### Dat e:

S ubject: 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON

, D.C. 20460



### June 6, 2015 OFF I CE OF CHEM ICAL SAFETY

AND POLLUTION PREVENTION



### FLUFENACET

. 

### Occ up at i o n al and Residential Exposu r e Assess m e nt for

R egistra ti o n R ev i ew

.

PC Co de: 1 2 190 3

Deci s i o n No.: 485585

Petition No.: NA DP Barcodc: 0427 11 9

R egistra ti o n No.: NA
Regu l at o r y Action: R eg i stra ti on Review

Case No.: 7245 Ri s k A ssess ment T y p e: Occupational/Residential Exposure Assessment

TX R No.: NA

MR ID No. : NA CAS No.: 142459-58-3

40 CFR : § 180 .527



### F r om:

Throug h :

To: 

### Kristin Rury, Bi o l og i s t 

# 'f-

# o~ Ri s k Assess m e nt Branch 

# l1I**C~ B**  

# 3p

Health Effects Di v i s i o n (7509P)

Barr y O ' Keefe, Senior Biol ogist 

# J J. 0 

## W o

1J,,

Ri sk Assess ment Branch III (RAB 3)

,

## ~ H ea lth Effec t s Di v ision (7509 P )

and

S h a lu S h e lat

, I ndu s tri a l H ygie ni s t

- · Zaida F i gueroa, I ndustrial H ygien i s t 

# '?£(., L£. t 

### Exposure Sc i e nce Advisory Committee (ExpoSAC) I 

### H ED

Kr i sti n Rur y , Ri s k Assessor

Risk Assessment Branch lfI 

### (RAB 3)

H ealt h Effec t s Division (7509 P )

A nd

Margaret H at haway
Chemica l R ev i ew Manager (C RM )


### Pesticide Re-Eva lu at i o n Di visio n (7508 P )

P age I 

### of 33 

# -Intr o du ct i o n

The H ea lth Effect s Di v i s i on ( H E D ) of th e O ffi ce of P est i cide Program s ( OPP ) i s c h arged wit h

es timatin g th e ri sk t o human h ea lth from expos ur e to pesticides. As part of R egistrat ion Re v i ew, the P esticide Re- e v a l uation Division ( PRD) of OPP has requ es ted that H E D eva lu ate th e h aza rd

and expos ur e dat a and conduct occ up atio n a l and r es identi a l ex posure assessment s, as n eeded, to

es timate the risk to human health that w ill r esu lt fr o m th e regi s t e r ed u ses of flufenacet. This

memorandum serve s as HED 's Regi s tration Revi e w assessment of th e occ up at i ona l handl e r and post-application expos ure and r es identia l post-app li cation expos ur e (spray drift ) and risk fr o m the regi s t e red use s.

Flufe n acet i s curr e ntl y r eg i s ter ed for u se on the following agricultural cro p s : corn (field

, seed,

s il age, a nd swee t ), grasses grown for see d

, soy b ea n s, tritic a l e , a nd w h ea t.



### It i s HED policy t o u se th e best avai labl e data to assess expo s ure. Severa l sourc es of gener i c data wer e u se d in thi s assessment as s urro ga te data in th e absence of chemical-sp e cific dat a,
in cludi n g: Pesticide Handl e r s Expos ur e Databas e Version I. I ( PHED I. I ); the Agricultural R e

E ntry T as k Force (A RTF ); a nd th e Agr i cu ltural H and l e r Expo s ur e Ta s k Force (A H ETF)

database. Some of the se d a t a are propri e tary

, and s ubject t o th e dat a prot ec tion pro v ision s of the

Fe deral In se cticid e, Fun g icid e , a nd R odc nticid e Ac t ( FIFRA ).

Note: Thi s mem oran dum was r eviewed by the Expos ure Sc i e nce Adv i so r y Com mitte e (Ex po SAC) o n February 1 2

, 20 1 5.

Page 2 of 33

### Page 3 of 33 Table of Contents

1.0 Executive Summary

................................ ................................ ................................ ............. 4
2.0 Risk Assessment Conclusions

................................ ................................ ............................. 6
2.1 Data Deficiencies and Requirements

................................ ................................ ............... 6
3.0 Hazard Characterization

................................ ................................ ................................ ....... 7
4. 0 Use Profile

................................ ................................ ................................ ......................... 10
5.0 Residential Exposure and Risk Estimates

................................ ................................ .......... 11
5.1 Spray Drift

................................ ................................ ................................ ...................... 11
5.1.2 Risk Estimates From Lawn Deposition Adjacent to Agricultural Applications

........ 12
5.2 Residential Bystander Post

- Application Inhalation Exposure

................................ ....... 14
6.0 Occupational Exposure and Risk Estimates

................................ ................................ ...... 15
6.1 Occupational Handler Exposure/Risk Estimates

................................ ............................ 15
6.2 Occupational Post

- application Exposure/Risk Estimates

................................ .............. 18
6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

...................... 18
6.2.2 Occupational Post

- application Dermal Exposure/Risk Estimates

.......................... 19 Appendix A. Summary of Occupational and Residential Non

- cancer Algorithms

..................... 22 Appendix B. Registered Flufenacet End

- Use Products

................................ ............................... 25 Appendix C. Rationale for Req uiring TTR and DFR Data

................................ ......................... 26 Appendix D. Occupational Handler Exposure Tables

................................ ................................ . 29

### Page 4 of 33

1.0 Executive Summary

HED has conducted an occupational and residential exposure assessment for Registration Review of the active ingredient (ai), flufenacet. Flufenacet is an anilide herbicide used to control grasses and broadleaf weeds; and is currently registered for use on corn, grasses grown for seed, soybeans, triticale, and wheat. This memorandum contains HED’s occupational exposure and risk estimates to pesticide handlers (i.e. , mixers, loaders, applicators) and to agricultural workers conducting post

- application activities . This assessment also contains a residential post

application assessment evaluating the exposure resulting from flufenacet drift from agricultural applicati ons onto residential areas.

Use Pattern Flufenacet is currently formulated as soluble concentrate (SC) and dry flowable (DF) end

- use products (EPs) containing between 24% and 60% ai. The maximum single application rates for each crop or use site range from 0.34 to 0.78 lb ai/A. The registered labels permit application via ground equipment and tractor drawn spreaders ( for impregnated fertilizer applications) only; use of aerial and chemigation application equipment is prohibited. Flufenacet is added to dry bulk fertilizers and then applied to the registered crops along with the fertilizer. The labels list a 12

- hour restricted entry interval (REI). Occupational handlers must wear the following personal protective equipment (PPE) when handling flufenace t: long sleeved shirt, long pants, chemical resistant gloves, shoes and socks. In addition to the PPE listed above, a respirator and coveralls are required when mixing/loading EPA Reg. No. 264

- 765. Chemical resistant aprons are also required when mixing/ loading and cleaning equipment for EPA Reg. Nos. 264

- 800 and 264

- 852 (co

- formulations with isoxaflutole) , which are t wo products classified as restricted use pesticides (RUPs )

.

Exposure Profile The occupational handler assessment was completed assuming the labeled maximum single application rate for each crop or use site. Based on the currently registered uses of flufenacet, the durations of exposure are expected to be both short

- term (1 to 30 days) and intermediate

- term (1 to 6 months) for occupationa l handlers. Long

- term exposures (greater than 6 months) are not anticipated based on the currently registered use pattern.

There are no currently registered residential uses of flufenacet; however, a post

- application exposure assessment was conducted for adults (dermal) and children 1 to 2 years old (dermal and incidental oral) to evaluate potential exposure from spray drift o nto residential areas from nearby agricultural applications.

