UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

Date: 

SUBJECT: 

FROM: 

June 10,2014 

Flumiclorac Pentyl: Registration Review Preliminary Risk Assessment. 

PC Code: 128724 DP Barcode: D409809 

Decision No.: 476006 Registration No.: NA 

Petition No.: NA Regulatory Action: Registration Review 

Risk Assessment Type: Single Case No.: 7232 

Chemical Aggregate 

TXRNo.: NA CAS No.: 87546-18-7 

MRIDNo.: NA 40 CFR: 180.477 

John 

William 

Liccione, 

H. Donovan, 

Ph.D., Tox

Ph.D., 

c9log~

Risk 

t 

As~~ss<J ~~ )A.!,!:JL ~~ ~~ 

Seyed 

Risk Assessment 

Tadayon, Chem

Branch 

ist 

V 

~ 

Health Effects Division (7509P) 

THROUGH: Matthew 

MichaelS. 

Lloyd, 

Metzger, 

CIH, 

Branch 

Industrial 

Chief 

Hyttg· ni 

t-

~ "":fi.~:..Jh'<-vRisk Assessment Branch V · 

Health Effects Division (7509P) 

TO: Eric Miederhoff, Chemical Review Manager 

Risk Management and Implementation Branch III 

Pesticide Re-evaluation Division (7508P) 

As part of Registration Review, the Pesticide Re-evaluation Division (PRD) of OPP has 

requested that HED evaluate the hazard and exposure data and conduct dietary, occupational, 

residential, and aggregate exposure assessments, as needed, to estimate the risk to human health 

that will result from the registered uses of flumiclorac pentyl. 

Page 1 of33 
EXECUTIVE SUMMARY 

The Health Effects Division (l-IED) has evaluated the current databases for the active ingredient 

flumiclorac pentyl to support the registration review of this active ingredient. Flumiclorac pentyl 

((2-chloro-4-fluoro-5-(1 ,3,4,5,6, 7 -hexahydro-1 ,3-dioxo-2H-isoindol-2-yl)phenoxy)acetic acid, 

pentyl ester] is an N-phenylphthalimide derivative herbicide used for the control of broadleaf 

weeds. 

Flumiclorac pentyl is registered for post-emergence application to field corn and soybeans, as a 

defoliant on cotton, as a Spring burndown herbicide prior to cotton, field corn, and soybean crop 

emergence, and for control ofbroadleafweeds, specifically morning glory and velvet leaf, in a 

variety of non-crop use sites including golf courses, parks, recreational areas, residential areas, 

schools, Christmas tree farms, sod farms, ornamental nurseries, industrial areas, commercial 

areas, rights-of-way, and habitat restoration and maintenance areas. The residue chemistry and 

occupational/residential exposure databases are considered complete. The hazard and exposure 

profiles for this active ingredient are adequately understood. There are no dietary (food and 

water), residential, aggregate, or occupational risks of concern associated with flumiclorac 

pentyl. 

The toxicology database for flumiclorac-pentyl is complete with the exception of a 28-day 

inhalation toxicity study. However, the Hazard and Science Policy Council (HASPOC) 

recommended in favor of a waiver of the inhalation study (TXR No. 0056913, dated March 20, 

2014). In determining the need for a subchronic inhalation study, EPA's Weight of Evidence 

(WOE) decision process included both hazard and exposure considerations as well as 

incorporation of a presumed lOX database uncertainty factor (UFos) for the lack of this study. 

Thus, the Agency's level of concern in the HASPOC's WOE evaluation for inhalation exposure 

risk assessment is a target MOE of 1,000 which includes the 1 OX inter-species extrapolation, 

1 OX intra-species variation, and the 1 OX UFoa. In case of flumiclorac pentyl, all handler 

occupational (MOE;::: 250,000) and residential (MOE ;::: 2,000,000) inhalation MOEs were higher 

than the LOC of 1000 when using an oral Point of Departure (POD). This indicates that the lack 

of an inhalation study does not reduce the overall confidence in the risk assessment or result in 

an uncertainty (i.e., that study will not provide a POD sufficiently low to result in a risk of 

concern). 

Human Studies Review 

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

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

the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1 ), the Agricultural Handler 

Exposure Task Force (AHETF) database, and the Residential SOPs (lawns and turf) are subject 

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

applicable ethics requirements. For certain studies that review may have included review by the 

Human Studies Review Board. Descriptions of data sources as well as guidance on their use can 

be found at http://www.epa.gov/pesticides/science/handler expos ure data.html and 

http://www.epa.gov/pesticides/science/post-app-exposure-data.html. 

Page 2 of33 
Page 3 of 33

Regulatory Recommendation

There are no human health risks of concern identified for flumiclorac pentyl. 

HED has evaluated the tolerances established for flumiclorac pentyl in 40 CFR §180.477 and 

recommends no changes to tolerance levels, crop listings, or the tolerance expression. Reevaluation of the livestock dietary burden confirms that no tolerances are needed for livestock 

commodities since flumiclorac pentyl uses may be classified under 40 CFR §180.6(a)(3); i.e., no 

expectation of finite residues in meat, milk, poultry or eggs. 

INTRODUCTION

Flumiclorac pentyl is an N-phenylphthalimide derivative herbicide used for the control of 

broadleaf weeds. Its mode of action is through the accumulation of porphyrins in susceptible 

plants; the photosensitizing action of accumulated porphyrins may cause membrane lipid 

peroxidation which leads to irreversible damage of membrane function and structure in the plant. 

The most recent comprehensive human health risk assessment for flumiclorac pentyl was

prepared in support of the Tolerance Reassessment Eligibility Document (TRED) (D302019, J. 

Liccione et. al., 6/28//05). In 2009, HED completed a Scoping Document that evaluated the 

available data and risk assessments for flumiclorac pentyl (D368451, W. Donovan et. al.,

8/28/09) and concluded that the only data needed were the standard toxicology studies required 

by the Revised Part 158 Toxicology Data Requirements for Conventional Pesticides. The 

Scoping Document also noted that the livestock dietary burden should be updated in registration 

review to reflect the substantial reduction in the maximum amount of cotton gin byproducts fed 

to livestock as reflected in the June 2008 update to Table 1. These topics have been addressed in 

this risk assessment. 

As part of the current review, the flumiclorac pentyl risk assessment team revised the residue of 

concern determination for the drinking water assessment. EFED has provided new estimated 

drinking water concentrations (EDWCs) for flumiclorac pentyl and these values have been 

incorporated into the current dietary and aggregate risk assessments.

 

USE INFORMATION

Flumiclorac pentyl is registered for post-emergence application to field corn and soybeans, as a 

defoliant on cotton, as a Spring burndown herbicide prior to cotton, field corn, and soybean crop 

emergence, and for control of broadleaf weeds, specifically morning glory and velvet leaf, in a 

variety of non-crop use sites including golf courses, parks, recreational areas, residential areas, 

schools, Christmas tree farms, sod farms, ornamental nurseries, industrial areas, commercial 

areas, rights-of-way, and habitat restoration and maintenance areas. Table 1 summarizes the 

maximum use patterns considered in this assessment. 
Page 4 of 33

Table 1. Maximum Use Patterns for Current Uses of Flumiclorac Pentyl

Product 

Label

(EPA Reg. 

No.);

Formulation

Active 

Ingredient 

(%)

Use

Max. Single 

App. Rate

(lbs a.i./A)

Max. 

Annual 

App. Rate 

(lbs a.i./A)

A

App. 

Interval 

(days)

PHI

(days)

Additional 

Application 

DirectionsC

Resource 

(59639-82);

Emulsifiable 

Concentrate

Flumiclorac 

pentyl ester

(10.1% by 

wt.)

Field corn 0.040 0.054

14

10-leaf stage Aerial or ground 

Aerial applications 

may not exceed 

0.054 lbs a.i./A.

Do not apply by 

any irrigation 

system.

