## Pa ge 3 of 39

1. Executive Summary

Sulfoxaflor {[N

- methyloxido[1

- [6

- (trifluoromethyl)

- 3

- pyridinyl]ethyl] λ4

- sulfanylidene] cyanamide} is the first member of a new class of insecticides, the sulfoximines. The sulfoximines act through a unique interaction with the nicotinic acetylcholine receptor in insects. Sulfoxaflor is a highly efficacious agonist of the nicotinic receptor. Furthermore, the structural novelty of sulfoxaflor makes it stable in the presence of monooxygenase enzymes that degrade neonicotinoids and cause virtually all known cases of resistance in the field of this class of

insecticides.

A Section 3 registration was requested by Dow AgroSciences for use of the new insecticide

sulfoxaflor on a variety of food crops, turfgrass (sod farms) and commercially grown ornamentals. The proposed uses are the first uses of sulfoxaflor in the United States. Sulfoxaflor may be applied through a variety of applica tion methods including air, ground, and chemigation at a maximum single application rate of 0.133 lb ai/A (0.266 lb ai/A/year)

.

This assessment addresses exposure and risk associated with the proposed end

- use products for

sulfoxaflor when used as direct ed by occupational workers . There is a potential for occupational exposure associated with handler activities (i.e., mixing, loading, and applying) as well as with

post

- application activities (i.e., re

- entering treated areas). There are no registered or proposed

residential uses associated with sulfoxaflor at this time. Based on the use patterns (i.e., 2

- 4 applications per season) and resistance management practices , the duration of exposure for the proposed food uses is expected to be short

- term (1 to 30 days) and intermediate

- term (1 to 6

months ) . L ong

- term exposures (greater than 6 months) are not anticipated.

No residential uses, and no commercial/professional uses at residential sites are being requested

for sulfoxaflor at this time

. There is a proposed use on ornamental plants; however, the proposed use is only for nurseries and commercial greenhouses. Furthermore, exposure from homeowners buying turfgrass (sod) and planting it as a residential turf would be minimal

. At this time, t here are no uses of sulfoxaflor that will result in residential exposures.

Hazard Profile and Points of Departure (POD)

In mammals, sulfoxaflor targets the neurological and hepatic organ systems. Neurological

effects include skeletal muscle contraction that can lead to increased neonatal deaths. The rat appears to be uniquely sensitive to this effect and the mode of actio n is likely not relevant to humans. Repeated exposure to sulfoxaflor can lead to tumor formation in the liver and preputial gland. The Cancer Assessment Review Committee ( CARC ) has classified sulfoxaflor as “Suggestive Evidence of Carcinogenic Potential. ”

Dermal and inhalation exposures are assessed using an oral endpoint , i ncreased neonatal deaths observed in the developmental neurotoxicity study at 7.1 mg/kg/day with a NOAEL of 1.8 mg/kg/day. A route

- specific dermal study was available for endpoint selection, however the developmental endpoint was chosen because it includes reproductive and developmental parameters not measured in the dermal study. The Agency is using 2.4% as the dermal absorption factor (DAF) for determining dermal

- equivalent doses

. Since a subchronic inhalation

## Pa ge 4 of 39

study is not available , t oxicity by the inhalation route is considered to be equivalent to toxicity by the oral route of exposure. Although t he database does not contain an inhalation study, HED

has determined that this st udy is not required for sulfoxaflor and is not considered a data gap

. Therefore, a database uncertainty factor is not required ( HASPOC Memo. TXR No. 0056310 ).

The residual uncertainty for developmental effects is low and therefore the FQPA Safety Factor for children and infants is reduced to 1X. Additionally, the uncertainty factor for extrapolating

from rat to human was also reduced from 10X to 3X based pharma codynamic differences

between the rat and human.

Daily dermal and inhalation doses associated with the proposed uses were combined to

determine a total margin of exposure (MOE), or risk estimate for occupational workers, because the same study (with the s ame effects) was used for both route s of exposure. The level of concern (LOC) for dermal and inhalation exposure estimates is an MOE of 30 (i.e., MOEs greater than 30 are not of concern).

Occupational Handlers Exposure

It is HED policy 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 the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), the Outdoor Residential Exposure Task Fo rce (ORETF) database and the Agricultural Handler Exposure Task Force (AHETF) database, or other registrant

- submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FI FRA. Default assumptions established by HED ’s Science Advisory Council for Exposure were used for parameters such as body weight, acres treated and amount handled.

The short

- and intermediate

- term PODs are the same and therefore, only a short

- term handle r exposure was estimated which is considered protective of intermediate

- term exposures. All combined (dermal + inhalation) occupational handler scenarios resulted in MOEs greater than

the LOC of 30 at the baseline level of personal protective equipment ( PPE ; i.e. single layer clothing , no gloves and no respirator), and with the use of engineering controls for aerial applications.

Occupational Post

- application Exposure

Inhalation

Since the proposed uses of sulfoxaflor are for outdoor settings where pos t

- application inhalation exposures are expected to be minimal, and because sulfoxaflor has a low vapor pressure (1.05 × 10 - 8 

## mm Hg at 25°C), handler inhalation exposure estimates are considered to be protective of occupational post

- application inhalation e xposure scenarios . A quantitative post

- application inhalation exposure assessment was not conducted, either for the proposed new uses (i.e., outdoor settings) or for the greenhouse use (i.e., indoor settings). Furthermore, the Worker

Protection Standard for Agricultural Pesticides contains requirements for protecting workers

## Pa ge 5 of 39

from inhalation exposures during and after greenhouse applications through the use of ventilation requirements [40 CFR 170.110, (3) (Restrictions associated with pesticide application s)].

Dermal

There is potential for short

- and intermediate

- term occupational exposure during post

- application

activities. Chemical

- specific dislodgeable foliar residue (DFR) studies were submitted by the registrant and reviewed by HED (MRID Nos. 47832415, 47832416). The results of the DFR studies are summarized in Appendix A. Post

- application dermal exposure and risk estimates resulted in MOEs greater than the LOC of 30 and are not of concern on D ay 0 ( i.e., 12 hours after application)

.

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

- and intermediate

- term post

- application risk estimates were not a concern on day 0 (12 hours following applicatio n) for all post

- application activities. Under 40 CFR 156.208 (c) (2) (iii), a ctive ingredients classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12

- hour REI. Therefore, the [156 subpart K] Worker Pr otection Statement interim REI of 12 hours is adequate to protect agricultural workers from post

- application exposures to sulfoxaflor. It should be noted that the petitioner has proposed a REI of 24 hours for the proposed products based on their interpreta tion of the acute ocular toxicity study of the TransformTM WG formulated product resulting in a Toxicity Category II for eye irritation. HED recommends that RD ensure that the proper REI is listed on both proposed labels according to the acute toxicity pro file of the active ingredient.

Review of Human Research

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 Pestic ide Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force (ORETF) database; the Agricultural Re

- entry Task Force (ARTF) database; other registrant

submi tted exposure studies ( MRID Nos. 47832415, 47832416 ); are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements. For certain studies that review may have included review by the Hum an Studies Review Board. Descriptions of data sources as well as guidance on their use can be found at : http://www.epa.gov/pesticides/science/handler

- exposure

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

- app

- exposure

- data.html

.

2. Hazard Characterization

Sulfoxaflor is the first member of a new class of insecticides, the sulfoximines, whose pesticidal mode of action is agonism of the nicotinic acetylcholine recept or. In mammals, sulfoxaflor primarily effect s the nervous system and liver. Similar to insects, sulfoxaflor is an agonist of the fetal isoform of the intermuscular nicotinic acetylcholine receptor. This interaction results in the

contraction of skeleta l muscles causing limb flexure and bent clavicle in fetuses and decreased

## Pa ge 6 of 39

neonatal survival due to the constriction of the diaphragm muscles. This mode of action ( MOA ) is restricted to the early lifestages in the rat (i.e., late gestation and postnatal da ys 0

- 4) and is not likely to be relevant to humans. The rat appears to be uniquely sensitive to this effect

. Repeated exposure to sulfoxaflor causes hepatoxicity.

In addition, tumors were observed in the liver of rats and mice and the preputial gland in rats in the chronic rat and mouse studies. The CARC, in accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005), determined that there is a “Suggestive Evidence of Carcinogenic Potential” for sulfoxaflor. When there is suggestive evidence, the Agency does not attempt a dose

- response assessment as the nature of the data generally would not support

one. Therefore, the Agency has determined that quantification of risk using a non

- linear approach (i.e., reference dose (RfD) ) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to sulfoxaflor.