Hazard Characterization The toxicity database for flufenacet is complete and adequate for risk assessment. In repeated

dose oral, dermal, and inhalation studies, the liver was consistently th e target organ; however in
most cases liver effects were not considered adverse. Thyroid hormone levels were also consistently depressed in oral, dermal, and inhalation studies, and the studies suggest the thyroid effects are secondary to the liver effect s. In developmental studies, flufenacet seems to delay ossification (especially in the skull), eye opening, and male puberty. Neurotoxic effects were

### Page 5 of 33

also observed in dogs and rats exposed as adults, and in female rats exposed in utero and during early p ostnatal period. After chronic exposure, eye effects were observed in the rat, dog, and mouse. Mild anemia was observed in rats exposed orally or via inhalation, and methemoglobinemia was observed in rats and mice after chronic oral exposure. Flufenacet is considered “not likely to be a human carcinogen”

. For the incidental oral and dermal exposures, the point of departure (POD) is based on effects observed in the rat developmental neurotoxicity study (decreased pup body weight and decreased caudate putamen size in offspring). The effect on the caudate putamen size was seen at higher doses than the selected POD; however, the effect was not evaluated at the low doses, therefore, a NOAEL was not observed for decreased caudate putamen size

. The level o f concern (LOC) for dermal and incidental oral exposures is 1 000 (10 x interspecies, 10 x intraspecies, 10 x for the lack of a no observed adverse effect level ( NOAEL ) and unavailability of comparative thyroid data). T he inhalation POD (all durations) is ba sed on

a route

- specific 28

- day inhalation study in rats

. The LOC for inhalation exposures is 3 0 0 which includes interspecies (3 x) and intraspecies (10 x ) uncertainty factors , as well as a 10x uncertainty
factor for the lack of a NOAEL in the study

. The in terspecies factor was reduced from default

10 x to 3 x, because the human equivalent concentration ( HEC ) calculation completed when using

a route

- specific inhalation study accounts for pharmacokinetic interspecies differences . The default intraspecies factor is retained at 10x because the HEC calculation does not account for pharmacodynamic intraspecies differences

.

Occupational Handler Exposure There are some occupational handler risk estimates of concern for the registered uses of
flufenacet at base line and label

- specified PPE. At baseline, occupational dermal margins of exposure ( MOEs ) ranged from 40 to 4 ,000; and occupational inhalation MOEs ranged from 22 to 1, 400

. Some risk estimates are of concern even with engineering controls.

Occupationa l Post

-

Application Exposure All occupational short

- and intermediate

- term risk estimates resulted in dermal MOEs of concern on day 0 with default dislodgeable foliar residue (DFR) inputs

. There are no chemical

- specific
DFR studies available for flufenacet

. The dermal post

- application MOEs for flufenacet range
from 88 to 800 on the day of application. The number of days for the MOE to reach the LOC of 1,000 range from 3 to 23 days for the registered uses of flufenacet. Therefore, the REI of 12
hours is n ot adequate and a DFR study on corn or soybeans is required

.

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

- cancer occupational post

- application inhalation exposure assessment was not performed for flufenacet at this time. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational
post

- application inhalation exposure assessment for flufenacet

.

Residential Exposure

- Spray Drift Assessment There are no registered residential uses of flu fenacet ; h owever, a quantitative non

- occupational spray drift assessment was conducted. Adult dermal and children’s (1 to < 2 year old) dermal and incidental oral risk estimates from indirect exposure to flufenacet related to spray drift
exceed the LOC at various distances from the edge of the field, depending on spray type/nozzle configuration . Results indicate that groundboom application to corn results in the worst

- case

### Page 6 of 33

estimate of exposure from drift. However, when using a low boom, and fine to mediu m/coarse sprays, there were no risks of concern estimated at the field’s edge.

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. The se data, which include studies from PHED 1.1; the AHETF database; and the ARTF database are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements. For certain studies, the ethics review may have included review by the Human Studies Review Board. Descriptions of data sources, as well as guidance on their use,
can be found at the Agency website 1



### .

2.0 Risk Assessment Conclusions

Occupational Handler
There are risks of concern at the label

- specified PPE for some occupational handler scenarios

even at the highest level of appropriate mitigation available ( e.g., engineering controls).

Occupational Post

-

Application All occupational short

- and intermed iate

- term risk estimates resulted in dermal MOEs of concern on day 0. Therefore, additional mitigation is required, such as increased REIs to protect workers entering treated fields. The days needed following flufenacet application in order for the MOEs to be not of concern are provided in Table 6.2.2.

Spray Drift For the registered uses of flufenacet, the dermal MOEs at the edge of the field ranged from 670 to 8,700 for adults; and combined dermal and incidental oral MOEs ranged from 260 to 3,400 fo r children 1 to < 2 years old. Some scenarios require differing boom heights, spray droplet sizes, or distances from the field edge to be not of concern (dermal and incidental oral LOC = 1000).

2. 1 Data Deficiencies and Requirements

Dislodgeable Fol iar Residue (DFR) Data : Since the highest estimated occupational post

application exposure using default DFR values for flufenacet is minimal in comparison to the level of concern (i.e., the calculated MOE is not greater than 2 times higher than the level of

concern, MOE = 2,000 compared to the LOC of 1,000 ); EPA is requiring the 40 CFR DFR data. Therefore, EPA is requiring the 40 C FR DFR data requirement to facilitate any necessary exposure assessments refinements and to further EPA’s general understanding of the availability of dislodgeable foliar pesticide residues. EPA is requesting that DFR studies be submitted on

1 http://www.epa.gov/pesticides/science/handler

- exposure

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

- app

- exposure

- data.html

### Page 7 of 33

corn or soyb eans in separate geographic locations. Additionally, a protocol should be submitted prior to starting these studies. 2



### 3 .0 Hazard Characterization

The toxicity database for flufenacet is complete and adequate for risk assessment. The requirement for a guideline immunotoxicology study has been waived (TXR 0056951, J. Leshin

2014 ). The mammalian toxicological database identifies several flufenacet target tissues, including liver, eye, blood, and nervous system; changes in thyroid ho rmones were associated
with non

- adverse liver effects, including metabolic enzyme induction. In developmental studies, delayed ossification, especially in the skull, was seen after in utero exposure to flufenacet. In an inhalation study, portal of entry effects were observed in the extrathoracic region after exposure
to flufenacet. Neurotoxic effects were also observed in dogs and rats exposed as adults, and in female rats exposed in utero and during early postnatal period. After chronic exposure, eye
ef fects were observed in the rat, dog, and mouse. Mild anemia was observed in rats exposed orally or via inhalation, and methemoglobinemia was observed in rats and mice after chronic oral

exposure. Flufenacet is considered “not likely to be a human carcino gen”

.

The dermal POD remain s unchanged since the previous risk assessment. However, t he
inhalation and incidental oral PODs have been revised since the previous assessment. For the
incidental oral and dermal exposures, the POD ( lowest observed adverse effect level; LOAEL = 1.7 mg/kg/day) is based on effects observed in the rat developmental neurotoxicity study (decreased pup body weight, delayed eye opening and preputial separation, and decreased caudate putamen size and motor activity in adult female offspring) . The LOC for dermal and
incidental oral exposures is 1 000 (10 x interspecies, 10 x intraspecies, 10 x for the lack of a NOAEL and unavailability of comparative thyroid data). For the inhalation POD (all durations) a LOAEL of 0.02 mg/L from a route

- specific 28

- day inhalation study in rats was used to
calculate a human

- equivalent dose (HED) of 0.143 mg/kg/day

. The LOC for inhalation

exposures is 3 0 0 which includes interspecies (3 x) and intraspecies (10 x ) uncertainty factors , as well as a 10x uncertainty factor for the lack of a NOAEL in the study

. The interspecies factor
was reduced from default 10 x to 3 x , because the HEC calculation accounts for pharmacokinetic interspecies differences

. The default intraspecies fac tor is retained at 10x because the HEC calculation does not account for pharmacodynamic intraspecies differences

.

Because the inhalation POD is based on a route

- specific study, and the incidental oral and dermal PODs are based on oral studies, the inhala tion and dermal risk estimates for flufenacet are not
combined into a total risk estimate.

Acute Toxicity

The acute toxicity of flufenacet is summarized in Table 3.1. Flufenacet has low acute toxicity via the oral (Toxicity Category III), dermal (Toxicity Category III), and inhalation routes

2 http://www.ecfr.gov/cgi

- bin/text

idx?SID=a5983c2e243fca24 493fbe7a02254834&mc=true&node=se40.24.158_11070&rgn=div8

### Page 8 of 33

(Toxicity Categories IV). Flufenacet produces slight eye irritation (Toxicity Category IV) and is
not a dermal irritant or sensitizer.

Table 3.1

. Acute Toxicity Profile

– Flufenacet

.