12 hour REI

30-day PBI

Soybeans 0.081 0.11 60

Spring burndown

[proposed use directions B]

0.027

[0.081 B]

Not stated

[0.11 B]

Not stated

[7 B]

NA

Cotton 0.054 0.094 7 7

Stellar

(59639-92);

Emulsifiable 

Concentrate

Flumiclorac 

pentyl ester

(7.6% by wt.)

and lactofen 

(26.6% by 

wt.)

Soybeans 0.038 0.055 14 60

Ground 

Do not apply by air 

or by any irrigation 

system.

12 hour REI

30-day PBI

Resource 80 

WP

(59639-100);

Wettable 

Powder

Flumiclorac 

pentyl ester

(80% by wt.)

Corn 0.054 0.054

14

10-leaf stage Ground 

Do not apply by air 

or by any irrigation 

system.

12 hour REI

30-day PBI

Soybeans 0.081 0.11 60

V-10097

(59639-122);

Emulsifiable 

Concentrate

Flumiclorac

pentyl ester

(0.576% by 

wt.) and 

glyphosate 

(40.700% by 

wt.)

Corn 0.014 0.028

14

10-leaf stage

Aerial or ground 

Do not apply by 

any irrigation 

system.

Cut stump 

treatments may be 

made on any site 

listed on this label.

Do not apply 

directly to or over 

ornamentals.

12 hour REI

30-day PBI

Soybeans 0.042 0.042 60

Spring burndown

[proposed use directions B]

0.028 Not stated

[0.056 B]

Not stated

[7 B]

NA

Golf courses, parks, 

recreational areas, 

residential areas, schools, 

Christmas tree farms, sod 

farms, ornamental 

nurseries, industrial areas, 

commercial areas, rightsof-way, habitat restoration 

and maintenance areas

[proposed use directions B]

0.028 Not stated

[0.056 B]

Not stated

[7 B]

NA

A Labels provide seasonal application rate limits that approximate annual limits.

B

 Proposed [bracketed and footnoted] label directions are intended for the next stamped label. The current label 

directions are not bracketed.

C

 REI = Re-entry Interval; PBI = Plant-back Interval.
Page 5 of 33

HAZARD CONSIDERATIONS

Available studies for flumiclorac-pentyl include: 1) subchronic oral toxicity study in the rat, 2)

chronic/carcinogenicity studies in rats and mice, 3) subchronic and chronic oral toxicity studies 

in the dog, 4) developmental and reproduction studies in rats, 5) a developmental study in 

rabbits, 6) acute neurotoxicity and subchronic neurotoxicity studies in the rat, 7) an 

immunotoxicity study, 8) a 21-day dermal study in the rat, 9) acute “six-pack” studies, 10) 

several metabolism studies in the rat, and 11) a mutagenicity battery. 

The toxicological database for flumiclorac pentyl is considered complete for characterization of 

potential developmental, reproductive, carcinogenetic, mutagenic, neurotoxic, and immunotoxic 

effects. 

Toxicity in the dogs was manifested as significant decreases in body weight (males) and 

alterations in activated partial thromboplastin time (females), a measurement of clotting time in 

the plasma. Prolongation of activated partial thromboplastin time was noted in female dogs 

administered 1000 mg/kg/day for 90 days or for 1 year. Long-term administration of flumiclorac 

at high doses to female rats resulted in urinary incontinence, increased water consumption, 

increased urine volume and increased kidney weights. Male rats treated with high doses 

displayed increased squamous epithelial cells in urinary sediment, increased urine volume and 

increased kidney weights. 

No dermal or systemic toxicity was observed in rats in the 21/28 day dermal toxicity up to the 

limit dose (1000 mg/kg/day).

There is no concern for increased quantitative or qualitative susceptibility of the young following 

in utero (rats and rabbits) and pre-and post-natal exposure (rats) to flumiclorac pentyl. Also, 

there is no evidence of developmental toxicity, reproductive toxicity, neurotoxicity, or 

immunotoxicity at dose levels that do not exceed the limit dose. The Food Quality Protection Act 

(FQPA) safety factor has been reduced to 1X. 

Flumiclorac pentyl is negative for carcinogenicity in rats and mice, and it did not show any 

genotoxic potential (classified as not likely to be carcinogenic to humans). 

Flumiclorac pentyl has low acute toxicity with no deaths occurring near the limit dose in oral, 

inhalation, and dermal studies. Clinical signs of toxicity suggestive of irritation were observed 

only in animals treated by inhalation. The chemical caused slight eye irritation, which cleared 

after 24 hours. It is a dermal sensitizer.

Flumiclorac pentyl metabolism in the rat shows low tissue accumulation (highest in blood, 

plasma, and kidney), rapid excretion in urine and feces, and extensive metabolic transformation 

consisting of (1) cleavage of the ester linkage, (2) cleavage of the imide bond, (3) hydroxylation, 

and (4) sulfonation. 

An acute reference dose (aRfD) was not established, since an endpoint attributable to a single 

exposure was not identified from the available database. A chronic reference dose (cRfD) of 1.0 
Page 6 of 33

mg/kg/day was established for flumiclorac pentyl based on the NOAEL of 100 mg/kg/day in the 

chronic dog study and an uncertainty factor of 100 (10X for interspecies extrapolation and 10X 

for intraspecies variation). Decreased body weight gain in males, and increased clotting time 

(males and females), and increased globulin levels and alpha-2 fraction of the serum protein 

electrophoresis occurred in this study at the LOAEL of 1000 mg/kg/day. 

The flumiclorac pentyl toxicity profile tables are included in this memo in Appendix A. The 

toxicity endpoints for risk assessment are shown in Tables 2 and 3. 

Table 2. Toxicological Doses and Endpoints for Flumiclorac-Pentyl 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)

No appropriate endpoint identified for this population. 

Acute Dietary

(Females 13-49 

years of age)

No appropriate endpoint identified for this population.

Chronic Dietary 

(All 

Populations)

NOAEL= 100

mg/kg/day

Total UF: 100X

UFA= 10x

UFH=10x

FQPA SF=1x

Chronic RfD = 1.0

mg/kg/day

cPAD

= 1.0 mg/kg/day

Chronic Dog 

LOAEL = 1000 mg/kg/day 

based on decreased body 

weight gain (males), increased 

clotting time (males and 

females), and increased 

globulin levels and increased 

alpha-2 fraction of the serum 

protein electrophoresis 

(females)

Incidental Oral 

(all durations)

NOAEL= 100

mg/kg/day

Total UF: 100X

UFA= 10x

UFH=10x

FQPA SF=1x

Chronic RfD = 1.0

mg/kg/day

cPAD

= 1.0 mg/kg/day

Chronic Dog 

LOAEL = 1000 mg/kg/day 

based on decreased body 

weight gain (males), increased 

clotting time (males and 

females), and increased 

globulin levels and increased 

alpha-2 fraction of the serum 

protein electrophoresis 

(females)

Dermal (all 

durations)

No hazard quantitation is required for any duration. No systemic effects were observed in the 21-day 

dermal rat study at dose levels up to 1000 mg/kg/day. There are no developmental or reproductive 

toxicity concerns. There are no long-term dermal exposures to flumiclorac pentyl in humans. 
Page 7 of 33

Table 2. Toxicological Doses and Endpoints for Flumiclorac-Pentyl 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

Inhalation (all 

durations)

NOAEL= 100

mg/kg/day

Total UF: 100X

UFA= 10x

UFH=10x

FQPA SF=1x

Chronic RfD = 1.0

mg/kg/day

cPAD

= 1.0 mg/kg/day

Chronic Dog 

LOAEL = 1000 mg/kg/day 

based on decreased body 

weight gain (males), increased 

clotting time (males and 

females), and increased 

globulin levels and increased 

alpha-2 fraction of the serum 

protein electrophoresis 

(females)

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be carcinogenic to humans.”

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. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. 

