### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON

, D.C

. 20460



### Date: September 20

, 20 15 O FFI C E OF C HEMI CA L SA FET Y

A N D P OL LUTION PRE V ENTI O N



### S u bject: Pronamide ( Pr opyzamide)

. Occupational and Residential Exposure Assessment

for the Registration Review Draft Risk Assessment and to Support the Section 3 Proposed Use on L eaf Lettuce.

PC Code: 101701

D ec i s ion No.: 494935

Pet i t i on No.: NA

R i s k Assessment T y p e: NA

TXR No.: NA

MR ID No.: 4495250 I

Fro m : Seyed Tadayon,

# emist**__/___£~** Risk Assessment

# Branch**~** Health Effects Di vision (7509P)

Office of Pesticide Programs DP Barcode: 0422661

R eg i s t r a ti o n No

. : NA Reg ul ato r y Act i o n : R egistration Review

Case No

. : 0082

CAS No.: 23950-58-5

40 CFR: 180.317

Cassi L. Walls, ExpoSAC R ev i ewer

# · J. '

# .\~**~** £i 

# ;_r

Nancy Keller, ExpoSAC Reviewer 

# (!j{? 

# :/!: r-o.

- Exposure Sc i ence Adviso r y Co mmi ttee (Expo SAC) 

### 7 HED

THR O UGH : Michael S. Metzger

, Branch Chief 

# μ

D 

# n 

# .P

- Risk Assessme nt Branches V and VII 

## 1/(tM

Health Effects Division (7509 P )

Office of Pesticide Pr ograms

TO: Ray Kent, Sen i or Risk Assesso r
Immediate Office ( T O)

Health Effects Di vis i on (7509P)

Office of P estic id e P rog r ams

P age 1 of 3 5

### Page 2 of 35

Introduction

This assessment has been conducted for the purpose of addressing two separate regulatory

actions: (1) Sections 3 for leaf lettuce, and (2) assessment of all currently registered uses to support the Draft Risk Assessment ( D RA) for R egistration R eview. T he Registration Division (RD) requested that HED conduct an exposure a nd risk assessment for a proposed use of pronamide on leaf lettuce

. In addition, a s part of Registration Review, the Pesticide Re

evaluation Division (PRD) of OPP has requested that HED evaluate the hazard and exposure data and conduct occupational and re sidential exposure assessments, as needed, to estimate the risk to human health that will result from the currently registered uses of pesticides. This memorandum serves as HED’s Registration Review risk assessment of the occupational and

residential hand ler and post

- application exposure s and risk s from the current registered uses of pronamide.

It is HED policy to use the best available data to assess exposure. Several sources of generic data were used in this assessment as surrogate data in the absenc e of chemical

- specific data, including Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1) ; the Agricultural Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force (ORETF) dataset

, and the Residential SOPs ( Lawns/ Turf ) . Some of these data are proprietary, and subject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA).

Note: This memorandum was reviewed by the Exposure Science Advisory Committee (ExpoSAC) on 07 / 09 /201 5

.

### Page 3 of 35 Ta ble 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

................................ ................................ ................................ .. 6

2.3 Data Deficiencies and Requirements

................................ ................................ ............... 6

3.0 Hazard Characterization

................................ ................................ ................................ ....... 7

4.0 Exposure and Use Profile

................................ ................................ ................................ ..... 9

5.0 Residential Exposure and Risk Estimates

................................ ................................ .......... 11

5.2 Residential Post

- application Exposure/Risk Estimates

................................ .................. 11

5.3 Residential Risk Estimates for Use in Aggregate Assessment

................................ ...... 13

5.4 Spray Drift

................................ ................................ ................................ ...................... 13

5.5 Residential Bystander Post

- Application Inhalation Exposure

................................ ....... 14

6.0 Occupational Exposure and Risk Estimates

................................ ................................ ...... 14

6.1 Occupational Handler Exposure/Risk Estimates

................................ ............................ 14

6.2 Occupational Post

- application Exposure/Risk Estimates

................................ .............. 21

6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

...................... 21

6.2.2 Occupational Post

- ap plication Dermal Exposure/Risk Estimates

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

- cancer Algorithms

..................... 25

### Page 4 of 35

1.0 Executive Summary

Pronamide, also called propyzamide, [3,5

- dichloro

- N

- (1,1

- dimethyl

- 2

- propynyl)benzamide] is a selective, systemic, pre

- and post

- emergence herbicide registered for the control of grasses and broadleaf weeds in several food and feed crops

, as well as

, woody ornamentals, Christmas trees, grasses grown for seed or turf (sod), golf course turf, recreational area turf, and fallow la nd. It is a soil active systemic herbicide with uptake by susceptible weeds occurring through the roots. This document assesses exposures and risk estimates from the proposed section 3 on leaf lettuce

and also registered uses of p ronamide

.

Exposure and Use Profile Pronamide may be applied using ground (Chemigation and groundboom) spray equipment s , soil incorporation

, or aircraft. There are two end

- use product labels registered with p ronamide as the active ingredient (ai) . These include liquid (EPA REG # 62719

- 578) and wettable powder

marketed in Water Soluble Package (WSP) formulations (EPA REG # 62719

- 397) . The labeled use sites include various agricultural crops, Christmas tree farms, golf courses, seedling nurseries, landscape ornamentals, non

- crop u se sites (such as railroad, highway, roadside, pipeline and utility rights

- of

- way , and industrial areas), residential/commercial turf, and sod

farms. The a pplication rate s range from 0.5 to 4 lb ai/A (0.0 12 lb ai/1000 ft 2 

### to 0.092 lb ai/1000

ft 2 

### or 0.0 25 to 0.2 lb ai/gal).

The proposed section 3 use on leaf lettuce is an addition to liquid formulation product (EPA

REG # 62719

- 578) for a soil

- directed application via aerial, chemigation and groundboom equipment. The maximum rate is 1.0 lb ai/A and two b roadcast application s can be made per

year

. The restricted entry interval (REI) for the registered uses and the proposed use is 24 hours

.

Hazard Profile

P ronamide has ad verse liver effects includ ing increases in liver weight

, liver

- related serum

enzymes
, and/or histopathology

. In the immunotoxicity study with pronamide in mice, there was no evidence of immunotoxicity nor significant systemic toxicity. Pronamide is classified as “ Not Likely to be Carcinogenic to Humans ” at doses that do not resul t in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes (CARC report 101701.004 CA.DOC; J. Rowland, 12/02/2014).

The level of concern (LOC) for occupational and non

- occupational dermal r isk estimates is for margins of exposure (MOEs) less than 100 , inhalation and incidental oral risk estimates is for margins of exposure (MOEs) less than 10 0 0. Pronamide is characterized as "not likely" to be a human carcinogen based on the negative carcin ogenicity bioassays and negative mutagenicity

studies.

Residential Exposure and Risk Residential handler exposures are not expected as pronamide is a Restricted Use Pesticide and as such can only be applied by Certified Applicator. The proposed use on l eaf lettuce will not result in residential exposure; however, the re are currently registered turf use s (e.g., residential turf, golf courses) that need to be re assessed to reflect updates to HED’s 2012 Residential SOPs.

### Page 5 of 35

All dermal and incidental oral risk estimates for post

- application exposure are no t of concern (i.e., dermal MOEs ≥ 100) ; all MOEs ≥ 200 for adults and ≥ 2,000 for children

.

A quantitative spray drift assessment for p ronamide is not required because the maximum application rate for a crop/target site multiplied by the adjustment factor for drift of 0.26 is less than the maximum direct spray residential turf application rate ( 1. 5 lb ai/A) 1 

### for any p ronamide product. Therefore, t he turf post

- application MOEs are protective for any potential exposures related to spray drift for p ronamide

.

Occupational Exposure and Risk The most recent exposure assessment for p ronamide was conducted in 2007 (D329436, M. Dow,

05/05/ 2007). At the maximum rate of 4 lb ai/A identified for most agricultural crops, including the proposed use on leaf lettu ce , there were no occupational handler risks of concern.