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

870.1100 Acute oral rat 43441104 LD 50 = 1617 mg/kg (M) 589 mg/kg (F) III

870.1200 Acute dermal rat 43441106 LD 50 ≥ 2000 mg/kg III

870.1300 Acute inhalation rat 43441108 LC 50 > 3.74 mg/L IV

870.2400 Acute eye irritation rabbit 43850017 slight eye irritant IV

870.2500 Acute dermal irritation rabbit 43850023 not a dermal irritant IV

870.2600 Skin sensitization guinea pigs

–

Buehler method 43850025 not a dermal sensitizer N/A

870.2600 Skin sensitization guinea pigs

–

Maximization method 43877601 dermal sensitizer N/A

Table 3.2

. Summary of Toxicol ogical Doses and Endpoints for Flufenacet for Use in Occupational and
Non

- Occupational Human Health Risk Assessments

.

Exposure/
Scenario Point of Departure Uncertainty /FQPA Safety

Factors Level of

Concern for
Risk
Assessment Study and Toxicological Effects

Incidental Oral
Short

- Term (1

- 30 days) and
Intermediate

- Term (1

- 6 months) L OAEL= 1.7

mg/kg/day UF A = 10 x

UF H = 10 x

FQPA SF=

10 x ( UF L ) Residential

LOC for MOE

= 1000 Developmental n eurotoxicity

study in rats. LOAEL = 1.7 mg/kg/day based on decreased pup body weight, delayed eye opening

, delayed preputial separation, and decreased caudate putamen size

.

Dermal Short

- Term (1

- 30 days) and
Intermediate

- Term (1

- 6 months) L OAEL= 1.7

mg/kg/day UF A = 10x

UF H = 10x

UF L = 10x Occupational

LOC for MOE

= 1000

Residential
LOC for MOE

= 1000 Developmental n eurotoxicity

study in rats. LOAEL = 1.7 mg/kg/day based on decreased pup body weight, delayed eye opening

, delayed preputial separation, and decreased caudate putamen size

.

### Page 9 of 33

Table 3.2

. Summary of Toxicol ogical Doses and Endpoints for Flufenacet for Use in Occupational and
Non

- Occupational Human Health Risk Assessments

.

Exposure/
Scenario Point of Departure Uncertainty /FQPA Safety

Factors Level of

Concern for
Risk
Assessment Study and Toxicological Effects

Inhalation Short

Term (1

- 30 days)
and Intermediate

Term (1

- 6 months) L OAEL = 0.0 2 mg/L

HEC = 0.00252 mg/L

f = 8.3 L/min

HED =
0. 143 mg/kg/day

f = 16.7 L/min

HED =
0. 289 mg/kg/day

f =
29 L/min

HED =
0. 501 mg/kg/day UF A = 3 x

UF H = 10x

UF L = 10x Occupational

LOC for MOE

= 300

Residential =

N/A 28

- day inha lation toxicity study

in rats. LOAEL = 0. 2 mg/kg/day based on portal of entry effects ( nasal cavity goblet cell hyperplasia in males and larynx inflammatory infiltrate in
females ) and increased incidence
of sperm

- related lesions of the testis and epididymis

.

Cancer (oral, dermal, inhalation) Classification: Not likely to be a human carcinogen (RfD Peer Revi ew Committee report, 7/16/1997)

. 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 ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. FQPA SF = FQPA Safety Factor. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. HEC = Human Equivalent Concentration. HED = Human Equivalent Dose. f = breathing rate
associated with a specific activity.



### Absorption : No dermal absorption data are available. However, for route

- to

- route extrapolation a factor of 4% has been established based on a comparison between the LOAEL of 6 mg/kg/day
in the 90

- day feeding study in rats (MRID 43743401) and a LOAEL of 150 mg/kg/day in the 21

- day dermal study in rats (MRID 43850027); endpoints in both studies are based on decreased thyroid hormone levels in plasma (K Raffaele, TXR 0051853, 4/23/2003; TXR 0013638, 02/19/1997). The 4% factor is appropriate for use in the absence of der mal absorption data
because it accounts for the differential effects between the dermal and oral routes of exposure, and it characterizes the differences between dermal and oral absorption together with differences in other processes that occur after flufe nacet enters the body through either route, such as metabolism and transport to the target organs.

Body Weight : Since the dermal POD is based on developmental and/or fetal effects, the adult body weight appropriate for dermal assessments is 69 kg. Since the inhalation POD is not based on developmental and/or fetal effects, the adult body weight appropriate for inhalation assessments is 80 kg. For the spray drift assessment, a default body weight of 11 kg was used for children 1 to < 2 years old.

### Page 10 of 33

4 .0 Use Profile

Flufenacet is currently formulated into seven liquid SC and DF EP s containing between 24% and 60% ai. Flufenacet is currently registered on field, silage, seed, and sweet corn; grass grown for seed; soybeans; triticale; and wheat. The maximum single application rates range from 0.34 to 0.78 lb ai/acre for the registered uses. Most of the labels only allow for one application of flufenacet per year ; however, EPA Reg. No. 264

- 766 allow s for multiple applications to triticale and wheat (R TI = 21 days) but it restricts the application amount to 0.34 lb ai/A per season

. All
labels list a 12

- hour REI. Occupational handlers must wear the following PPE when handling
flufenacet: long sleeved shirt, long pants, chemical resistant gloves, shoes and socks. In addition to the PPE listed above, a respirator and coveralls are required when mixing/loading EPA Reg.

No. 264

- 765. Chemical resistant aprons are also required when mixing/loading and cleaning equipment for EPA Reg. Nos. 264

- 800 and 264

- 852 (co

- formulations with isoxaflutole).

The uses and application rates are summarized in Table 4.1.

Table 4 .1. Su mmary of Directions for Use of Flufenacet

.

Applic. Timing, Type, and

Equip. Max.

Applic.

Rate Max. No.

Applic. per
Season Max.

Seasonal Applic. Rate RTI 1

(days) Use Directions and Limitations

Corn (field, silage, seed, and sweet)
Groundboom, Dry Bulk
Fertilizer 0.78 lb

ai/A 1 0.78 lb ai/A N/A Preplant surface, preplant incorporated, or preemergent application only

Dry Bulk Fertilizer 3 7.88 lb
ai/ton 1 7.88 lb ai/ton NA Use a minimum of 200 pounds and a maximum of 450 pounds per acre

Soybeans

Groundboom 0.46 lb
ai/A 1 0.46 lb ai/A N/A Preplant surface, preplant incorporated, or preemergent application only

Dry Bulk Fertilizer 3 4.56 lb
ai/ton 1 4.56 lb ai/ton NA Use a minimum of 200 pounds and a maximum of 450 pounds per acre

Triticale & Wheat

Groundboom 0.34 lb
ai/A N/A 2 0.34 lb ai/A 21 Preemergent to early postemergent applications only

Grass Grown for Seed

Groundboom 0.44 lb
ai/A 1 0.44 lb ai/A N/A Allow a minimum of 4 weeks between application of flufenacet and other photosynthetic inhibitor herbicides

1. RTI = Re

- Treatment Interval

. 2. Sequential applications are allowed to triticale and wheat on EPA Reg. No. 264

- 766. However, the maximum seasonal application rate is 0.34 lb ai/A. Reduced maximum single application rates must be used if multiple applications per season are required.
3. To calculate the dry bulk fertilizer rate: Application Rate (fl oz product/A) × (1 gallon product/128 fl oz product) × (lb ai/gallon product) × (1 A/200 lb fertilizer) × (2000 lb fertilizer/1 ton fertilizer) = lb ai/ton fertilizer

.

### Page 11 of 33

5 .0 Residential Exposure and Risk Estimates

There are no proposed or registered residential uses of flufenacet at this tim e; however, there are existing agricultural uses that could result in potential drift onto residential areas and result in potential post

- application exposure.

5

. 1 Spray Drift

Off

- target movement of pesticides can occur via many types of pathways and it is governed by a variety of factors. Sprays that are released and do not deposit in the application area end up off

target and can lead to exposures to those it may directly contact. They can also deposit on surfaces where contact with residues can eventually lead to exposures ( e.g. , children playing on lawns where residues have deposited next to treated fields). The potential risk estimate s from these residues can be calculated using drift modeling coupled with methods employed for residential risk assessments for turf products.