Table 3. Summary of Toxicological Doses and Endpoints for Flumiclorac-Pentyl for Use in Occupational 

Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of Concern 

for Risk 

Assessment

Study and Toxicological Effects

Dermal (all 

durations)

No hazard quantitation is required for any duration. No systemic effects were observed in the 

21-day dermal rat study at dose levels up to 1000 mg/kg/day. There are no developmental or 

reproductive toxicity concerns. There are no long-term dermal exposures to flumiclorac pentyl 

in humans.

Inhalation (all 

durations)

NOAEL= 

100

mg/kg/day

(100% 

absorption 

assumed)

UFA=10x

UFH=10x

Occupational 

LOC for MOE = 

100

Chronic Dog 

LOAEL = 1000 mg/kg/day based on 

decreased body weight gain (males), 

increased clotting time (males and 

females), and increased globulin levels 

and increased alpha-2 fraction of the 

serum protein electrophoresis (females)

Cancer (oral, 

dermal, 

inhalation)

Classification: Not likely to be carcinogenic to humans. The cRfD is considered protective of 

potential cancer effects.

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. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). DAF = dermal absorption factor. MOE = 

margin of exposure. LOC = level of concern. 
Page 8 of 33

Endocrine Disruption

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

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

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

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

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

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

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

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

taxonomic groups. As part of its reregistration decision for flumiclorac pentyl, EPA reviewed 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals 

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

scheduled for registration review and chemicals found in water. Neither of these lists should be 

construed as a list of known or likely endocrine disruptors.

METABOLISM CONSIDERATIONS

The 2005 TRED identified parent flumiclorac pentyl as the only residue of concern in plants and 

livestock. For drinking water the residue of concern was flumiclorac pentyl and IMCA. The 

flumiclorac pentyl risk assessment team has confirmed the earlier decision for plants and 

livestock. However, as detailed recently (D417544, W. Donovan and J. Liccione, 27-JAN2014), in consultation with EFED, the residue of concern for drinking water has been expanded 

to include the following: flumiclorac pentyl, IMCA, 031-HA, IMCA-HA, IMFP, IMFP-HA, and 

 

1

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

chemicals.
Page 9 of 33

SAT IMFP-HA (Appendix E). The decision to include the additional degradates was based on 

the structural similarity to the parent compound and the relative abundance of these compounds 

found in soil and water studies. Table 4 summaries the residues of concern selected for 

flumiclorac pentyl.

Table 4. Summary of Metabolites and Degradates to be included in the Risk 

Assessment and Tolerance Expression

Matrix Residues included in Risk Assessment

Residues included in 

Tolerance Expression

Plants

Flumiclorac pentyl Flumiclorac pentyl

Livestock

Flumiclorac pentyl Flumiclorac pentyl

Drinking 

Water

Flumiclorac pentyl, IMCA, 031-HA, IMCA-HA, 

IMFP, IMFP-HA, and SAT IMFP-HA

Not Applicable

RESIDUE CHEMISTRY CONSIDERATIONS

The flumiclorac pentyl residue chemistry database is complete. The nature and magnitude of the 

residue in plants has been adequately delineated. The residue of concern in plants and livestock

is the parent compound only. Adequate storage stability, method validation data and processing 

studies have been submitted. An adequate GC/NPD (Gas Chromatography/Nitrogen-Phosphorus 

Detector) analytical method, which has undergone successful independent laboratory validation

(ILV) and successful EPA/BEAD validation, is available to enforce the established tolerances. 

The stability of flumiclorac pentyl in frozen storage is matrix dependent, with stability to two 

years in soybean, 30-45 days in corn, and 2-4 months in cotton matrices. Processing studies for 

corn, soybean, and cotton indicate residue concentration in soybean hulls as reflected by the 0.02 

ppm tolerance level for this processed commodity. Confined rotational crop studies showed low 

levels of residue uptake supporting a 30-day plant back interval (PBI) for unlabeled crops. 

The 2009 flumiclorac pentyl scoping document noted that all residue chemistry data 

requirements had been met and that the livestock dietary burden should be updated in registration 

review to reflect the reduced usage of cotton gin byproducts as a feedstuff. Appendix D presents 

the updated dietary burden calculations for flumiclorac pentyl based on current procedures. The 

maximum dietary burden to cattle is now 0.044 ppm, which is significantly less than the previous 

value of 0.73 ppm. Thus, the previous conclusion that there is no reasonable expectation of 

finite residues in livestock commodities is strengthened when using current procedures. Since 

2009, no new crop uses have been requested for flumiclorac pentyl; accordingly, the residue 

chemistry database for flumiclorac pentyl remains complete.
Page 10 of 33

No CODEX or Canadian MRLs have been set for flumiclorac pentyl (Appendix C). As a result, 

no international harmonization issues are expected. 

Water Residue Profile

Environmentally, flumiclorac pentyl has very low water solubility and is expected to degrade 

quickly through multiple fate processes (with half-lives of hours to several days) under 

environmental conditions. There are no monitoring data available, thus drinking water 

concentrations were estimated using models. 

The flumiclorac pentyl residues of concern (ROC) in drinking water include the parent 

compound and the six major degradates with an intact imido/carboxamido bridge: flumiclorac

acid (IMCA), 031-HA, IMCA-HA, IMFP, IMFP-HA, and SAT IMFP-HA (USEPA, 2014). 

EFED made use of the Total Residues of Concern (TRC) modeling approach to estimate aquatic 

exposure with the ROC half-lives, the soil mobility of flumiclorac acid, and the 

physical/chemical properties of flumiclorac pentyl (D414425, G. Orrick, 04-MAR-2014). The 

TRC approach was selected because there are multiple degradates of concern, none of which 

have a full environmental fate data profile.

Surface and ground water EDWCs for use in the human health risk assessment for flumiclorac 

pentyl are shown in Table 5. The surface water EDWCs are recommended for use in the dietary 

assessments since these values are protective for potential ground water residue levels. Thus, the 

recommended acute EDWC is 9.0 ppb and the chronic EDWC is 1.3 ppb, as indicated by Tier 1 

computer modeling results.

Table 5. Summary of Estimated Surface Water and Ground Water Concentrations for Flumiclorac 

pentyl

Scenario Surface Water Conc., ppb a Ground Water Conc., ppb b

Acute 9.0 0.5

Chronic (non-cancer) 1.3 0.45

a From the Tier I FIRST model (Soybeans (0.11 lbs a.i./A))

b From the Tier I PRZM-GW model (Soybeans (0.11 lbs a.i./A)) [acute] and Tier I SCI-GROW model 

[chronic]

Highest value for use in risk assessment is in bolded

Dietary Risk Assessment

A chronic aggregate dietary food and drinking water exposure and risk assessment was 

conducted using the Dietary Exposure Evaluation Model software with the Food Commodity 

Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption 

data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in America, (NHANES/WWEIA). 
Page 11 of 33

No acute dietary exposure and risk analysis was performed since there were no appropriate 

studies identified in the toxicology database that demonstrated evidence of toxicity attributable to 

a single dose. The chronic dietary exposure and risk analysis was based on tolerance-level 

residues, 100% crop treated assumptions, and default processing factors (1 for all commodities 

except field corn syrup/syrup-babyfood where 1.5 was used). Estimates of residues in drinking 

water were directly incorporated in the assessments. Using conservative assumptions, the 

chronic dietary risk estimates were <1% of the chronic population adjusted dose (cPAD) for all 

population subgroups (see Table 6). Generally, HED is concerned when dietary risk estimates 

exceed 100% of the PAD; therefore, the chronic dietary risk estimates for flumiclorac pentyl are 

below HED’s level of concern (LOC) for all population subgroups, including those comprised of 

infants and children.

Table 6. Summary of Estimated Dietary (Food + Drinking Water) Exposures and Risk for Flumiclorac pentyl 

Population Subgroup cPAD, 

mg/kg/day

Chronic Estimates

Dietary Exposure 

(mg/kg/day) % cPAD

U.S. Population

1

0.000057 <1

All infants (< 1 year old)* 0.000123 <1

Children 1-2 yrs old 0.000107 <1

Children 3-5 yrs old 0.000103 <1

Children 6-12 yrs old 0.000075 <1

Youth 13-19 yrs old 0.000054 <1

Adults 20-49 yrs old 0.000053 <1

Adults 50-99 yrs old 0.000043 <1

Females 13-49 yrs old 0.000051 <1

*The subpopulation with the highest risk estimates.

