Date :

S ubj ect: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

D ecember 4, 2015 OFFICE OF CHEMICAL SAFETY AN D POLLUTION PREVENTION

F luensulfone. Occupational an d Residential Exposure Assessment for Proposed
Uses on Golf Courses, Sports Fie ld s, Commerc i a l Areas, Sod Farms

, and
R esidential Turfgrass and Lawns

.

PC Co d e : 050410
D e ci s i on No

. : 496677
Pet ition No.: NA DP B a r code : 430164 Regi s tration No.: 53883-GL T Reg ulat ory Act i o n: Section 3 Registration
Case No.: NA Risk A ssess m e n t Type: Exposure Assessment
T XRNo .:NA CAS No.: 318290-98-1
40 CF R: 1 80.680 MRID No .: 49552503

From:

Through:

To:

Introduction Zaida Figueroa, DrPH

, Indu str ial H ygienist
Risk Assessment Branch II Health Effects D ivision (7509P)

Christina Swartz

, Chief

# ~_}~ Risk Assessment Branch II Health Effec ts Division (7509P)

and 

# 11

Kr i st in Rury

, ExpoSAC

# Reviewe**{j;;t ~**  Joshua Godshall

, ExpoSAC Reviewer 

### J7 Exposure Science Advisory Committe{fExpoSAC) I HED

Rita Kumar/Marianne Lewis / Mered i th Laws Invertebrate and Vertebrate Branch 3 Registration Division (7505 P )

The Reg i stration Division ( RD) requested that the Health Effects D iv i sion (HED) conduct an
exposure and risk assessment for proposed uses of fluensulfone for nematode control on golf

courses , sports fields

, commerc i a l areas , sod farms and residential lawns. This risk assessment addresses the potent i a l occupat i ona l and residential exposures associated with the proposed u ses

. It is HED policy to use the best available data to assess exposure

. Severa l sources of gene ri c data were used in this assessment as surrogate data i n the absence of chem i cal

- specific data

,

Page 1of37Page 2 of 37 including : Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1) ; the Outdoor Residential Exposure Task Force (ORETF) database; the Agricultural Reentry Task Force (ARTF) database; the Residential SOPs (Turf SOP), and other registrant

- submitted ex posure monitoring studies ( MRID No. 49552503 )

. Some of these data are proprietary, and subject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIF RA).

Note: This memorandum was reviewed by the Exposure Science Advisory Committee (ExpoSAC) on November 19 , 2015

.Page 3 of 37 Table of Contents

1.0 Executive Summary

................................ ................................ ................................ .................. 4 2.0 Risk Assessment Conclusions and Recommendations

................................ ............................. 6 2.1 Summary of Risk Estimates

................................ ................................ ................................ .. 6 2.2 Label Recommendations from Occupational and Residential Assessment

.......................... 7 2.3 Data Deficiencies and Requirements

................................ ................................ .................... 7 3.0 Hazard Characterization

................................ ................................ ................................ ............ 7 4.0 Use Profile

................................ ................................ ................................ .............................. 13 5.0 Resident ial Exposure and Risk Estimates

................................ ................................ ............... 14 5.1 Residential Handler Exposure/Risk Estimates

................................ ................................ .... 14 5.2 Residential Post

- application Exposure/Risk Estimates

................................ ...................... 17 5.3 Residential Risk Estimates for Use in Aggregate Assessment

................................ .......... 19 6.0 Non

- Occupational Spray Drift Exposure and Risk Estimates

................................ ................ 20 7.0 Non

- Occupational Bystander Post

- Application Inhalation Exposure and Risk Estimates

..... 20 8.0 Occupational Exposure and Risk Estimates

................................ ................................ ........... 20 8.1 Occupational Handler Exposure/Risk Estimates

................................ ................................ 20 8.2 Occupational Post

- application Exposure/Risk Estimates

................................ ................... 24 8.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

........................... 24 8.2.2 Occupational Post

- application Dermal Exposure/Risk Estimates

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

- cancer Algorithms

..................... 27Page 4 of 37 1.0 Executive Summary

Fluensulfone [5

- chloro

- 2

- [(3,4,4

- trifluoro

- 3

- buten

- 1

- yl)sulfonyl]thiazole] is a nematicide of the fluoroalkenyl group for the control of nematodes [e.g., control r oot

- knot ( Meloidogyne spp. ),

s ting ( Belonolaimus spp. ) , lance ( Hoplolaimus spp. ) and l esion nematodes ( Pr atylenchus spp. ) ]

. The previous 2014 risk assessment evaluated fluensulfone as a new active ingredient for use on

c ucurbits and fruiting v egetables ( D403814 , Z. Figueroa, 7/18/2014 ).

This document assesses the occupational and residential exposures and risks from the propose d

use s of fluensulfone on golf courses, sports fields, commercial areas, sod farms and residential lawns . This assessment includes the first proposed use of fluensulfone i n residential settings (i.e., turf/lawns) . This document also evaluates the proposed residential scenarios for aggregate risk assessment.

Proposed Use Profile The proposed end

- use (EP) granular product MCW2 1.5% ( EPA Registration No. 53883

- GLT and alternate brand names: Quali

- Pro® Nimitz® 1.5 G Nematicide or Quali

- Pro® Nimitz PRO G Nematicide) may be applied broadcast overtop turfgrass at a maximum single applic ation rate of 1.8 lb ai/A and may be applied as a rescue treatment to sod on sod farms using ground spreaders at a maximum application rate of 3.6 lb a i/A

. Treated areas should be irrigated following applications in order to get the active ingredient into the root zone and soil. The proposed label requires handlers to wear long

- sleeved shirt, long pants, shoes, socks, and chemical

- resistant gloves. Ro tation with nematicides with a different mode of action is suggested on the proposed label

.
Exposure Profile Based on the proposed application rate and label information, only short

- and intermediate

- term dermal and inhalation exposures are expected for occupational handlers and post

- application workers. O nly short

- term dermal and inhalation exposures are expected for use on turf/lawns by residential handlers. Short

- term dermal residential post

- application exposure is expected for adults , youth

, and children from treated turf ( i.e., golf course and residential lawns) and incidental oral post

- application exposure is expected for children . Chronic exposure is not expected from the proposed use pattern.

Hazard Profile HED has determined that the toxicology database for fluensulfone is complete and adequate to assess occupational /residential exposure. The short

- and intermediate

- term dermal points of departure (PODs) and short

- term incidental oral POD are based on decre ased body weight, increased mean hemoglobin concentration distribution width, and increased relative and absolute reticulocyte counts in both sexes, decreased prothrombin time in males, and increased platelets in females seen in the co

- critical subchronic and chronic dog studies (no observed adverse effect level ( NOAEL ) . The NOAEL of 3.1 mg/kg/day was selected for dermal risk assessment based on dose

- spacing

. The selected POD is applicable to incidental oral risk assessment since the effects were seen sta rting at w eek 6 in both studies and the lack of progression observed in the toxicity database

.Page 5 of 37 For short

- and intermediate

- term inhalation risk assessment, a NOAEL could not be identified in th e available subchronic inhalation toxicity study ; therefore , an additional 10X uncertainty factor for the use of a LOAEL to extrapolate to a NOAEL was applied to short

- and intermediate

- term inhalation exposure scenarios. For purposes of estimating inhalation risk resulting from occupational and residential expos ure, a portal of entry human equivalent concentration (HEC) and human equivalent dose (HED) were derived in accordance with standard methodology that results in a reduction in the interspecies uncertainty factor (UF) from 10X to 3X. The HED s determined fo r occupational inhalation risk assessment are 0.244, 0.491 and 0.853 mg/kg/day; the residential inhalation risk assessment HED is 0. 164 mg/kg/day (see session 3.0 for HEC and HED calculations)

.

T he Food Quality Protection Act (FQPA) safety factor was redu ced to 1X based on the completeness of the toxicity database and no residual uncertainties concerning pre

- or post

- natal toxicity . In addition, the endpoints and doses chosen for risk assessment are protective of the qualitative susceptibility observed in the 2

- generation reproduction study and the evidence of neurotoxicity observed in the acute neurotoxicity (ACN) study. The level of concern (LOC) for dermal exposure is equal to a margin of exposure (MOE) of 100, based on the combined interspecies (10X) and intraspecies (10X) uncertainty factors. The LOC for inhalation exposure is equal to a MOE of 300, based on the use o f the lowest observed adverse effect level (LOAEL) to extrapolate a NOAEL (10X) and the combined interspecies (3X) and intraspecies (10X) uncertainty factors. Fluensulfone is classified as “Suggestive Evidence of Carcinogenicity” based on an increased inc idence of alveolar/bronchiolar adenomas and carcinomas in the lung of mid

- and high

- dose female mice in the oncogenicity study. The EPA has determined that quantification of risk using a non

- linear approach for fluensulfone will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to fluensulfone.