The approach to be used for quantitatively incorporating spray drift into risk assessment is based on a premise of compliant applications which, by definition, should not result in direct exposures to individuals because of existing label language and other regulatory requirements intended to prevent them. 3 

### Direct exposures would include inhalation of the spray plu me or being sprayed directly. Rather, the exposures addressed here are thought to occur indirectly through contact with impacted areas, such as residential lawns, when compliant applications are conducted. Given this premise, exposures for children (1 to < 2 years old) and adults who have contact with turf where residues are assumed to have deposited via spray drift thus resulting in an indirect exposure are the focus of this analysis analogous to how exposures to turf products are
considered in risk asse ssment.

In order to evaluate the drift potential and associated risks, an approach based on drift modeling coupled with techniques used to evaluate residential uses of pesticides was utilized. Essentially, a residential turf assessment based on exposur e to deposited residues has been completed to address drift from the agricultural applications of flufenacet

. In the spray drift scenario, the deposited residue value was determined based on the amount of spray drift that may occur at varying distances fr om the edge of the treated field using the AgDrift ( v2.1.1) model and the Residential Exposure Assessment Standard Operating Procedures Addenda 1: Consideration of Spray Drift Policy

. Once the deposited residue values were determined, the remainder of the spray drift assessment was based on the algorithms and input values specified in the recently revised (2012) Standard Operating Procedures For Residential Risk Assessment (SOPs)

.

A screening approach was developed based on the use of the AgDrift model i n situations where specific label guidance that defines application parameters is not available. 4 

### AgDrift is appropriate for use only when applications are made by aircraft, airblast orchard sprayers, and groundboom sprayers. When AgDrift was developed, a series of screening values (i.e., the Tier 1 option) were incorporated into the model and represent each equipment type and use under

3 This approach is consistent with the requirements of the EPA’s Worker Protection Standard.

4 http://www.epa.gov/pesticides/scienc e/models_pg.htm

### Page 12 of 33

varied conditions. The screening options specifically recommended in this methodology were selected because they are pl ausible and represent a reasonable upper bound level of drift for common application methods in agriculture. These screening options are consistent with how spray drift is considered in a number of ecological risk assessments and in the process used to
de velop drinking water concentrations used for risk assessment. In all cases, each scenario is to be evaluated unless it is not plausible based on the anticipated use pattern (e.g., herbicides are not typically applied to tree canopies) or specific label pr ohibitions (e.g., aerial applications are not allowed). Section 5.1.2 provides the screening level drift related risk estimates.

In many cases, risks are of concern when the screening level estimates for spray drift are used as the basis for the analysi s. In order to account for this issue and to provide additional risk management options additional spray drift deposition fractions were also considered. These drift estimates represent plausible options for pesticide labels

5.1.2 Risk Estimates From L awn Deposition Adjacent to Agricultural Applications

Flufenacet is used on numerous agricultural crops and can only be applied via groundboom equipment. The spray drift risk estimates are based on an estimated deposited residue
concentration as a result of the screening level agricultural application scenarios. The recommended drift scenario screening level options are listed below:

 Groundboom applications are based on the AgDrift option for high boom height and using very fine to fine spray type using the 90 th 

### percentile results.

The highest exposure resulted from drift following flufenacet applications to corn using groundboom equipment . T here were der mal risk estimates of concern at the field edge for adults following application to corn, and dermal and incidental oral combined risk estimates of concern
for children 1 to <2 years old following application to corn, soybeans, and grasses grown for
seed

. However, if a low boom or medium/coarse sprays are used or the distance from the field edge is increased, these MOEs are not of concern. See Table s 5. 1.2 .1 and 5.1.2.2 for detail ed
results.

Table 5.1.2 .1 . Adult Dermal Risk Estimates (MOEs) Related to S pray Drift Exposure to Flufenacet from the Registered Agricultural Uses.
Application Type Spray Type/Nozzle

Configuration Appl. Rate

(lb ai/A) TTR ( μg/cm 2 ) 2 At Edge (LOC = 1000) 10 Feet (LOC =

1000)

Corn

Groundboom High Boom Very

fine to Fine

0.78 0.086697 670 1,300

Low Boom Very
fine to Fine 1,500

N/A High Boom Fine to
Medium/Coarse 2,600

Low Boom Fine to
Medium/Coarse 3,800

Soybeans

### Page 13 of 33

Table 5.1.2 .1 . Adult Dermal Risk Estimates (MOEs) Related to S pray Drift Exposure to Flufenacet from the Registered Agricultural Uses.
Application Type Spray Type/Nozzle

Configuration Appl. Rate

(lb ai/A) TTR ( μg/cm 2 ) 2 At Edge (LOC = 1000) 10 Feet (LOC =

1000)

Groundboom High Boom Very

fine to Fine

0.46 0.051129 1,100

N/A Low Boom Very
fine to Fine 2,500

High Boom Fine to
Medium/Coarse 4,300

Low Boom Fine to
Medium/Coarse 6,400

Grass Grown for Seed

Groundboom High Boom Very

fine to Fine

0.44 0.048906 1,200

N/A Low Boom Very
fine to Fine 2,600

High Boom Fine to
Medium/Coarse 4,500

Low Boom Fine to
Medium/Coarse 6,700

Wheat/Triticale

Groundboom High Boom Very

fine to Fine

0.34 0.037791 1,500

N/A Low Boom Very
fine to Fine 3,400

High Boom Fine to
Medium/Coarse 5,900

Low Boom Fine to
Medium/Coarse 8,700

1 HED’s default assumption that 10 % of the application is available for transfer on day 0 following the application and the residues dissipate at a rate of 10% each following day.

Table 5. 1.2.2

. Children 1 to < 2 Years Old Combined Dermal and Hand

- to

- Mouth Risk Estimates (MOEs) Related to Spray Drift Exposure to Flufenacet from the Registered Agricultural Uses.

Application Type Spray

Type/Nozzle Configuration Appl.

Rate (lb ai/A) TTR ( μg/cm 2 ) 1 At Edge (LOC = 1000) 10 Feet

(LOC = 1000) 25 Feet

(LOC = 1000) 50 Feet

(LOC = 1000)

Corn

Groundboom High Boom Very

fine to Fine

0.78 0.086697 260 520 870 1,400

Low Boom Very
fine to Fine 570 1,500

N/A N/A High Boom Fine

to
Medium/Coarse 990 2,600

### Page 14 of 33

Table 5. 1.2.2

. Children 1 to < 2 Years Old Combined Dermal and Hand

- to

- Mouth Risk Estimates (MOEs) Related to Spray Drift Exposure to Flufenacet from the Registered Agricultural Uses.

Application Type Spray

Type/Nozzle Configuration Appl.

Rate (lb ai/A) TTR ( μg/cm 2 ) 1 At Edge (LOC = 1000) 10 Feet

(LOC = 1000) 25 Feet

(LOC = 1000) 50 Feet

(LOC = 1000)

Low Boom Fine

to
Medium/Coarse 1,500 N/A

Soybeans

Groundboom High Boom Very

fine to Fine

0.46 0.051129 440 880 1,500

N/A Low Boom Very
fine to Fine 970 2,600

N/A High Boom Fine

to Medium/Coarse 1,700

N/A Low Boom Fine

to Medium/Coarse 2,500

Grass Grown for Seed

Groundboom High Boom Very

fine to Fine

0.44 0.048906 460 920 1,500

N/A Low Boom Very
fine to Fine 1,000

N/A N/A High Boom Fine

to
Medium/Coarse 1,800

Low Boom Fine

to
Medium/Coarse 2,600

Wheat/Triticale

Groundboom High Boom Very

fine to Fine

0.34 0.037791 600 1,200

N/A N/A Low Boom Very
fine to Fine 1,300

N/A High Boom Fine

to
Medium/Coarse 2,300

Low Boom Fine

to
Medium/Coarse 3,400

1 HED’s default assumption that 10 % of the application is available for transfer on day 0 following the application and the residues dissipate at a rate of 10% each following day.



### 5

. 2 Residential Bystander Post

- Application Inhalation Exposure

Volatilization of pesticides may be a source of post

- application inhalation exposure to individuals nearby pesticide applications. The agency sought expert advice and input on issues

### Page 15 of 33

related to volatilization of pesticides from its Federal Insecticide, Fu ngicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The agency has evaluated the SAP report and has develope d a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2014

- 0219). During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux

st udies, route

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

.

6 .0 Occupational Exposure and Risk Estimates

6 .1 Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individual s who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each task. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used by a handler can cause exposure levels to differ in a manner specific to each application event.