Residential (Non-Occupational) Exposure/Risk Characterization

Flumiclorac pentyl may be applied in residential settings (EPA Reg. No. 059639-122). HED 

determined that adults and children (toddlers) could potentially be exposed to flumiclorac pentyl 

based on occupational use in the following use sites: golf courses, parks, recreational areas, 

lawns and turf, on ornamental plants and school grounds. No dermal or inhalation assessment 

was conducted since no dermal endpoint was selected and outdoor postapplication inhalation 

exposure is anticipated to be negligible. A residential handler assessment has been included to 

cover the possibility of non-occupational applications around residential premises since the 

product is not a restricted use product. The residential handler and residential post-application 

exposure assessments have been conducted according to HED’s 2012 Residential Standard 

Operating Procedures (SOPs)2. 

Residential Handler Exposure

The registered uses of flumiclorac pentyl on turf and ornamentals may result in residential 

handler exposure. Residential handler exposure is expected to be short-term in duration as 

 

2 Available: http://www.epa.gov/pesticides/science/residential-exposure-sop.html
Page 12 of 33

intermediate- or long-term exposures are not likely because of the intermittent nature of 

applications by homeowners. Residential handlers are assumed to be wearing short-sleeved 

shirts, short pants, shoes and socks during application of flumiclorac pentyl (i.e., no protective 

equipment). The assessments were conducted assuming the maximum application rate (0.028 lbs 

ai/acre, 0.0056 lbs ai/gallon) and used unit exposure values and estimates for area treated or 

amount handled along with algorithms taken from HED’s 2012 Residential SOPs. 

The quantitative exposure/risk assessment developed for residential handlers is based on the 

following scenarios: 

 Mixing/Loading/Applying Liquid to turf and ornamentals with Hose-End Sprayer

 Mixing/Loading/Applying Liquid to turf and ornamentals with Manually-pressurized 

handwand

 Mixing/Loading/Applying Liquid to turf and ornamentals with Backpack

 Mixing/Loading/Applying Liquid to turf and ornamentals with a Sprinkler Can

Since no dermal hazard was identified for flumiclorac pentyl in the toxicological database, only 

quantitative inhalation exposure assessments were conducted for residential handlers. Inhalation 

margins of exposure (MOEs) are above the LOC of 100 for all scenarios assessed and are not of 

concern (MOEs ≥ 100). Short-term inhalation residential handler estimated exposure and risk 

estimates are shown in Table 7 below.

Table 7. Short-Term Residential Handler Non-cancer Exposure and Risk Estimates for Flumiclorac pentyl

Exposure Scenario Level of 

Concern

Inhalation 

Unit 

Exposure 

(mg/lb ai)

Maximum 

Application 

Rate1

(lbs ai/gallon or 

lb ai/A)

Area Treated 

or Amount 

Handled 

Daily2

(gallons or A)

Inhalation

Dose 

(mg/kg/day)3 MOE4

Mixer/Loader/Applicator

Manually-pressurized 

handwand

100

0.018 0.0056 5 gal. 0.0000063 16,000,000

Hose-end Sprayer 0.0014 0.028 lb ai/A 0.5 A 0.0000039 26,000,000

Backpack 0.14 0.0056 5 gal. 0.000049 2,000,000

Sprinkler can 0.022 0.028 lb ai/A 0.023 A 

(1000 ft2)

0.00000018 570,000,000

1 Based on registered labels.

2 Based on HED’s 2012 Residential SOPs 

3 Inhalation Dose = Inhalation Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or gal) × Area Treated or Amount 

Handled (A/day or gallons/day) ÷ BW (80 kg)

4 Inhalation MOE = Inhalation NOAEL (100 mg/kg/day) ÷ Inhalation Dose (mg/kg/day)

Post-Application Exposure

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

an environment that has been previously treated with flumiclorac pentyl. The quantitative 

exposure/risk assessment for residential post-application exposures includes the following 

scenario: 

 Incidental ingestion (i.e., hand-to-mouth, object-to-mouth, soil ingestion exposure) from 

contact with treated turf 
Page 13 of 33

Residential Post-application Exposure for Turf Use

Residential Post-application Exposure Data and Assumptions for Turf Use

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 

SOPs2.

Chemical-specific TTR Data 

There is no chemical specific TTR data available for flumiclorac pentyl.

Combining Exposure and Risk Estimates

There is no potential hazard via the dermal route for flumiclorac pentyl. Only incidental oral risk

estimates were quantitatively assessed. The incidental oral scenarios (i.e., hand-to-mouth and 

object-to-mouth) should be considered inter-related and it is likely that they occur interspersed 

amongst each other across time. Combining these scenarios would be overly-conservative 

because of the conservative nature of each individual assessment. 

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

The residential post-application risk estimates are not of concern for flumiclorac pentyl (MOEs 

are greater than the level of concern of 100) for all incidental oral scenarios.

Table 8. Residential Post-application Non-cancer Exposure and Risk Estimates for Flumiclorac pentyl

Lifestage

Post-application Exposure 

Scenario

Application 

Rate (lb 

ai/A)1

Dose 

(mg/kg/day)2 MOEs3 Combined Routes

Combined 

MOEs Use Site Route of Exposure

1 to <2 years Turf

Hand-to-Mouth

0.028

0.0004 250,000

Object-to-Mouth 0.000001 7,700,000 NA NA

Soil Ingestion 0.00000095 110,000,000

1 Based on registered label.

2 Dose equations can be found in Appendix F.

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

Residential Risk Estimates for Use in Aggregate Assessment

Table 9 shows the residential risk estimates that are recommended for use in the aggregate 

assessment for flumiclorac pentyl.

 The recommended residential exposure for use in the adult (male and female) aggregate

assessment reflects inhalation exposure from mixing/loading/applying the liquid 

flumiclorac pentyl formulation with a backpack sprayer. 

 The recommended residential exposure for use in the children aggregate assessment 

reflects oral exposure from hand-to-mouth activity on turf. 
Page 14 of 33

Table 9. Recommendation for the Short-Term Residential Exposures for the Flumiclorac pentyl Aggregate 

Assessment1

Lifestage

Residential

Dose (mg/kg/day)2 MOE3

Dermal Oral Inhalation Total Dermal Oral Inhalation Total

Short-Term

Adult Handler N/A NA 0.000049 0.000049 N/A NA 2,000,000 2,000,000

Children 1-2 NA 0.0004 NA 0.0004 NA 250,000 NA 250,000

1 Bolded risk estimates should contribute to the residential exposure portion of the aggregate assessment. 

2 Residential Dose = the highest dose for each applicable lifestage of all scenarios assessed from Tables 7 and 8. Total = dermal + oral +

inhalation.

3 Residential MOE = the MOEs associated with the highest doses identified in Tables 7 and 8.. Total = 1 ÷ (1/Dermal MOE) + (1/Inhalation 

MOE) + (1/Oral MOE)).

Residential Bystander Post-application Inhalation Exposure

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for flumiclorac pentyl at this time primarily because of the low 

acute inhalation toxicity (Toxicity Category IV), low vapor pressure (1 x 10-7 mm Hg @ 22.4

oC), and the low registered use rate (0.081 lb ai/A). However, volatilization of pesticides may 

be a source of post-application inhalation exposure to individuals nearby pesticide applications. 

The Agency sought expert advice and input on issues related to volatilization of pesticides from 

its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in 

December 2009, and received the SAP’s final report on March 2, 20103. The Agency is in the 

process of evaluating the SAP report and may, as appropriate, develop policies and procedures to 

identify the need for and, subsequently, the way to incorporate post-application inhalation 

exposure into the Agency's risk assessments. If new policies or procedures are developed, the 

Agency may revisit the need for a quantitative post-application inhalation exposure assessment 

for flumiclorac pentyl

Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations. 