Residential Exposure and Risk Assessment There are residential handler and post

- application exposure scenarios associated with the new proposed uses on treated t urf. All residential handler and post

- application exposure risk estimates were assessed using the single maximum application rate of 1.8 lb ai/acre and resulted in MOEs greater than their respective LOCs. The risk estimates are not of concern. Furthermo re, a ll residential scenarios selected for the aggregate assessment resulted in MOEs greater than the LOC and are not of concern.

Occupational Exposure and Risk Assessment No chemical

- specific handler exposure data were submitted in support of this draft risk assessment; therefore, HED relied on the best available data to assess handler exposure. Default assumptions established by HED’s Science Advisory Council for Exposure (ExpoSAC) were used for parameters such as body weight and amount handled. All oc cupational handler scenarios for the proposed uses resulted in MOEs that are not of concern at some level of risk mitigation (e.g., baseline attire with no gloves and no respirator

, or baseline attire with a PF5 respirator).

Occupational post

- application dermal exposure and risk estimates resulted in MOEs that are
≥ 100 and are not of concern. Fluensulfone is classified as Toxicity Category III via the dermal route and Toxicity Category IV for skin and eye irritation potential

. The granular formulation isPage 6 of 37 not a skin sensitizer. Short

- and intermediate

- term post

- application risk estimates for workers conducting post

- application activities on sod farms and golf courses (maintenance) were not a

concern on D ay 0 (following applic ation) for al l post

- application activities.

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

- cancer occupational post

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

- application inhalation exposure assessment for fluensulfone.

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 PHED 1.1; the ORETF database; the ARTF database; the Residential SOPs ( Turf SOP); and other registrant

- submitted exposure monitoring studies (MRI D No. 49552503 ), 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 and Recommendations

2.1 Summary of Risk Estimates

Residential All residential handler exposure risk estimates were assessed using the single maximum application rate of 1.8 lb ai/acre and resulted in MOEs greater than their respective LOCs and not of concern. All residential post

- application exposure scenarios as we ll as the risk estimates selected for the aggregate assessment resulted in MOEs greater than the LOC and are not of

concern.

Occupational All occupational handler scenarios for the proposed uses resulted in dermal risk estimates that are greater than the LOC of 100 at baseline level of risk mitigation (i.e., baseline attire with no gloves), and therefore, are not of concern. The inhalation risk estimates are higher than the LOC of 300 at baseline (i.e., no respirator) or using some level of mitigation (e. g., PF5 respirator). The following scenarios require a PF5 respirator to reach an inhalation MOE above the LOC of 300:

• mixing/loading a granular formulation being applied using tractor

- drawn spreader at an application rate of 1.8 lb ai/A (sod application rate)

,

• mixing/loading a granular formulation being applied using tractor

- drawn spreader at an

1 http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/occupational

- pesticide

- handler

- exposure

- data and http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/occupational

- pesticide

- post

- application

exposurePage 7 of 37 application rate of 3.6 lb ai/A (sod rescue treatment application rate)

, and

• applying a granular formulation being applied using tractor

- drawn spreader at an app lication rate of 3.6 lb ai/A (sod rescue treatment application rate).

All other inhalation MOEs ranged from 390 to 790 (LOC=300) with no respirator.

Occupational post

- application dermal exposure and risk estimates resulted in MOEs that are ≥100 and are n ot of concern.

2.2 Label Recommendations from Occupational and Residential Assessment

Based on the occupational inhalation risk estimates, additional personal protective equipment (PPE) will be needed on the proposed label to protect occupational handlers (i.e., PF5 respirator).

2. 3 Data Deficiencies and Requirements

A chemical

- specific turf transferable residue (TTR) study ( EPA MRID No. 49552503) is available for fluensulfone and it was used for this risk assessment

. There are no data deficiencies that would require submission of additional exposure data for this Section 3 action

.

3 .0 Hazard Characterization

The toxicity database for fluensulfone is complete for the purpose of assessing the proposed use of fluensulf one . The primary effects in the toxicity database were changes in hematology parameters which were observed in rats, mice, and dogs following subchronic and chronic exposure. Other effects observed included changes in clinical chemistry parameters and de creased body weight in all three species. In addition to the effects above, fluensulfone caused lung toxicity following chronic dietary exposure in rats, but not mice or dogs. Fluensulfone also caused portal

- of

- entry effects in rats consisting of histopa thological changes in the forestomach and pharynx following subchronic dietary exposure and in the epiglottis and nasal cavity following subchronic inhalation exposure.

There was no evidence of increased quantitative susceptibility in the developmental an d reproduction studies as all effects in the pups were observed in the presence of maternal effects. However, there was increased qualitative susceptibility of pups in the 2

- generation reproduction study. In this study, pup death was observed at the same dose causing decreased body weight in the parental generation. T he endpoints and doses chosen for risk assessment are protective of the qualitative susceptibility observed in the 2

- generation reproduction study and the evidence of neurotoxicity observed in the ACN study

. Therefore, the FQPA safety factor was reduced to 1X based on the completeness of the toxicity database, there are no residual uncertainties concerning

pre

- or post

- natal toxicity.

Evidence of neu rotoxicity was limited to findings in the acute neurotoxicity study. There was no evidence of immunotoxicity in the toxicity database. Fluensulfone and its major metabolites were determined to be non

- mutagenic following a battery of genotoxicity studies. FluensulfonePage 8 of 37 did result in an increased incidence of lung adenomas and carcinomas in female rats following chronic dietary exposure, however no tumors were observed in rats or dogs.

Fluensulfone is classified as “Suggestive Evidence of Carcinogenicity” based on an increased incidence of alveolar/bronchiolar adenomas and carcinomas in the lung of mid

- and high

- dose female mice in the oncogenicity study. Tumors were not observed in the rat chronic toxicity/carcinogenicity study in either sex or in male mi ce and mutagenicity is not of concern. The EPA has determined that quantification of risk using a non

- linear approach for fluensulfone will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to fluensulf one.

Acute Toxicity

Testing in acute lethality studies with fluensulfone technical

- grade material resulted in low toxicity classifications via the oral (Toxicity Category III), dermal (Toxicity Category III), and inhalation (Toxicity Category IV) routes of exposure. Fluensulfone technical

- grade material was not an irritant to eyes (Toxicity Category IV) or skin (Toxicity Category IV) but was a skin sensitizer. Similar results were obtained in acute lethality stud ies with a granular formulation.
T he gra nular formulation was determined not to be a skin sensitizer. A summary of the acute toxicity of fluensulfone is presented in Table 3.1 a and 3.1b

.

Table 3.1 a . Acute Toxicity Profile

- Fluensulfone Technical.

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

870.1100 Acute oral

- rat 48574745 LD 50 = 671 III

870.1200 Acute dermal

- rat 48575035 LD 50 > 2000 mg/kg III

870.1300 Acute inhalation

- rat 48574748 LC 50 > 5.1 mg/L IV

870.2400 Acute eye irritation

- rabbit 48574750 Non

- irritant IV

870.2500 Acute dermal irritation

- rabbit 48574749 Non

- irritant IV

870.2600 Skin sensitization

- guinea pig 48574751 Sensitizer N/A

Table 3.1b. A cute Toxicity Profile

- Fluensulfone Granular F ormulations

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

870.1100 Acute oral

– rat, 15GR 49488603 LD 50 > 2000 mg/kg III
870.1100 Acute oral

– rat, 1.5GR 49488608 LD 50 > 2000 mg/kg III
870.1200 Acute dermal

– rat, 15GR 49488604 LD 50 > 2000 mg/kg III
870.1300 Acute inhalation

- rat waived

- - 870.2400 Acute eye irritation

– rabbit, 15GR 49488605 Non

- irritant IV
870.2500 Acute dermal irritation

– rabbit, 15GR 49488606 Slightly irritating IV

870.2600 Skin sensitization

– mice, 15GR 49488607 Not a sensitizer N/APage 9 of 37 Toxicological PODs Used for Risk Assessment

The chronic dietary study and a 90

- day dietary study in dogs were chosen as co

- critical studies for the short

- and intermediate

- term dermal endpoints. The NOAEL and LOAEL are derived from the chronic dog study based on the dose spacing. The NOAEL of 3.1 mg/kg/day was determined based on decreased body weight, increased mean hemoglobin concentration distribution width, and increased relative and absolute reticulocyte counts in both sexes, decreased prothrombin time in males, and increased platelets in fema les. While there was a 28

- day dermal study in the rat available which showed minimal toxicity, HED determined to use an oral study due to the high dermal absorption (58%) observed in vivo in rat studies using the 480 EC formulation. Since dermal exposure s to the formulation are expected to occur, the oral study with a dermal absorption factor was selected to assess dermal exposures.