Based on the anticipated use patterns and current lab eling, types of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed uses. The quantitative exposure/risk assessment developed for occupational handlers is based on the
scenarios listed in Tabl e 6.1.1.

Occupational Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis.

Application Rate : The maximum single application rates are listed in Table 4.1.

Unit Exposures: It is the policy of HED to use the best available data to assess handler exposure. Sources of generic handler data, used as surrogate data in the absence of chemical

- specific data, include PHED 1.1, the AHETF database, or other registrant

- submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard valu es recommended for use in predicting handler exposure that are used in this assessment, known as “unit exposures”

, are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 5 

### ”, which, along with

additional information on HE D policy on use of surrogate data, including descriptions of the various sources, can be found at the Agency website 6



### .

5 Available: http://www.epa.gov/opp00001/science/handler

- exposure

- table.pdf

6 Available: http://www.epa.gov/pesticides/science/handler

- exposure

- data.html

### Page 16 of 33

Area Treated or Amount Handled : The amount/area treated for each scenario is listed in Appendix D

.

Exposure Duration: HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months as intermediate

- term. Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggering the use of the pesticide, and the cultural practices surrounding that use site. For most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for
more than a one

- month time frame; however, there may be a la rge agribusiness and/or commercial applicators who may apply a product over a period of weeks (e.g., completing multiple applications for multiple clients within a region).

For flufenacet, based on the proposed use, short

- and intermediate

- term exposures are expected. However, since the short

- and intermediate

- term inhalation and dermal PODs are the same for both durations, the assessment is protective of both durations.

Mitigation/Personal Protective Equipment: Estimates of dermal and inhal ation exposure were calculated for various levels of PPE. Results are presented for “baseline”

, 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 bas eline with various levels of PPE as necessary (e.g., gloves, respirator, etc). Occupational handlers must wear the following PPE when handling
flufenacet: long sleeved shirt, long pants, chemical

- resistant gloves, shoes and socks. In addition
to the PPE listed above, a respirator and coveralls are required when mixing/loading EPA Reg.

No. 264

- 765. Chemical resistant aprons are also required when mixing/loading and cleaning equipment for EPA Reg. Nos. 264

- 800 and 264

- 852 (co

- formulations with isoxaflutole ).

Occupational Handler Non

- Cancer Exposure and Risk Estimate Equations

The algorithms used to estimate non

- cancer exposure and dose for occupational handlers can be found in Appendix A

.

Summary of Occupational Handler Non

- Cancer Exposure and Risk Estim ates

There are some occupational handler risk estimates of concern for the registered uses of
flufenacet at baseline, PPE, and engineering control mitigation . The level of concern (LOC) for occupational handler dermal risk estimates is a MOE of 1,000. The LOC for occupational
handler inhalation risk estimates is a MOE of 30 0 . At baseline, occupational dermal MOEs ranged from 40 to 4 ,000; and occupational inhalation MOEs ranged from 22 to 1

, 4 00.

The following scenarios are not of concern at baseline PPE :

 Applying sprays via groundboom equipment to sod; and

 Applying flufenacet in on

- farm impregnated dry bulk fertilizers to soybeans

.

The following scenario requires gloves to be not of concern :

 Mixing/loading liquid fl ufenacet to produce impregnated dry bulk fertilizers on

- farm to

### Page 17 of 33

treat soybeans

.

The following scenarios require the use of a PF5 respirator to be not of concern :

 Mixing/loading dry flowable flufenacet for groundboom application to sod; and

 Applying flufenacet sp rays via groundboom equipment to corn.

T he following scenario requires gloves and a double layer of clothing to be not of concern :

 Mixing/loading dry flowable flufenacet for groundboom application to wheat.

The following scenario requires gloves

, a double layer of clothing, and a PF10 respirator to be
not of concern :

 Mixing/loading liquid flufenacet for groundboom application to soybeans.

The following scenarios require the use of engineering controls to be not of concern :

 Mixing/loading dry flowa ble flufenacet to produce impregnated dry bulk fertilizers on

farm to treat corn and soybeans;

 Mixing/loading dry flowable flufenacet for groundboom application to corn and soybeans;

 Mixing/loading liquid flufenacet to produce impregnated dry bulk fertili zers on

- farm to treat corn; and

 Mixing/loading liquid flufenacet for groundboom application to corn.

The following scenarios are of concern at all levels of PPE (including engineering controls):

 Mixing/loading dry flowable flufenacet to produce impregna ted dry bulk fertilizers
commercial ly to treat corn and soybeans; and

 Mixing/loading liquid flufenacet to produce impregnated dry bulk fertilizers
commercial ly to treat corn and soybeans

.

The use of gloves when handling flufenacet is already required on the flufenacet labels. In addition to gloves, a respirator and coveralls are already required when mixing/loading EPA Reg. No. 264

- 765. Chemical resistant aprons are also required when mixing/loading and cleaning equipment for EPA Reg. Nos. 264

- 800 and 264

- 852. Therefore, HED recommends that

P RD require the appropriate PPE on all relevan t labels so that the scenarios above are not of

concern. For the scenarios of concern with the maximum PPE level, P RD should evaluate additional mitigation options with the Registrant

.

A summary of the occupational handler scenarios and the PPE required to be not of concern for each scenario is provided in Table 6.1.1. Detailed scenarios and exposure estimates are provided

in Appendix D

.

Table 6.1.1. Summary of PPE Required (if any) for MOEs to be Not of Concern for Occupational Handler s of Flufenac et

.

Exposure Scenario and Formulation Crop or Target PPE Required to be not of concern (Dermal LOC = 1000) (Inhalation LOC = 300)

Mixer/Loader

### Page 18 of 33

Table 6.1.1. Summary of PPE Required (if any) for MOEs to be Not of Concern for Occupational Handler s of Flufenac et

.

Exposure Scenario and Formulation Crop or Target PPE Required to be not of concern (Dermal LOC = 1000) (Inhalation LOC = 300)

Mixing/Loading Dry Flowables for Commercial Treatment To

Produce Impregnated Fertilizers Corn

X 1 Soybeans

Mixing/Loading Dry Flowables for On

- Farm Treatment To

Produce Impregnated Fertilizers Corn Engineering Controls Soybeans

Mixing/Loading Dry Flowables for Groundboom Application Sod Gloves + PF5 Respirator

Corn Engineering Controls Soybeans Engineering Controls

Wheat Double Layer Clothing + Gloves +

PF10

Mixing/Loading Liquids for Commercial Treatment To Produce

Impregnated Fertilizers Corn

X 1 Soybeans

Mixing/Loading Liquids for On

- Farm Treatment To Produce

Impregnated Fertilizers Corn Engineering Controls

Soybeans Gloves

Mixing/Loading Liquids for Groundboom Application Corn EC Soybeans Applicator

Applying Sprays via Groundboom Equipment Sod None (Baseline)

Corn Gloves + PF5 Respirator Soybeans Gloves

Wheat Gloves Applying Impregnated Dry Bulk Fertilizer

- Commercial

Treatment Corn PF5 Respirator Soybeans

Applying Impregnated Dry Bulk Fertilizer

- On

- Farm Treatment Corn Soybeans None (Baseline)

1

. Scenarios of concern with maximum PPE (engineering controls). PRD should evaluate other mitigation options (e.g., reduced application rates, etc.) with the Registrant.



### 6

. 2 Occupational Post

- application Exposure/ Risk Estimates

HED uses the term post

- application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re

entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting. Post

- application exposure levels vary over time and depend o n such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can g reatly reduce the potential for post

- application exposure.

6

. 2 .1 Occupational Post

- application Inhalation Exposure/Risk Estimates

There are multiple potential sources of post

- application inhalation exposure to individuals performing post

- application acti vities 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

### Page 19 of 33

pesti cides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The agency has

eva luated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( http://www.regulations.gov/#!docketDetail;D=EP A

- HQ

OPP

- 2014

- 0219 ). During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux studies, route

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

.

In addition, the Agency is c ontinuing to evaluate the available post

- application inhalation exposure data generated by the Agricultural Reentry Task Force. Given these two efforts, the Agency will continue to identify the need for and, subsequently, the way to incorporate occupation al post

- application inhalation exposure into the agency's risk assessments.