This is particularly the case with aerial application, but, to a lesser extent, could also be a 

potential source of exposure from the ground application method employed for flumiclorac 

pentyl. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices 

and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift 

management practices (see the Agency’s Spray Drift website for more information4). The 

Agency has completed its evaluation of the new database submitted by the Spray Drift Task 

Force, a membership of U.S. pesticide registrants, and is developing a policy on how to 

appropriately apply the data and the AgDRIFT computer model to its risk assessments for 

pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in 

place, the Agency may impose further refinements in spray drift management practices to reduce 

off-target drift with specific products with significant risk estimates associated with drift.

It is noted that the 0.028 lb ai/acre application rate for turf was modeled to estimate postapplication residential exposure of toddlers. As this rate is similar to the agricultural application 

 

3 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html

4 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htm 
Page 15 of 33

rates, this scenario is protective of any exposure of farm children via spray drift from agricultural 

flumiclorac pentyl applications.

Aggregate Exposure/Risk Characterization

In accordance with the FQPA, HED must aggregate pesticide exposures and risks from three 

major sources: food, drinking water, and residential exposures. In an aggregate assessment, 

exposures from relevant sources are added together and compared to quantitative estimates of 

hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When aggregating 

exposures and risks from various sources, HED considers both the route and duration of 

exposure. For flumiclorac pentyl, potential exposures from food, drinking water, and residential 

scenarios were aggregated. This assessment incorporates the changes in the new Residential 

SOPs implemented in January of 2012. 

Acute Aggregate Risk

An acute aggregate risk assessment is not required for flumiclorac pentyl as no toxic effects 

attributable to a single dose were identified. 

Short-Term Aggregate Risk

There is a potential for short-term exposure to flumiclorac pentyl via dietary and residential 

exposure pathways. To estimate short-term aggregate risk, HED therefore combined chronic 

dietary (food and water) exposures (as a measure of average background dietary exposure) with 

short-term residential exposures. These pathways lead to exposure via oral and inhalation routes 

only, since no dermal hazard has been identified for flumiclorac pentyl

The most conservative residential exposure scenario was chosen for the adult population which 

reflects inhalation exposure from mixing/loading/applying the liquid flumiclorac pentyl 

formulation with a backpack sprayer. For background dietary exposure, the adult sub-population 

with the highest exposure, adults 20-49 years old, was chosen since this is protective for all other 

adult sub-populations. There is potential for residential exposure to children through several 

post-application scenarios following turf treatment. Calculated hand-to-mouth activity provides

the highest exposure and dose estimate for children 1-2 years old, so this exposure scenario was 

aggregated with background dietary exposure to assess short-term aggregate risk to children.

Short-term aggregate margins of exposure for adults and children are above the LOC of 100 and 

are not of concern (MOEs ≥ 100). Short-term estimated exposures and risks are shown below in 

Table 10. 
Page 16 of 33

Table 10. Short-Term Aggregate Risk Calculations

Population

Short- Term Scenario

NOAEL 

mg/kg/day LOC1

Max 

Allowable 

Exposure2

mg/kg/day

Average 

Food and 

Water 

Exposure3

mg/kg/day

Residential 

Exposure4

mg/kg/day

Total 

Exposure5

mg/kg/day

Aggregate 

MOE (food, 

water, and 

residential) 6

Adult 20-49 100 100 1 0.000053 0.000049 0.000102 980,000

Children 1-2 100 100 1 0.000107 0.0004 0.000507 200,000

1 Intraspecies factor= 10x; Interspecies factor = 10x

2 Maximum Allowable Exposure (mg/kg/day) = NOAEL (100 mg/kg/day)/LOC (100)

3 Average food and water exposure for adults = chronic dietary exposure for adults 20-49 (the highest exposed adult 

sub-population); for children = chronic dietary exposure for children1-2 years old, since all infants are assumed to 

have negligible residential postapplication exposure to residues following turf applications. See Table 6. 

4 Residential Exposure = Inhalation exposure for adults; oral exposure for children. See Table 9. 

5 Total Exposure = Avg Food & Water Exposure + Residential Exposure)

6 Aggregate MOE = NOAEL/(Avg Food & Water Exposure + Residential Exposure)

Chronic Aggregate Risk

As there are no uses that are expected to result in long-term residential exposure, long-term 

(chronic) aggregate risk includes only chronic dietary (food and water) exposure. As noted

previously, there are no chronic dietary risks of concern for flumiclorac pentyl.

Cumulative Exposure/Risk Characterization

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 flumiclorac pentyl and any other substances and flumiclorac pentyl does not appear to 

produce a toxic metabolite produced by other substances. For the purposes of this action,

therefore, EPA has not assumed that flumiclorac pentyl 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/.

Occupational Exposure/Risk Characterization

An occupational exposure and risk assessment was conducted to support the registered uses of 

flumiclorac pentyl. 

Short-/Intermediate- Term Handler Risk

Flumiclorac pentyl is an N-phenylphthalimide derivative herbicide used for the control of 

broadleaf weeds. Application methods, maximum application rates and use sites were 

summarized previously in Table 1. The occupational exposure and risk assessment generally 

addresses risks to workers exposed in an occupational setting via the dermal and inhalation 

routes of exposure. However, since no dermal hazard was identified in the toxicity database for 
Page 17 of 33

flumiclorac pentyl, a quantitative dermal assessment is not required and risks were quantitatively 

assessed for inhalation exposure only. Based on the registered use pattern of flumiclorac pentyl, 

short- and intermediate-term exposures are anticipated. Long-term exposure is not expected for 

the registered use patterns. 

Estimates of inhalation exposure were calculated for various levels of personal protective 

equipment (PPE). Results are presented for “baseline” level of attire defined as a single layer of 

clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no protective gloves, and 

no respirator, as well as closed system (i.e., engineering control). For aerial applicators, closed 

cockpit was assessed (i.e., engineering control). Wettable powder formulation is packaged in 

water soluble bags (i.e., engineering control). The flumiclorac pentyl product labels direct 

mixers, loaders, applicators and other handlers to wear long-sleeved shirts, long pants, protective 

eyewear, chemical-resistant gloves, and shoes plus socks.

All application equipment must use lock and load engineering controls. All wettable powder 

formulations must be packaged in water soluble bags. Closed cabs are required for all ground 

equipment.

All occupational handler scenarios assessed for the registered uses of flumiclorac pentyl

resulted in estimated inhalation margins of exposure (MOEs) above the LOC of 100 for all 

scenarios assessed and, therefore, are not of concern (MOEs ≥100). Occupational handler risk 

estimates are shown in Table 11. 
Page 18 of 33

Table 11. Occupational Handler Non-Cancer Exposure and Risk Estimates for Flumiclorac Pentyl.

Exposure 

Scenario Crop or Target

Inhalation Unit 

Exposure 

(μg/lb ai)1

Maximum

Application 

Rate2

Area 

Treated 

or 

Amount 

Handled 

Daily3

Inhalation

Baseline Dose 

(mg/kg/day)4 MOE5

Mixer/Loader

Aerial

Corn, Cotton 

0.219

0.054 lb ai/acre 1200 0.000178 560,000

Soybeans 0.081lb ai/acre 0.000266 380,000

Sod 0.028 lb ai/acre 350 0.0000269 3,700,000

Corn, Cotton 0.24 (WP in 

WSB)

0.054 lb ai/acre 1200 0.000195 510,000

Soybeans 0.081lb ai/acre 0.000291 340,000

Groundboom

Corn, Cotton 

0.219

0.054 lb ai/acre

200

0.0000296 3,400,000

Soybeans 0.081lb ai/acre 0.0000444 2,300,000

Sod 0.028 lb ai/acre 80 0.00000614 16,000,000

Corn, Cotton 0.24

(WP in WSB)

