/kg/day

NOAEL = 73.5 mg/kg/day in males and 102 

mg/kg/day in females.

LOAEL = 287 mg/kg/day in males and 358 

mg/kg/day in females based on immunological 

findings in both sexes.

870.3100

90-Day Oral 

Toxicity in Rodents 

(mouse)

44848733 (1998)

Acceptable/nonguideline

0, 100, 1000, or 10,000 

ppm

M: 0, 45.2, 472, or 4,554 

mg/kg/day

F: 0, 61.2, 603, or 6,429 

mg/kg/day

NOAEL = >4,554 mg/kg/day in males and 6,429 

mg/kg/day in females.

LOAEL >4,554 mg/kg/day in males and 6,429 

mg/kg/day in females. There were no signs of 

toxicity attributable to treatment at any dose level.

870.3100

90-Day Oral 

Toxicity in Rodents 

(mouse)

44848725, 44848726 

(1998)

Acceptable/guideline

0, 260, 780, 2340, or 

7,000 ppm

M: 0, 77, 209, 696, or 

2,083 mg/kg/day

F: 0, 115, 337, 1038, or 

3,051 mg/kg/day

NOAEL = > 2,083 mg/kg/day in males and 3,051 

mg/kg/day in females.

LOAEL > 2,083 mg/kg/day in males and 3,051 

mg/kg/day in females. There were no signs of 

toxicity attributable to treatment at any dose level.

870.3150

90-Day Oral 

Toxicity in NonRodent (dog)

44848735, 44848736 

(1996)

Acceptable/nonguideline

0, 1000, 5000, or 50,000 

ppm

M: 0, 33.1, 164, or 1,614 

mg/kg/day

F: 0, 36.1, 171, or 1,319 

mg/kg/day

NOAEL = 164 mg/kg/day in males and 171 

mg/kg/day in females.

LOAEL = 1,614 mg/kg/day in males and 1,319 

mg/kg/day in females based on decreased body 

weight gain, decreased food consumption, 

decreased T4 levels and increased thyroxinebinding capacity, induction of microsomal enzymes, 

increased liver weight and liver histopathology in 

both sexes.

870.3150

90-Day Oral 

Toxicity in NonRodent (dog)

44848737, 44848733 

(1998) 

Acceptable/guideline

0, 1000, 5000, or 50,000 

ppm

M: 0, 33.8, 162, or 1,674 

mg/kg/day 

F: 0, 35.2, 170, or 1,750 

mg/kg/day 

NOAEL = 33.8 mg/kg/day in males and 35.2 

mg/kg/day in females with the occurrence of slight, 

adaptive induction of hepatic microsomal enzymes.

LOAEL = 162 mg/kg/day in males and 170 

mg/kg/day in females based on decreased T4 levels, 

increased thyroxine-binding capacity, induction of 

microsomal enzymes, gross pathology and 

histopathology in the stomach, and histopathology 

in the liver in both sexes.

870.3200 21/28-Day Dermal 

Toxicity (rat)

44848734 (1996)

Acceptable/guideline

M & F: 0, or 1,000 

mg/kg/day

NOAEL 1,000 mg/kg/day for both sexes.

LOAEL >1,000 mg/kg/day.

There were no signs of toxicity attributable to 

treatment at any dose level.
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Guideline No. Study Type MRID No. (year)/ 

Classification/Doses Results

870.3465 90-Day Inhalation 

Toxicity (rat)

46168501 (2003)

Acceptable/non-guideline

0, 5.0, 30.0, 180, or 500 

mg/m3(0, 0.005, 0.03, 

0.18, or 0.5 mg/L) for 28 

days

LOAEL = 0.18 mg/L based on eosinophilic 

globules (nasal cavity) and squamous cell 

metaplasia (larynx) in males and females.

NOAEL = 0.03 mg/L.

870.3700a

Prenatal 

Developmental in 

Rodent (rat)

44848748, 44848749, 

44848750, 44848751, 

44848752 (1998)

Acceptable/guideline

F: 0, 100, 300, or 1,000 

mg/kg/day

Maternal NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day.

Developmental NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day.

870.3700b

Prenatal 

Developmental in 

Non-Rodent (rabbit)

44848753, 44848801, 

44848802 (1997)

Acceptable/guideline

F: 0, 100, 300, 500, or 

1,000 mg/kg/day

Maternal NOAEL = 100 mg/kg/day.

LOAEL = 300 mg /kg/day based on decreased food 

consumption and increased clinical signs.