The occupational handler exposure and risk estimates indicate that the short

- an d intermediate

term dermal and inhalation MOEs are not of concern to HED (i.e., MOEs > 100 for dermal and

MOEs > 100 0 for inhalation) from the wettable powder formulation in Water Soluble Package (WSP)

. For the liquid formulation

, the short

- and intermedi ate

- term dermal and inhalation MOEs are not of concern to HED (i.e., MOEs > 100 for dermal and MOEs > 100 0 for

inhalation ) , as long as label recommended PPE of double layer clothing and gloves are worn during mixing/loading of liquid formulation for aerial application to high

- acreage crops ( corn, soybeans and wheat )



### .

Occupational post

- application dermal exposure and risk estimates were assessed for the registered uses that are not soil

- directed (e.g., turf), and resulted in MOEs greater than the LOC

of 100 (ranging from 100 to 2,600) on day 1 ( 24 hours after application) ; and, therefore, are not

of concern to HED.

The REI specified on registered and the proposed label is based on a s hort

- and intermediate

term risk estimates for post

- application scenarios of p ronamide. Pronamide technical has a low order of acute toxicity via the oral, dermal, and inhalation routes of exposure (Toxicity Category III or IV), produces mild irritation to the eyes and skin (Toxicity Cate gory IV), and is not a

dermal sensitizer. Under 40 CFR 156. 307 (c) (2) (iii), ai’s classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12

- hour REI. However, based on a quantitative post

- application asse ssment, an REI of 24 hours is required to protect workers from exposures to pronamide

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

- cancer occupational post

- application inhalation exposure assessment was not performed for p ronamide 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 p ronamide

.

Human Studies Review

1 4 lb ai/A x 0.26 ≤ 1.04 lb ai/A

### Page 6 of 35

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical. These data, which include studies from the PHED 1.1, the AHETF database, and the ARTF database are (1) subject to ethics review pursuant to 40 CFR 26, (2) h ave 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 2



### .

2.0 Risk Assessment Conclusions and Recommendations

2.1 Summary of Risk Estimates

There are no occupational or residential risk estimates of concern for the registered and proposed

use of p ronamide (exception is for handset irrigation of lettuce and ornamentals)

 The occupational handler exposure and risk estimates indicate that the short

- and

intermediate

- term dermal and inhalation MOEs are not of concern to HED (i.e., MOEs > 100 for dermal and MO Es > 10 0 0 for inhalation) from the wettable powder formulation in Water Soluble Package (WSP). For the liquid formulation, the short

- and

intermediate

- term dermal and inhalation MOEs are not of concern to HED i.e., MOEs > 100 for dermal and MOEs > 10 0 0 fo r inhalation) , as long as label recommended PPE of double layer clothing and gloves are worn during mixing/loading of liquid formulation

for aerial application to high

- acreage crops ( corn, soybeans and wheat )



### .

 Occupational post

- application dermal exposure and risk estimates were assessed for the

uses that are not soil

- directed (e.g., turf), and are > 100 on the day of application, ranging

from 100 to 2

, 600

. For handset irrigation of lettuce and ornamentals

, a one day REI is required ( i.e., MOEs > 100 ).

 All residential post

- application risk estimates are not of concern (i.e., Dermal MOEs ≥ 100); all MOEs ≥ 200 for adults and ≥ 100 for children.

2.2 Label Recommendations

The current PPE on registered uses and the purposed use are c overalls over short

- sleeved shirt and short pants

, w aterproof gloves , c hemical

- resistant footwear plus socks , are adequate and no extra PPE is required.



### 2.3 Data Deficiencies and Requirements

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

- application exposure using default DFR values for p ronamide is equal 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 = 100 compared to the LOC of 100); EPA is requiring the 40CFR DFR data requirement.

2 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 35

3 .0 Hazard Characterization

P ronamide has ad verse liver effects including increases in liver weight

, liver

- related serum

enzymes
, and/or histopathology . In the immunotoxicity study with pronamide in mice, there was no evidence of immunotoxicity nor significant systemic toxicity. Pronamide is classified as “ Not Likely to be Carcinogenic to Humans ” at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to d isruption of thyroid or gonadal endocrine axes (CARC report 101701.004 CA.DOC; J. Rowland, 12/02/2014).

The level s of concern (LOC) for occupational and non

- occupational dermal is 100

, and for

inhalation and incidental oral risk estimates is for margins o f exposure (MOEs) less than 100 0

. Pronamide is characterized as "not likely" to be a human carcinogen based on the negative carcinogenicity bioassays and negative mutagenicity studies.

P ronamide is classified as acute toxicity category I V for acute ora l, and category III for acute dermal, and acute inhalation toxicity. It is classified as toxicity category IV for eye irritation potential and skin irritation potential. It is not a dermal sensitizer. Table 3.1 presents a summary of the acute toxicity information for p ronamide

Table 3.1. Acute Toxicity Profile of Pronamide

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

870.1100 Acute oral [Rat] 00085505 LD 50 > 5000 mg/kg IV

870.1100 Acute oral [Rat] 43583901 LD 50 > 5000 mg/kg IV

870.1200 Acute dermal [Rabbit] 43583902 LD 50 > 2000 mg/kg III

870.1300 Acute inhalation [Rat] 44034201 LC 50 > 2.1 mg/L III

870.2400 Acute eye irritation [Rabbit] 43583904 Non

- Irritating IV

870.2500 Acute dermal irritation [Rabbit] 43583903 Non

- Irritating IV

870.2600 Skin sensitization [Guinea Pig] 00062605 Negative Non

- Sensitizing



### Dermal (Short and Intermediate

- Term) Endpoints for Occupational and Non

- Occupational Exposure Scenarios : The dermal endpoint was selected from a 28

- day dermal toxicity study in

rats. The point of departure ( POD ) was a NOAEL of 100 mg/kg/day. The LOAEL was 500 mg/kg/day based on decreases in body weight and food consumption in males. No target organ (liver) toxicity was seen followi ng repeated dermal dosing. This is considered a conservative endpoint since the animals could have tolerated a higher dose. The endpoint is appropriate for the route and duration of exposure as well as the population of concern.

Incidental Oral (short and intermediate term), and Inhalation Endpoint (short and intermediate term) :
T he LOAEL of 40 mg/kg/day based on motor activity and foot splay was selected for assessing risk from chronic dietary and non

- dietary (short/ intermediate term incidental oral and inhalation)

exposures. A chronic RfD of 0.04 mg/kg/day is derived using the LOAEL of 40 mg/kg/day from the ACN study and a 1000X Uncertainty Factor which includes 10X for inter

- species extrapolation, 10X for intra

- species variation and a 10X for the u se of a LOAEL (UF L 

### ).

### Page 8 of 35

In accordance with the Agency’s 2005 Guideline for Carcinogen Risk Assessment, pronamide is

classified as “ Not Likely to be Carcinogenic to Humans” at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes (CARC J. Rowland, 12/02/2014)

.

The toxicity endpoints and the PODs for various exposure scenarios are described below and presented in Table 3.2.

Table 3.2. Summary of Toxicological Doses and Endpoints for Pronamide/Propyzamide for Non

- Occupational and occupational Human Health Risk Assessments

Exposure/

Scenario Point of

Departure (POD) Uncertainty/

FQPA Safety

Factors RfD, PAD, Level

of Concern for

Risk Assessment Study and Toxicol ogical Effects

Incidental Oral

Short

- Term (1

- 30 days) LOAEL = 40

mg/kg/day UFA=10X

UFH=10X

UFL= 10X FQPA SF=10X

Based on U F L Residential and

Occupational LOC

for MOE = 1000 The POD of 40 mg/kg/day was selected based on a

weight of evidence approach using the results from the

3 studies listed below. Subchronic neurotoxicity (SCN): NOAEL of 2.38 mg/kg/day is based on the significant decreases in body weight, body weight gain, and food consumption seen at 11.28 mg/kg/day (LOAEL) in males.