The endpoint used for short

- and intermediate

- term dermal and inhalation exposure was

increased neonatal deaths observed in th e developmental neurotoxicity study at 7.1 mg/kg/day with a NOAEL of 1.8 mg/kg/day. This effect is restricted to exposures during the early lifestages in the rat (i.e., late gestation and postnatal days 0

- 4) and is not likely to be relevant to

humans. Ho wever, it is protective of pregnant workers and

, therefore

, appropriate for occupational exposure scenarios. A route

- specific dermal study was available for endpoint selection, however the developmental endpoint was chosen because it includes reproductive and developmental parameters not measured in the dermal study. Although a route

- specific dermal study was available for endpoint selection, the developmental endpoint was chosen because it is protective of reproductive and developmental parameters not mea sured in the dermal study. The Agency is using 2.4% as the dermal absorption factor (DAF) for determining dermal

- equivalent doses. The DAF was determined from a comparison of a rat in vivo and rat and human in vitro studies. An inhalation study is not available so the Agency is as suming similar toxicity for the oral and inhalation routes of exposure (i.e., a 100% inhalation factor )

.

An acceptable guideline inhalation study is required for all food

- use registrations; however in the case of sulfoxaflor, the use of an oral study is c onsidered protective for inhalation exposure for the following reasons:

1) The acute inhalation toxicity (Category IV) is lower than the acute oral LD50 (Category III); 2) The vapor pressure is low (≤1.4×10

- 6 

## Pa or 1.05×10 - 8 

## mm Hg) at 20°C); 3) There is adequate characterization of toxicity; 4) Oral absorption is >90%

– substantially higher absorption via the inhalation route is not expected; 5) Oral absorption is rapid; 6) Sulfoxaflor is not subject to enterohepatic circulation, making the absorbed oral dose available systemically; and 7) Sulfoxaflor is not subject to in vivo metabolism and therefore potential first

- pass effects are not relevant.

## Pa ge 7 of 39

Therefore, the subchronic inhalation study is waived for sulfoxafl or. The lack of a subchronic inhalation study is not considered a data gap and a database uncertainty factor is not required ( HASPOC Memo. TXR No. 0056310 ).

The FQPA Safety for the protection of infants and children is reduced to 1X. Although there

w as quantitative susceptibility observed in the DNT, there is no residual uncertainty because the effects are well characterized, a clear NOAEL was identified, and the endpoints chosen for risk assessment are protective of potential in utero and development al effects. In addition to reducing the FQPA safety factor, HED further reduced the 10X interspecies factor (UF A 

## ) to 3X for scenarios assessed using the neonatal death endpoint (i.e., dermal and inhalation risk assessments). This recommendation is based on mechanistic data which indicate that rats are uniquely sensitive to the developmental effects of sulfoxaflor and the human muscle nicotinic receptor is not responsive to perturbation by sulfoxaflor. Therefore, from a pharmacodynamic stance, the human i s not more sensitive than the rat and therefore the pharmacodynamic portion

of the UF A 

## can be reduced.

Daily dermal and inhalation doses associated with the proposed uses were combined to determine a total MOE, or risk estimate for occupational workers, b ecause the same study (with the same effects) was used for both route s of exposure. The LOC for dermal and inhalation exposure estimates is an MOE of 30 (i.e., MOEs greater than 30 are not of concern).

The acute toxicity for the technical sulfoxaflor (EP A Reg. No. 66330

- 65) is summarized in Table

2.1a

.

Table 2.1a . Acute Toxicity Profile for Sulfoxaflor.

Guideline

No. MRID

(Annex II Point) Route/

method Species/

strain (sex) Result Classification

870.1100 47832144

(5.2.1) Oral/

gavage Rat/

Fischer 344 (both) LD 50 

### =1000

mg/kg Category III

47832040 (5.2.1) Oral/

gavage Mouse/ CD1

(male) LD 50 

### =750

mg/kg Category III

870.1200 47832051

(5.2.2) Dermal/

topical Rat/

Fischer 344 (both) LD 50 

### >5000

mg/kg Category IV

870.1300 47832052

(5.2.3) Inhalation/

nose only Rat/

Fischer 344 (both) LC 50 

### >2.09 mg/L

(4hr) Category IV

870.2400 47832055

(5.2.5) Eye/

instillation Rabbit/

NZW (female) Slight Irritation Category III

870.2500 47832053

(5.2.4) Dermal/

topical Rabbit/

NZW (female) Minimal

Irritation Category IV

870.2600 47832041

(5.2.6) Dermal/

LLNA Mouse/ CBA/J

(female) No Sensitization None



## A summary of the sulfoxaflor endpoints used for risk assessment is shown in Table 2.1b

.

## Pa ge 8 of 39

Table 2.1b

. Summary of Toxicological Doses and Endpoints for Sulfoxaflor for Use in Occupational Human Health

Risk Assessments

. Exposure/

Scenario Point of Departure Uncertainty

Factors Level of Concern for

Risk Assessment Study and Toxicological Effects

Dermal

Short

- and

Intermediate

Term NOAEL= 1.8 mg/kg/day

DAF = 2.5% UF A 

### =3x

UF H 

### =10x Occupational LOC

for MOE = 30 Developmental Neurotoxicity Study

LOAEL = 7.1 mg/kg/day based on

decreased neonatal survival on postnatal day (PND ) 0 through 4

. Inhalation

Short

- and

Intermediate

Term NOAEL= 1.8 mg/kg/day

( Inhalation absorption

a ssumed equivalent to oral absorption

. ) UF A 

### =3x

UF H 

### =10x Occupational LOC

for MOE = 30 Developmental Neurotoxicity Study

LOAEL = 7.1 mg/kg/day based on decreased neonatal survival (PND 0

- 4)

.

Cancer (oral, dermal, inhalation) Sulfoxaflor is classified as “Suggestive Evidence of Carcinogenic Potential.” Quantification of risk

using a non

- linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity.
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). MOE = margin of expos ure. LOC = level of concern. DAF = dermal absorption factor. RfD = reference dose.



## 3. Use Profile

Sulfoxaflor products are intended to be used as insecticides for the control or suppression of aphids, plant bugs, stinkbugs, whiteflies and certain scales, thri ps and psyllids in a wide variety of crops as well as turf grass and ornamentals. Sulfoxaflor is generally applied 2 to 4 times with a minimum 5 to 14 day spray interval, depending on crop /use and pest. The recommended maximum single application rate range is 0.012

- 0.133 lb ai/A. Occupational exposure is expected to be short

- or intermediate

- term in duration based on information provided on the proposed label s.

A summary of the proposed use s and directions is provided in Table 3.1

.

T wo agricultural products are proposed for use on the various crops , turf grass and ornamentals : GF

- 2032 SC and Transform TM WG.

GF

- 2032 SC is formulated as a suspension concentrate (SC) which contains 21.8 % of the active ingredient, sulfoxaflor

. Transf orm TM WG is formulated as a w ater dispersible granule (WG) which contains 50% of the active ingredient, sulfoxaflor

. The Personal Protective Equipment (PPE) statement on the proposed labels requires applicators and other handlers to wear : long

sleeved shi rt and long pants, shoes plus socks. D ue to the Category II finding in the acute ocular toxicity testing of Transform TM WG , t he PPE statement on the proposed Transform TM WG label adds protective eyewear.

These end use products may be applied through a variety of application methods including: aerial, chemigation (for potatoes only), ground boom, airblast, backpack, and hand held equipment.

## Pa ge 9 of 39

Table 3.1

. Summary of Proposed Uses and Directions for Sulfoxaflor.

Crop or Target Formulation

% A.I. Application Timing,

Type and Equipment † Max. Single App lication

Rate (lb ai/A) Max

.

Seasonal Applic. Rate ( lb ai /A

per season ) Max. No.

Appl ic.

per S eason PHI (days) Use Directions and

Limitations

Barley, Triticale, Wheat Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or groundboom 0.012

- 0.043 0.09 0

2 14 PHI = 7 days for forage, fodder, or hay; 14 days for grain or straw

REI = 24 hours Water D ispersible G ranule

50 % 0.013

- 0.047 0.09 0

Brassica (Cole) Leafy Vegetables

– Crop Group

5 Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or groundboom 0.023

- 0.090 0.266

4 7 PHI = 3 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.086 0.266

Bulb Vegetables

- Crop Group 3

- 07 Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or groundboom 0.090 0.266

3 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.086 0.266

Canola (Rapeseed)

- Subgroup 20A Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or groundboom 0.012

- 0.043 0.09 0

2 14 PHI = 14

REI = 24 hours Water D ispersible G ranule

50 % 0.013

- 0.047 0.09 0

Citrus

- Crop Group 10 Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or airblast 0.023

- 0.133 0.266

4 7 PHI = 1 day

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.133 0.266

Cotton Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or groundboom 0.012

- 0.090 0.266

4 5 PHI = 14

REI = 24 hours Water D ispersible G ranule

50 % 0.013

- 0.086 0.266

Cucurbit Vegetables

- Crop Group 9 Suspension Concentrate

21.8 % (2 lb ai /gal) foliar; aerial or groundboom 0.023

- 0.090 0.266 4 7 PHI = 1 day

REI = 24 hours

Water D ispersible G ranule 0.023

- 0.086 0.266

## Pa ge 10 of 39

Table 3.1

. Summary of Proposed Uses and Directions for Sulfoxaflor.