Developmental NOAEL = 300 mg/kg/day.

LOAEL = 500 mg/kg/day based on decreased fetal 

weight and increased incidence of delayed fetal 

ossification.

870.3800 Reproduction and 

Fertility Effects (rat)

44848745, 44848746, 

44848747 (1998)

Acceptable/guideline

0, 50, 4000, 

20,000/12,000 ppm (dose 

reduced in week 6)

F0 M: 3.5, 287 or 800 

mg/kg/day, F0 F: 4.2, 340, 

or 991 mg/kg/day F1 M: 

4.2, 346 or 1,059 

mg/kg/day 

F1 F: 5.5, 453, or 1,249 

mg/kg/day

Parental/Systemic NOAEL = 287 mg/kg/day for 

males and 340 mg/kg/day for females with a slight, 

increased incidence of moderate cecal enlargement 

occurring as an adaptive response to treatment.

LOAEL = 800 mg/kg/day for males based 

decreased liver weight and 991 mg/kg/day for 

females based on decreased uterine weight and 

increased incidence of severe cecal enlargement.

Reproductive/Offspring NOAEL = 287 mg/kg/day 

for males and 340 mg/kg/day for females.

LOAEL = 800 mg/kg/day for males and 991 

mg/kg/day for females based on reduced pup 

weights, decreased liver weight in male pups, 

marbled liver, air filled stomach. 

870.4100a Chronic Toxicity

(rodent) See 870.4300 See 870.4300

870.4100b Chronic Toxicity

(dog)

44848729, 44848730, 

44848731 (1998)

Acceptable/guideline

0, 200, 1000, or 5,000 

ppm

M: 0, 6.7, 35.9, or 183 

mg/kg/day 

F: 0, 7.43, 37.1, or 187 

mg/kg/day

NOAEL = 35.9 mg/kg/day in males and 37.1 

mg/kg/day in females.

LOAEL = 183 mg/kg/day in males and 187 

mg/kg/day in females based upon body weight gain 

depression and increased N-demethylase levels in 

both sexes, decreased T4 levels and marginally 

increased liver weight in females.

870.4200a Carcinogenicity (rat) See 870.4300 See 870.4300

870.4200b Carcinogenicity 

(mouse)

44848740, 44848741, 

44848742 (1998)

Acceptable/guideline

0, 50, 1000, or 7,000 ppm

M: 0, 12.2, 275, or 2,066 

mg/kg/day

F: 0, 22.6, 459, or 3,212 

mg/kg/day

NOAEL = 275 mg/kg/day in males and 459 

mg/kg/day in females.

LOAEL = 2,066 mg/kg/day in males and 3,212 

mg/kg/day in females based on decreased body 

weight in both sexes and increased food 

consumption in males.

No evidence of carcinogenicity.
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Guideline No. Study Type MRID No. (year)/ 

Classification/Doses Results

870.4300

Combined Chronic 

Toxicity/

Carcinogenicity (rat)

44848739, 44848743, 

44848744 (1998)

Acceptable/guideline 

M/F: 0, 2.5, 7.5, 125, or 

1,000 mg/kg/day

NOAEL = 125 mg/kg/day in males and females.

LOAEL = 1,000 mg/kg/day in males and females 

based on decreased body weight and increased food 

consumption in females, thickened mucosa of the 

glandular stomach in both sexes, inflammatory 

infiltrates (males), vacuolation of the squamous 

epithelium in the fore-stomach (females) and 

immunological effects in males. 

No evidence of carcinogenicity.

870.5100 Bacterial reverse 

mutation

44848803 (1993)

Acceptable/guideline

There was no evidence of induced mutant colonies 

over background.

870.5100 Bacterial reverse 

mutation

44848705 (1999)

Acceptable/guideline

MKH 10868, an animal, 

plant, and soil metabolite

There was no evidence of induced mutant colonies 

over background.

870.5300 In vitro mammalian 

cell gene mutation

44848804 (1996)

Acceptable/guideline

No increase in mutant frequency above that of 

negative controls up to the limit dose.

870.5375

In vitro mammalian 

chromosome 

aberration (RL)

44848805 (1996)

Acceptable/guideline

No increases in aberrant metaphases were observed 

up to the limit dose.

870.5395

Mammalian 

micronucleus 

(mouse)

44848806 (1996)

Acceptable/guideline 

There was no significant increase in the frequency 

of micronucleated polychromatic erythrocytes in 

bone marrow at 2000 mg/kg.