Acute neurotoxicity (ACN): NOAEL was not established. The LOAEL of 40 mg/kg/day with a 10X LOAEL to NOAEL uncertainty factor (UFL) yields

a derived POD of 4 mg/kg/day (40÷10). Combined chronic toxicity / carcinogenicity NOAEL

of 8.46/10.69 mg/kg/day is based on increased relative liver weight and histopathological lesions in the liver, thyroid, and ovaries at 42.59/55.09 mg/kg/day (LOAEL).

Dermal Short

Term (1

- 30 days)

and Intermediate

Term (1

- 6 months) NOAEL=

100 mg/kg/day FQPA SF=1x Residential and

O ccupational LOC

for MOE = 100 ( includes UF A =10x

and UF H =10x) 28

- day dermal toxicity study in rat: LOAEL = 500

mg/kg/day based on decreases in body weight and food consumption in males. No target organ (liver) toxicity was seen following repeated dermal dos ing

Inhalation Short

Term (1

- 30 days)

and Intermediate

Term (1

- 6 months) LOAEL =

40 mg/kg/day UFA=10X

UFH=10X

UFL= 10X FQPA SF=10X

Based on U F L Residential and

O ccupational LOC

for MOE = 100 0 The POD of 40 mg/kg/day was selected based on a

weight of evidence approach using the results from the

3 studies listed below. Subchronic neurotoxicity (SCN): NOAEL of 2.38 mg/kg/day is based on the significant decreases in body weight, body weight gain, and food consumption seen at 11.28 mg/kg/day (LOAEL) in ma les. Acute neurotoxicity (ACN): NOAEL was not established. The LOAEL of 40 mg/kg/day with a 10X LOAEL to NOAEL uncertainty factor (UFL) yields

a derived POD of 4 mg/kg/day (40÷10). Combined chronic toxicity/ carcinogenicity NOAEL

of 8.46/10.69 mg/kg/day is based on increased relative liver weight and histopathological lesions in the liver, thyroid, and ovaries at 42.59/55.09 mg/kg/day (LOAEL).

Cancer (oral, dermal, inhalation) Classification: “ Not Likely to be Carcinogenic to Humans” at doses that do not result in induction of

hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes

.

### Page 9 of 35

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL

= no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. 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. UF S = use of a short

- term study for long

- term risk

assessment. UF DB = to ac count for the absence of key data (i.e., lack of a critical study). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of

concern. N/A = not applicable.



### The toxicology and exposure data bases for pronamide are complete and the toxicology studies

are adequate for assessing increased susceptibility under FQPA. There was no evidence of quantitative or qualitative susceptibility in the developing organism an d evidence for neurotoxicity was limited to effects seen following a single gavage dosing in the acute neurotoxicity study. For acute and chronic dietary and incidental oral and inhalation exposure
assessments, the FQPA Safety Factor is retained in the for m of a LOAEL to NOAEL (UF L 

### ) of

10X.

Absorption: Since the short

- and intermediate

- term dermal POD is based on dermal toxicity

stud y
, an absorption factor is not required for dermal assessment

. For inhalation risk assessment absorption is assumed to be equivalent to the oral dose; an absorption factor was not used.

Body Weight: T he dermal, inhalation

, or incidental oral POD s are not based on developmental and/or fetal effects, therefore the body weight appropriate for these assessments is 80 kg

.

4 .0 Exposure and Use Profile

There are two end

- use product s registered with p ronamide as the active ingredient. These include liquid and wettable powder in Water Soluble Packages ( WSP ) formulations. The registered use sites include various agricultural crops, Christmas tree farms, golf courses, seedling nurseries, landscape ornamentals, non

- crop use sites (such as railroad, highway, roadside, pipeline and utility rights

- of

- way, and industrial areas), residential/co mmercial turf,

and sod farms. Most of the uses are soil

- directed, and are applied either via aerial, c hemigation

, g roundboom

, or handheld equipment. The application rate s for all uses range from 0.5 to 4 lb

ai/A

. The REI for the registered use s is 24 hour s

. All of the pronamide registered labels require handlers to wear a double layer of clothing (long sleeved shirt and long pants) with either waterproof or chemical

- resistant gloves.

The proposed section 3 is an addition to liquid formulation product (EPA REG # 62719

- 578)

. The purposed use on leaf lettuce is for a soil

- directed application via aerial, chemigation

, and groundboom equipment. The single maximum application rate is 1.0 lb ai/A. Two broadcast application s can be made per year. The REI for the proposed use is 24 hours

.

Based on the proposed and registered use patterns, it has been determined that the potential exposure scenarios that will need to be assessed include short

- and intermediate

- term occupati onal (handler and post

- application?) and residential exposures (handler and post

application). A summary of the proposed use directions based on all registered and proposed

labels are included in Table 4.1 below.

### Page 10 of 35 Table 4.1. Summary of Registered and Proposed Uses for Pronamide

Crop/Use Site Application Timing and Type of Application Registered

Formulations Maximum

Application

Rate Personal Protective

Equipment (PPE) and Restricted Entry Interval (REI)
Agricultural Fallow/Idleland Agricultural Uncultivated Areas September/December/Broadcast Aerial L/WP (WSP) 0.5 24 hrs REI

Alfalfa Spring/Fall/Winter/ Broadcast/ Aerial Chemigation /

Groundboom L/WP (WSP) 2 24 hrs REI 50 days PHI

Apple Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Apricot Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Artichoke Ratoon/ Broadcast/Aerial Chemigation/ Groundboom L/WP (WSP) 4 24 hrs REI 60 days PHI Blackberry Fall/Winter/ Broadcast/ Chemigation/ Groundboom L/WP (WSP) 3 24 hrs REI Blueberry Fall/Winter/ Broadcast/ Chemigation/ Groundboom

, L/WP (WSP) 3 24 hrs REI Boysenberry Fall/Winter/ Broadcast/ Chemigation/ Groundboom L/WP (WSP) 3 24 hrs REI Cherry Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Christmas Tree Plantations Early winter/Fall/ direct spray/ Aerial L/WP (WSP) 4 24 hrs REI 365 days PHI

Clover Fall/Winter/ Broadcast/ Chemigation/ Groundboom L/WP (WSP) 2 24 hrs REI 120 days PHI

Commercial/Industrial Lawns Spring/Broadcast/Aerial/ Chemigation/ Groundboom L 1.44 24 hrs REI

Crown Vetch Fall/Winter/ Broadcast/ Chemigation/ Groundboom L/WP (WSP) 2 24 hrs REI 120 days PHI

Endiv e Postplant/Broadcast/Aerial / Chemigation/ Groundboom L/WP (WSP) 2 24 hrs REI 55 d ays PHI

Golf Course Turf Spring/Broadcast/Aerial/ Chemigation/ Groundboom L/ WP (WSP) 1.44 24 hrs REI

Grapes Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Grasses Grown For Seed Fall/Preemergence/Early Winter WP (WSP) 0.375 24 hrs REI

Leafy Greens Postemergence/ Chemigation/ Groundboom L 2 24 hrs REI 55 days PHI WP (WSP) 1.5

Lettuce Postplant/Broadcast/Aerial / Chemigation/ Groundboom L/WP (WSP) 2 24 hrs REI 55 days PHI

Leaf Lettuce (Section 3 ) Postplant/Broadcast/Aerial / Chemigation/ Groundboom/ Hand held sprayer L 1 24 hrs REI 45 days PHI

Nectarine Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Ornamental And/ o r Shade Trees Fall/ direct spray/ Hand held sprayer L/WP (WSP) 2 24 hrs REI

Ornamental Grasses Broadcast/Aerial/ Chemigation/ Groundboom/ Hand held

sprayer WP (WSP) 1.5 24 hrs REI

Ornamental Herbaceous Plants Fall/ direct spray/ Hand held sprayer L/WP (WSP) 2 24 hrs REI

Ornamental Lawns And Turf Spring/Broadcast/Aerial/Chemigation/ Groundboom/ Hand held sprayer L/WP (WSP) 1.44 24 hrs REI