Crop or Target Formulation

% A.I. Application Timing,

Type and Equipment † Max. Single App lication

Rate (lb ai/A) Max

.

Seasonal Applic. Rate ( lb ai /A

per season ) Max. No.

Appl ic.

per S eason PHI (days) Use Directions and

Limitations

50 %

Fruiting Vegetables

- Crop Group 8

- 10 Suspension Concentrate

21.8 %

, (2 lb ai /gal) foliar; aerial or groundboom 0.02 2

- 0.090 0.266

4 7 PHI = 1 day

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.086 0.266

Leafy Vegetables, e xcept
Brassica

- Crop Group 4

& Watercress Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial or groundboom 0.023

- 0.090 0.266

4 7 PHI = 3 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.086 0.266

Leaves of Root and Tuber Vegetables

- Crop Group 2 Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial or groundboom 0.023

- 0.090 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.086 0.266

Ornamentals

– ( Herbaceous & Wood ) y Growing O utdoors, in Nurseries (including

C onifer Seed O rchards),

or in Greenhouses Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial, airblast, groundboom , handheld equipment 0.043

- 0.133 (0.00 133 lb ai/gal) 0.266

2 7 PHI = NA

REI = 24 hours Water D ispersible G ranule

50 % 0.047

- 0.133 (0.00 133 lb ai/gal) 0.266

Pome Fruits

- Crop Group 11 Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar;

aerial or airblast 0.023

- 0.133 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.133 0.266

Root and Tuber Vegetables

- Crop Group

1 Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial or groundboom (chemigation for potatoes

only) 0.023

- 0.090 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.086 0.266

Small Fruit Vine Climbing, except Fuzzy

Kiwifruit

- Subgroup 13

-

07F Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar;

aerial or ground 0.043

- 0.090 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.047

- 0.086 0.266

Low Growing Berry

- Subgroup 13

- 07 G Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial or groundboom 0.043

- 0.090 0.266

4 7 PHI = 1 day

REI = 24 hours Water D ispersible G ranule

50 % 0.047

- 0.086 0.266

## Pa ge 11 of 39

Table 3.1

. Summary of Proposed Uses and Directions for Sulfoxaflor.

Crop or Target Formulation

% A.I. Application Timing,

Type and Equipment † Max. Single App lication

Rate (lb ai/A) Max

.

Seasonal Applic. Rate ( lb ai /A

per season ) Max. No.

Appl ic.

per S eason PHI (days) Use Directions and

Limitations

Soybean Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial or groundboom 0.012

- 0.090 0.266

4 7 PHI = 7 days for grain, 14 days for forage or hay

REI = 24 hours Water D ispersible G ranule

50 % 0.013

- 0.086 0.266

Stone Fruits

- Crop Group 12 Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar;

aerial or airblast 0.023

- 0.133 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.133 0.266

Succulent, Edible Podded, and Dry Beans Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; aerial or groundboom 0.023

- 0.090 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.086 0.266

Tree Nuts

- Crop Group

14 & Pistachio Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar;

aerial or airblast 0.02 2

- 0.133 0.266

4 7 PHI = 7 days

REI = 24 hours Water D ispersible G ranule

50 % 0.023

- 0.133 0.266

Turfgrass

- Commercial

Sod Farms and Grass

Grown for Seed Suspension Concentrate

21.8 %, (2 lb ai /gal) foliar; groundboom or hand held 0.043

- 0.133 ( 0.00133 lb ai/gal) 0.266

2 7 PHI = NA

REI = 24 hours Water D ispersible G ranule

50 % 0.047

- 0.133 (0.00 133 lb ai /gal) 0.266



### NA = not applicable. † The minimum proposed spray volume is 3 gal/A for aerial applications and 5

- 10/gal/A for row crop applications. Based on information provided by the registrant and on the proposed labels, a total spay volume of 100 gal/A was assumed during turfgrass (sod farms) and ornamentals applications using handheld equipment

.

## Pa ge 12 of 39

4. Residential Exposure and Risk Estimates

N o residential uses, and no commercial/professional uses at residential sites are being requested

for sulfoxaflor at this time; therefore, no residential risk assessment has been conducted. There

are proposed uses on ornamental plants and turfgrass , but th ose uses are for

nurseries / commercial greenhouses and for sod farms, respectively

.

For sulfoxaflor

, HED believe s that the post

- application exposure for homeowners buying and planting ornamental plants or turf grass (sod) would be minimal based on the expos ure data

available , the time between application and purchase, and the watering

- in of turf

. At this time, there are no uses of sulfoxaflor that will result in residential exposures.

4.1 Spray Drift

Spray drift is always a potential source of exposure to residents nearby spraying operations. This is particularly the case with aerial application, but, to a lesser extent could also be a potential source of exposure from ground applications of sulfoxaflor. The Agency has been working with the Spray Drift T ask Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices 1 

## . On a

chemical

- by

- chemical basis, the Agency is now requiring interim mitigation measures for aerial

a pplications that must be placed on product labels/labeling. The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practice s to reduce off

- target drift with specific products with significant risks associated with drift.

Although a quantitative residential post

- application inhalation exposure assessment was not performed to address pesticide drift from neighboring treated agr icultural fields, an inhalation exposure assessment was performed for flaggers. This exposure scenario is representative of a

wors t

- case inhalation (drift) exposure and may be considered protective of most outdoor agricultural and commercial post

- applicat ion inhalation exposure scenarios

.

4.2 Residential Bystander Post

- application Inhalation Exposure

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

- application inhalation exposure assessment was not performed for sulfoxaflor at this time prima rily because of the low acute inhalation toxicity (Toxicity Category I V), low vapor pressure ( 1.05 × 10 - 8 

## mm Hg at 25°C ), and the low proposed use rate (0. 133 lb ai/A). However, volatilization of pesticides may be a source of post

- application inhalation e xposure to individuals nearby pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009

, and received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The Agency is in the

1 

### S ee http://www.epa.gov/opp00001/fact sheets/spraydrift.htm for more information on spray drift.

## Pa ge 13 of 39

process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the ne ed for and, subsequently, the way to incorporate post

- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are developed, the Agency may revisit the need for a quantitative post

- application inhalation exposure assessment
for sulfoxaflor

.

5. Occupational Exposure and Risk Estimates

The proposed uses are on agricultural crops , turf grass and ornamentals ; therefore, there is the potential for occupational handler and post

- application exposure.

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.

5. 1 Occupational Handler Exposure and Risk Estimates

T wo agricultural products are proposed for use on the various crops , turf grass and ornamentals : GF

- 2032 SC ( 21.8% ai; suspension concentrate ; 2 lb ai/gal ) and Transform TM WG ( 50% ai;

w ater dispersible granule )

.

Both products are proposed for use on: barley, Brassica (cole) leafy vegetables, bulb vegetables, canola (rapeseed), citrus, cotton, cucurbit vegetables, fruiting vegetables, leafy vegetables (except Brassica ), leaves of root and t uber vegetables, low growing berry, okra, ornamentals (herbaceous and woody), pome fruits, small fruit vine, soybean, stone fruits, succulent, edible podded and dry beans, tree nuts, pistachio, triticale, turfgrass (sod farms) , watercress and wheat.

Expos ure Scenarios

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 develope d for occupational handlers is based on the following scenarios:

• Mixing/Loading Dry Flowable and Liquids for Groundboom Application,

• Mixing/Loading Dry Flowable and Liquids for Aerial Application,

• Mixing/Loading Dry Flowable and Liquids for Chemigation,

• Mixing/Loading Dry Flowable and Liquids for Airblast Application

,

• Applying Sprays with Groundboom Equipment,

• Applying Sprays with Aerial Equipment,

• Applying Sprays with Airblast Equipment,

• Flagging for Aerial Applications

,

• Mix er

/Lo ad er/Applicator for Mechanically

- pressurized Handgun Sprayer,

## Pa ge 14 of 39

• Mix er

/Load er/Applicator for Backpack Sprayer, and

• Mix er

/Load er/Applicator for Manually

- pressurized Handwand.