For incidental oral exposure to children, HED also chose the co

- critical dog studies. The two dog studies are appropriate for short

- term exposure because the effects (hematology and clinical chemistry parameters) were seen starting at Week 6 in both studies and the lack of progression observed in the toxicity database (subchronic and chronic studies of all species had similar NOAELs and LOAELs). The endpoint is protective of all effects observed in the database including the offspring effects observed in the 2

- generation toxicity study in rats.

The short

- and intermediate

- term inhalation dose and endpoint for was selected fr om the 90

- day inhalation study. Decreased weight loss, decreased thymus weight, and histopathological changes in the nasal cavity in males, prolonged prothrombin time in females, and histopathological changes in the epiglottis for both sexes were observed at the lowest dose tested of 0.04 mg/L. Since a NOAEL could not be identified in this study, an additional 10X uncertainty factor for the use of a LOAEL to extrapolate to a NOAEL was applied to short

- and intermediate

- term inhalation occupational exposur e scenarios. The human equivalent concentrations (HECs) and the human equivalent doses (HEDs) were calculated using the methods and dosimetry equations described in EPA’s Reference Concentration (RfC) Guidance (1994) and OPP’s Guidance on the Application of the RfC Methodology (2014) for use in MOE calculations and presented in T able 3.2

.Page 10 of 37 Table 3.2

. Fluensulfone: HECs and HEDs: 90

- day Subchronic Inhalation Study in Rats ( MRID 49067003 )

.

Short and
intermediate

term Inhalation Inhalation NOAEL = not identified UF A = 3X
UF H =10X
UF L =10X Residential and Occupational LOC
for MOE = 300 Inhalation LOAEL = 0.04 mg/L based on weight loss in males, prolonged prothrombin time in females, decreased thymus weight in males, histopathological changes in the epi glottis in both sexes, and histopathological changes in the nasal cavity of
males.

. Exposure Scenario HECs HEDs
Occupational
Handler HECs and
HEDs Ventilation rate=8.3 L/min 0.00429 mg/L 0.244 mg/kg/day

Ventilation rate=16.7 L/min 0.491 mg/kg/day
Ventilation rate=29 L/min 0.853 mg/kg/day

Residential
Handler HECs and
HEDs Handler 0.00572 mg/L 0.164 mg/L

Although some of the toxicological effects for the dermal and inhalation exposure routes were similar (e.g., decrease body weigh t ), these exposure routes are not combined in this assessment because the inhalation POD is primarily based on portal of entry effects ( D424168 )

. I ncidental oral and dermal routes of exposure are combined because the PODs for risk assessment a re based on studies wi th the same toxicological effects.

A summary of the toxicological doses and endpoints for fluensulfone are summarized in Table 3. 3 below.

Table 3. 3 . Summary of Toxicological Doses and Endpoints for use in Residential and Occupational Human Health Risk Assessments for Fluensulfone

. Exposure/ Scenario Point of Departure Uncertainty/ FQPA Safety Factors Level of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary (All Populations, including Infants and Children and Females 13

- 49 years of age) Offspring NOAEL= 16.2 mg/kg/day UF A = 10x
UF H =10x FQPA SF= 1x Acute RfD = 0.16 mg/kg/day

aPAD = 0.16 mg/kg/day 2

- generation reproduction

– rat Offspring LOAEL = 122.0 mg/kg/day based on

an increase in pup loss between PND 1 and 4 in the F1 and F2 offspring with the majority of deaths occurring on day 2.Page 11 of 37 Table 3. 3 . Summary of Toxicological Doses and Endpoints for use in Residential and Occupational Human Health Risk Assessments for Fluensulfone

. Exposure/ Scenario Point of Departure Uncertainty/ FQPA Safety Factors Level of Concern for Risk Assessment Study and Toxicological Effects

Incidental Oral ( Short

- term ) NOAEL = 3.1 mg/kg/day UF A = 10x
UF H =10x FQPA SF= 1x Residential LOC for MOE = 100 Co

- critical 90

- day dog and chronic dog

Chronic: LOAEL = 16 mg/kg/day based on decreased body weight, increased mean hemoglobin concentration distribution width, and increased relative and absolute reticulocyte counts in both sexes, decreased prothrombin time in males and increased platelets in females.

Subchronic: NOAEL = 1.6 mg/kg/day LOAEL = 17.1 mg/kg/day based on decreased body weight in females and increased relative and absolute reticulocyte counts, decreased bilirubin, decreased albumin, decreased A/G ratio, incr eased TSH, and pigmented Kupffer cells in both sexes.
Dermal Short

and Intermediate

Term (1

- 30 days and 1

- 6 months) NOAEL= 3.1 mg/kg/day

DAF = 9.5 % UF A =10x UF H =10x FQP A SF= 1x Residential and Occupational LOC for MOE = 100 Co

- critical 90

- day dog and chronic dog

Chronic: LOAEL = 16 mg/kg/day based on decreased body weight, increased mean hemoglobin concentration distribution width, and increased relative and absolute reticulocyte counts in both sexes, decreased prothrombin time in males and increased platelets in females.

Subchronic: NOAEL = 1.6 mg/kg/day LOAEL = 17.1 mg/kg/day based on decreased body weight in females and increased relative and absolute reticulocyte counts, decreased bilirubin, decreased albumin, decreased A/G ratio, incr eased TSH, and pigmented Kupffer cells in both sexes.
Inhalation Short

- and Intermediate

Term (1

- 30 days and 1

- 6 months) NOAEL= not established (<0.04 mg/L)

b HEC = 0.00429 mg/L

c HED = 0.244 mg/kg/day (low breathing rate), = 0.491 mg/kg / day ( m edium breathing rate), = 0.853 mg/kg/day (high breathing rate) = 0.164 mg/kg/day ( medium breathing rate for residential handlers) UF A =3x
UF H =10x UF L =10x FQPA = 1X Residential and Occupational LOC for MOE = 300 90

- day inhalation toxicity

– rat LOAEL = 0.04 mg/L (lowest dose tested) based

on weight loss in males, prolonged prothrombin time in females, decreased thymus weight in males, histopathological changes in the epiglottis in both sexes, and histopathological changes in the nasal cavity of males.

Cancer C lassification: Suggestive evidence of carcinogenicity in humans based on lung tumors in female rats. The RfD is protective of potential cancer effects.Page 12 of 37 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 = uncertaint y 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. DAF = dermal absorption factor. MOE = margin of exposure. LOC = level of concern. FQPA =

b HEC = rat NOAEL *(daily duration adjustment)*weekly daily duration adjustment*RDDR =0.04 mg/l *(6 hr/8 hr)*(1)*0.143 = 0.00429 mg/L.

c HED = HEC x human specific conversion factor x activity factor for the exposure scenario x daily duration. = 0.00429 mg/L x 11.8 L/hr

- kg x (0.6, 1.2, and 2.1 for activities assigned a breathing rate of 8.3, 16.7, and 29 L/min, respectively) x 8 hr.

Absorptio n: Based on in vivo dermal absorption observed in the rat and in vitro comparative rat:human absorption data, an estimated human dermal absorption factor (DAF) of 9.5% was obtained and used in the exposure assessment. The dermal absorption values from th e in vivo and in vitro studies were calculated based on dermal loadings of 90.2

- 98.0 μg/cm 2

, reflecting typical concentrations recommended for the use in the field

. Since the short

- and intermediate

term inhalation PODs were based on route

- specific toxici ty studies, no absorption factors were necessary to estimate exposure.