Ornamental Nonflowering Plants Fall/ direct spray/ Hand held sprayer L/WP (WSP) 2 24 hrs REI

Ornamental Sod Farm (Turf) Spring/Broadcast/Aerial/Chemigation/ Groundboom / Hand held sprayer L 1.44 24 hrs REI

Ornamental Woody Shrubs And

Vines Fall/ direct spray/ Hand held sprayer L/WP (WSP) 2 24 hrs REI

Peach Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Pear Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Peas Broadcast/Early winter/ Chemigation/ Groundboom L/WP (WSP) 1.5 24 hrs REI

Plum Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI

Prune Fall/Postharvest direct spray L/WP (WSP) 4 24 hrs REI Raspberry (Black

- Red) Fall/Winter/ Broadcast/ Chemigation/ Groundboom L/WP (WSP) 3 24 hrs REI

Rhubarb Fall/Broadcast/ Chemigation/ Groundboom L/WP(WSP ) 2 24 hrs REI 38 days PHI

Sainfoin Fall/Winter/ Broadcast/Chemigation/Groundboom L/WP (WSP) 2 24 hrs REI 120 days PHI
Sugar Beet Fall/Winter/ Broadcast/Chemigation/ Groundboom L/WP (WSP) 1 24 hrs REI

Trefoil Fall/Winter/ Broadcast/ Chemigation/ Groundboom L/WP (WSP) 2 24 hrs REI 120 days PHI


### PPE Applicators and other handlers must wear:

• Coveralls over short

- sleeved shirt and short pants • Waterproof gloves

• Chemical

- resistant footwear plus socks

### Page 11 of 35

• Chemical

- resistant headgear for overhead exposure

• Chemical

- resistant apron when cleaning equipment, mixing or loading

L/WP in in Water Soluble Package ( WSP ) = Liquid(35.6% active ingredient, 3.3 L b ai/gal, EPA R eg # 62719

- 578)/Wettable

Powder in water soluble package)(50% active ingredient, EPA R eg # 62719

- 397)



### 5.0 Residential E xposure and Risk Estimates

The proposed use on leaf lettuce is not expected to result in residential exposure. In this

assessment p ronamide is assessed for r esidential uses on turf grass using the 2012 Residential

SOPs , and covers all of the scenarios necessary for the new S ection 3 and Registration Review. Residential handler and post

- application scenarios were assessed at a maximum application rate

of 1.44 lb ai/A for liquid and 1.5 lb ai/A for wettable powder in Water Soluble Package (WSP)

formulati ons. There were no residential risk estimates of concern identified.

5.1 Residential Handler Exposure/Risk Estimates

Residential handler exposures are not expected as pronamide is a Restricted Use Pesticide and as such can only be applied by Certified Applicator. There are sufficient data available to perform a

residential assessment.

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 environ ment that has been previously treated with p ronamide The quantitative exposure/risk assessment for residential post

- application exposures is based on the following scenarios:

 Physical activities on turf: adults (dermal) and children 1 to < 2 years old (dermal and incidental oral);

 Mowing: adults (dermal) and children 11 to < 16 years old (dermal); and

 Golfing: adults (dermal), children 11 to < 16 years old (dermal), and children 6 to < 11 years old (dermal).

The lifestages selected for each post

- appli cation scenario are based on an analysis provided as an Appendix in the 2012 Residential SOPs 3 

### . While not the only lifestage potentially exposed for these post

- application scenarios, the lifestage that is included in the quantitative assessment is

health protective for the exposures and risk estimates for any other potentially exposed lifestage.

Residential Post

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

post

- ap plication risk assessment. Each assumption and factor is detailed in the 2012 Residential

SOPs 3



### .

Application Rate: The application rates used in this assessment are provided in Table 4.1.

3 Available: http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html

### Page 12 of 35

Exposure Duration: Residential post

- application exposure is expected to be short

- term in

duration. While multiple applications may be possible, it is anticipated that these applications

will be intermittent in nature and dissipation due to rainfall/irrigation, grass growth, and grass

m owing is expected. There is the potential for intermediate

- term exposure to p ronamide in the however, s ince the maximum yearly application rate is the same as the maximum singl e application rate, the short

- term assessment is protective of intermediate

- term soil ingestion

exposure.

TTR Data:

MRID NO.

- 4495 2501 Turf Transferrable Residues for Pronamide Applied to Turf Turf transferable residues (TTR) were monitored using the Modified California Roller sampling methodology for the typical end

- use product (EPA Reg. No. 707

- 159), a wettable powder formulation containing 50 % active ingredient (ai). The product was applied at one geographically representative site in North Caroli na (NC) with three replicated subplots. A single application by ground sprayer was applied prior to monitoring. The product was applied once at the label specified maximum application rate of 1.5 lb ai/A. Three replicate samples

were collected at interv als from 0 to 14 days after treatment (DAT). The residue values from site

one in California was used in this assessment. The summary of statistic for TTR data are presented below in Table 6.2.2.2.

Table 6.2.2.2. Summary of Pronamide TTR Residues and Re gression Analysis Results for Turf

Turf TTR (liquid) MRID # 4495 2501

Statistic Pronamide WP Formulation Application Rate (lb ai/A) 1.5 Measured Average Day 0 Residue (μg/cm 2 ) 0. 252 Predicted Day 0 Residue (μg/cm 2 ) 0.14 8 Slope

- 0. 363

Half

- Life (days) 2

R 2 0.8 8



### Residential Post

- application Non

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

- application exposure and dose can be found in Appendix A and/or the 2012 Residential SOPs 3



### .

Combining Exposure and Risk Estimates The incidental oral scenarios (i.e., hand

- to

- mouth and object

- to

- mouth) should be considered

inter

- related and it is likely that they occur interspersed amongst each other across time. Combining these scenarios would be overly

- conservative because of the conservative nature of each individual assessment. Therefore, these scenarios have not been combined.

Summary of Residential Post

- application Non

- Cancer Exposure and Risk Estimates

Table 5. 2 .1 provides a summary of the residential post

- application exposu res and risk estimates

for p ronamide

. All dermal and incidental oral risk estimates for post

- application exposure are

no t of concern ( for dermal MOEs ≥ 100) and (for incidental oral MOEs ≥1,000) ; all MOEs ≥ 200
for adults and ≥ 2,000 for children

.

### Page 13 of 35

Tabl e 5.2.1. Short

- Term Residential Post

- application Exposure and Risk Estimates for Pronamide

Lifestage Post

- application Exposure Scenario Dose (mg/kg/day) 1 MOEs 2 Combined

MOEs Liquid formulation and wettable powder (WSP)**

Adult

Turf

Liquid

formulation

1.5 lb ai/A Dermal Physical Activities on Turf 0.50 200

N/A Mowing 0.01 9,800 Golfing 0.039 2,500

Child 11 to < 16 years old Dermal Mowing 0.012 8,600 Golfing 0.046 2,200

Child 6 to < 11 years old Dermal Golfing 0.054 1,900

Child 1 to < 2 year old Dermal Physical Activities on Turf 0.99 100

Hand to Mouth 0.020 2

, 00 0 Object to Mouth 0.00062 65

, 00 0

Short

- and Intermediate

- term Incidental Soil

Ingestion 0.000051 79 0 ,000

1 Dose (mg/kg/day) equations provided in Appendix [A].

2 MOE = POD (Dermal = 100 mg/kg/day and Incidental oral = 4 0 mg/kg/day) ÷ Dose (mg/kg/day). LOC = 100 for dermal and 1,000

for Incidental oral.



### 5.3 Residential Risk Estimates for Use in Aggregate Assessment

Table 5.3.1 reflects the residential risk estimates that are recommended for use in the aggregate

assessment for p ronamide

 The recommended residential exposure for use in the adult short

- term aggregate assessment reflects dermal exposure from applications to turf via backpack sprayer.

 The recommended residential exposure for use in the children 1 to <2 years old short

term aggregate assessment reflects dermal exposure from post

- application exposure to

turf applications.