870.5550 Other genotoxicity 44848807 (1996)

Acceptable/guideline 

There was no evidence of unscheduled DNA 

synthesis up to cytotoxic levels.

870.6200a

Acute Neurotoxicity 

Screening Battery 

(rat)

44848809 (1998)

Acceptable/guideline

M & F: 0, 125, 500 or 

2000 mg/kg/day

NOAEL = 500 mg/kg/day for males and females.

LOAEL = 2000 mg/kg/day based on increased 

incidence of perianal staining in males, decreased 

motor activity and locomotor activity in both sexes 

and increase in the incidence of animals exhibiting 

low levels of activity in open field in both sexes.

870.6200b

Subchronic 

Neurotoxicity 

Screening Battery 

(rat)

44848808 (1998)

Acceptable/guideline

0, 250, 2000, or 20,000 

ppm

M: 0, 18.5, 147, or 1,482 

mg/kg/day

F: 0, 21.9, 174, or 1,736 

mg/kg/day

NOAEL = 147 mg/kg/day in males and 1,736 

mg/kg/day in females.

LOAEL = 1,482 mg/kg/day based on decreased 

body weight, decreased body weight gain, and 

decreased food consumption in males. LOAEL 

>1,736 mg/kg/day in females.

870.7485 Metabolism and 

Pharmacokinetics

44848830 (1998)

Acceptable/guideline

M & F: 17.5 mg/kg of 

phenyl-C

14; M: 398.5 

mg/kg of phenyl-C

14; M: 

Repeat 14 days of 

unlabeled followed by 

17.6 mg/kg of phenyl-C

14

. 

Also, bile fistula, plasma 

concentration and expired

air studies were 

conducted.

There were no sex-related differences in the 

absorption, distribution, metabolism, or excretion. 

Based on urinary excretion, absorption was 15-30% 

and maximum plasma concentrations were achieved 

within 30 minutes. At sacrifice, tissues and carcass 

contained less than 1% of radioactivity. The highest 

residue in the tissues was in the liver. Greater than 

90% of the administered dose was eliminated within 

24 hours. The major component in urine and feces 

was unchanged parent which represented 90-95% of 

the administered dose. 

870.7485 Metabolism and 

Pharmacokinetics

44848831 (1998)

Acceptable/nonguideline 

together with 44848830

M: 17.7 mg/kg of 

triazolinone-3-C

14

Major component in urine and feces was unchanged 

parent which represented 94% of the administered 

dose. Less than 1% of the administered dose was 

recovered in the carcass, tissues, expired air, or cage 

wash. Highest residue was in the liver.
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Guideline No. Study Type MRID No. (year)/ 

Classification/Doses Results

870.7485 Metabolism and 

Pharmacokinetics

44848833 (1998)

Acceptable/guideline

M: 5.13 mg/kg of phenylUL-C

14 MKH 6562 

sulfonamide lactate ( plant 

metabolite of MKH 6562)

Metabolized via two pathways. One pathway 

involved the oxidative decarboxylation of 

sulfonamide lactate to form sulfonamide acetate. 

The other pathway involved the hydrolysis of 

sulfonamide lactate and sulfonamide acetate to give 

sulfonamide.

870.7485 Metabolism and 

Pharmacokinetics

44848832 (1998)

Acceptable/guideline

M: 5 mg/kg of phenyl-C

14

MKH 6562 sulfonamide 

alanine (a plant metabolite 

of MKH 6562)

Approximately 70% absorption and elimination 

with 98% recovery in urine and feces. Several 

metabolites in addition to parent (17%). Less than 

1% of the administered dose was recovered in the 

carcass, tissues, expired air, or cage wash. Highest 

residue was in the liver.

870.7800 Immunotoxicity

44848703 (1999)

0, 15, 150, or 1,000 

mg/kg/day

NOAEL = >1,000 mg/kg/day.

LOAEL >1,000 mg/kg/day.

870.7800 Immunotoxicity

44848707 (1999)

0, 15, 150, or 1,000 

mg/kg/day

NOAEL = >1,000 mg/kg/day.

LOAEL >1,000 mg/kg/day.

870.7800 Immunotoxicity

44848704 (1999)

0, 15, 150, or 1,000 

mg/kg/day

NOAEL = >1,000 mg/kg/day.

LOAEL >1,000 mg/kg/day.

870.7800 Immunotoxicity

44848709 (1999)

0, 15, 150, or 1,000 

mg/kg/day

NOAEL = >1,000 mg/kg/day.