Handler exposure is expected to be short

- or intermediate

- term in duration based on information provided on the proposed labels. Since the same endpoint and point of departure were selected

for short

- and intermediate

- term durations, short

- term exposure and risk estimates are considered to be protective of intermediate

- term exposure and risk. Long

- term exposures are not expected; therefore, a long

- term assessment was not conducted. No handler exposures are expected from applying sprays via chemigation systems.

Occupational Handler Exposure Data and Assumptions

Application Rate

The maximum single application rate on the proposed label s was used to assess all handler exposure scenarios. The maximum single application rate s for all uses range from 0.012

- 0. 133

lb ai/A. The maximum application rate per acre per year is 0. 266 lb ai /A/yr . The number of application s per year at the maximum single application rate ranged from 2

- 4 depending on the

use

.

Area Treated

Based on HED’s Exposure Science Advisory Council Policy Number 9.1, the following assumptions were used for acres treate d or amount handled per day :

• 80

- 200 acres/day for groundboom application,

• 350

- 1,200 acres/day for aerial application

, • 350 acres/day for chemigation, • 40 acres/day for airblast application,

• 40

- 1,000 gals/day for mechanically

- pressurized handgun s prayer
,

• 40 gals/day for backpack s prayer , and,

• 40 gals/day for manually

- pressurized h andwand

.

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 the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), t he Agricultural Handler Exposure Task Force (AHETF) database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant

- submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard 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 Refere nce Table” (http://www.epa.gov/opp00001/science/handler

- exposure

table.pdf), which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at:

## Pa ge 15 of 39

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

- exposure

- data.html

.

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 socks, no protective gloves, and no respirator, as well as baseline with various levels of PPE as necessary (e.g., gloves, respirator, etc). T he personal protective equipment (PPE) proposed on the Transform TM WG label requires applicators and other handlers to wear long

- sleeved shirt and long pants, shoes plus socks, and protective eyewear. The personal protective equipment (PPE) proposed on th e GF

- 2032 SC label requires applicators and other handlers to wear long

- sleeved shirt and long pants, and shoes plus socks.

Exposure Frequency

HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six months

as intermediate

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

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

No data on the number of exposure days per year was provided. Based on the prop osed labels’ use pattern and directions (e.g., 2

- 4 applications per season with a minimum 5 to 14 day spray interval), only short

- and intermediate

- term exposures are expected for handlers.

In the past HED has considered ornamentals and greenhouse uses to have the potential for long

term dermal exposure. However, the pests that are targets for sulfoxaflor have biological and

life

- stage properties that provide for short windows of opportunity for control

. T o avoid development of sulfoxaflor

- resistant pests, the sulfoxaflor labels require switching periodically to another insecticide. Therefore, based on the proposed use pattern and resistance management strategies (i.e., avoid consecutive applications o f insecticides with the same mode of action), long

- term exposure is not expected to occur.

Absorption Factors

HED has compared data depicting in vivo and in vitro dermal absorption of sulfoxaflor in rats

with in vitro dermal absorption in human skin to derive a human

- equivalent in vivo dermal absorption factor of 2.5%. A dermal absorption factor of 2.5 % was used for the exposure

assessment.

Furthermore, s ince the short

- and intermediate

- term inhalation endpoint was b ased on an oral study and no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure.

## Pa ge 16 of 39

Body Weight

An average female adult body weight of 69 kg was u sed to estimate exposure and risk to handlers because the selected dermal and inhalation endpoints were based on developmental

effects.

Occupational Handler Exposure and Risk Equations

Potential daily exposures for occupational handlers were calculated using the following

formulas:

Daily Exposure (mg ai/day) = UE (μg ai / lb ai) * AR (lb ai /A) * AT (A /day) * CF (1E

- 3 mg/μg)

where: Daily Exposure = Amount (mg ai/day) that is available for dermal or inhalation exposure
, UE = Unit Exposure (μg ai / lb ai),

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

AT = D aily acres treated (A /day) or amount handled

.



## The daily doses were calculated using the following formula:

Daily Dose (mg ai/kg/day) = [Daily Expo sure (mg ai/day) * Absorption Factor (%)] / Body Weight (kg)

where: Daily Dose = Absorbed dose received from exposure to a pes ticide in a given scenario (mg pesticide active ingredient/kg body weight/day), Daily Exposure = Amount (mg ai/day) that is available for dermal or inhalation absorption, Absorption Factor = A measure of the amount of chemical that crosses a biological boundary such as the skin and lungs (%), and Body Weight = Body weight determined to represent the population of interest in a risk assessment (kg).



## Margin of Exposure: Non

- cancer inhalation risks 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 handlers were compared to the appropriate POD (i.e.

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

MOE = POD (t ypically a NOAEL in mg/kg/day) / D aily D ose (mg/kg/day)

where:

MOE = Margin of Exposure is the value used by HED to represent risk or risk estimates (unitless),

POD = Point of Departure (mg/kg/day)

, NOAEL = No Observed Adverse Effect Level (mg/kg/day) (i.e., d ose level in a toxicity study, where no

observed adverse effects occurred in the study ) , and

DD = Daily Dose (mg/kg/day) is the absorbed dose received from exposure to a pesticide in a given

scenario.



## Dermal and inhalation risks were combined i n this assessment, since the toxicological effects for these exposure routes were similar. Dermal and inhalation risks were combined using the following formula:

## Pa ge 17 of 39

Total MOE = Point of De parture (mg/kg/day)/ Combined (Dermal + I nhalation ) D ose (mg/kg/day)



## Occupational Handler Exposure and Risk Estimates

Tables 5.1a and 5.1b present the estimated short

- and intermediate

- term dermal and inhalation risk estimates for occupational handlers ( i.e., mixer/loaders, applicators, flaggers). All occupational handler scenarios for the proposed use s resulted in estimated MOEs that are greater

tha n 30 (i.e., not of concern) at the baseline level of PPE (i.e.

, baseline clothing, no gloves and no respirator ) and engineering controls ( i.e., enclosed cockpit) for aerial app lications. The estimated combined ( dermal + inhalation) MOEs are all higher than HED’s level of concern of
an MOE of 30, with the lowest MOE of 80 identified for handlers conducting mixer/loader

activities with dry flowable for aerial applications.

The Agency has evaluated scenarios that may be limited in nature such as flagging during aerial applications because engineering controls (i.e., Global Positioning Satellite technology) are now predominantly used as indicated by the 1998 National Agricultural Aviation Association (NAAA) survey of their membership. It appears, however, flaggers are still used in approximately 10 to 15 percent of aerial application operations. In cases like these, the Agency strongly encourages the use of the engineering contr ol system but will continue to evaluate risks for flaggers and any other population where a clear exposure pathway exists until the potential for exposure is eliminated. The Agency is aware that NAAA is conducting another survey on exposure issues and wil l consider those results as are timely and appropriate.

HED has no data to assess exposure for pilots using open cockpits. The only data available represent exposure for pilots in enclosed cockpits. Therefore, pilot exposure and risk estimates

are deter mined assuming use of engineering control ( i.e., enclosed cockpits) and baseline attire (i.e., long

- sleeve shirt, long pants, shoes, and socks); pilots are not required to wear protective gloves. With this level of protection, there are no risk estimates of concern for aerial applicators treating melons, peppers and soybeans with fluazinam in accordance with the proposed label.

## Pa ge 18 of 39 Table 5.1a

. Short

- and Intermediate

- term Occupational Handler Exposure and Risk Estimates for Proposed U se s of Sulfox aflor ( Transform TM WG )

. Exposure

Scenario Crop or Target (C rop G roup #) Dermal Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Inhalation Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Max Single

App Rate (lb ai/A or lb ai/gal ) 2 Area Treated or

Amount Handled Daily 3 Dermal Inhalation Combined MOE 8

(LOC=30) Dose 4
(mg/kg/day) MOE 5 Dose 6
(mg/kg/day) MOE 7

Mixer/Loader
Dry Flowable for

Groundboom Application (AHETF) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans 0.227 (Baseline) 0.00896

(No respirator) 0.086 80 A 0.00057 3,200 0.00089 2,000 1,200

Ornamentals, Turf grass (Sod Farm) 0.227 (Baseline) 0.00896

(No respirator) 0.133 80 A 0.00088 2,100 0.00140 1,300 800

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.227 (Baseline) 0.00896

(No respirator) 0.047 200 A 0.00077 2,300 0.00120 1,500 900

Cotton, Soybean 0.227 (Baseline) 0.00896

(No respirator) 0.086 200 A 0.0014 1,300 0.0022 0 810 49 0

Dry Flowable for

Aerial Application (AHETF) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans 0.227 (Baseline) 0.00896