Body Weight: The standard body weight for the general population (80 kg) was used for all adult exposure scenarios covered in this risk assessment since the endpoint s selected w ere no t from a developmental study and/or based on developmental or fetal effects. A body weight of 57 kg was used for youth 11 to <16 years old. Body weights of 32 kg and 11 kg were used for children 6 to <11 years old and 1 <2 years old, respectively.Page 13 of 37 4

. 0 Use Profile

Fluensulfone [5

- chloro

- 2

- [(3,4,4

- trifluoro

- 3

- buten

- 1

- yl)sulfonyl]thiazole] is a nematicide of the fluoroalkenyl group used to control nematodes [e.g., control root

- knot (Meloidogyne spp.), sting (Belonolaimus spp.), lance (Hoplolaimus spp.) and lesion nematodes (Pratylenchus spp.)].

The proposed end

- use (EP) granular product MCW2 1.5% ( EPA Registration No. 53883

- GLT and alternate brand names: Quali

- Pro® Nimitz® 1.5 G Nematicide or Quali

- Pro® Nimitz PRO G Nematicide) may be applied bro adcast overtop turfgrass at a maximum single application rate of 1.8 lb ai/A (3.6 lb ai/A per year) using typical ground spreaders (including tractors, rotary or drop spreaders)

. In addition, this EP could be applied as a one

- time rescue treatment on sod at a maximum single application rate of 3.6 lb ai/A.

Treated areas should be irrigated following applications in order to get the active ingredient into the root zone and soil. The label recommends this product to be applied by a licensed applicator; how ever, it is not a restricted use product. Rotation with nematicides with a different mode of action is suggested.

The proposed label requires handlers to wear long

- sleeved shirts, long pants, shoes, socks, and chemical

- resistant gloves.

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

Applic. Timing, Type, and

Equip. Formulation [EPA Reg. No.] Applic. Rate (lb ai/A) Max. No. Applic. per

Season Max. Seasonal Applic. Rate

(lb ai/A) PHI (days) Use Directions and Limitations

G olf courses, sports fields, commercial areas, sod farms and residential lawns

Broadcast;

Ground spreaders MCW2 1.5%
[ 53883

- GLT ]

Granular;

1.5% ai 0.9

- 1.8 (0. 00002066

- 0.000041 32 lb ai/ft 2 ) 1

- 4 (depending

on rate) 3.6 lb ai/A NA Treated areas should be irrigated following applications in order to get the active ingredient into the root zone and soil.

M ay be applied at 0.9 lb ai/A

- 1 month intervals for 4 c onsecutive months limited to 3.6 lb ai/A/year.

M ay be applied at 1.2 lb ai/A for 1 month intervals for 3 co nsecutive months limited to 3.6 lb ai/A/year.

M ay be applied at 1.8 lb ai/A in spring or early summ er with a second application
2

- 6 months following the initial broadcast application with a limit of 3.6 lb ai/A/year.
3.6 (for sod farms only as

a rescue treatment) 1 3.6 lb ai/A NA Rescue treatment. B roadcast application
1

- 2 months prior to harvesting or cutting turfgrass sod.Page 14 of 37 5 .0 Residential Exposure and Risk Estimates

5 .1 Residential Handler Exposure/Risk Estimates

HED uses the term “handlers” to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct tasks related to applications and that exposures can vary depending on the specifics of each task. Resi dential handlers are addressed somewhat differently by HED as homeowners are assumed to complete all elements of an application without use of any protective equipment.

The proposed label recommends the end

- use product to be applied by a licensed applica tor; however, fluensulfone is not a restricted use pesticide and is not restricted to commercial areas

. T here fore, there is potential for residential handler exposure. A quantitative exposure/risk assessment was developed for residential handlers based on the following scenarios applied broadcast :

• Mixer/Loader/Applicator granules using a push

- type rotary spreader;

• Mixer/Loader/Applicator granules using a belly grinder; and,

• Mixer/Loader/Applicator granules using a shaker can.

Since fluensulfone is to be applied broadcast, spoon and cup equipment as well as hand dispersal applications are not anticipated.

Residential Handler Exposure Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the residential handler risk assessments. Each assumption and factor is detailed below.

Application Rate : The proposed application rates are listed on Table 4.1. Refer to section 4 .0 for a complete use pattern description.

Unit Exposures and Area Treated : Unit exposure values and estimates for area treated or amount handled were taken from HED’s 2012 Residential SOPs 2

.

Exposure Du ration: Residential handler exposure is expected to be short

- term in duration. Intermediate

- term exposures are not likely bec ause of the intermittent nature of applications by homeowners.

Residential Handler Non

- Cancer Exposure and Risk Estimate Equations The algorithms used to estimate exposure and dose for residential handlers can be found in the 2012 Residential SOPs 3

.

Summ ary of Residential Handler Non

- Cancer Exposure and Risk Estimates

2 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

residential

- pesticide

3 Av ailable: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

residential

- p esticidePage 15 of 37 The exposure and risk estimates for residential handler exposure are provided in Table 5.1 .1. All estimated risks are above HED’s LOC for residential risk ( dermal MOE ≥ 100 or inhalation MOE
≥ 300 ) and are not of concern.Page 16 of 37 Table 5.1.1. Residential Handler Non

- cancer Exposure and Risk Estimates for Fluensulfone

.

Exposure Scenario Dermal Unit Exposure (mg/lb ai) Inhalation Unit Exposure

(mg/lb ai) Maximum Application
Rate 1 Area Treated or Amount Handled Daily 2 Dermal Inhalation

Dose (mg/kg/day) 3 MOE 4 Dose (mg/kg/day) 5 MOE 6

Mixer/Loader/Applicator

Granules

- Push

- type rotary spreader 0.81 0.0026 1.8 lb ai/A 0.5 A 0.00087 3,600 0.000029 5,600

Granules

– Belly grinder 360 0.039 0.000041 32 lb ai/ft 2 1,200 ft 2 0.021 150 0.000024 6,800

Granules

– Shaker can (surrogate granules with cup) 0.11 0. 0 13 0.000041 32 lb ai/ft 2 100 ft 2 0.00000054 5,700,000 0.00000 067 240,000

1 Based on proposed label (EPA Reg. No. 53883

- GLT ). AR=1.8 lb ai/A (1 A/43,560 ft 2 )=0.000041 32 lb ai/ft 2

. 2 Based on HED’s 2012 Residential SOPs ( http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

- residential

- pesticide ). 3 Dermal Dose = Dermal Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or ft 2 ) × Dermal Absorption Factor (9.5%) x Area Treate d (A or ft 2 /day ) ÷ Body Weight ( 80 kg).
4 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day). LOC=100. 5 Inhalation Dose = Inhalation Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre or ft 2 ) × Area Treated (A /day or ft 2 /day) ÷ BW ( 80 kg ).
6 Inhalation MOE = Inhalation HED (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). LOC=300.Page 17 of 37 5

. 2 Residential Post

- application Exposure/Risk Estimates

There is the potential for post

- application exposure for individuals exposed as a result of being in an environment that has been previously treated with fluensulfone. The quantitative exposure/risk assessment for residential post

- application exposures is based on the following scenarios:

• Dermal exposure for adults during high contact lawn activities, mowing turf and golfing;

• Dermal exposure for youth 11 < 16 years old during mowing turf and golfing;

• Dermal exposure for children 6 < 11 year old during g olfing and 1 < 2 years old during high contact lawn activities ; and,

• Incidental oral exposure (i.e., hand

- to

- mouth, object

- to

- mouth, soil ingestion and episodic granular ingestion) for children 1 < 2 years old.

The lifestages selected for each post

- applic ation scenario are based on an analysis provided as an Appendix in the 2012 Residential SOPs 4

. While not the only lifestage potentially exposed for these post

- application scenarios, the lifestage that is included in the quantitative assessment is health p rotective for the exposures and risk estimates for any other potentially exposed lifestage.

Residential Post

- application Exposure Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the residential post

- application risk assessment . Each assumption and factor is detailed in the 2012 Residential SOPs 4

.
Application Rate: The proposed applicatio n rates are listed on Table 4.1. Refer to section 4.0 for a complete use pattern description.