LOAEL >1,000 mg/kg/day.

870.7800 Immunotoxicity

44848810, 44848811, 

44848812 (1998)

0, 1000, 5000, or 20,000 

ppm

M: 0, 107, 510, or 2,205 

mg/kg/day

F: 0, 115, 612, or 2,556 

mg/kg/day

NOAEL = 2,205 mg/kg/day in males and 2,556 

mg/kg/day in females.

LOAEL >2,205 mg/kg/day in males and 2,556 

mg/kg/day in females.
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Attachment C. Summary of Toxicological Doses and Endpoints for Flucarbazone-sodium

for Use in Human health Risk Assessment (taken from 2009 risk assessment).

Exposure/ Scenario POD

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, 

LOC for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary

(females 13-49 

years of age)

NOAEL = 

300 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

aRfD = aPAD = 

3.0 mg/kg/day

Developmental Toxicity Study (Rabbit)

Developmental LOAEL = 500 mg/kg/day based 

on decreased fetal body weight and delayed 

ossification.

Chronic Dietary

(all populations)

NOAEL = 

35.9 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

cRfD = cPAD = 

0.36 mg/kg/day

Chronic Toxicity Study (Dog)

LOAEL = 183 mg/kg/day based on decreased 

body weight gain, decreased thyroxine, increased 

N-demethylase, and increased liver weight.

Incidental oral

Short- and 

Intermediate-term 

(1-30 days and 1-6 

months)

NOAEL = 

33.8 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

LOC for MOE 

= 100 

(Residential)

90-Day Oral Study (Dog)

LOAEL = 162 mg/kg/day based on decreased 

thyroxine, increased thyroxine-binding capacity, 

induction of microsomal liver enzymes, gross 

pathology and histopathology in the stomach, and 

histopathology in the liver.

Dermal 

Short- and 

Intermediate-term 

(1-30 days and 1-6 

months) 

NOAEL = 

33.8 mg/kg/day

(Dermal absorption 

= 25%)

UFA = 10X

UFH = 10X

FQPA SF = 1X

Residential and 

Occupational 

LOC for MOE 

= 100

90-Day Oral Study (Dog)

LOAEL = 162 mg/kg/day based on decreased 

thyroxine, increased thyroxine-binding capacity, 

induction of microsomal liver enzymes, gross 

pathology and histopathology in the stomach, and 

histopathology in the liver.

Dermal 

Long-Term (>6 

months)

NOAEL = 

35.9 mg/kg/day

(Dermal absorption 

= 25%)

UFA = 10X

UFH = 10X

FQPA SF = 1X

Residential and 

Occupational 

LOC for MOE 

= 100

Chronic Toxicity Study (Dog)

LOAEL = 183 mg/kg/day based on decreased 

body weight gain, decreased thyroxine, increased 

N-demethylase, and increased liver weight.

Inhalation

Short-, 

Intermediate-, and 

Long-Term (1-30 

days, 1-6 months, 

>6 months) 

NOAEL = 

0.03 mg/L 

(8.1 mg/kg/day1)

UFA = 10X

UFH = 10X

FQPA SF = 1X

Residential and 

Occupational 

LOC for MOE 

= 100 

Subchronic Inhalation Toxicity Study (Rat)

LOAEL = 0.18 mg/L (48.8 mg/kg/day) based on 

eosinophilic globules (nasal cavity) and 

squamous cell metaplasia (larynx) in males and 

females.

Cancer (oral, 

dermal, inhalation)

Not likely to be carcinogenic to humans (2000).

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

used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF = 

uncertainty factor. FQPA SF = FQPA Safety Factor. PAD = population-adjusted dose (a = acute, c = chronic). 

RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

1Calculated as follows: 0.03 mg/L * 45.2 L/hr/kg * 6 hr/day = 8.1 mg/kg/day.
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Attachment D: Summary of Residential Registered Flucarbazone-sodium Uses

Formulation Use Site Application 

Equipment Application Timing Max App Rate(lb ai/A) Comments

WDG

Residential turf sites 

(including homes, 

schools, playgrounds, 

parks, recreational 

areas and sports 

fields, common areas)

Handheld 

equipment

Postemergence application to 

actively-growing broadleaf 

and grass weeds that are in 

the seedling growth stage.

0.027 lb ai/A

Do not apply this product 

using aerial application 

equipment or through any 

type of irrigation system.