0.054 lb ai/acre

200

0.0000324 3,100,000

Soybeans 0.081lb ai/acre 0.0000486 2,100,000

Chemigation

Corn, Cotton 

0.219

0.054 lb ai/acre

350

0.0000518 1,900,000

Soybeans 0.081lb ai/acre 0.0000776 1,300,000

Sod 0.028 lb ai/acre 0.0000269 3,700,000

Corn, Cotton 0.24

(WP in WSB)

0.054 lb ai/acre 0.0000568 1,800,000

Soybeans 0.081lb ai/acre 0.000085 1,200,000

Applicator

Aerial

Corn, Cotton 0.0049 0.054 lb ai/acre 1200 0.000004 2,500,000

Soybeans 0.081lb ai/acre 0.000006 17,000,000

Sod 0.028 lb ai/acre 350 0.0000006 170,000,000

Groundboom

Corn, Cotton 

0.043

0.054 lb ai/acre 200 0.0000459 2,200,000

Soybeans 0.081lb ai/acre 0.0000689 1,500,000

Sod 0.028 lb ai/acre 80 0.00000953 10,000,000

Flagger

Flagger All crops 0.35 0.081 lb ai/acre 350 0.000124 810,000

Mixer/Loader/Applicator

Backpack 

(broadcast foliar)

Ornamentals and turf 140

0.0056 lb ai/gal

40 gals 0.000393 250,000

Manuallypressurized 

Handwand

(broadcast foliar)

Ornamentals and turf 30 40 gals 0.000084 1,200,000

Mechanicallypressurized 

Handgun

(broadcast foliar)

Ornamentals and turf 3.9 1000 gals 0.000273 370,000

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (September 2012); Level of 

mitigation: Baseline.

2 Based on registered label (Reg. No. 59639-122, 59639-100 and 59639-82 VALENTV- 10097TM HERBICIDE).

3 Exposure Science Advisory Council Policy #9.1.

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

Area Treated or Amount Handled Daily (A or gal/day) ÷ BW (kg) (see appendix F).
Page 19 of 33

5 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

Short-/Intermediate- Term Post-Application Risk

Dermal Post-application Risk

There is the potential for post-application exposure to workers as a result of registered uses of 

flumiclorac pentyl. However, since no dermal hazard was identified in the toxicity database for

flumiclorac pentyl, a quantitative occupational post-application dermal risk assessment was not 

completed.

Inhalation Post-application Risk

Based on the Agency's current practices, a quantitative post-application inhalation exposure 

assessment was not performed for flumiclorac pentyl at this time primarily because of the low 

acute inhalation toxicity (Toxicity Category IV), low vapor pressure (<1 x 10-7 mm Hg @ 22.4

oC), and the low registered use rate (0.081 lb ai/A). However, there are multiple potential 

sources of post-application inhalation exposure to individuals performing post-application 

activities in previously treated fields. These potential sources include volatilization of pesticides 

and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert 

advice and input on issues related to volatilization of pesticides from its Federal Insecticide, 

Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and 

received the SAP’s final report on March 2, 20105. The Agency is in the process of evaluating 

the SAP report as well as available post-application inhalation exposure data generated by the 

ARTF and may, as appropriate, develop policies and procedures, to identify the need for and, 

subsequently, the way to incorporate occupational post-application inhalation exposure into the 

Agency's risk assessments. 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 flumiclorac pentyl.

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

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

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

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

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

inhalation exposure scenarios. Inhalation risks for handlers were not of concern.

Additionally, the Worker Protection Standard (WPS) for Agricultural Pesticides contains 

requirements for protecting workers from inhalation exposures during and after greenhouse 

applications through the use of ventilation requirements [40 CFR 170.110, (3) (Restrictions 

associated with pesticide applications)]. It is assumed that the user will have met the ventilation 

requirement within the 12 hour REI (unless there is no ventilation capability, then the user must 

wait 24 hours). It is reasonable to assume that based on the WPS ventilation requirements, 

postapplication inhalation exposure will be negligible. 

 

5 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html
Page 20 of 33

References

Author Barcode Date Title

U. Habiba TXR No. 

0056913

3/20/2014

Flumiclorac pentyl: Summary of Hazard and Science Policy 

Council (HASPOC) Meeting of February 27, 2014: 

Recommendations on the Need for a Subchronic Inhalation 

Toxicity Study.

S. Tadayon D418485 3/16/2014

Flumiclorac pentyl. Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk Assessment in Support of 

Registration Review.

G. Orrick D414245 3/4/2014 Flumiclorac-pentyl: Drinking Water Exposure Assessment for 

Registration Review

W. Donovan 

and J. 

Liccione

D417544 1/24/2014

Flumiclorac Pentyl. Recommendation for the Residue of 

Concern in Drinking Water.

W. Donovan

et. al. D368451 8/28/2009 Flumiclorac Pentyl: Revised Human Health Assessment Scoping Document in Support of Registration Review.

W. Donovan D365080 6/10/2009

Flumiclorac Pentyl. Poultry Metabolism Study Sample 

Storage Information Submitted In Response to a Condition of 

Registration.

M. Hawkins 

and J. 

Cordova

-- 5/7/2009 Updated Review of Flumiclorac Incident Reports

J. Liccione et 

al.

D302019 6/28/2005 Flumiclorac Pentyl: HED Chapter of the Tolerance 

Reassessment Eligibility Decision Document (TRED). 

W. Donovan D308674 6/24/2005 Flumiclorac Pentyl: Summary of Residue Chemistry Data for 

the Tolerance Reassessment Eligibility Decision (TRED) 

Document and a Petition (PP#3F6767) for the Establishment of 

Tolerances on Cotton.

W. Donovan D302003 6/24/2005 Flumiclorac Pentyl Tolerance Reassessment Eligibility 

Decision (TRED). Product Chemistry Considerations.

R. Travaglini D301998 6/9/2005 Residential Exposure Assessment for the Tolerance 

Reassessment Eligibility Decision (TRED) Document for 

Flumiclorac-pentyl.

R. Loranger -- 7/27/1994 HED Metabolism Committee Meeting of 7/13/1994. 

Flumiclorac Pentyl (Resource).
Page 21 of 33

Appendix A. Toxicology Profile and Executive Summaries

A.1 Toxicology Data Requirements

The requirements (40 CFR 158.340) for food use for flumiclorac pentyl are shown below in Table 1. 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 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 28-Day Dermal..............................................................

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

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

yes

yes

yes

no

no

yes

yes

yes

no

no

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 (rat)............................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

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

870.5375 Mutagenicity—Structural Chromosomal Aberrations...

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

870.5550 Mutagenicity—Unscheduled DNA Synthesis...............

yes

yes

yes

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

yes

Special Studies for Ocular Effects

Acute Oral (rat)...........................................................

Subchronic Oral (rat)..................................................

Six-month Oral (dog)..................................................

no

no

no

-

-

-
Page 22 of 33

Acute Toxicity of Flumiclorac-Pentyl 

Guideline No./Study Type MRID Results Toxicity 

Category

870.1100 Acute oral toxicity (rat) (S-23031) 42169812 LD50 = >5000 mg/kg IV

870.1100 Acute oral toxicity (rat) (V-23031 0.83 EC) 42169813 LD50 = 4.1 g/kg (m)

LD50 = 3.2 g/kg (f)

LD50 = 3.6 g/kg (both)

III

870.1200 Acute dermal toxicity (rat) (S-23031) 42169814 LD50 = >2000 mg/kg III

870.1200 Acute dermal toxicity (rat) (V-23031 0.83 EC) 42169815 LD50 = >2000 mg/kg III

870.1300 Acute inhalation toxicity (rat) (S-23031) 42169816 LC50 = >5.94 mg/L IV

870.1300 Acute inhalation toxicity (rat) (V-23031 0.83 

EC)

42169817 LC50 = 5.51 mg/L IV

870.2500 Acute dermal irritation [rabbit]

(V-23031 0.83 EC)

42169820 moderate II

870.2600 Skin sensitization (guinea pig) (S-23031) 42169822 extreme 

(Maximization 

method)

Sensitizer

870.2600 Skin sensitization (guinea pig) 42883902 Not a dermal sensitizer NA

NA = Not Applicable
Page 23 of 33

Subchronic, Chronic, and Other Toxicity Studies for Flumiclorac-Pentyl

Guideline No./ 

Study Type

MRID No. (year)/ 

Classification /Doses

Results

870.3100

90-Day oral toxicity 

(rat)

42169823 (1990)

42310801 (addendum)

Acceptable/guideline

M: 0, 6.6, 67, 664, 1359 

mg/kg/d

F: 0, 7.4, 73.8, 726, 1574 

mg/kg/d

NOAEL = 1359/1574 mg/kg/day (M/F)

LOAEL = not identified

870.3150

90-Day oral toxicity 

(dog)

42169827 (1991)

42310802 (addendum)

Acceptable/guideline

M&F: 0, 10, 100, 1000 

mg/kg/d

NOAEL = 100 mg/kg/day

LOAEL = 1000 mg/kg/day based on increased clotting time 

in females.