A chemical

- specific turf transferable residue (TTR) study (“Determination of Transferable Residues of Fluensulfone Turf Treated with MCW

- 2 1.5% GR Nematicide”, EPA MRID No. 49552503 ) was used to assess post

- application exposures from treated turf using a granular formulation. The study was reviewed by HED o n June 29, 201 5 (D425403 , J. Godshall ) . The study summary reflects current policies and provide reliable i nformation for residential turf use risk assessments. B ased on the results from the TTR study, the half

- life of fluensulfone on treated turf ranged from 1.8 to 12.4 days

. The predicted day 0 residue value of 0.0 022 ug/cm 2

was from the New York site at an application rate of 3.6 lb ai/A (i.e., initial C 0 right after application) . A residue value of 0.0011 ug/cm 2 was adjusted by the proposed maximum single application rate of 1.8 lb ai/ A and was used to estimate residential post

- application exposure a nd risk.

Exposure Duration: Residential handler exposure is expected to be short

- term in duration. Intermediate

- term exposures are not likely because of the intermittent nature of applications by homeowners and the use directions (i.e., irrigat ion fol lowing applications in order to get the active ingredient into the root zone and soil )

.

4 Available : http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

residential

- pesticidePage 18 of 37 Characterization Granular Ingestion Ingestion of granules is considered an episodic event and not a routine behavior. Because HED does not believe that this would occur on a regular basis, our concern for human health is related to acute poisoning rather than short

- term residue exposure. Therefore, an acute dietary dose is used to estimate exposure and risk resulting from episodic ingestion of granules. For these same reasons, the episodic ingestion scenario is not recommended for inclusion in the aggregate

assessment.

Residential Post

- application Non

- Cancer Exposure and Risk Equations The algorithms used to estimate residential post

- application exposure and dose can be found in the 2012 Residential SOPs 5

.
Combining Exposure and Risk Estimates Since dermal and incidental oral exposure routes share a common toxicological endpoint, risk estimates have been combined for those routes. The incidental oral scenari os (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 with the dermal exposure scenario would be overly

- conservative because of the conservative nature of each individual assessment. Therefore, the post

- application exposure scenarios that were combined for children 1 < 2 years old are the dermal and hand

- to

- mouth scenarios. This combination should be considered a protective es timate of children’s exposure.

Summary of Residential Post

- application Non

- Cancer Exposure and Risk Estimates The post

- application exposure scenarios presented in Table 5 .2 .1 are considered protective of all the proposed residential uses. All residential post

- application MOEs are above the LOC of 100 and are not of concern

, except for episodic granular ingestion for children (MOE=40 with LOC=100)

. However, the episodic oral ingestion of pellets is listed only as a poiso ning scenario and its likelihood is diminished because the label instructs users to irrigated (“water

- in”) treated

areas following applications in order to get the product into the root zone and soil.

Table 5

. 2 .1

. Residential Post

- application Non

- cancer Exposure and Risk Estimates for Fluensulfone.

Lifestage Post

- application Exposure Scenario Application Rate 1 Dose (mg/kg/day) 2 MOEs 3 Combined Routes (X indicates included in Combined MOE) Combined MOEs Use Site Route of Exposure

Adult Turf (High Contact Activities) Dermal 1.8 lb ai/A 0.0003 9 7,900 N/A

Turf (Mowing Turf) Dermal 1.8 lb ai/A 0.00000 72 4 3 0,000 N/A

Turf (Golfing) Dermal 1.8 lb ai/A 0. 00002 70 1 1 0,000 N/A

Youth 11 < 16 old years old Turf (Mowing Turf) Dermal 1.8 lb ai/A 0.0000082 38 0,000 N/A

Turf (Golfing) Dermal 1.8 lb ai/A 0.00003 2 0 96 ,000 N/A
Children 6 < 11 years old Turf (Golfing) Dermal 1.8 lb ai/A 0. 00003 78 8 2 ,000 N/A

5 http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

- residential

pesticidePage 19 of 37 Table 5

. 2 .1

. Residential Post

- application Non

- cancer Exposure and Risk Estimates for Fluensulfone.

Lifestage Post

- application Exposure Scenario Application Rate 1 Dose (mg/kg/day) 2 MOEs 3 Combined Routes (X indicates included in Combined MOE) Combined MOEs Use Site Route of Exposure

Child 1 < 2 years old Turf (High Contact Activities) Dermal 1.8 lb ai/A 0. 0007 695 4,0 00 X 3, 7 00 Hand

- to

- Mouth 1.8 lb ai/A 0. 0000747 41,000 Object

- to

- Mouth 1.8 lb ai/A 0.0000046 680,000 N/A

Soil Ingestion 1.8 lb ai/A 0.000061 0 51,000 N/A

Episodic Granular Ingestion 1.8 lb ai/A 0.41 40 N/A

1

. Based on proposed label ( EPA Reg. No

. 53883

- GLT ). 2

. Dose (mg/kg/day) algorithms provided in 2012 Residential SOPs ( http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/standard

- operating

- procedures

- residential

- pesticide ). 3

. MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day). 4

. Combined MOE = 1 ÷ (1/dermal MOE) + (1/inhalation MOE) + (1/incidental oral MOE), where applicable.

5

. 3 Residential Risk Estimates for Use in Aggregate Assessment

Although dermal and inhalation exposures both resulted in similar clinical signs (e.g.

, decrease body weight), the inhalation endpoint selected for risk assessment was based on portal of entry effects since these effects resulted in lower Human Equivalent Concentrations (HECs) than the HEC for systemic effects. Therefore, the portal of entry HEC is p rotective of the systemic effects and the d ermal and inhalation exposure estimates were not combined since the toxicological effects are different for these routes of exposure.

The child dermal and oral routes of exposure have been combined as it is lik ely that they can occur simultaneously based on the use pattern and because the toxicological effects across these routes of exposure are the same.

Table 5. 3.1 reflects the residential risk estimates that are recommended for use in the aggregate

assessm ent for fluensulfone

.

• The recommended residential exposure for use in the adult aggregate assessment reflects dermal exposure only from handler applications to turf via belly grinder spr eader

.

• The recommended residential exposure for use in the children 1< 2 years old aggregate assessment reflects dermal and hand

- to

- mouth exposures from post

- application exposure to outdoor turf/lawn applications (h igh c ontact a ctivities)

.

Table 5. 3 .1. Recommendations for the Residential Exposures for the Fluensulfone Aggregate Assessment.

Lifestage Exposure Scenario Dose (mg/kg/day) 1 MOE 2

Dermal Inhalation Oral Total Dermal Inhalation Oral Total

Adult Turf 0.021 0.000029 N/A NA 150 5,600 N/A NA

Child 1 < 2 years old Turf (High Contact Activities) 0.0007 695 N/A 0. 0000747 0.00084 42 4, 0 00 N/A 41,000 3, 7 00

1

. Dose = the highest dose for each applicable lifestage of all residential scenarios assessed . Total = dermal + inhalation + incidental oral (where

applicable)

. Dermal adult dose is from the residential handler belly grinder scenario. Inhalation adult dose is from push

- type rotary spreader scenario. Both scenarios are listed in Table 5.1.1. 2

. MOE = the MOEs associated with the highest residential doses

.Page 20 of 37 6.0 Non

- Occupational Spray Drift Exposure and Risk Estimates

Spray drift is a potential source of exposure to those nearby pesticide applications. This is particularly the case with aerial application, but, to a lesser extent, spray drift can also be a potential source of exposure from the ground application method s employed for fluensulfone. The agency has been working with the Spray Drift Task Force (a task force composed of various registrants which was developed as a result of a Data Call

- In issued by EPA), EPA Regional Offices and State Lead Agencies for pesti cide regulation and other parties to develop the best spray drift management practices (see the agency’s Spray Drift website for more information). 6 The agency has also developed a policy on how to appropriately consider spray drift as a potential source of exposure in risk assessments for pesticides. The potential for spray drift will be quantitatively evaluated for each pesticide during the Registration Review process which ensures that all uses for that pesticide will be considered concurrently. The approach is outlined in the revised (2012) Standard Operating Procedures For Residential Risk Assessment (SOPs)

- Residential Exposure Assessment Standard Operating Procedures Addenda 1: Consideration of Spray Drift. This document outlines the quantificat ion of indirect non

- occupational exposure to drift.