Attachment E: Summary of Occupational Registered Flucarbazone-sodium Uses

Formulation Use Site Application 

Equipment Application Timing Max App Rate(lb ai/A) REI Comments

WDG

Residential turf sites 

(including homes, 

schools, playgrounds, 

parks, recreational 

areas and sports fields, 

common areas)

Handheld 

equipment

Postemergence application to 

actively growing broadleaf

and grass weeds that are in 

the seedling growth stage.

0.027 lb ai/A N/A

Do not apply this 

product using aerial 

application equipment 

or through any type of 

irrigation system.

Golf courses

Groundboom, 

handheld 

equipment

Postemergence application to 

actively growing broadleaf 

and grass weeds that are in 

the seedling growth stage.

0.027 lb ai/A N/A

Sod farms

Groundboom, 

handheld 

equipment

Postemergence application to 

actively growing broadleaf 

and grass weeds that are in 

the seedling growth stage.

0.027 lb ai/A 12 hrs

Tree nurseries

Groundboom, 

handheld 

equipment

Postemergence application to 

actively growing broadleaf 

and grass weeds that are in 

the seedling growth stage.

0.027 lb ai/A 12 hrs

Wheat, spring

Groundboom

Apply prior to jointing, when 

the majority of plants have 

from one leaf to a maximum 

of 4 leaves on the main stem 

plus two tillers.

0.027 lb ai/A 12 hrs

Wheat, winter

Apply in the fall or spring 

when the majority of plants 

have one leaf to full tillering, 

but prior to jointing.

0.027 lb ai/A 12 hrs

WDG in 

Water 

Soluble 

Packets

Wheat, spring

Groundboom

Apply prior to jointing, when 

the majority of plants have 

from one leaf to a maximum 

of 4 leaves on the main stem 

plus two tillers.

0.027 lb ai/A 12 hrs Do not apply this 

product using aerial 

application equipment 

or through any type of 

irrigation system. Wheat, winter

Apply in the fall or spring 

when the majority of plants 

have one leaf to full tillering, 

but prior to jointing.

0.027 lb ai/A 12 hrs

Liquid Wheat, spring

Wheat, winter

Groundboom, 

Aerial

Apply after wheat emergence 

up to 4 leaf 2 tillered stage of

growth or prior to wheat 

jointing.

0.027 lb ai/A 12 hrs

Do not apply this 

product through any 

type of irrigation 

system.

Liquid Grasses grown for 

Seed

Groundboom, 

Aerial Postemergence. 0.027 lb ai/A 12 hrs SLNs in WA, OR, MN, and ID
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Attachment F: Flucarbazone-Sodium International Residue Limit Status

Flucarbazone-sodium (114009; 05-28-2013)

Summary of US and International Tolerances and Maximum Residue Limits. 

Residue Definition:

US Canada Mexico1 Codex

40 CFR §180.562: Combined residues of 

the herbicide flucarbazone-sodium, 4,5-

dihydro-3-methoxy-4-methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-1H1,2,4-triazole 1-carboxamide, sodium salt) 

and its N-desmethyl metabolite; and its 

metabolites converted to 2-

(trifluoromethoxy)benzene sulfonamide and 

calculated as flucarbazone-sodium 

4,5-dihydro-3-methoxy-4-

methyl-5-oxo-N-[[2-

(trifluoromethoxy)phenyl]su

lfonyl]-1H-1,2,4-triazole1-carboxamide, sodium salt

None

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico1 Codex

Cattle, liver 1.50 0.05

Cattle, meat 0.01 0.01

Cattle, meat byproducts, except liver 0.01 0.01

Goat, liver 1.50 0.05

Goat, meat 0.01 0.01

Goat, meat byproducts, except liver 0.01 0.01

Hog, liver 1.50 0.05

Hog, meat 0.01 0.01

Hog, meat byproducts, except liver 0.01 0.01

Horse, liver 1.50 0.05

Horse, meat 0.01 0.01

Horse, meat byproducts, except liver 0.01 0.01

Milk 0.005 0.0025

Sheep, liver 1.50 0.05

Sheep, meat 0.01 0.01

Sheep, meat byproducts, except 

liver

0.01 0.01

Wheat, forage 0.30

Wheat, grain 0.01 0.01

Wheat, hay 0.10

Wheat, straw 0.05

MRLs with No US Tolerances

Eggs 0.01

Meat byproducts of poultry 0.01

Meat of poultry 0.01

Completed: M. Negussie; 05/30/2013

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.