Table 5.3.1. Recommendations for th e Residential Exposures for the Pronamide Aggregate Assessment.

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

Dermal Inhalation 3 Oral Dermal Inhalation 3 Oral

Short

- term

Child 11 to < 16 years old Post

- application exposure from golfing (liquid formulation) 0.0 46 NA NA 2, 200 NA NA

Child 6 to < 11 years old Post

- application exposure from golfing (liquid formulation) 0.05 4 NA NA 1,900 NA NA

Child to 1 < 2 year old Post

- application exposure from activities on turf (liquid formulation) 0.9 9 NA 0.020 100 NA 2

, 00 0

1 Dose = the highest dose for each applicable lifestage of all residential scenarios assessed.

2 MOE = the MOEs associated with the highest residential doses.

3 I nhalation risk estimates were not combined with dermal or oral risk estimates in this assessment since the toxicological effects in the

inhalation toxicological study were different from th ose seen in the dermal and oral toxicological studies

.



### 5

. 4 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

### Page 14 of 35

lawns where residues have deposited next to treated fie lds). The potential risk estimates from these residues can be calculated using drift modeling coupled with methods employed for residential risk assessments for turf products.

The approach to be used for quantitatively incorporating spray drift into risk assessment include assessing 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 r esulting in an exposure scenario. Aside from the predicted residues available for transfer, the routes of exposure and assessment methodology is analogous to how exposures to turf products are considered in risk assessment.

Several p ronamide products ha ve existing labels for use on turf, thus it was considered whether the risk assessment for turf may be considered protective of any type of exposure resulting from spray drift. If the maximum application rate on crops adjusted by the amount of drift expec ted is less than or equal to existing turf application rates, the existing turf assessment is considered protective of spray drift exposure. The proposed maximum single application rate of p ronamide

for several registered agricultural crops is 4 lb ai/ A

. The highest fraction of spray drift noted for any application method immediately adjacent to a treated field results in a deposition fraction of

0.26 4 

### of the application rate. A quantitative spray drift assessment for p ronamide is not required

because th e maximum application rate for a crop/target site multiplied by the adjustment factor for drift of 0.26 is less than the maximum direct spray residential turf application rate ( 4 lb ai/A) 5


### for any p ronamide products. The turf post

- application MOEs are pro tective for any potential exposures related to spray drift for p ronamide and have previously been discussed in Section 5. 2

.

5

. 5 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 related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in D ecember 2009, and received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html )

. 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

Pronamide

.

6.0 Occupational Exposure and Risk Estimates

6.1 Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe tho se 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 task. Job requirements

4 Tier 1 output from the aerial application using fine to medium spray quality based on AgDrift output files

5 4.0 lb ai/A x 0.26 ≤ 4.0 lb ai/A

### Page 15 of 35

(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 a review of registered p ronamid e labels

, uses on Christmas tree farms and landscape ornamentals were identified which are not covered by the previous assessment. These use pattern s have been assessed in this document to complete the Registration Review for p ronamide

U pdated risk estim ate tables have also been included for occupational handlers for all registered

uses since the inhalation point of departure and LOC for p ronamide ha ve been changed since the previous assessment.

The quantitative exposure/risk assessment developed for o ccupational handlers is based on the following scenarios which cover s all the registered and proposed uses of p ronamide :

 Mixing/loading liquids to support aerial applications,

 Mixing/loading liquids to support chemigation applications,

 Mixing/loading liquids to support groundboom applications,

 Mixing/loading wettable powder in Water Soluble Package (WSP) to support aerial applications,

 Mixing/loading wettable powder in Water Soluble Package (WSP) to support chemigation applications,

 Mix ing/loading wettable powder in Water Soluble Package (WSP) to support groundboom applications,

 Mixing/loading wettable powder in Water Soluble Package (WSP) for groundboom applications,

 Applying sprays with aircraft,

 Applying sprays with groundboom equipment,

 Mixing/loading/applying wettable powder in Water Soluble Package (WSP) or liquids via backpack,

 Mixing/loading/applying wettable powder in Water Soluble Package (WSP) or liquids

via mechanically

- pressurized handgun,

 Mixing/loading/applying wetta ble powder in Water Soluble Package (WSP)

, or liquids via manually

- pressurized handwand,

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 application rates used in this assessment are provided in Table 4.1. For similar crop/application method scenarios, the highest application rate was assessed assuming this would be protective of lower application rates.

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 chemic al

- specific data, include PHED 1.1, the AHETF database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant

- submitted occupational exposure studies. Some of these

### Page 16 of 35

data are proprietary (e.g., AHETF data), and subject to the da ta 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 Pesticide Handler Unit Exposure Surrogate Reference Ta ble 6 

### ”, 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 7



### .

Area Treated or Amount Handled : The inputs for area treated were mostly based on information in Expo SAC Policy 9.1. 1200 acres for aerial application to high acreage crops

 350 acres for aerial application to typical acreage crops

 60 acres for aerial and groundboom applications to nurseries

 200 acres for ground application to high acr eage crops

 80 acres for ground application to typical acreage crops

 80 acres for ground application to sod farms

 40 acres for ground application to golf courses and field ground ornamentals

 350 acres for chemigation applications

 350 acres for flaggers

 5 acres or 40 gallons for backpack and manually

- pressurized handwand applications

 5 acres or 1000 gallons for mechanically

- pressurized handgun

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 large agribusiness and/or commercial applicators who may apply a product over a period of weeks

. For the proposed use pattern, short

- and intermediate

- term exposures are anticipated for the following reasons: (1) up to two applications ca n be made 60 days apart; and (2) commercial applicators may apply this product at various locations within a re gion over a period of weeks. The same exposure durations are anticipated for all registered p ronamide uses, and it should be

noted that the short

- and intermediate

- term PODs are the same; therefore, short

- term risk estimates are protective of longer

- term exposures.

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., gloves, respirator, etc). All of the p ronamide registered labels require

handlers to wear a double layer of clothing (long sleeved shirt and long pants) with either waterproof or chemical

- resistant gloves.

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

- exposure

- table.pdf

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

- exposure

- data.html

### Page 17 of 35

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.

Combi ning Exposures/Risk Estimates

Dermal and inhalation risk estimates were not combined in this assessment, since the toxicological effects for these exposure routes were not the same

.

Summary of Occupational Handler Non

- Cancer Exposure and Risk Estimates

Th e occupational handler exposure and risk estimates indicate that the short

- and intermediate

term dermal and inhalation MOEs are not of concern to HED (i.e., MOEs > 100 for dermal and

MOEs > 10 0 0 for inhalation) , as long as double layer and gloves are worn for the highest application rate for mixing/loading liquids for aerial application to high

- acreage crops and wettable powder used in Water Soluble Packages (WSP)

.

HED has no data to assess exposures to pilots using open cockpits. The onl y data available is for exposure to pilots in enclosed cockpits. Therefore, risks to pilots are assessed using the engineering control (enclosed cockpits) and baseline attire (long

- sleeve shirt, long pants, shoes, and socks); per the Agency’s Worker Prote ction Standard stipulations for engineering controls, pilots are not required to wear protective gloves for the duration of the application. With this level of protection, there are no risk estimates of concern for applicators.

The Agency matches quantitative occupational exposure assessment with appropriate characterization of exposure potential. While HED presents quantitative risk estimates for human flaggers where appropriate, agricultural aviation has changed dramatically over the past two decades. According the 2012 National Agricultural Aviation Association (NAAA) survey of their membership, the use of GPS for swath guidance in agricultural aviation has grown steadily from the mid 1990’s. Over the same time period, the use of human flaggers for aerial pesticide applications has decreased steadily from ~15% in the late 1990’s to only 1% in the most recent (2012) NAAA survey. The Agency will continue to monitor all available information sources to best assess and characterize the exposure potential for human flaggers in agricultural aerial applications.