7.0 Non

- Occupational Bystander Post

- Application Inhalation Exposure and Risk Estimates

Volatilization of pesticides may be a source of post

- application inhalation exposure to individuals nearby pesti cide 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 repo rt on March 2, 2010 ( http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2009

- 0687

- 0037 ). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http://www.regulat ions.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2014

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

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

.

8 .0 Occupational Exposure and Risk Estimates

8 .1 Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each t ask. 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.

6 Available: http://www2.epa.gov/reducing

- pesticide

- driftPage 21 of 37 Based on the anticipated use patterns and current labeling, 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 occupat ional handlers is based on the following scenarios:

• Mixing/loading granules for a t ractor

- drawn spreader ;

• Applying granules using a t ractor

- drawn spreader ;

• Loader/applicator granules using a belly grinder; and

• Loader/applicator granules using a rotary spr eader.

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 proposed application rates are listed on Table 4.1. Refer to section 4.0 for a complete use pattern description.

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 Outdoor Residential Exposure Task Force (ORETF) database, or other registrant

- submitted occupational exposure studies. Some of these data are prop rietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting handler exposure that are used in this assessment, known as “unit exposures”, are outlined in the “Occupational Pesti cide Handler Unit Exposure Surrogate Reference Table 7 ”, which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at the Agency website 8

.

Area Treated or Amount Handled : The inputs for area treated were based on the Science Advisory Council for Exposure Policy 9.1: Standard Values for Daily Acres Treated in Agriculture (values are listed in Table 8.1 .1).

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 surround ing 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 large 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).

7 Available: http://www2.epa.gov/sites/production/files/2015

- 09/documents/handler

- exposure

- table

- 2015.pdf

8 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/occupational

- pesticide

- handler

exposure

- dataPage 22 of 37 B ased on the proposed use pattern (i.e., 1

- 4 applications per year)

, short

- and intermediate

- term
exposures are expected for o ccupational handlers . In addition, the propose d label suggests to rotate the end

- use product with nematicides with a different mode of action

.
Mitigation/Personal Protective Equipment: Estimates of dermal and inhalation exposure were calculated for various levels of personal protective equipment (PPE). Results are presented for “baseline,” defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus s ocks, no protective gloves, and no respirator, as well as baseline with various levels of PPE as necessary (e.g., PF5 respirator). The fluensulfone product labels direct mixers, loaders, applicators and other handlers to wear long

- sleeved shirts, long pan ts, shoes, socks, and chemical

- resistant gloves.

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 Occupation al Handler Non

- Cancer Exposure and Risk Estimates All occupational handler scenarios for the proposed uses resulted in dermal risk estimates that are greater than the LOC of 100 at baseline level of risk mitigation (i.e., baseline attire with no gloves), a nd therefore, are not of concern. The lo west dermal MOE is 140 (LOC=100) associated with loading/applying a granular formulation using belly grinder over 1 acre. All other dermal MOEs were higher ranging from 660 to 4,300 (LOC=100).

The inhalation risk estimates are higher than the LOC of 300 at baseline (i.e., no respirator) or using some level of mitigation (e.g., PF5 respirator). The following scenarios require a PF5 respirator to reach an inhalation MOE above the LOC of 300:

• mixing/loading a granul ar formulation being applied using tractor

- drawn spreader at an application rate of 1.8 lb ai/A (sod application rate) over up to 80 acre s ,

• mixing/loading a granul ar formulation being applied using tractor

- drawn spreader at an applic ation rate of 3.6 lb ai/A (sod rescue treatment application rate) over up to 80 acres, and

• applying a granular formulation being applied using tractor

- drawn spreader at an application rate of 3.6 lb ai/A (sod rescue treatment application rate) over up to 8 0 acres.

All other inhalation MOEs ranged from 390 to 790 (LOC=300) at baseline ( i.e., no respirator )

.Page 23 of 37 Table 8 .1.1. Occupational Handler Non

- Cancer Exposure and Risk Estimates for Fluensulfone.

Exposure Scenario Crop or Target Dermal Unit Exposure ( μ g/lb ai) 1 Inhalation Unit Exposure ( μ g/lb ai) 1 Maximum Application Rate 2 Area Treated Daily 3 Dermal Inhalation

Mitigation Level Mitigation Level Dose (mg/kg/day) 4 MOE 5 (LOC=100) Dose (mg/kg/day) 6 MOE 7 (LOC=300)

Mixer/Loader

Tractor

- drawn spreader Golf course 8.4 [Baseline] 1.7 [Baseline] 1.8 lb ai/A 40 A 0.000718 4,300 0.00153 560

Tractor

- drawn spreader Sod (Typical Application) 8.4 [Baseline] 1.7 [Baseline] 1.8 lb ai/A 80 A 0.00144 2,200 0.00306 280

8.4 [Baseline] 0.34 [PF5 respirator] 0.00144 2,200 0.000613 1,400

Sod (Rescue Treatment) 8.4 [Baseline] 1.7 [Baseline] 3.6 lb ai/A 80 A 0.00287 1,100 0.00613 140

8.4 [Baseline] 0.34 [PF5 respirator] 0.00287 1,100 0.00122 700

Applicator

Tractor

- drawn spreader Golf course 9.9 [Baseline] 1.2 [Baseline] 1.8 lb ai/A 40 A 0.000847 3,700 0.00108 790

Tractor

- drawn spreader Sod (Typical Application) 9.9 [Baseline] 1.2 [Baseline] 1.8 lb ai/A 80 A 0.00170 1,800 0.00216 390

Sod (Rescue Treatment) 9.9 [Baseline] 1.2 [Baseline]

3.6 lb ai/A 80 A 0.00338 920 0.00433 200

0.24 [PF5 respirator] 0.000864 990
Loader/Applicator

Belly grinder Landscaping, turf (lawns, athletic fields, parks) 10,000 [Baseline] 62 [Baseline] 1.8 lb ai/A 1 A 0.0214 140 0.0014 610

Rotary spreader Golf course, Landscaping, turf (lawns, athletic fields, parks) 440 [Baseline] 10 [Baseline]

1.8 lb ai/A 5 A 0.0047 660 0.00113 430

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( September

, 2015 ); Level of mitigation: Baseline, PPE (PF5 R espirator). 2 Based on registered or proposed label ( EPA Reg. No. 53883

- GLT ). 3 Exposure Science Advisory Council Policy #9.1. 4 Dermal Dose = Dermal Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre) × Area Treated Daily (A/day) × DAF ( 9.5 %) ÷ BW ( 80 kg). 5 Dermal MOE = Dermal NOAEL (mg/kg/day) ÷ Dermal Dose (mg/kg/day). LOC=100.
6 Inhalation Dose = Dermal Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Appli cation Rate (lb ai/acre) × Area Treated Daily (A/day) ÷ BW ( 80 kg).
7 Inhalation MOE = Inhalation HED (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). LOC=300.Page 24 of 37 8

. 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 nat ure of the crop or target that was treated, the type of pesticide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post

- applicat ion exposure.

8

. 2 .1 Occupational Post

- application Inhalation Exposure/Risk Estimates

There are multiple potential sources of post

- application inhalation exposure to individuals performing post

- application activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungici de, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 ( http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2009

- 0687

- 0037 ). The agency has evaluated the SAP report and has devel oped a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2014

- 0219 ). During Regist ration 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 fluensulfone.

In addition, the Agency is continuing to evaluate the available post

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

- application inhala tion exposure into the agency's risk assessments.

8

. 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 interm ediate

- term. Based on the proposed use pattern (i.e., 1

- 4 applications per year), short

- and intermediate

- term exposures are expected. In addition, the proposed label suggests to rotate the end

- use product with nematicides with a different mode of action

.Page 25 of 37 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 exposur e 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”, ar e presented in the ExpoSAC Policy 3 9 ” which, along with additional information about the ARTF data, can be found at the Agency website 10

. Table 8 .2.2.1 provides a summary of the anticipated post

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

Table 8

. 2 .2

. 1

. Anticipated Post

- Application Activities and Dermal Transfer Coefficients.

Proposed Crops Policy Crop Group Category Crop Height Foliage Density Transfer Coefficients

(cm 2 /hr ) Activities

Sod/Turf Turf/Sod Low Full 6,700 Maintenance

, Harvesting, Slab Transplanting/Planting

Golf Course Turf/Sod Low Full 2,500 Maintenance (greens only)
3,700 Maintenance

Application Rate: Application Rate: The proposed application rates are listed on Table 4.1. Refer to section 4.0 for a complete use pattern description.