870.3200

21/28-Day dermal 

toxicity

42825815 (1991)

Acceptable/guideline

M&F: 0, 100, 300, 1000 

mg/kg/day

NOAEL = 1000 mg/kg/day (limit dose)

870.3250

90-Day dermal 

toxicity

N/A N/A

870.3465

90-Day inhalation 

toxicity

Study requirement 

waived

N/A

870.3700a

Prenatal 

developmental (rat)

42169832 (1990)

42169831 (range-finding, 

1990)

Acceptable/guideline

F: 0, 50, 500, 1500 

mg/kg/d (GD 6-15)

Maternal NOAEL = 1500 mg/kg/day

LOAEL = not identified

Developmental NOAEL = 1500 mg/kg/day

LOAEL = not identified

870.3700b

Prenatal 

developmental 

(rabbit)

42169830 (1991)

42169829, 42169828 

(range-finding, 1990) 

Acceptable/guideline

F: 0, 100, 200, 400, 800 

mg/kg/d (GD 6-19)

Maternal NOAEL = 400 mg/kg/day

LOAEL = 800 mg/kg/day based on mortality

Developmental NOAEL = 800 mg/kg/day

LOAEL = not determined

870.3800

Reproduction and 

fertility effects

(rat)

42169835 (1991)

42169834 (range-finding, 

1990)

Acceptable/guideline

M: 0, 16, 781, 1610 

mg/kg/d

F: 0, 18, 925, 1869 

mg/kg/d

Parental/Systemic NOAEL = 16/18 mg/kg/day (M/F)

LOAEL = 781/925 mg/kg/day (M/F) based on increased 

kidney weight in males and females and nephropathy in 

males.

Reproductive NOAEL = 1610/1869 mg/kg/day (M/F)

LOAEL = not identified.

Offspring NOAEL = 781/925 mg/kg/day (M/F)

LOAEL = 1610/1869 mg/kg/day (M/F) based on decreased 

body weight/body weight in F2 pups.

870.4100b

Chronic toxicity 

(dog)

42825817 (1992)

Acceptable/guideline

M&F: 0, 10, 100, 1000 

mg/kg/d

NOAEL = 100 mg/kg/day

LOAEL = 1000 mg/kg/day based on decreased body weight 

gain in male; increased clotting time, increased globulin 

levels, and increased alpha-2 fraction of the serum protein 

electrophoresis in females.
Page 24 of 33

Subchronic, Chronic, and Other Toxicity Studies for Flumiclorac-Pentyl

Guideline No./ 

Study Type

MRID No. (year)/ 

Classification /Doses

Results

870.4200b

Carcinogenicity

(mouse)

42883905 (1992)

Acceptable/guideline

M: 0, 31.5, 307.9, 731.4 

mg/kg/d

F: 0, 37.8, 368.1, 850.2 

mg/kg/d

NOAEL = 731.4/850.2 mg/kg/day (M/F)

LOAEL = not identified

no evidence of carcinogenicity

870.4300

Chronic/Carcinogenicity

(rat)

42883906 (1992)

Acceptable/guideline

M: 0, 3.5, 35.4, 360.4, 

744.9 mg/kg/d

F: 0, 4.3, 43.6, 443.8, 

919.4 mg/kg/d

NOAEL = 360.4 mg/kg/day (♂); 43.6 mg/kg/day (F)

LOAEL = 744.9 mg/kg/day (♂) based on increased 

squamous epithelial cells in urinary sediment and increased 

kidney weights; 443.8 mg/kg/day (♀) based on urinary 

incontinence, increased water consumption, increased urine 

volume and increased kidney weights. 

no evidence of carcinogenicity

Gene Mutation

870.5100

(Salmonella 

typhimurium)

42169836 (1989)

Acceptable/nonguideline 

negative up to 5000 μg/plate with and without metabolic 

activation

Cytogenetics

870.5375

(CHO)

42169838 (1989)

Acceptable/nonguideline 

negative for chromosome aberration up to 400 μg/mL with 

metabolic activation; weak, positive response without 

activation

Micronucleus

870.5395

(mouse)

42169837 (1990)

Acceptable/guideline

negative at doses up to 5000 mg/kg

Unscheduled DNA 

Synthesis

870.5550

(rat hepatocytes)

42169839 (1989)

Acceptable/guideline

negative at concentration up to 300μg/mL in cultured rat 

hepatocytes 

870.6200a

Acute neurotoxicity 

screening battery

48923403 and 48923405 

(2012)

Acceptable/guideline

NOAEL = 2000 mg/kg bw/day

LOAEL = not identified.

870.6200b

Subchronic 

neurotoxicity 

screening battery

48923401 and 48923404 

(2012)

Acceptable/guideline

NOAEL = 969 and 1255 mg/kg bw/day for males and 

females.

LOAEL = not identified.

870.6300

Developmental 

neurotoxicity

not required

870.7485

Metabolism and 

pharmacokinetics

(rat)

42825822 (1993)

42825823 (1993)

Acceptable/guideline 

Rapid absorption and excretion; major metabolic route is 

deesterification to a phenoxyacetic acid derivative followed 

by cleavage of the imide moiety or hydroxylation and/or 

sulfonation reactions

870.7800

Immunotoxicity

48923406 The LOAEL for immunotoxicity was not identified. The 

male CD-1 mouse NOAEL for immunotoxicity was 7000 

ppm (1340 mg/kg bw/day). 
Page 25 of 33

Appendix B. Physical/Chemical Properties

Table B. Physical/Chemical Properties of Flumiclorac Pentyl

Structure 

F

Cl

O

O

O

N

O

O

Common Name Flumiclorac pentyl

IUPAC Name Pentyl (2-chloro-5 (cyclohex-1-ene-1,2-dicarboximido)-4-fluorophenoxy) acetate

CAS Name Pentyl[2-chloro-4-fluoro-5-(1,3,4,5,6,7- hexahydro-1,3-dioxo-2H-isoindol-2-

yl)phenoxy]acetate

CAS Number 87546-18-7

Melting Point Range 88.9-90.1 C

pH 6.03 at 25 C

Density 1.3316 g/mL at 20 C

Water solubility 0.189 mg/L at 25 C

Solvent solubility in g/L @ 

20oC

Solvent g/100 mL at 25 C:

hexane 0.328

n-octanol 1.60

methanol 4.78

Solvesso 150 27.1

acetonitrile 58.9

acetone 59.0

tetrahydrofuran 69.7

N-methyl 2-pyrrolidinone 134.0

methylene chloride 288.0

Vapor pressure <1 x 10-7 mm Hg at 22.4 C

Dissociation constant, pKa No dissociation at pH 7; flumiclorac pentyl decomposes at pH 9.