### Page 18 of 35

Table 6.1.1. Occupational Handler Non

- Canc er Exposure and Risk Estimates for Pronamide

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

Unit Exposure (μg/lb ai) 1 Maximum

Application Rate (lb ai/A) 2 Area

Treated (acres) 3 Dermal

(LOC = 100) Inhalation (LOC = 100 0 )

Mitigation Level = baseline

unless indicated otherwise Dose (mg/kg/day) 4 MOE 5 Dose (mg/kg/day) 6 MOE 7

Mixer/Loader Aerial application of Wettable powder in Water Soluble Package (WSP) Nursery (ornamentals, vegetables, trees, container stock) 8.6 (E ngineering

Control ) 0.083

( E ngineering

Control ) 1.5 60 0.011 9,100 0.00027 15 0 ,000

Sod 1.5 350 0.0644 1,600 0.00158 25,000 Field crop, typical acreage 8 and Orchard 4 0.171 580 0.0042 9

, 50 0 Field crop, high

- acreage 9 2 1200 0.294 340 0.0072 5

, 60 0 Chemigation application of Wettable powder in Water Soluble Package (WSP) Sod 1.5

350 0.0644 1,600 0.00158 25

, 00 0 Field crop, typical acreage 8

and Orchard 4 0.171 580 0.0042 9

, 50 0

Field crop, high

- acreage 9 2 0.0585 1,200 0.0021 19

, 00 0
Nursery (ornamentals, vegetables, trees, container stock) 1.5 60 0.011 9,100 0.00027 15 0 ,000

Groundboom application of Wettable powder in Water Soluble Package (WSP) Golf course (fairways, tees, greens) 1.5 40 0.00735 14,000 0.00018 22 0 ,000 Field

- grown ornamental crops Nursery (ornamentals, vegetables, trees, container stock) 1.5 60 0.011 9,100 0.00027 15 0 ,000

Sod 1.5 80 0.0148 8,800 0.00036 11 0 ,000 Field crop, typical acreage 8 and Orchard 4 0.0393 2,500 0.00096 42

, 00 0 Field crop, high

- acreage 9 2 200 0.049 2,000 0.0012 33

, 00 0 Aerial application of liquid formulation Nursery (ornamentals, vegetables, trees, container stock) 37.6 ( Single layer / Glove ) 0.219 2 60 0.0564 1,800 0.000329 12 0 ,000

Sod 1.44

350 0.238 420 0.00138 29

, 00 0 Field crop, typical acreage 8 and Orchard 4 0.658 150 0.00384 1 0 ,000 Field crop, high

- acreage 9 29.1 ( DL/G ) 0.219 2 1200 0.873 110 0.00658 6

, 10 0 Chemigation application of a liquid

formulation Nursery (ornamentals, vegetables, trees, container stock) 37.6 ( Single layer / Glove ) 0.219 2 60 0.0564 1,800 0.000329 12 0 ,000

Sod 1.44

350 0.238 420 0.00138 29

, 00 0 Field crop, typical acreage 8 and Orchard 4 0.658 150 0.00384 1 0 ,000 Field crop, high

- acreage 9 2 0.329 300 0.00768 20,000

Groundboom application of liquid

formulation Nursery (ornamentals, vegetables, trees, container stock) 2 60 0.0564 1,800 0.000329 12 0 ,000

Sod 1.44 80 0.0541 1,800 0.000315 13 0 ,000 Golf course (fairways, tees, greens) 40 0.0271 3,700 0.000158 25 0 ,000 Field crop, typical acreage 8 4 80 0.15 670 0.000876 46

, 00 0 Field crop, high

- acreage 9 2 200 0.188 530 0.0011 36

, 00 0

### Page 19 of 35

Table 6.1.1. Occupational Handler Non

- Canc er Exposure and Risk Estimates for Pronamide

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

Unit Exposure (μg/lb ai) 1 Maximum

Application Rate (lb ai/A) 2 Area

Treated (acres) 3 Dermal

(LOC = 100) Inhalation (LOC = 100 0 )

Mitigation Level = baseline

unless indicated otherwise Dose (mg/kg/day) 4 MOE 5 Dose (mg/kg/day) 6 MOE 7

A pplicator

Aerial spray application Nursery (ornamentals, vegetables, trees, container stock) 2.08 (E ngineering

Control ) 0.0049

(E ngineering

Control ) 2 60 0.00313 32,000 0.00000735 5

, 40 0 ,000

Sod 1.5 350 0.0136 7,400 0.0000321 1

, 20 0 ,000 Field crop, typical acreage 8 and orchard 4 0.0364 2,700 0.0000858 47 0 ,000 Field crop, high

- acreage 9 2 1200 0.0624 1,600 0.000148 27 0 ,000

Groundboom spray application Golf course (fairways, tees, greens) 78.6 0.34 1.5 40 0.059 1,700 0.000255 16 0 ,000 Field

- grown ornamental crops Nursery (ornamentals, vegetables, trees, container stock) 2 60 0.118 850 0.00051 78

, 00 0

Sod 1.5 80 0.118 850 0.00051 78

, 00 0 Field crop, typical acreage 8 and orchard 4 0.315 320 0.00136 29

, 00 0
Field crop, high

- acreage 9 2 200 0.393 250 0.0017 24 ,0 00
Flagger

Flagger for aerial spray application Nursery (ornamentals, vegetables, trees, container stock) 11 0.35 2 60 0.0165 6,100 0.00525 76

, 00 0

Sod 1.5

350 0.0723 1,400 0.0023 17

, 00 0 Field crop, typical acreage 8 and orchard 4 0.193 520 0.00613 6

, 50 0
Field crop, typical and high

- acreage 9 2 0.0963 1,000 0.00306 13

, 00 0

### Page 20 of 35

Table 6.1.1. Occupational Handler Non

- Canc er Exposure and Risk Estimates for Pronamide

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

Unit Exposure (μg/lb ai) 1 Maximum

Application Rate (lb ai/A) 2 Area

Treated (acres) 3 Dermal

(LOC = 100) Inhalation (LOC = 100 0 )

Mitigation Level = baseline

unless indicated otherwise Dose (mg/kg/day) 4 MOE 5 Dose (mg/kg/day) 6 MOE 7

Mixer/Loader/Applicator Wettable powder in Water Soluble Package (WSP) via Backpack Orchard crops (ground soil directed) 8260 2.58 0.1 lb ai/gal

40 gallons 0.413 240 0.000129 31 0 ,000

Wettable powder in Water Soluble Package (WSP) via Backpack Landscaping, turf (lawns, athletic fields, parks, etc.) 8,260 2.58

0.075 0.31 320 0.0000968 41 0 ,000

Wettable powder in Water Soluble Package (WSP)via Manually

Pressurized Handwand Landscaping, turf (lawns, athletic fields, parks, etc.) 430 ( Single layer / Glove ) 30 0.0161 6,200 0.00113 35

, 00 0

Wettable powder in Water Soluble Package (WSP) via Mechanically

pressurized Handgun Golf course (fairways, tees, greens)

1 350 18 1.5 5 0.126 790 0.00169 24 ,0 00 Landscaping, turf (lawns, athletic fields, parks, etc.)

Liquids via Backpack Orchard crops (ground soil directed) 8,260 2.58 0.2

40 gallons 0.826 120 0.000258 16 0 ,000

Nursery (ornamentals, vegetables, trees, container stock)

0.072 0.298 340 0.0000929 43 0 ,000

Liquids via Manually

pressurized Handwand Landscaping, turf (lawns, athletic fields, parks, etc.) 430 ( Single layer / Glove ) 30 0.0155 6,500 0.00108 37

, 00 0

Liquids via Mechanically

pressurized Handgun Golf course (fairways, tees, greens) 1,140 1.9 1.44 5 0.103 970 0.000171 23,000 Landscaping, turf (lawns, athletic fields, parks, etc.) Orchard crops (ground soil directed) 390 ( Single layer / Glove ) 3.9 0.2 1000 gallons 0.971 100 0.00975 4

, 10 0

Nursery (ornamentals, vegetables, trees, container stock) 0.072 0.351 280 0.00351 11 0 ,000

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( March 2013 );

2 Based on registered and proposed labels

. 3 Exposure Science Advisory Council Policy #9.1 and Registrant information

. 4 Dermal Dose = Dermal Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre) × Area Treated (A/day) ÷ BW ( 80 kg).