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

Turf Transferable Residues : A chemical

- specific turf transferable residue (TTR) study (“Determination of Transferable Residues of Fluensulfone Turf Treated with MCW

- 2 1.5% GR Nematicide”, EPA MRID No. 49552503) was used to assess post

- application exposures from treated using a granul ar formulation. The predicted day 0 residue value of 0.0022 ug/cm 2 was from the New York site at an application rate of 3.6 lb ai/A and it was used to estimate occupational post

- application dermal exposure and risk for sod farms (rescue treatment only)

. A residue value of 0.0011 ug/cm 2 adjusted by the proposed maximum single application rate of 1.8 lb ai/A was used to estimate occupational post

- application exposure and risk for sod/ turf (typical application) and golf courses

.
Occupational Post

- applicat ion 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 post

- application dermal exposure and risk estimates from use of fluensulfone on treated sod/turf is provided in Table 8 .2.2. 2 . Post

- application dermal exposure and risk estimates resulted in MOEs greater than 100 and are not of concern.

9 Available: http://www2.epa.gov/sites/production/files/2015

- 08/documents/exposac

- policy

- 3

- march2013.pdf

10 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/occupational

- pesticide

- post

application

- exposurePage 26 of 37 Table 8

. 2 .2.2

. Occupational Post

- application Non

- Cancer Exposure and Risk Estimates for Fluensulfone

.
Crop/Site Activities Transfer Coefficient (cm 2 /hr) TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3

Short

- and Intermediate

- term

Sod Farm (Rescue Treatment) Maintenance

, Harvesting, Slab Transplanting/Planting 6,700 0.0022 0.000032 25,000

Sod Farm /Turf (Typical Application) 0.0011 0.000064 49,000

Golf Course Maintenance (greens only) 2,500 0.0011 0.000024 130,000

Maintenance 3,700 0.0011 0.000035 88,000

1

. Predicted TTR at initial concentration (t 0 ) = 0.00 22 ug/cm 2 at 3.6 lb ai/A or 0.0011 ug/cm 2 at 1.8 lb ai/A from chemical

- specific study ( EPA

MRID No. 49552503 )

. 2

. Daily Dermal Dose = [ TTR (μg/cm 2 ) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption ( 9.5 %)] ÷ BW ( 80 kg). 3

. MOE = POD ( mg/kg/day) / Daily Dermal Dose. LOC=100.

Restricted Entry Interval

Fluensulfone is classified as Toxicity Category III via the dermal route and Toxicity Category IV for skin and eye irritation potential. The granular formulation is not a skin sensitizer. Short

- and intermediate

- term post

- application risk estimates for sod farm s and golf course s (maintenance) were not a concern on Day 0 (following application) for all post

- application activities.Page 27 of 37 Appendix A. Summary of Residential and Occupational Non

- cancer Algorithms

Residential Handler Dermal and Inhalation Exposure Algorithms

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

- application method combination, is estimated by multiplying the formulation

application method

- specific unit exposure by an estimate of th e amount of active ingredient handled in a day, using the equation below:

E = UE * AR * A

where:

E = exposure (mg/day); UE = unit exposure (mg/lb ai); AR = application rate (e.g., lb ai/ft 2 or lb ai/A); and A = area treated or amount handled (e.g., ft 2 /day or A/day).

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

D = E *AF / BW

where:

D = dose (mg/kg

- day); E = exposure (mg/day); AF = absorption factor (dermal and/or inhalation); and BW = body weight (kg).

Residential Post

- application Dermal Exposure Algorithm

– Physical Activities on Turf

Exposure resulting from contacting previously treated turf while performing physical activities is calculated as shown below. Residential post

- application exposure asses sment must include calculation of exposure on the day of application. Therefore, though an assessment can present exposures for any day “t” following the application, it must include “day 0” exposure.

E = TTRt * CF1 * TC * ET

where:

E = exposure (mg/da y); TTRt = turf transferable residue on day t (μg/cm 2 ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm 2 /hr); and ET = exposure time (hr/day).Page 28 of 37 If chemical

- specific TTR data are available, then surface residues from the day of application should be used (assume that individuals could be exposed to residues immediately after application). However, if data are not available, then TTR t can be calculated using the following formula:

TTR t = AR * F * (1

- FD) t * CF2 * CF3

where:

T TRt = turf transferable residue on day t (μg/cm 2 ); AR = application rate (lbs ai/ft 2 or lb ai/acre); F = fraction of ai as transferable residue following application (unitless); FD = fraction of residue that dissipates daily (unitless); t = post

- applicatio n day on which exposure is being assessed; CF2 = weight unit conversion factor (4.54 x 10 8 μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 ft 2 / cm 2 or 2.47 x 10

- 8 acre/cm 2 ).

Dermal absorbed doses are calculated as:

BW AF E D *

=

where:
D = dose (mg/kg

- day);
E = exposure (mg/day);
AF = absorption factor (dermal); and
BW = body weight (kg).

Table A .1

. Turf (Physical Activities)

-- Inputs for Residential Post

- application Dermal Exposure.

Algorithm Notation Exposure Factor (units) Point Estimate(s)

AR Application rate (mass active ingredient per unit area) 1.8 lb ai/A

F Fraction of AR as TTR following application (if chemical

- specific data is unavailable) L/WP/WDG 0.01

Granules 0.002

F D Daily residue dissipation (if chemical

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

Granules 0.1

TC Transfer Coefficient

(cm 2 /hr) L/WP/WDG Adults 180,000 Children 1 < 2 years old 49,000

Granules Adults 200,000 Children 1 < 2 years old 54,000

ET Exposure Time (hours per day) Adults 1.5 Children 1 < 2 years old 1.5Page 29 of 37 Table A .1

. Turf (Physical Activities)

-- Inputs for Residential Post

- application Dermal Exposure.

Algorithm Notation Exposure Factor (units) Point Estimate(s)

BW Body Weight (kg) Adults 80 Children 1 < 2 years old 11 L/WP/WDG = Liquids/Wettable Powders/Water

- dispersible Granules

Residential Post

- application Hand

- to

- Mouth Exposure Algorithm

– Physical Activities on Turf

Exposure from hand

- to

- mouth activity is calculated as follows (based on the algorithm utilized in the SHEDS

- Multimedia model ):

E = [HR * ( F M * SA H ) * (ET * N_Replen) * (1

- (1

- SE ) (Freq_HtM/N

- Replen) )]

where:

E = exposure (mg /day); HR = hand residue loading (mg/cm 2 ); FM = fraction hand surface area mouthed / event (fraction/event); SAH = typical surface area of one hand (cm 2 ); ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (intervals/hour); SE = saliva extraction factor (i.e., mouthing removal efficiency); and Freq_HtM = number of hand

- to

- mouth contacts events per hour (events/hour).

and



### 2 * SA DE * Fai HR

H hands


### =

where:

HR = hand residue loading (mg/cm 2 ); Fai hands = fraction ai on hands compared to total surface residue from dermal transfer coefficient study (unitless); DE = dermal exposure (mg); and SA H = typical surface area of one hand (cm 2 ).

Dose, normalized to body weight, is calculated as:

BW

E D =

wher e:Page 30 of 37 D = dose (mg/kg

- day);
E = exposure (mg/day); and
BW = body weight (kg).