6

. 2 .2 Occupational Post

- application Dermal Exposure/Risk Estimates

Occupational Post

- application Dermal Exposure Data and Assumptions

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

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

Exposure Duration: HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months as intermediate

- term. For flufenacet , based on the proposed use, only short

and intermediate

- term post

- application exposure s a re expected. However, since the short

- and
intermediate

- term dermal POD is the same, it is protective of both durations.

Transfer Coefficients : It is the policy of HED to use the best available data to assess post

application exposure. Sources of generic post

- application data, used as surrogate data in the
absence of chemical

- specific data, are derived from ARTF exposure monitoring studies, and, as proprietary data, are subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting post

- application exposure that are used in this assessment, known as “transfer coefficients”, are presented in the ExpoSAC Policy 3 7 

### ” which, along with additional information about the ARTF data, can be found at the Agency website 8



### . Table 6.2.2 provides a summary of the anticipated post

- application activities and associated transfer coefficients for the proposed crops/use sit es.

For flufenacet, because it is applied only early in the crop growth cycle for the agricultural crops (pre

- emergent, or early post

- emergent applications), only post

- application exposure to low crop heights and minimum foliage density was evaluated fo r corn, soybeans, and wheat. Hand weeding was not evaluated because flufenacet is an herbicide used to control weeds and grasses; therefore, hand weeding the field would not be necessary.

7 Available: http://www.epa.gov/pesticides/science/exposac_policy3.pdf

8 Available: http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.html

### Page 20 of 33

However, flufenacet can be applied to established grasses grown for seed; therefore all crop heights and foliage densities were evaluated.

Application Rate: A summary of the registered application rates for flufenacet is provided in
Table 4.1.

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

Dislodgeable Foliar Residues : Chemical

- specific dislodgeable foliar residue data have not been
submitted for flufenacet

. Therefore, this assessment uses HED’s default assumption that 25% of the application is available for transfer on day 0 following the application and the residues dissipate at a rate of 10% each following day.

Dislodgeable Foliar Residue (DFR) Data: Since the highest estimated occupational post

application exposure using default DFR values for flufenacet is minimal in comparison to the level of concern (i.e., the calculated MOE is not greater than 2 times higher than the level of

concern, MOE = 2,000 compared to the LOC of 1,000 ); EPA is requiring the 40 CFR DFR dat a. Therefore, EPA is requiring the 40 CFR DFR data requirement to facilitate any necessary exposure assessments refinements and to further EPA’s general understanding of the availability of dislodgeable foliar pesticide residues. For additional informati on on this data requirement, see Appendix C.

Occupational Post

- application Non

- Cancer Dermal Exposure and Risk Estimate Equations The algorithms used to estimate non

- cancer exposure and dose for occupational post

- application workers can be found in Appendix A

.

Occupational Post

- application Non

- Cancer Dermal Risk Estimates A summary of the occupational dermal post

- application MOEs for the registered uses of flufenacet are pr ovided in Table 6.2.2. The LOC for occupational post

- application risk is a MOE of 1,000. All occupational short

- and intermediate

- term risk estimates resul t ed in dermal MOEs of concern on day 0, except for sod maintenance (LOC = 1,000). The dermal post

- application MOEs for flufenacet range from 88 to 800 on the day of application. The days to reach an MOE of 1,000 for each activity are listed in Table 6.2.2. Therefore, HED recommends that P RD require the appropriate REIs on all relevant labels to addre ss these concerns

.

Table 6

. 2 .2

. Occupational Post

- application Non

- Cancer Exposure and Risk Estimates for Flufenacet

.

Crop/Site Activities Transfer Coefficient (cm 2 /hr) DFR/TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3 Days for MOE to
Reach LOC of 1,000

Corn Scouting 210 2.19 0.0021 800 3

Hand

- Set Irrigation 1,900 0.019 88 23

Grasses
Grown for
Seed* Hand

- Set Irrigation 1,900 1.23 0.011 160 18

Scouting 1,100 1.23 0.0063 270 13

Soybean Scouting 1,100 1.29 0.0066 260 13

### Page 21 of 33 Table 6

. 2 .2

. Occupational Post

- application Non

- Cancer Exposure and Risk Estimates for Flufenacet

.

Crop/Site Activities Transfer Coefficient (cm 2 /hr) DFR/TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3 Days for MOE to
Reach LOC of 1,000

Wheat Scouting 1,100 0.95 0.0049 350 10

1 DFR = Application Rate × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

- 8 acre/cm 2 ; wher e F = 0.25 and D = 0.10 per day (used for corn, soybeans,
wheat); TTR = Application Rate × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

- 8 acre/cm 2 ; where F = 0.1 and D = 0. 10 per day (used for sod).

2 Daily Dermal Dose = [DFR /TTR (μg/cm 2 ) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption ( 4.0 %)]  BW ( 69 kg).

3 MOE = POD ( 1.7 mg/kg/day) / Daily Dermal Dose.
* The post

- application exposure inputs for “forage crops” was used as a surrogate.



### Restricted Entry Interval The REI specified on the proposed label is based on the acute toxicity of flufenacet

. Flufenacet is classified as Toxicity Category III via the dermal route and Toxicity Category IV for skin irritation potential. It is not a skin sensitizer. Short

- and intermediate

- term post

- application risk estimates were not a concern on day 0 (12 hours following application) for activities related to sod production . However, there were risk estimates of concern related to scouting and hand

- set irrigation in corn, and scouting for soybeans and wheat. T herefore, HED is recommending that
the REI s be revised on the label to address those concerns.

### Page 22 of 33

App endix A. 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 = e xposure (mg ai/day),

UE = u nit e xposure (μ g ai/ lb ai),

AR = m aximum application rate according to registered label (lb ai A or lb ai/gal ), and

A = a rea 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 a bsorbed in a given scenario (mg ai/ kg / day),

E = e xposure (mg ai/day),

AF = absorption fa ctor (dermal and/or inhalation), and

BW = body weight (kg)

.

Margin of Exposure: Non

- cancer risk estimates for each application handler scenario are calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. The daily dermal and inhalation dose received by occupational

h andlers a re compared to the appropriate POD ( i.e.

, NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values a re calculated using the following formula:

MOE= POD

ADD

where:

MOE = m argin of e xposure: value used by HED to represent risk estimates (unitless),

POD = p oint of d eparture (mg/kg/day)

, and

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

.

Occupational Non

- cancer Post

- application Algorithms

### Page 23 of 33

Potential daily exposures for occupational post

- ap plication workers are calculated using the following formulas:

DFR t 

### =AR * F* (1

- D) t 

### * ( 4.54E8 ug
lb ) * ( 2.47E

- 8 A

cm 2 

### )

where:

DFR t 

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

### ),

AR = a pplication r ate (lb ai/acre),

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

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

t = number of days after application day (days)

.

E=TC * DFR t 

### * ET * 0.001 mg

ug

where:

E = e xposure (mg ai/day),

TC = t ransfer coefficient (cm 2 

### /hr),

DFR t 

### = d islodgeable f oliar r esidue on day “t” (μg/cm 2 

### ), and

ET = e xposure t ime (hours/day).

The daily doses are calculated using the following formula:

ADD= E * AF

BW

where:

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

E = e xposure (mg ai/day),

AF = absorption fa ctor (dermal and/or inhalation), and

BW = body weight (kg).

Margin of Exposure: Non

- cancer risk estimates for each scenario are calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern. The daily dermal dose received by occupational post

- application workers is compared to the appropriate POD ( i.e.

, NOAEL) to assess the risk to occupational post

- application workers

. All
MOE values a re calculated using the following formu la:

MOE= POD

ADD

where:

### Page 24 of 33

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 25 of 33

Appendix B. Registered Flufenacet End

- Use Products

Table B.1. Registered Flufenacet End

- Use Products.