Octanol/water partition 

coefficient

Log POW = 4.99 at 19.7-21.0 C

UV/visible absorption 

spectrum

max = 226 and 284 nm @ pH =7
Page 26 of 33

Appendix C. International Residue Limit Status

Table C. Summary of US and International Tolerances and Maximum Residue Limits for 

Flumiclorac Pentyl (128724)

Residue Definition:

US Canada Mexico1 Codex

40 CFR 180.477:

Plant: parent only [flumiclorac pentyl]

None None

Commodity

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

US Canada Mexico1 Codex

Corn, field, forage 0.01

Corn, field, grain 0.01

Corn, field, stover 0.01

Cotton, gin byproducts 3.0

Cotton, undelinted seed 0.2

Soybean, hulls 0.02

Soybean, seed 0.01

Completed: M. Negussie; 03/05/14

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.
Page 27 of 33

Appendix D. Revised Dietary Burden Calculations for Flumiclorac Pentyl.

Table 5.3.4.1. Calculation of Dietary Burdens of Flumiclorac Pentyl Residues to Livestock.

Feedstuff Type1 % Dry 

Matter2 % Diet2

Indicate if 

HAFT or 

Median 

Residue Level 

(ppm)

Dietary 

Contribution 

(ppm)3

Beef Cattle (R = 15%; CC = 80%; PC = 5%)

Soybean, meal PC 92 5 Median 0.005 0.00027

Corn, field, grain CC 88 80 Median 0.005 0.00454

Corn, field, forage R 40 10 HAFT 0.01 0.0025

Cotton gin byproducts R 90 5 Median 0.66 0.0367

TOTAL BURDEN -- -- 100 -- 0.0440

Dairy Cattle (R = 45%; CC = 45%; PC = 10%)

Cotton, undelinted seed PC 88 10 Median 0.03 0.00341

Corn, field, grain CC 88 45 Median 0.005 0.00256

Corn, field, forage R 40 45 HAFT 0.01 0.0113

TOTAL BURDEN -- -- 100 -- 0.0172

Swine (CC = 85%; PC = 15%)

Corn, field, grain CC 88 85 Median 0.005 0.00425 

Cotton, meal PC 89 15 Median 0.03 0.00450

TOTAL BURDEN -- -- 100 -- 0.00875

Poultry (CC = 75%; PC = 25%)

Corn, field, grain CC 88 75 Median 0.005 0.00375

Soybean, meal PC 92 5 Median 0.005 0.00025

Cotton, meal PC 89 20 Median 0.03 0.0060

TOTAL BURDEN -- -- 100 -- 0.0100

1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate.

2 Table 1 Feedstuffs (July 2008). 

3 Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for 

poultry and swine.
Page 28 of 33

Appendix E. Flumiclorac Pentyl Residues of Concern in Drinking Water.

Code Name/ Synonym Chemical Name Chemical Structure

Flumiclorac-pentyl

S-23031

V-23031

Pentyl 2-chloro-4-fluoro-5-(3,4,5,6-

tetrahydrophthalimido)phenoxyacetate

CAS No.: 87546-18-7

Formula: C21H23ClFNO5

MW: 423.87 g/mol

F

Cl

O

O

O

N

O

O

031-HA Pentyl 2-chloro-4-fluoro-5-(2-

carboxycyclohexenylcarboxanido)phenoxyacetate

Formula: C21H25ClFNO6

MW: 441.89 g/mol

F

Cl

O

O

O

N

O

O

HO

Flumiclorac acid

IMCA

2-chloro-4-fluoro-5-(3,4,5,6-

tetrahydrophthalimido)phenoxyacetic acid

CAS No.: 87547-04-4

Formula: C16H13ClFNO5

MW: 353.74 g/mol

F

Cl

O

O

OH

N

O

O

IMCA-HA N-(5-carboxymethoxy-4-chloro-2-fluorophenyl)-

3,4,5,6-tetrahydrophthalamic acid

Formula: C16H15ClFNO6

MW: 371.75 g/mol

F

Cl

O

O

OH

N

O

O

HO

IMFP N-(4-chloro-2-fluoro-5-hydroxyphenol)-3,4,5,6-

tetrahydrophthalimide

Formula: C14H11ClFNO3

MW: 295.70 g/mol

F

Cl

HO

N

O

O

IMFP-HA N-(4-chloro-2-fluoro-5-hydroxyphenyl)-3,4,5,6-

tetrahydrophthalamic acid

Formula: C14H13ClFNO4

MW: 313.72 g/mol

F

Cl

HO

N

O

O

HO

SAT IMFP-HA N-(4-chloro-2-fluoro-5-hydroxyphenyl) 

hexahydrophthalamic acid

Formula: C14H15ClFNO4

MW: 315.73 g/mol

F

Cl

HO

N

O

O

HO
Page 29 of 33

Appendix F. Summary of Occupational and Residential 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 proposed label (lb ai A or lb ai/gal), and

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

The daily doses are calculated using the following formula:

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 (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 inhalation dose received by occupational handlers is

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

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

MOE= 

POD

ADD

where:

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

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

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).
Page 30 of 33

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

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

the SHEDS-Multimedia model):

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

(Freq_HtM/N-Replen))]

Where :

E = exposure (mg/day);

HR = hand residue loading (mg/cm2);

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

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

ET = exposure time (hr/day);

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

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

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

and

SA * 2

Fai *DE

HR

H

hands



where:

HR = hand residue loading (mg/cm2);

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

study (unitless);

DE = dermal exposure (mg); and

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

Dose, normalized to body weight, is calculated as:

BW

E

D 

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table F-1: Turf (Physical Activities) – Inputs for Residential Post-application Hand-to-Mouth Exposure 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

Faihands Liquid formulations 0.06
Page 31 of 33

Table F-1: Turf (Physical Activities) – Inputs for Residential Post-application Hand-to-Mouth Exposure 

Algorithm 

Notation

Exposure Factor

(units) Point Estimate(s)

Fraction of ai on hands from 

dermal transfer coefficient 

study

(unitless)

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SAH Typical surface area of one hand (cm2), children 1 < 2 years old 150

AR Application rate (mass active ingredient per unit area) See table 1

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

FM Fraction hand surface area mouthed (fraction/event) 0.127

N_Replen Replenishment intervals per hour (intervals/hr) 4

ET Exposure time (hrs/day) 1.5

SE Saliva extraction factor (unitless) 0.48

Freq_HtM Hand-to-mouth events per hour (events/hr) 13.9

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

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

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

in SHEDS-Multimedia):

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

(Freq_OtM/N_Replen))]

where:

E = exposure (mg/day);

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

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

SAMO = area of the object surface that is mouthed (cm2/event);

ET = exposure time (hr/day);

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

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

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

and

OR = AR * FO * CF2 * CF3

where:

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

AR = application rate (lbs ai/ft2or lb ai/acre);

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

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

CF3 = area unit conversion factor (1.08 x 10-3ft2/cm2or 2.47 x 10-8acre/cm2).

Dose, normalized to body weight, is calculated as:
Page 32 of 33

BW

E

D 

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table F-2: 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) See table 1

FO Fraction of AR as OR following application 1 0.01

SAMO

Surface area of object mouthed 

(cm2/event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SEO

Saliva extraction factor

(fraction) 0.48

ET Exposure time 

(hours per day) 1.5

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

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

1 This SOP assumes that all of the residue on the turf could be transferred to the object (e.g., object residue is equal to turf 

transferable residue).

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

Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1

where:

E = exposure (mg/day);

SRt = soil residue on day "t" (μg/g);

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

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

and

SRt = AR * FS * (1-FD)

t

* CF2 * CF3 * CF4

where:

SRt = soil residue on day "t" (μg/g);

AR = application rate (lbs ai/ft2or lb ai/acre);

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

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

T = post-application day on which exposure is being assessed;
Page 33 of 33

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

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

CF4 = soil volume to weight unit conversion factor (0.67 cm3/g soil).

Dose, normalized to body weight, are calculated as:

BW

E

D 

where:

D = dose (mg/kg-day);

E = exposure (mg/day); and

BW = body weight (kg).

Table F-3: 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) See table 1

FS Fraction of AR available in uppermost 1 cm of soil (unitless) 1

FD Daily residue dissipation (fraction) 0.1

SIgR Soil ingestion rate (mg/day) 50

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