Table A .2. Turf (Physical Activities)

– Inputs for Residential Post

- application Incidental Oral Hand

- to

Mouth Exposure. Algorithm Notation Exposure Factor (units) Point Estimate(s)

Fai hands Fraction of ai on hands from dermal transfer

coefficient study (unitless) Liquid formulations 0.06

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SA H Typical surface area of one hand (cm 2 ), children 1 < 2 years old 150

AR Application rate (mass active ingredient per unit area) 1.8 lb ai/A

HR Residue available on the hands (mg/cm 2 ) Calculated via (DE * Fai hands )/SA H

F M Fraction hand surface area mouthed (fraction/event) 0.127

N_Replen Replenishment intervals per hour (intervals/hr) 4

ET Exposure time (hrs/day) 1.5

SE Saliva extraction factor (unitless) 0.48

Freq_HtM Hand

- to

- mouth events per hour (events/hr) 13.9

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

Residential Post

- application Object

- to

- Mouth Exposure Algorithm

– Physical Activities on Turf

Exposure from object

- to

- mouth activity is calculated as follows (based on the algorithm utilized in SHEDS

- Multimedia):

E = [OR* CF1 * SAM O * (ET * N_Replen) * (1

- (1

- SE O ) (Freq_OtM/N_Replen) )]

where:

E = exposure (mg/day); OR = chemical residue loading on the object on day “t” (ug/cm 2 ); CF1 = weight unit conversion factor (0.001 mg/μg); SAM O = area of the object surface that is mouthed (cm 2 /event); ET = exposure time (hr/day); N_Replen = number of repl enishment intervals per hour (intervals/hour);Page 31 of 37 SE O = saliva extraction factor (i.e., mouthing removal efficiency); and Freq_OtM = number of object

- to

- mouth contact events per hour (events/hour).

and

OR = AR * F O * CF2 * CF3

where:

OR = chemical residue loading on the object (μg/cm 2 ); AR = application rate (lbs ai/ft 2 or lb ai/acre);
F O = fraction of residue available on the object (unitless); CF2 = weight unit conversion factor (4.54 x 10 8 μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 ft 2 /cm 2 or 2.47 x 10

- 8 acre/cm 2 ).

Dose, normalized to body weight, is calculated as:

BW

E D =

where:
D = dose (mg/kg

- day);
E = exposure (mg/day); and
BW = body weight (kg).

Table A. 3

. Turf (Physical Activities)

– Inputs for Residential Post

- application Object

- to

- Mouth Exposure.

Algorithm Notation Exposure Factor (units) Point Estimate(s)

AR Application rate (to turf) (mass active ingredient per unit area) 1.8 lb ai/A

F O Fraction of AR as OR following application 1 0.01

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

N_Replen Replenishment intervals per hour (intervals/hour) 4

SE O Saliva extraction factor (fraction) 0.48

ET Exposure time (hours per day) 1.5

Freq_OtM Object

- to

- mouth events per hour (events/hr) 8.8
BW Body Weight (kg) Children 1 < 2 years old 11

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

Residential Post

- application Incidental Soil Ingestion Exposure Algorithm

– Physical Activities on TurfPage 32 of 37 Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1

where: E = exposure (mg/day); SRt = soil residue on day "t" (μg/g); SIgR = ingestion rate of soil (mg/day); and CF1 = weight unit conversion factor (1 x 10

- 6 g/μg).

and

SRt = AR * FS * (1

- F D ) t * CF2 * CF3 * CF4

where:

SR t = soil residue on day "t" (μg/g); AR = application rate (lbs ai/ft 2 or lb ai/acre); FS = fraction of ai available in uppermost cm of soil (fraction/cm);
F D = fraction of residue that dissipates daily (unitless); T = post

- application day on which exposure is being assessed; CF2 = weight unit conversion factor (4.54 x 10 8 μg/lb); CF3 = area unit conversion factor (1.08 x 10

- 3 ft 2 /cm 2 or 2.47 x 10

- 8 acre/cm 2 ); and CF4 = soil volume to weight unit conversion factor (0.67 cm 3 /g soil).

Dose, normalized to body weight, are calculated as:

BW

E D =

where : D = dose (mg/kg

- day);
E = exposure (mg/day); and
BW = body weight (kg).

Table A .4

. Turf (Physical Activities)

– Inputs for Residential Post

- application Incidental Soil Ingestion Exposure.

Algorithm Notation Exposure Factor (units) Point Estimate(s )

AR Application rate (mass active ingredient per unit area) 1.8 lb ai/A

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

F D Daily residue dissipation (fraction) 0.1

SIgR Soil ingestion rate (mg/day) 50Page 33 of 37 Table A .4

. Turf (Physical Activities)

– Inputs for Residential Post

- application Incidental Soil Ingestion Exposure.

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

Residential Post

- application Dermal Exposure Algorithm

– Mowing

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

E = TTRt * CF1 * TC * ET

where :

E = exposure (mg/day);
TTR t = turf transferable residue on day "t" (μg/cm 2 ); CF1 = weight unit conversion factor (0.001 mg/μg); TC = transfer coefficient (cm 2 /hr); and ET = exposure time (hr/day).

and

TTRt = AR * F AR * (1

- F D ) t * CF2 * CF3

where :

TTR t = turf transferable residue on day "t" (μg/cm 2 ); AR = application rate (lbs ai/ft 2 or lb ai/acre);
F AR = fraction of ai retained on turf (unitless);
F D = fraction of residue that dissipates daily (unitless); t = post

- application day on which exposure is being assessed; CF2= weight unit conversion factor (4.54 x 10 8 μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 ft 2 /cm 2 or 2.47 x 10

- 8 acre/cm 2 ).

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

BW

AF E D *

=

where : D = dose (mg/kg

- day);
E = exposure (mg/day);
AF = absorption factor (dermal); and
BW = body weight (kg).Page 34 of 37 Table A .5

. Turf (Mowing)

– Inputs for Residential Post

- application Dermal Exposure.

Algorithm Notation Exposure Factor (units) Point Estimate(s)

AR Application rate mass active ingredient per unit area 1.8 lb ai/A

F AR Fraction of AR as TTR following

application L/WP/WDG 0.01

Granules 0.002

F D Daily residue dissipation L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient (cm 2 /hr) Adult 5,500 Children 11 < 16 years old 4,500

ET Exposure time (hours per day) 1

BW Body Weight (kg) Adults 80 Children 11 < 16 years old 57

L/WP/WDG = liquid/wettable powder/water dispersible granule

Residential Post

- application Dermal Exposure Algorithm

– Golfing

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

E = TTRt * CF1 * TC * ET

where :

E = exposure (mg/day);
TTR t = turf transferable residue on day "t" (μg/cm 2 ); CF1 = weight unit conversion f actor (0.001 mg/μg); TC = transfer coefficient (cm 2 /hr); and ET = exposure time (hr/day).

and

TTRt = AR * F * (1

- F D ) t * CF2 * CF3

where :

TTR t = turf transferable residue on day "t" (μg/cm 2 ); AR = application rate (lbs ai/ft 2 or lb ai/acre); F = fraction of ai retained on turf (unitless);’
F D = fraction of residue that dissipates daily (unitless); t = post

- application day on which exposure is being assessed;Page 35 of 37 CF2 = weight unit conversion factor (4.54 x 10 8 μg/lb); and CF3 = area unit conversion factor (1.08 x 10

- 3 ft 2 /cm 2 or 2.47 x 10

- 8 acre/cm 2 ).

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

BW

AF E D *

=

where : D = dose (mg/kg

- day);
E = exposure (mg/day);
AF = absorption factor (dermal); and
BW = body weight (kg).

Table A .6

. Turf (Golfing)

– Inputs for Residential Post

- application Dermal Exposure. Algorithm Notation Exposure Factor (units) Point Estimate(s)

AR Application rate (mass active ingredient per unit area) 1.8 lb ai/A

F Fraction of AR as TTR following application L/WP/WDG 0.01
Granules 0.002

F D Daily residue dissipation L/WP/WDG 0.1
Granules 0.1
TC Transfer Coefficient (cm 2 /hr) Adult 5,300 Children 11 < 16 years old 4,400 Children 6 < 11 years old 2,900
ET Exposure time (hours per day) Pesticides used on greens, tees, and fairways 4

Pesticides used only on greens and tees 1

BW Body Weight (kg) Adults 80 Children 11 < 16 years old 57 Children 6 < 11 years old 32 NA = not applicable L/WP/WDG = liquid/wettable powder/water dispersible granule

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 proposed label (lb ai A or lb ai/gal ), and
A = a rea treated or amount handled (e.g., A/day, gal/day)

.Page 36 of 37 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 sc enario 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 handlers a re compared to the appropriate POD ( i.e.

, NOAEL) t o 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

Potential daily exposures for occupational post

- application workers are calculated using the following fo rmulas:

E=TC * TTR t * ET * 0.001 mg

ug

where:
E = e xposure (mg ai/day), TC = t ransfer coefficient (cm 2 /hr),
TTR t = turf transferable residue on day “t” (μg/cm 2 ), and
ET = e xposure t ime (hours/day).

The daily doses are calculated using the following formula:Page 37 of 37 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
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 formula:

MOE= POD

ADD

where:

MOE = margin of exposure: value used by HED to represent risk estimates (un itless), POD = point of departure (mg/kg/day), and
ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).