EPA Reg. No. Formulation

Type Product Label Name Company

264

- 819 SC DEFINETM SC HERBICIDE

Bayer CropScience 264

- 818 SC Flufenacet 500 SC FLOWABLE

HERBICIDE

264

- 800 DF EpicTM DF Herbicide

264

- 765 DF DEFINETM DF HERBICIDE

264

- 852 SC Flufenacet & Isoxaflutole SC Herbicide

264

- 771 DF DomainTM DF Herbicide

264

- 766 DF Axiom® DF Herbicide

### Page 26 of 33

Appendix C

. Rationale for Requiring TTR and DFR Data

Turf Transferable Residue (TTR): In accordance with 40 CFR 158, TTR data are required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses that could result in post

- application exposure to turf. In the absence of chemical

- specific TTR data, EPA uses default values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an analysis of all TTR data, available at the time, which
resulted in the selection of revise d liquid and granular default values for the fraction of the application rate available for transfer after a turf application (F AR 

### ). These values are based on an analysis of 59 TTR studies performed with the Modified California Roller Method (36 studies

u sing liquids, 11 studies using wettable powders/water dispersible granules, and 12 studies using granules). The liquid results (N=131) indicate a range of F AR 

### values from 0.0005% to 6.1% and the granular results (N=37) indicate a range of 0.00064% to 0.69 %. In both the liquid and granular data, a large range of transferability is observed and this variability can potentially be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e.g., h umidity); or many other difficult to quantify factors. Although witnessed across multiple chemicals, this range in F AR 

### values is not expected when considering TTR data for a single chemical. HED selected 1% and 0.2% as high

- end default values for liquid and granular products, respectively. Because TTR data are not available for flufenacet

, EPA is using the default value of [appropriate value for liquid or granular product]. Although there may be a small degree of uncertainty in the use of the default T TR value for flufenacet (i.e.,
there is a small chance that the F AR 

### value may exceed the applicable default value ), it is likely
that the health

- protective aspects of EPA’s occupational post

- application turf assessment methodology will more than compensat e for this potential uncertainty (i.e., the methodology is likely to overestimate exposure by a factor greater than the factor than the highest measured F AR 

### values exceed the defaults ). For example, when assessing residential post

- application turf

expos ure, EPA assumes the following: exposures occur to zero

- day (i.e., day of application ) residues every day of the assessed exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn’t rain, the grass is not mowed, etc); indi viduals perform the same
post

- application activities performed in the turf transfer coefficient study day after day (e.g., tumbling, playing on turf with toys, etc.); and individuals engage in these post

- application
activities for a high

- end amount of tim e every day that is represented by data reflecting time children spend outdoors and not specifically engaged in activities on turf, when in actuality children do not spend all of their outdoor time on turf and high

- end levels of activity will not

occur eve ry day.

Given the conservatisms discussed above and the potential compounding nature of these conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that exposure is not being underestimated.

Since the estimated residential turf post

- application exposure for sod using default TTR values
for flufenacet is not minimal in comparison to the level of concern (i.e., the calculated MOE is not greater than 10 times higher than the level of concern, MOE = 10,000 compared t o the LOC of 1,000 ), future refinements of this post

- application exposure for flufenacet may be necessary

### Page 27 of 33

due to increased use of flufenacet or advances in EPA risk assessments. Therefore, EPA is requiring the 40CFR TTR data requirement to facilitate any necessary exposure assessments refinements and to further EPA’s general understanding of the availability of turf transferable pesticide residues.

Dislodgeable Foliar Residue (DFR): In accordance with 40C FR158, DFR data are required for all occupational (e.g., crop, nursery, greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own farms, retail tree farms) uses that could result in post

application exposure to foliage. I n the absence of chemical

- specific DFR data, EPA uses default
values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure

Assessment includes an analysis of a number of DFR studies, which resulted in the selection of a
revised defaul t values for the fraction of the application rate available for transfer after a foliar application (F AR 

### ). These values are based on an analysis of 19 DFR studies. Since that time, the Agricultural Re

- entry Task Force has submitted information (MRID 492 99201) that corrects an application rate error made in the original submission of “ARF039

– Determination of Dermal and Inhalation Exposure to Reentry Workers During Chrysanthemum Pinching in a Greenhouse” (EPA MRID 45344501). As a result, the range of F A R 

### values was revised from 2%

- 89% to 2%

- 47%. In the data, a large range of transferability is observed and this variability can potentially be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e.g., humidity); or many other difficult to quantify factors. Although witnessed across multiple chemicals, this range in F AR 

### values is not expected when considering DFR data for a single chemical. At this time, the ARTF submission did not a lter the selection of 25% as the reasonable, high

- end default value. Because DFR data are not available
for flufenacet , EPA is using the default value of 25%. Although there may be a small degree of uncertainty in the use of the default DFR value for flu fenacet (i.e., there is a small chance that
the F AR 

### value may exceed the applicable default value ), it is likely that the health

- protective aspects of EPA’s occupational post

- application assessment methodology will more than compensate for this potential u ncertainty. For example, when assessing residential and occupational post

- application exposure to gardens and ornamentals, EPA assumes the following:

exposures occur to zero

- day (i.e., day of application ) residues every day of the assessed exposure du ration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn’t rain, etc); individuals perform the same post

- application activities performed in the transfer coefficient study day after day (e.g., weeding, harvesting, pruning, etc.); and i ndividuals engage in these post

- application activities for a high

- end amount of time every day (represented by data reflecting time spent gardening based on survey data).

Given the conservatisms discussed above and the potential compounding nature of thes e conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that exposure is not being underestimated.

Since the highest estimated occupational post

- application exposure using default DFR values for
flufenacet is not minimal in comparison to the level of concern (i.e., the calculated MOE is not greater than 2 times higher than the level of concern, MOE = 2,000 compared to the LOC of 1,000 ); EPA is requiring the 40 CFR DFR data. Therefore, EPA is requiring the 40CFR DFR

### Page 28 of 33

data requirement to facilitate any necessary exposure assessments refinements and to further EPA’s general understanding of the availability of dislodgeable foliar pesticide residues.

### Page 29 of 33

Appendix D

. Occupational Handler Exposure Tables

Table D.1. Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet at Baseline PPE.

Exposure Scenario Crop or Target Dermal Unit

Exposure (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

Baseline * Baseline * Dose (mg/kg/day) 4 MOE 5

(LOC = 1000) Dose

(mg/kg/day) 6 MOE 7

(LOC = 300)

Mixer/Loader

Mixing/Loading Dry Flowables for
Commercial Treatment with Impregnated Fertilizers Corn

9.8 0.24 7.8 8 lb
ai/ton 960 tons 0.04 3 40 0.02 228 22

Soybeans 4. 56 lb
ai/ton 0.02 49 68 0.01 31 38

Mixing/Loading Dry Flowables for

On

- Farm Treatment with Impregnated Fertilizers Corn

227 8.96 0.78

160 acres 0.0164 100 0.0140 21

Soybeans 0.46 0.00968 180 0.00824 35

Mixing/Loading Dry Flowables for Groundboom Application Sod

227 8.96 0.44 80 acres 0.00463 370 0.00 394 73

Corn 0.78

200 acres 0.0205 83 0.0 175 17 Soybeans 0.46 0.0121 140 0.01 03 28

Wheat 0.34 0.00893 190 0.00 761 38

Mixing/Loading Liquids for
Commercial Treatment with Impregnated Fertilizers Corn

8.6 0.083 7.88 lb
ai/ton 960 tons 0.0377 45 0.00785 64

Soybeans 4.56 lb
ai/ton 0.0218 48 0.00454 110

Mixing/Loading Liquids for On

Farm Treatment with Impregnated

Fertilizers Corn
220 0.219 0.78
160 acres 0.0159 110 0.000341 850

Soybeans 0.46 0.00939 180 0.000201 1,400

Mixing/Loading Liquids for Groundboom Application Corn 220 0.219 0.78 200 acres 0.0199 85 0.000428 680 Soybeans 0.46 0.0117 150 0.000251 1,200 Applicator

Applying Sprays via Groundboom

Equipment Sod

78.6 0.34 0.44 80 acres 0.00161 1,100 0.001 50 950

Corn 0.78

200 acres 0.00713 240 0.000 662 220 Soybeans 0.46 0.00419 410 0.000 391 370

Wheat 0. 3 4 0.0031 550 0.000 289 490 Applying Impregnated Dry Bulk
Fertilizer

- Commercial Treatment Corn 9.9 1.2 0.78 320 acres 0.00143 1,200 0.00375 130 Soybeans 0.46 0.000846 2,000 0.00221 230 Applying Impregnated Dry Bulk
Fertilizer

- On

- Farm Treatment Corn 9.9 1.2 0.78 160 acres 0.000719 2,400 0.00188 270 Soybeans 0.46 0.000423 4,000 0.00110 460

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, Eng. Controls. *Baseline for mixing/loading for commercial treatment of impregnated fertilizers is engineering controls in a closed system.