(No respirator) 0.086 350 A 0.00250 730 0.00390 460 280

Citrus (CG 10), Pome Fruits (CG 11), Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 0.227 (Baseline) 0.00896

(No respirator) 0.133 350 A 0.00380 470 0.00600 300 180

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.277 (Baseline) 0.00896

(No respirator) 0.047 1200 A 0.00460 390 0.00730 250 150

Cotton, Soybean 0.277 (Baseline) 0.00896

(No respirator) 0.086 1200 A 0.0085 0 210 0.0134 0 130 80

Dry Flowable for Chemigation (AHETF) Potatoes 0.227 (Baseline) 0.00896

(No respirator) 0.086 350 A 0.00250 730 0.00390 460 280

Dry Flowable for

A irblast Application (AHETF) Citrus (CG 10), Pome Fruits (CG 11),

Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 0.227 (Baseline) 0.00896

(No respirator) 0.133 40 A 0.00044 4,100 0.00069 2,600 1,600

Applicator Sprays for

Groundboom Application Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. 0.0786 (Baseline) 0.00034

(No respirator) 0.086 80 A 0.00020 9,200 0.000034 53,000 7,800

## Pa ge 19 of 39 Table 5.1a

. Short

- and Intermediate

- term Occupational Handler Exposure and Risk Estimates for Proposed U se s of Sulfox aflor ( Transform TM WG )

. Exposure

Scenario Crop or Target (C rop G roup #) Dermal Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Inhalation Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Max Single

App Rate (lb ai/A or lb ai/gal ) 2 Area Treated or

Amount Handled Daily 3 Dermal Inhalation Combined MOE 8

(LOC=30) Dose 4
(mg/kg/day) MOE 5 Dose 6
(mg/kg/day) MOE 7

(AHETF) (Except Brassica CG 4 & Watercress),

Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans Ornamentals, Turf grass (Sod Farm) 0.0786 (Baseline) 0.00034

(No respirator) 0.133 80 A 0.00030 5,900 0.000052 34,000 5,100

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.0786 (Baseline) 0.00034

(No respirator) 0.047 200 A 0.00027 6,700 0.000046 39,000 5,700

Cotton, Soybean 0.0786 (Baseline) 0.00034

(No respirator) 0.086 200 A 0 .00049 3,700 0.000085 21,000 3,1 00

Sprays for Aerial Application (PHED ) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans 0.005 (Engineering

Controls

- Enclosed cockpit) 0.0 00068

(Engineering

Controls

- Enclosed cockpit) 0.086 350 A 0.000055 33,000 0.000030 61,000 21,000

Citrus (CG 10), Pome Fruits (CG 11), Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.133 350 A 0.000084 21,000 0.000046 39,000 14,000

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.047 1200 A 0.00010 18,000 0.000056 32,000 11,000

Cotton, Soybean 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.086 1200 A 0.00019 9,600 0.0001 18,000 6,200

Sprays for

A irblast Application ( AHETF) Citrus (CG 10), Pome Fruits (CG 11),

Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 1.77 (Baseline) 0.00471

(No respirator) 0.133 40 A 0.00340 530 0.00036 5,000 480

Flagger Flagging for

Aerial Application All Low Acreage Crops 0.011 (Baseline) 0.00035

(No respirator) 0.133 350 A 0.00019 9,700 0.00024 7,600 4,200

## Pa ge 20 of 39 Table 5.1a

. Short

- and Intermediate

- term Occupational Handler Exposure and Risk Estimates for Proposed U se s of Sulfox aflor ( Transform TM WG )

. Exposure

Scenario Crop or Target (C rop G roup #) Dermal Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Inhalation Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Max Single

App Rate (lb ai/A or lb ai/gal ) 2 Area Treated or

Amount Handled Daily 3 Dermal Inhalation Combined MOE 8

(LOC=30) Dose 4
(mg/kg/day) MOE 5 Dose 6
(mg/kg/day) MOE 7

(PHED) Flagging for

Aerial Application (PHED) All High Acreage Crops 0.011 (Baseline) 0.00035

(No respirator) 0.086 350 A 0.00012 15,000 0.00015 12,000 6,700

Mixer/Loader/Applicator

Mechanically

pressurized Handgun Sprayer Ornamentals , Greenhouses 3.5 (Baseline) (PHED) 0.120

(No respirator) (PHED) 0.00 133 1,000 gal/day 0.00169 1,100 0.00231 780 450

Turf grass (Sod farms) 1.96 (Baseline) (ORETF) 0.042

(No respirator) (ORETF) 0.133 5 A 0.00047 3,800 0.00040 4,400 2,100

Backpack Sprayer Ornamentals 13.2 (Baseline) (AHETF) 0.140

(No respirator) (AHETF) 0.00 133 40 gal/day 0.00025 7,200 0.00011 16,000 5,000

Turf grass (Sod farms) 8.26 (Baseline) (MRID 44339801) 0.00258

(No respirator) (MRID 44339801) 0.00 133 40 gal/day 0.00016 11,000 0.000002 900,000 11,000

Manually

pressurized

Handwand (PHED) Ornamentals

, Turf grass (Sod farms) 100 (Baseline) 0.030

(No respirator) 0.00 133 40 gal/day 0.00193 930 0.000023 78,000 920

1. Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (OPHED; March, 2012).

2. Application Rate is based on the proposed label.

3. Acres Treated per Day is based on Exposure SAC SOP #9: Standard Values for Daily Acres Treated.

4. Dermal Dose = [Dermal Unit Exposure (mg/lb ai) x Application Rate (lb ai/A) x Acres Treated (A/day) x % DAF (2.5%)]/%)/BW (69 kg).

5. Dermal MOE = Dermal NOAEL (1.8 mg/kg/day)/Dermal Dose (mg/kg/day) ; LOC = 30

. 6. Inhalation Dose = [Inhalation Unit Expo sure (mg/lb ai) x Application Rate (lb ai/A) x Acres Treated (A/day)]/)/BW (69 kg).

7. Inhalation MOE = NOAEL (1.8 mg/kg/day)/Inhalation Dose (mg/kg/day) ; LOC = 30

. 8. Combined MOE = NOAEL (1.8 mg/kg/day)/Combined Dose (mg/kg/day) ; LOC = 30

.

## Pa ge 21 of 39 Table 5.1b

. Short

- and Intermediate

- term Occupational Handler Exposure and Risk Estimates for Proposed U se s of Sulfoxaflor ( GF

- 2032 SC ). Exposure

Scenario Crop or Target (CG #) Dermal Unit Exposure 1
(mg/lb ai) (Mitigation Level) Inhalation Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Max Single

App Rate (lb ai/A or lb ai/gal ) 2 Area Treated or

Amount Handled Daily 3 Dermal Inhalation Combined MOE 8

(LOC=30) Dose 4
(mg/kg/day) MOE 5 Dose 6
(mg/kg/day) MOE 7

Mixer/Loader
Liquids for

Groundboom Application (AHETF) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans 0.220 0.000219 0.090 80 A 0.00057 3,100 0.000023 79,000 3,000

Ornamentals, Turf grass (Sod Farm) 0.220 0.000219 0.133 80 A 0.00085 2,100 0.000034 53,000 2,000

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.220 0.000219 0.043 200 A 0.00069 2,600 0.000027 66,000 2,500

Cotton, Soybean 0.220 0.000219 0.090 200 A 0.0014 0 1,300 0.00 0057 32,000 1,2 00

Liquids for

Aerial Application (AHETF) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans 0.220 0.000219 0.090 350 A 0.00250 720 0.00010 18,000 690

Citrus (CG 10), Pome Fruits (CG 11), Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 0.220 0.000219 0.133 350 A 0.00370 490 0.00015 12,000 470

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.220 0.000219 0.043 1200 A 0.00410 440 0.00016 11,000 420

Cotton, Soybean 0.220 0.000219 0.090 1200 A 0.00860 210 0.00034 5,300 200 Liquids for Chemigation (AHETF) Potatoes 0.220 0.000219 0.0 90 350 A 0.00250 720 0.00100 18,000 690

Liquids for

A irblast Application (AHETF) Citrus (CG 10), Pome Fruits (CG 11),

Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 0.220 0.000219 0.133 40 A 0.00042 4,200 0.000017 110,000 4,100

Applicator Sprays for

Groundboom Application (AHETF) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), 0.0786 (Baseline) 0.00034

(No respirator) 0.090 80 A 0.00021 8,800 0.000035 51,000 7,500

## Pa ge 22 of 39 Table 5.1b

. Short

- and Intermediate

- term Occupational Handler Exposure and Risk Estimates for Proposed U se s of Sulfoxaflor ( GF

- 2032 SC ). Exposure

Scenario Crop or Target (CG #) Dermal Unit Exposure 1
(mg/lb ai) (Mitigation Level) Inhalation Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Max Single

App Rate (lb ai/A or lb ai/gal ) 2 Area Treated or

Amount Handled Daily 3 Dermal Inhalation Combined MOE 8

(LOC=30) Dose 4
(mg/kg/day) MOE 5 Dose 6
(mg/kg/day) MOE 7

Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans Ornamentals, Turf grass (Sod Farm) 0.0786 (Baseline) 0.00034

(No respirator) 0.133 80 A 0.00030 5,900 0.000052 34,000 5,100

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.0786 (Baseline) 0.00034

(No respirator) 0.043 200 A 0.00024 7,300 0.000042 42,000 6,300

Cotton, Soybean 0.0786 (Baseline) 0.00034

(No respirator) 0.090 200 A 0.00051 3,500 0.000089 20,000 3,000

Sprays for Aerial Application (PHED ) Brassica (Cole) Leafy Veg., Bulb Veg.