5 Dermal MOE = Dermal NOAEL ( 100 mg/kg/day) ÷ Dermal Dose (mg/kg/day). LOC = 100

6 Inhalation Dose = In halation Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre) × Area Treated (A / day) ÷ BW ( 80 kg).

7 Inhalation MOE = Inhalation NOAEL ( 4 0 mg/kg/day) ÷ Inhalation Dose (mg/kg/day). LOC =1000 8 Field crops, typical acreage category covers the following crops: asparagus, Brassica, head and stem, Brassica, leafy greens, cabbage

, berries, edamame, fallow cropping systems, flax, fruiting vegetables, okra, horseradish, lima beans, melons, rhubarb, strawberry, succulent p eas, tobacco, turnips, Christmas tree farms , mint, peanuts, peppermint, spearmint, potato sugarcane, dry shelled peas

and beans and sunflower @ a maximum of 2lb ai/A and for berries @ 3 lb ai/A 9 Field crops, high acreage crops category covers the followi ng crops: corn, soybeans and wheat @2 lb ai/A

. 10 Orchard crops, apples, apricot, artichoke, cherry, peach, pear, peach, pear, plum, nectarine, citrus fruits, tree nuts, grapes, Christmas t ree p lantations @4 lb ai/A

### Page 21 of 35

6

. 2 Occupational Post

- ap plication 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 on such things as the

ty pe 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 greatly reduce the pote ntial for post

- application exposure. The majority of pronamide usage occurs preemergence or when the plants are dormant. The only crop with post

- application activities is lettuce.

6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

Th ere 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 par ticulates that contain pesticides. The agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent 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 studi es, route

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

.

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 inhalation exposure into the agency's risk assessments.

Although a quantitative occupational post

- applicat ion inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post

- application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post

- application inhalation exposure scenarios

.

6

. 2 .2 Occupational Post

- application Dermal Exposure/Risk Estimates

Most of the registered uses (with exception of lettuce)

, for p ronamide are soil

- directed preplant

or pre

- e mergent uses where no crop foliage is present. Currently, HED has no transfer coefficients or other data to assess post

- application dermal exposure s to soil by occupational

### Page 22 of 35

workers. In general, such exposures are considered to be negligible. Therefore, for the soil

directed uses, post

- application exposures and risks to occupational workers were not assessed.

The registered and p ro posed uses lettu ce, turf (golf courses and sod farms) and ornamentals are not specifically soil

- directed and, therefore, could result in potential post

- application exposures. These exposures have been assessed in this memo.

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 classi fies exposures from 1 to 30 days as short

- term and exposures 30 days to six mo nths as intermediate

- term. For the proposed use pattern, short

- and intermediate

term exposures are anticipated for the following reasons: (1) up to two applications ca n be made 60 days apart; and (2) commercial applicators may apply this product at various locations within a region over a period of weeks. The same exposure durations are anticipated for all registered

p ronamide uses, and it should be noted that the short

- and in termediate

- term PODs are the same; therefore, short

- term risk estimates are protective of longer

- term exposures.

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

application exposure. Sources of generic post

- ap plication 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 i n predicting post

- application exposure that are used in this assessment, known as “transfer coefficients”, are presented in the ExpoSAC Policy 3 8 

### ” which, along with additional information about the ARTF data, can be found at the Agency website 9



### .

Table 6.2.2.1. Summary of Post

- Application Activities and Dermal Transfer Coefficients.

Crop Policy Crop

Group Category Crop

Height Foliage

Density Transfer

Coefficients (cm 2 /hr ) Activities

Landscape

ornamentals (Container, Field grown Ornamental plantings) Nursery Crop

(Ornamentals,

Non

- bearing Plants) Low Min

230 Grafting, Propagating, Transplanting

Low Full Hand Harvesting, Hand Pruning, Scouting, Hand Weeding, Transplanting, Pinching, Tying/Training

High Min Hand Harvesting, Hand Pruning, Transplanting

High Full Hand Harvesting, Hand Pruning, Scouting, Container Moving, Hand Weeding, Transplanting, Pinching Low/High Full 1,900 Handset Irrigation

Golf Courses

Turf/Sod Low Full 2,500 Maintenance, greens only
3,700 Maintenance

Sod Low Full 6,700 Maintenance, Slab Harvesting, Transplanting/Planting

Lettuce Low Full 1,900 Handset Irrigation

8 Available: http://www.epa.gov/pestic ides/science/exposac_policy3.pdf

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

- app

- exposure

- data.html

### Page 23 of 35

Application Rate: The application rates used in this assessment are provided in Table 4.1.

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

Dislodgeable Foliar Residue (DFR): In accordance with the updated Part 158 data requirements (2007), one or more DFR studies are required when a pesticide has residential or occupational

uses th at could result in post

- application dermal exposure. As part of the recent revision to the Health Effects Division’s 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment , HED analyzed a number of DFR studies and selected a new default value for the fraction of the application rate available to be dislodged after a foliar application (F AR 

### ). This default value is 25% and is based on an analysis of 19 DFR studies where the F AR 

### value ranged from 2% to 89%. This value is recommende d for use in both residential and occupational

post

- application assessments. Of the analyzed DFR studies, the maximum F AR 

### value seen was 89% or 3.6 times higher than the default residue transfer value. Therefore, the HED has decided

that a calculated MOE of approximately 2 times higher than the LOC (e.g., an MOE > 200 if the

LOC = 100 ) using the default dislodged residue values would provide an adequate margin of safety for any potentially higher residues seen in a chemical

- specific DFR study ( Guidance for Requiring/Waiving Turf Transferrable Residue (TTR) and Dislodgeable Foliar Residue (DFR)

Studies . 12/12/2012, Exposure Science Advisory Council).

Since the highest estimated occupational post

- application exposure using default DFR values for pronamide i s 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 = 100 on day 1 compared to the LOC of 100; EPA is requiring the 40CFR DFR data. Therefore, EPA is requiring the 40CFR 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.

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

The short

- and intermediate

- term post

- application exposure scenarios associated with the registered uses of p ronamide are summarized in Table 6.2.2.2. All scenarios resulted in MOEs greater than the LOC of 100 (ranging from 100 to 2,600 ) on day 1 ( 24 hour s after application) ; and, therefore, are not of concern to HED.

Table 6

. 2 .2.2

. Occupational Post

- application Non

- Cancer Exposure and Risk Estimates for Pronamide

Crop/Site Activities Transfer

Coefficient (cm 2 /hr) Application

Rate (lb ai/A) DFR or

TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3

(LOC = 100)

Short

- and Intermediate

- term

Landscape

ornamentals (Container, Field

grown Ornamental plantings) Hand Harvesting, Hand Pruning,

Transplanting, Hand Harvesting, Hand Pruning, Scouting, Container Moving,

Hand Weeding, Transplanting,

Pinching 230 2 5.61 0.129 780

Handset Irrigation 1,900 1.066 94 (day0)

### Page 24 of 35

Table 6

. 2 .2.2

. Occupational Post

- application Non

- Cancer Exposure and Risk Estimates for Pronamide

Crop/Site Activities Transfer

Coefficient (cm 2 /hr) Application

Rate (lb ai/A) DFR or

TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3

(LOC = 100)

Short

- and Intermediate

- term

5.05 0.959 100 (day1)

Golf Courses Maintenance, greens only 2,500

1.5 0. 148 0.038 2600

Maintenance 3,700 0.05 5 1800

Sod Maintenance, Slab Harvesting,

Transplanting/Planting 6,700 0.099 1,000

Lettuce Handset Irrigation 1900 2 5.61 1.066 94 (day0)

5.05 0.959 100 (day1)