### Page 30 of 33 2 Based on registered labels. See Appendix B.

3 Exposure Science Advisory Council Policy #9.1.

4 Dermal 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 (A or tons /day) × DAF (4 %) ÷ BW (69 kg).
5 Dermal MOE = Dermal LOAEL (1.7 mg/kg/day) ÷ Dermal Dose (mg/ kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal ) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL (0.143, 0.289, or 0. 501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

Table D.2 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenario requiring Gloves to Be Not of Concern.

Exposure Scenario Crop or Target Dermal Unit Exposure (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

Gloves Baseline Dose (mg/kg/day) 4 MOE 5

(LOC = 1000 ) Dose

(mg/kg/day) 6 MOE 7

(LOC = 300)

Mixer/Loader Mixing/Loading Liquids for

On

- Farm Treatment with Impregnated Fertilizers Soybeans 37.6 0.219 0.46 160 acres 0.00161 1,100 0. 0002 01 1, 4 00

Applicator Applying Sprays via Groundboom Equipment Soybeans 16.1 0.34 0.46 200 acres 0.000858 2,000 0.000391 370

Wheat 0.34 0.000632 2,700 0.000289 490

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, En g. Controls.

2 Based on registered labels. See Appendix B

. 3 Exposure Science Advisory Council Policy #9.1.

4 Dermal 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 (A or gal/day) × DAF ( 4 %) ÷ BW ( 69 kg).
5 Dermal MOE = Dermal L OAEL ( 1. 7 mg/kg/day) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal ) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhala tion NOAEL ( 0.143, 0.289, or 0.501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

Table D.3 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenarios Requiring Gloves and a PF5 Respirator to be Not of
Concern.

Exposure Scenari o Crop or Target Dermal Unit

Exposure (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

Gloves PF5 Respirator Dose (mg/kg/day) 4 MOE 5

(LOC = 1000 ) Dose

(mg/kg/day) 6 MOE 7

(LOC = 300)

Mixer/Loader Mixing/Loading Dry
Flowables for Groundboom Application Sod 51.6 1.792 0.44 80 acres 0.00106 1,600 0.000789 370

Applicator

### Page 31 of 33 Table D.3 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenarios Requiring Gloves and a PF5 Respirator to be Not of
Concern.

Exposure Scenari o Crop or Target Dermal Unit

Exposure (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

Gloves PF5 Respirator Dose (mg/kg/day) 4 MOE 5

(LOC = 1000 ) Dose

(mg/kg/day) 6 MOE 7

(LOC = 300) Applying Sprays via Groundboom Equipment Corn 16.1 0.068 0.78 200 acres 0.00146 1,200 0.0001 33 1,10 0

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, En g. Controls.

2 Based on registered labels. See Appendix B

. 3 Exposure Science Advisory Council Policy #9.1.

4 Dermal 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 (A or gal/day) × DAF ( 4 %) ÷ BW ( 69 kg).
5 Dermal MOE = Dermal L OAEL ( 1.7 mg/kg/day) ÷ Dermal Do se (mg/kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal ) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL ( 0.143, 0.289 , or 0.501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

Table D.4 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenarios Requiring a PF 5 Respirator to be Not of Concern.

Exposure Scenario Crop or Target Dermal Unit

Exposu re (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

Baseline P F5 Respirator Dose (mg/kg/day) 4 MOE 5

(LOC = 1000 ) Dose

(mg/kg/day) 6 MOE 7

(LOC = 300 ) Applicator Applying Impregnated Dry
Bulk Fertilizer

- Commercial

Treatment Corn

9.9 0.24 0.78
320 acres 0.00143 1,200 0.000 749 670

Soybeans 0.46 0.000846 2,000 0.000 441 1.100

Applying Impregnated Dry
Bulk Fertilizer

- On

- Farm

Treatment Corn 0.78 160 acres 0.000719 2,400 0.000 375 1, 3 00

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, En g. Controls.

2 Based on registered labels. See Appendix B

. 3 Exposure Science Advisory Council Policy #9.1.

4 Dermal 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 (A or gal/day) × DAF ( 4 %) ÷ BW ( 69 kg).
5 Dermal MOE = Dermal L OAEL ( 1.7 mg/kg/d ay) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal ) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAE L ( 0.143, 0.289, or 0.501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

### Page 32 of 33 Table D.5 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenarios requiring Double Layer and Gloves Not of
Concern.

Exposure Scenario Crop or Target Dermal Unit

Exposure (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

DL + G Baseline Dose (mg/kg/day) 4 MOE 5

(LOC = 1000) Dose

(mg/kg/day) 6 MOE 7

(LOC = 3 0 0)

Mixer/Loader Mixing/Loading Liquids for Groundboom Application Soybeans 29.1 0.219 0.46 200 acres 0.00155 1,100 0.000 251 1,200

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, Eng. Controls.

2 Based on registered labels. See Appendix B

. 3 Exposure Science Advisory Council Policy #9.1.

4 Dermal 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 (A or gal/day) × DAF ( 4 %) ÷ BW ( 69 kg).
5 Dermal MOE = Dermal L OAEL ( 1.7 mg/kg/day) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal ) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL ( 0.143, 0.289, or 0.501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

Table D.6 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenarios requiring Double Layer, Glove s , and a PF10 Respirator to be Not of Concern.

Exposure Scenario Crop or Target Dermal Unit

Exposure (μg/lb ai) 1 Inhalation Unit

Exposu re (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

DL + G PF10 Dose (mg/kg/day) 4 MOE 5

(LOC = 1000) Dose

(mg/kg/day) 6 MOE 7

(LOC = 3 0 0)

Mixer/Loader Mixing/Loading Dry
Flowables for Groundboom Application Wheat 41.2 0.896 0.34 200 acres 0.00162 1,000 0. 000761 3 8 0

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, En g. Controls.

2 Based on registered labels. See Appendix B

. 3 Exposure Science Advisory Council Policy #9.1.

4 Dermal 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 (A or gal/day) × DAF ( 4 %) ÷ BW ( 69 kg).
5 Dermal MOE = Dermal L OAEL ( 1.7 mg/kg/day) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal ) × Area Treated or Amount Handled (A or gal /day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL ( 0.143, 0.289, or 0.501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).

### Page 33 of 33 Table D.7 . Occupational Handler Non

- Cancer Exposure and Risk Estimates for Flufenacet

- Scenarios requiring Engineering Controls to be Not of
Concern.

Exposure Scenario Crop or Target Dermal Unit

Exposure (μg/lb ai) 1 Inhalation Unit

Exposure (μg/lb ai) 1 Maximum

Application

Rate 2 (lb ai/A) Area

Treated or
Amount

Handled Daily 3 Dermal Inhalation

EC EC Dose (mg/kg/day) 4 MOE 5

(LOC = 1000) Dose

(mg/kg/day) 6 MOE 7

(LOC = 3 0 0)

Mixer/Loader Mixing/Loading Dry
Flowables for On

- Farm

Treatment with Impregnated
Fertilizers Corn

9.8 0.24 0.78

160 acres 0.00071 2,400 0.000375 1,300

Soybeans 0.46 0.00042 4,100 0.000221 2,300

Mixing/Loading Dry
Flowables for Groundboom Application Corn 0.78
200 acres 0.00089 1,900 0.000468 1,100

Soybeans 0.46 0.00052 3,300 0.000276 1,800

Mixing/Loading Liquids for
On

- Farm Treatment with Impregnated Fertilizers Corn 0.78 160 acres 0.00062 2,700 0.000130 3,900

Mixing/Loading Liquids for Groundboom Application Corn 8.6 0.083 0.78 200 acres 0.00078 2,200 0.000161 3,100

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table”; Level of mitigation: Baseline, PPE, Eng. Controls.

2 Based on registered labels. See Appendix B

. 3 Exposure Science Advisory Council Policy #9.1.

4 Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Tr eated or Amount Handled (A or gal/day) × DAF ( 4 %) ÷ BW ( 69 kg).
5 Dermal MOE = Dermal L OAEL ( 1.7 mg/kg/day) ÷ Dermal Dose (mg/kg/day).

6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled (A or gal/day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL ( 0.143, 0.289, or 0.501 mg/kg/day) ÷ Inhalation Dose (mg/kg/day)

.