(CG 3

- 07), Cucurbit Veg. (CG 9), Fruiting Veg. (CG 8), Leafy Veg. (Except Brassica CG 4 & Watercress), Leaves Root/Tuber Veg. (CG 2), Root/Tuber Veg. (CG 1), Small Fruit Vine (Sub CG 13

- 07F), Low Growing Berry (Sub 13

- 07G), Succulent, Edible Podded, Dry Beans 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.090 350 A 0.000057 32,000 0.000031 58,000 25,000

Citrus (CG 10), Pome Fruits (CG 11), Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.133 350 A 0.000084 21,000 0.000046 39,000 19 ,000

Barley, Tricale, Wheat, Canola (Sub CG 20A) 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.043 1200 A 0.000093 19,000 0.000051 35,000 12,000

Cotton, Soybean 0.005 (Engineering

Controls

- Enclosed cockpit) 0.000068

(Engineering

Controls

- Enclosed cockpit) 0.090 1200 A 0.00020 9,200 0.00011 17,000 6,000

Sprays for

A irblast Application ( AHETF ) Citrus (CG 10), Pome Fruits (CG 11),

Ornamentals, Stone Fruits (CG 12), Tree Nuts (CG 14 & Pistachio) 1.77 (Baseline) 0.00471

(No respirator) 0.133 40 A 0.00340 530 0.00036 5,000 480

Flagger Flagging for

Aerial Application (PHED) All Low Acreage Crops 0.011 (Baseline) 0.00035

(No respirator) 0.133 350 A 0.00019 9,700 0.00024 7,600 4,200

## Pa ge 23 of 39 Table 5.1b

. Short

- and Intermediate

- term Occupational Handler Exposure and Risk Estimates for Proposed U se s of Sulfoxaflor ( GF

- 2032 SC ). Exposure

Scenario Crop or Target (CG #) Dermal Unit Exposure 1
(mg/lb ai) (Mitigation Level) Inhalation Unit

Exposure 1
(mg/lb ai) (Mitigation Level) Max Single

App Rate (lb ai/A or lb ai/gal ) 2 Area Treated or

Amount Handled Daily 3 Dermal Inhalation Combined MOE 8

(LOC=30) Dose 4
(mg/kg/day) MOE 5 Dose 6
(mg/kg/day) MOE 7

Flagging for

Aerial Application (PHED) All High Acreage Crops 0.011 (Baseline) 0.00035

(No respirator) 0.090 350 A 0.00013 14,000 0.00016 11,000 6,300

Mixer/Loader/Applicator

Mechanically

pressurized Handgun Sprayer Ornamentals , Greenhouses 3.5 (Baseline) (PHED) 0.120

(No respirator) (PHED) 0.00 133 1,000 gal/day 0.00169 1,100 0.00231 780 450

Turf grass (Sod farms) 1.14 (Baseline) (ORETF) 0.0019

(Baseline) (ORETF) 0.133 5 A 0.00047 3,800 0.00040 4,400 2,100

Backpack Sprayer Ornamentals 13.2 (Baseline) (AHETF) 0.140

(No respirator) (AHETF) 0.00 133 40 gal/day 0.00025 7,200 0.00011 16,000 5,000

Turfgrass (Sod farms) 8.26 (Baseline) (MRID 44339801) 0.00258

(No respirator) (MRID 44339801) 0.00 133 40 gal/day 0.00016 11,000 0.000002 900,000 11,000

Manually

pressurized

Handwand (PHED) Ornamentals

, Turfgrass (Sod farms) 100 (Baseline) 0.030

(No respirator) 0.00 133 40 gal/day 0.00193 930 0.000023 78,000 920

1. Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (OPHED; March, 2012).

2. Application Rate is based on the proposed label.

3. Acres Treated per Day is based on Exposure SAC SOP #9: Standard Values for Daily Acres Treated.

4. Dermal Dose = [Dermal Unit Exposure (mg/lb ai) x Application Rate (lb ai/A) x Acres Treated (A/day) x % D AF (2.5%)]/%)/BW (69 kg).

5. Dermal MOE = Dermal NOAEL (1.8 mg/kg/day)/Dermal Dose (mg/kg/day) ; LOC = 30

. 6. Inhalation Dose = [Inhalation Unit Exposure (mg/lb ai) x Application Rate (lb ai/A) x Acres Treated (A/day)]/)/BW (69 kg).

7. Inhalation MOE = NOAEL (1.8 mg/kg/day)/Inhalation Dose (mg/kg/day) ; LOC = 30

. 8. Combined MOE = NOAEL (1.8 mg/kg/day)/Combined Dose (mg/kg/day) ; LOC = 30

.

## Page 24 of 39

5.2 Occupational Post

- A pplication Exposure and 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 fun ctions, 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 type of activity, the nature of the crop or target that was treated, the ty pe 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

- application exposure.

5.2.1 Occupational Post

- Application Inhalation Exposure and Risk Estimates

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

- application inhalation exposure assessment was not performed for sulfoxaflor at this time primarily because it has a low vapor pressure ( 1.05 × 10 - 8 

## mm Hg at 25°C ) and it is applied at low application rates ( 0.133 lb ai/A). However, volatilization of pesticides may be a potential source of post

- application inhalation exposure to individuals nearby to 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 P anel (SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).

Although a quantitative occupational post

- application inhalation exposure assessment was not

per formed, an inhalation exposure assessment was performed for occupational handlers. This

assessment resulted in risk estimates that did not exceed HED’s level of concern at baseline inhalation PPE. 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.

Furthermo re, the Worker Protection Standard for Agricultural Pesticides contains requirements for protecting workers from inhalation exposures during and after greenhouse applications through the use of ventilation requirements [40 CFR 170.110, (3) (Restrictions as sociated with pesticide applications)].

5.2.2 Occupational Post

- Application Dermal Exposure and Risk Estimates

Occupational workers who enter treated fields to perform post

- application activities such as hand weeding and scouting may be exposed to sulfox aflor residues

. Based on the use pattern, workers may be exposed to short

- and intermediate

- term exposure duration s.

Dislodgeable Foliar Residue Data: I t is HED ’s policy to use the best available data to assess

post

- application exposure. The registrant submit ted dislodgeable foliar r esidue (DFR) studies in support of th e proposed agricultural uses. These studies were reviewed by HED (MRID No.

47832415 on Treated Wheat ; MRID No

. 47832416 on Treated Broccoli ) . Both studies

## Page 25 of 39

demonstrated that di slodgeable foliar residue values declined over time for all sites and both

formulations

. The available DFR data were matched to the proposed agricultural crop s (except

cotton ; see below ) as surrogate data based on available information about foliage type, region of use, use pattern, etc. (see ExpoSAC Minutes dated 06/30/11). The results of the DFR studies are summarized in Appendix A. Dermal post

- application exposure resulting from application of

sulfoxaflor was estimated using the best available surrogate DFR predicted Day

- 0 residue value from treated wheat (0.0210 ug/cm 2 

## ) and treated broccoli (0.115 ug/cm 2 

## ) calculated by a first

order dissipation kinetics and decay model

. Maximum single application rates were u sed in this assessment. Day

- 0 DFR values were adjusted by application rate.

Dislodgeable residue data were not submitted for cotton. Calculation of dermal post

- application exposure resulting from application of sulfoxaflor to cotton during harvesting activities (e.g., module builder, picker operator, raker, tramper) requires an estimate of the "dislodgeable" residue on the cotton bolls. Since that information was unavailable, exposure was estimated using cotton field trial residues (see Appendix C). Additionally, since the proposed PHI for cotton is 14 days, the Day

- 14 residue value from the cotton field trials is considered adequate to estimate dermal post

- application exposures and risks during harvesting activities. Adjusted to the proposed maximum seasonal application rate, the Day

- 14 residue is 0.000129 mg ai/g cotton.