1 DFR = Application Rate × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

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

. TTR= obtained from pronamide TTR study MRID # 449525

- 01

2 Daily Dermal Dose = [DFR (μg/cm 2 ) × Transfer Coeffici ent × 0.001 mg/μg × 8 hrs/day ]  BW ( 80 kg).

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



### Restricted Entry Interval The REI specified on registered and the proposed label is based on a s hort

- and intermediate

term risk estimates for post

- application scenarios of p ronamide

. Pronamide technical has a low order of acute toxicity via the oral, dermal, and inhalation routes of exposure (Toxicit y Category III or IV), produces mild irritation to the eyes and skin (Toxicity Category IV), and is not a

dermal sensitizer. Under 40 CFR 156. 307 (c) (2) (iii), ai’s classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12

- hour REI. However, based on a quantitative post

- application assessment, an REI of 24 hours is required to protect workers

from exposures to pronamide

### Page 25 of 35

Appendix A. Summary of Occupational and Residential Non

- cancer Algorithms

OCCUPATIONAL NON



### - CANCER HANDLER ALGOR ITHMS



### Potential daily exposures for occupational handlers are calculated using the following formulas:

E=UE * AR * A * 0.001 mg/ug

where:

E = exposure (mg ai/day),

UE = unit exposure (μg ai/lb ai),

AR = maximum application rate according to proposed label (lb ai A or lb ai/gal), and

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

The daily d oses are calculated using the following formula:

ADD= E * AF

BW

where:

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

E = exposure (mg ai/day),

AF = absorption factor (dermal and/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 are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values are calculated using the following formula:

MOE= POD

ADD

where:

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

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

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

OCCUPATIONAL NON



### - CANCER POST



### - APPLICATION ALGORITH MS

### Page 26 of 35

Potential daily exposures for occupational post

- appl ication 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 = dislodgeable foliage residue on day "t" (μg/cm 2 

### ),

AR = application rate (lb ai/acre),

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

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

t = number of days after application day (days).

E=TC * DFR t 

### * ET * 0.001 mg

ug

where:

E = exposure (mg ai/day),

TC = transfer coefficient (cm 2 

### /hr),

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

### ), and

ET = exposure time (hours/day).

The daily doses are calculated using the following formula:

ADD= E * AF

BW

where:

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

E = exposure (mg ai/day),

AF = absorption factor (dermal and/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 are calculated using the following formula:

MOE= POD

ADD

where:

### Page 27 of 35

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).

RESIDENTIAL NON



### - CANCER HANDLER ALGOR IT HMS



### Dermal and Inhalation Handler Exposure Algorithm

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

formulation

- application method combination, is estimated by multiplying the formulation

application method

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

E = UE * AR * A

where:

E = exposure (mg/day); UE = unit exposure (mg/lb ai); AR = application rate (e.g., lb ai/ft 2 

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

### /day, gal/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 NON



### - CANCER POST



### - APPLICATION ALGORITH MS



### Post

- application Dermal Exposure Algorithm

– Physical Activities on Turf Exposure resulting from contacting previously treated turf while performing physical ac tivities is calculated as shown below. Residential post

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

E = TTRt * CF1 * TC * ET

where:

E = exposure (mg/day);

### Page 28 of 35

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).

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:

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

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

### or lb ai/acre); F = fraction of ai as transferable residue following application (unitless); FD = fraction of residue that dissipates daily (unitless);

t = post

- application day on which exposure is being assessed; CF2 = weight unit conversion factor (4.54 x 10 8 

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

- 3 

### ft 2 

### / cm 2 

### or 2.47 x 10

- 8 

### acre/cm 2 

### ).

Dermal absorbed doses are calculated as:

where:

D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table A

- X: 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) See table 4.1

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

### Page 29 of 35

Table A

- X: Turf (Physical Activities)

-- Inputs for Residential Post

- application Dermal Exposure

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

Children 1 < 2 years old 54,000

ET Exposure Time (hours per day) Adults 1.5
Children 1 < 2 years old 1.5

BW Body Weight (kg) Adults 69 Children 1 < 2 years old 11 L/WP/WDG = Liquids/Wettable Powders/Water

- dispersible Granules



### 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

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:

where:

D = dose (mg/kg

- day);

### Page 30 of 35

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- X: Turf (Physical Activities)

– Inputs for Residential Post

- application 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) See table 4.1

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

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

N_Replen Replenishment intervals per hour (intervals/hr) 4

ET Exposure time (hrs/day) 1.5

SE Saliva extraction factor (unitless) 0.48 Freq_HtM Hand

- to

- mouth events per hour (events/hr) 13.9

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



### Post

- application Object

- to

- Mouth Exposure Algorithm

– Physical Activities on Turf Exposure from object

- to

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

in SHEDS

- Multimedia):

E = [OR* CF1 * SAM O 

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

- (1

- SE O 

### ) (Freq_OtM/N_Replen) 

### )]

where:

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

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

SAM O 

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

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

SE O 

### = saliva extraction factor (i.e., mouthing removal eff iciency); 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

### Page 31 of 35

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:

where:

D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- X: Turf (Physical Activities)

– Inputs for Residential Post

- application Object

- to

- Mouth Exposure

Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate (to turf)

(mass active ingredient per unit area) See table 4.1

F O Fraction of AR as OR following application 1 0.01

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

N_Replen Replenishment intervals per hour (intervals/hour) 4

SE O Saliva extraction factor(fraction) 0.48

ET Exposure time (hours per day) 1.5 Freq_OtM Object

- to

- mouth events per hour (events/hr) 8.8

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

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



### Post

- application Incidental Soil Ingestion Exposure Algorithm

– Physical Activities on Turf Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1

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

- 6 

### g/μg).

and

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);

### Page 32 of 35

T = post

- application day on whic h 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, normaliz ed to body weight, are calculated as:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- X: Turf (Physical Activities)

– Inputs for Residential Post

- application Incidental Soil Ingestion Exposure

Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate (mass active ingredient per unit area) See table 4.1

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

F D Daily residue dissipation (fraction) 0.1 SIgR Soil ingestion rate (mg/day) 50

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



### Post

- application Episodic Granular Ingestion Exposure Algorithm

– Physical Activities on Turf Exposure from incidental ingestion of pesticide pellets or granules is calculated as follows:

E = GIgR* FD * CF1

where: E = exposure (mg/day); GIgR = ingestion rate of dry pesticide for mulation (g/day); FD = fraction of ai in dry formulation (unitless); and CF1 = weight unit conversion factor (1,000 mg/g).

Dose, normalized to body weight, are calculated as:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- X: Turf (Physical Activities)

– Inputs for Residential Post

- application Episodic Granular Ingestion Exposure

Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

F D Fraction of active ingredient in dry formulation See table 4.1

### Page 33 of 35

Table A

- X: Turf (Physical Activities)

– Inputs for Residential Post

- application Episodic Granular Ingestion Exposure

AR Application rate (lbs/A or lbs/1,000 ft 2 ) See table 4.1 GIgR Granule ingestion rate per day (g/day) 1 0.3

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

1 See discussion below on how this value may be adjusted if product specific information is available.



### 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 = p ost

- 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:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table A

- X: 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 See table 4.1

### Page 34 of 35

Table A

- X: Turf (Mowing)

– Inputs for Residential Post

- application Dermal Exposure

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 69 Children 11 < 16 years old 57 L/WP/WDG = liquid/wettable powder/water dispersible granule



### Post

- application Dermal Exposure Algorithm

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

E = TTRt * CF1 * TC * ET

where :

E = exposure (mg/day);

TTR t 

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

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

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

and

TTRt = AR * F * (1

- F D 

### ) t 

### * CF2 * CF3

where :

TTR t 

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

### );

AR = application rate (lbs ai/ft 2 

### or lb ai/acre); F = fraction of ai retained on turf (unitless);’

F D 

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

t = post

- application day on which exposure is being assessed; CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and CF3 = area unit conversion 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:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

### Page 35 of 35

Table A

- X: 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) See table 4.1

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 69 Children 11 < 16 years old 57 Children 6 < 11 years old 32

NA = not applicable L/WP/WDG = liquid/wettable powder/water dispersible granule