Note also that the cotton field trial residue data reflect solvent

- extractable residues, which are likely to be significantly greater than dislodgeable cotton boll residue during h arvesting activities. Therefore, use of the residue data from the cotton field trials, even after being reduced to account for the difference in application rate, results in a conservative estimate for the daily

dose.

Turf transferable residue (TTR) data were not submitted for turfgrass ( sod farms ); therefore,

default TTR values were used to assess dermal post

- application exposure and risk.

Transfer Coefficients: Sources of generic post

- application exposure data, used as surrogate data

in the absence of chemical

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

- appl ication exposure that are used in this assessment, known as “transfer coefficients, Tc ” are presented in the “Science Advisory Council for Exposure (ExpoSAC) Policy 3” (http://www.epa.gov/pesticides/science/exposac_policy3.pdf), which, along with additiona l information about the ARTF data, can be found at: http://www.epa.gov/pesticides/science/post

app

- exposure

- data.html.

Dermal exposures during post

- application activities were estimated using standard default and surrogate contact activity values ( Appendi x B ), chemical

- specific DFR (Appendix A ) for all agricultural crops except cotton, default TTR for sod farms, and field trial data for cotton (Appendix C )

.

Post

- A pplication Exposure and Risk Estimates

A summary of the post

- application exposure and risk estimates for all proposed crops except

cotton is provided in Table 5.2.2

. Only risk estimates for the highest contact activity per crop

## Page 26 of 39

group are shown below ; not all the TCs used in the assessment appl y to each of the specific crop s requested

. Post

- application dermal exposure and risk estimates resulted in MOEs greater than 30

and are not of concern.

A summary of the post

- application exposure and risk estimates from use of sulfoxaflor on cotton

duri ng harvesting activities is provided in Table 5.2.3 . Post

- application dermal exposure and risk estimates resulted in MOEs greater than 30 and are not of concern.

## Page 27 of 39 Table 5.2.2 . Post

- Application Exposure and Risk Estimates for use of Sulfoxaflor

.

Crop Group Proposed

Uses / Crop Group Proposed

Maximum Application

Rate † (lb ai/A) Activity 1 TC 2

(cm 2 /hr) Days

After

Treatment Adjusted

Dislodgeabl

e Foliar

Residue /

Turf

Transferable

Residue 3
(ug/cm 2 ) Daily

Dose (mg/kg/d) 4 MOE 5

DFR Data on Treated Wheat (MRID No. 47832415)

Field / Row Crop,

L ow /M edium Barley, Tricale,

W heat ; Canola (SG 20A) 0.047 Scouting 1,100 0 0.022 0. 0000007 2,600,000

Cotton 0.090 Scouting 210 0 0.042 0.0000003 7,000,000 Soybean 0.090 Scouting 1,100 0 0.042 0.0000014 1,300,000

Succulent Edible Podded and Dry

Beans 0.090 Irrigation (Hand S et) 1,900

0 0.042 0.0000023 770,000

DFR Data on Treated Broccoli (MRID No. 47832416) Vegetable, head

and stem

Brassica Brassica (Cole)

Leafy Vegetables (CG5) 0.090 Hand Weeding 4

, 200 0 0.115 0.00001 130,000

Vegetable,

" R oot" Bulb Vegetables

( CG 3

- 07) 0.090 Hand Weeding 4

, 200 0 0.115 0.00001 130,000

Le aves of Root

and Tuber Vegetables ( CG 2);

Root and Tuber Vegetables ( CG 1) 0.090 Irrigation (Hand Set) 1,900 0 0.115 0.000006 280,000

Tree Fruit, Evergreen Citrus ( CG 10) 0.133 Thinning Fruit 3,600 0 0.170 0.00002 100,000

Vegetable,

C ucurbit Cucurbits

Vegetables ( CG 9) 0.090 Irrigation (Hand S et) 1,900 0 0.115 0.00001 280,000

Vegetable, Fruting Fruiting

Vegetables ( CG 8) 0.090 Irrigation (Hand S et) 1,900 0 0.115 0.00001 280,000

Vegetable, Leafy Leafy Vegetables

except Brassica

– (CG 4 ) & Watercress) 0.090 Irrigation (Hand S et) 1

, 900 0 0.115 0.000006 280,000

Nursery/

Greenhouse (Unassigned) Ornamentals

0.133 Irrigation (Hand Set) 1,900 0 0.170 0.00001 190,000

Tree, "F ruit",

D eciduous Pome Fruits ( CG

11); Stone Fruits ( CG 12) 0.133 Thinning Fruit 3,600 0 0.170 0.00002 100,000

Vine/Trellis Small Fruit Vine

Climbing except fuzzy kiwifruit

– (SG 13

- 07F) 0.090 Turning, Girdling 19,300 0 0.115 0.0001 28,000

Berry, Low Low Growing

Berry (S G 13

- 07G) 0.090 Irrigation (Hand Set) 1,900 0 0.115 0.000006 280,000

Tree, “Nut” Tree Nuts ( CG

14 ) & Pistachio) 0.133 Hand Harvesting 1,400 0 0.170 0.000007 260 ,000

Default TTR Approach ‡

## Page 28 of 39 Table 5.2.2 . Post

- Application Exposure and Risk Estimates for use of Sulfoxaflor

.

Crop Group Proposed

Uses / Crop Group Proposed

Maximum Application

Rate † (lb ai/A) Activity 1 TC 2

(cm 2 /hr) Days

After

Treatment Adjusted

Dislodgeabl

e Foliar

Residue /

Turf

Transferable

Residue 3
(ug/cm 2 ) Daily

Dose (mg/kg/d) 4 MOE 5

Turf, Sod Turfgrass, Sod

farms 0.133 Maintenance, Harvesting, Slab Transplanting/Planting 6,700 0 0.002 0.0000004 4,700,000

† Maximum single application rates were used in this assessment. ‡ Turf Transferable Residue = TT R t (μg/cm 2 ) = AR (lb ai/acre) × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

- 8 acre/cm 2 ; Where, AR = Application Rate, F = F raction of ai retained on foliage ( 0.2; unitless), D = F raction of residue th at dissipates daily ( 0.1; unitless).

1. Only risk estimates for the high contact activities are shown

. 2. Transfer Coefficients from HED Policy No. 3.0., March 2012 ( s ee Appendix B)

. Only the dose and risk estimates for the highest contact activities are shown above.

3. Dislodgeable Foliar Residue (DFR) from Treated Wheat = 0.0210 ug/cm 2 is based on predicted day 0 residue value

calculated from chemical

- specific data (MRID No. 47832415) and then adjust ed by application rate

. Dislodgeable Foliar Residue (DFR) from Treated Broccoli = 0.115 ug/cm 2 is based on predicted day 0 residue value calculated from chemical

specific data (MRID No. 47832416) and then adjusted by application rate. Representative site

, surrogate DFR data and crop selection were determined using available information about foliage type, region of use, use pattern, etc. (see ExpoSAC Minutes dated 06/30/11).

4. Dermal Dose (mg/kg/day) = [DFR or TTR (ug/cm 2 ) x TC (cm 2 /hr) x hr/day (8 hrs/day) x (0.001 μg/mg) x DAF (2.5%)]/ BW 69 kg).

5. Dermal MOE = NOAEL (1.8 mg/kg/day)/Dermal Dose (mg/kg/day); LOC = 30.

## Page 29 of 39

Table 5.2.3 . Post

- Application Exposure and Risk Estimates for use of Sulfoxaflor on Cotton during Harvesting Activities.

Crop Proposed

Maximum

Seasonal Application

Rate (lb ai/A) Activity TC 1
(g cotton/hr) Days After

Treatment Residue from

Cotton Field

Trial 2

( mg ai/g cotton) Daily Dose

(mg/kg/d) 3 MOE 4

Cotton 0. 266 Harvesting

Mechanical (Module Builder) 900

14 0.000129 0.00034 5,300

Harvesting Mechanical (Picker Operator; Raker) 2400 0.00089 2,000

Harvesti ng Mechanical (Tramper) 5050 0.00189 950

1. Transfer Coefficients from HED Policy No. 3.0., Non

- Foliar Transfer Coefficient Table, March 2012 (p 122)

. 2. Residue Value from Cotton Field Trial (Table 9) adjusted to Max. Seasonal Application Rate (mg ai /g cotton) = (0.182 mg ai/kg cotton) (0.001 mg/g) ((0. 266 lb ai/A )/(0.375 lb ai/A)) = 0. 000 129 mg ai/g cotton.

3. Dermal Dose (mg/kg/day) = [Cotton Field Trial Residue Value adjusted (mg ai/g cotton ) x TC (g cotton/hr) x hr/day (8 hrs/day) x DAF (2.5%)]/ BW ( 69 kg).

4. Dermal MOE = NOAEL (1.8 mg/kg/day)/Dermal Dose (mg/kg/day); LOC = 30.



## Restricted Entry Interval (REI)

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

- and intermediate

- term post

- application risk estimates were not a concern on day 0 (12 hours following application) for all post

- application activities. Under 40 CFR 156.208 (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. Therefore, the [156 subpart K]

Worker Protection Statement interi m REI of 12 hours is adequate to protect agricultural workers from post

- application exposures to sulfoxaflor. It should be noted that the petitioner has proposed a REI of 24 hours for the proposed products based on their interpretation of the acute

ocular toxicity study of the TransformTM WG formulated product resulting in a Toxicity Category II for eye irritation. HED recommends that RD ensure that the proper REI is listed on both proposed labels according to the acute toxicity profile of the active ingred ient.

## Page 30 of 39

APPENDICES

Appendix A : Summary of the Dislodgeable Foliar Residues (DFR) Studies

.

Secondary Review: Dissipation of Dislodgeable Foliar Residues of Sulfoxaflor from Treated

Wheat ; MRID No. 47832415.

The study “Dissipation of Dislodgeable Foliar Sulfoxaflor Residues from Treated Wheat” was submitted by Dow AgroSciences LLC, in support of the registration of sulfoxaflor.

This study was designed to determine the dissipation of dislodgeable foliar residu es (DFR) of sulfoxaflor formulated as a 22.5% ai suspension concentrate (XDE

- 240 SC) and a 49.9% water dispersible granular (500 WDG) applied via groundboom to wheat at two trial sites: Porterville, CA and Chula, GA. Each trial site consisted of one contr ol plot and two treatment plots (one for each formulation). Each treatment plot received two foliar broadcast spray applications of the test substance at a single application rate of 50 g ai/ha (0.0446 lb ai/A/application), for a total application rate of 100 g ai/ha (0.89 lb ai/A) for the two applications. The re

- treatment interval was 14 days. Applications were made in a spray volume of approximately 19.8

- 20.8 gallons per acre and an adjuvant was added to the spray mixture for all applications.

Sampl es were collected prior to each application, as soon as the spray dried after each application (0 to 8 hours), and at intervals of 1, 2, 4, 7, 10, 14, 21, 28, and 35 days after the final treatment (28 and 35 day samples were collected only at the GA site). At each sampling interval, single samples were collected from the control plot and triplicate samples were collected from the treated plots. Field

- fortified samples prepared using wheat samples from the untreated control plot were prepared on Days 1 and 14 after the last application at the California site and on Days 1, 14, and 28 after the last application at the Georgia site.

The Registrant provided DFRs in μg/cm 2 

## , corrected for an average procedural recovery of 91%. Versar also calculated DFRs in μ g/cm 2 

## , but did not correct the results for either procedural recoveries or field fortification recoveries as average recoveries were >90%. For calculation purposes, DFR values reported as between the limit of quantitation (LOQ) and the limit of

detection ( LOD) were assigned a value of 1⁄2 LOQ and DFR values less than the LOD were assigned a value of 1⁄2 LOD. The LOQ was 0.20 ng/mL (0.0001 μg/cm 2 

## ) and the limit of LOD was 0.075 ng/mL (0.000038 μg/cm 2 

## ).

Average DFR values declined rapidly at all sites. The ma ximum average DFR values of 0.037 to 0.119 μg/cm 2 

## were observed either immediately after the first application or treatment (0DAT1) or second application (0DAT2). Residue levels dropped significantly within the first 10 days after the second application a nd were <LOQ or close to the LOQ by the end of the sampling period. The maximum percent of the application rate which was dislodgeable also occurred at 0DAT1 or 0DAT2 and ranged from 7.35% to 24.3%. The 24.3% value occurred at the 500

WDG California site after the second application. The value was significantly higher than the value after the first application at the same site (8.9%), in addition to all other sites. No explanation was provided for the high DFR values at the 0DAT2 interval at the 500 WDG

California trial.

## Page 31 of 39

The magnitude of sulfoxaflor residues and the dissipation of sulfoxaflor between the 240 SC and 500 WDG formulations and the trial locations were similar, with the exception of the 0DAT2

DFRs at the 500 WDG California trial.

Versar as sumed first

- order dissipation kinetics to generate dissipation curves for sulfoxaflor. Versar conducted the linear regression analysis using the natural logarithm of the individual foliar residue values collected immediately after the second application t hrough the last day of sampling or when all residues were <LOQ (22DAT2 for California trials and 20DAT2 for Georgia trials). Based on linear regression of the natural log transformed data, Versar’s

calculated half

- lives for sulfoxaflor wheat leaves were 3 .46 days (R 2 

## = 0.719) for the 240 SC California site, 3.10 days (R 2 

## = 0.959) for the 240 SC Georgia site, 3.46 days (R 2 

## = 0.584) for the 500 WDG California site and 2.85 days (R 2 

## = 0.966) for the 500 WDG Georgia site. A comparison of the actual and predic ted values shows that the actual values were higher than the predicted values for the 0DAT2, 1DAT2, and/or 2DAT2 intervals for all trials, with significant

differences observed for the California site.

Rainfall (2.3 inches) occurred on the day prior to t he 10DAT2 sampling interval at the Georgia site. Residues had already declined significantly by ; therefore, it is not expected that the results were significantly impacted by the rainfall. The Registrant calculated half

- lives for the Georgia plots using only the 0DAT2 through 7DAT2 data to determine the affect of the rainfall event on 9DAT2 at this site. As compared to the entire sampling period after the second application, the

half

- life values reduced slightly to 2.4 days (R 2 

## = 0.952) for the 240 SC t rial and 2.7 days (R 2 

## = 0.973) for the 500 WDG trial.

HED concurs with Versar’s primary review of the sulfoxaflor DFR Study on wheat. This study review was presented and discuss at the HED Science Advisory Council for Exposure on June 30, 2011. The council agreed that foliar residue values for the 240 SC formulation (California = 0.047 ug/cm 2 

## (0DAT2); Georgia = 0.030 ug/cm 2 

## (0DAT2)) and the 500 WSG (California = 0.119 ug/cm 2 

## (0DAT2); Georgia = 0.026 ug/cm 2 

## (0DAT2)) collected immediately after the

sec ond application, would be used for calculating predicted day 0 residue values using first

- order dissipation kinetics and decay model. The predicted day 0 residue values of 0.0175 ug/cm 2


## (240 SC Georgia) and 0.0210 ug/cm 2 

## (500 WDG Georgia) should be used t o estimate occupational postapplication exposure and risk. A summary of the key inputs/results is presented in the table below.

Table A .1

. Summary of DFR Values and Linear Regression Analysis Results for Treated Wheat with Sulfoxaflor.

Parameter 240 SC Formulation

California Georgia Application Rate (lb ai/A) Target Appl. Rate = 0.0446 lb ai/A 0.0438 (first application)

0.0452 (second application) 0.0446 (first application)

0.0446 (second application)

Measured Actual Average Day 0 Residue (μg/cm 2 ) 0.047 (first application) 0.047 (second application) 0.037 (first application) 0.030 (second application) Predicted Day 0 Residue (μg/cm 2 ) 0.009524 0.01755 Slope

- 0.2003

- 0.2234

Half

- life (days) 3.46 3.10

R 2 0.719 0.959

Parameter 500 WDG Formulation

California Georgia

## Page 32 of 39

Table A .1

. Summary of DFR Values and Linear Regression Analysis Results for Treated Wheat with Sulfoxaflor.

Parameter 240 SC Formulation

California Georgia Application Rate (lb ai/A) Target Appl. Rate = 0.0446 lb ai/A 0.0439 (first application)

0.0440 (second application) 0.0446 (first application)

0.0446 (second application)

Measured Actual Average Day 0 Residue (μg/cm 2 ) 0.045 (first application) 0.119 (second application) 0.049 (first application) 0.026 (second application) Predicted Day 0 Residue (μg/cm 2 ) 0.01163 0.02103 Slope

- 0.2001

- 0.2435

Half

- life (days) 3.46 2.85

R 2 0.584 0.966

Note: Linear r egression analysis based on DFRs after second application.



## Secondary Review: Dissipation of Dislodgeable Foliar Residues of Sulfoxaflor from Treated Broccoli; MRID No. 47832416.

T he study “Dissipation of Dislodgeable Foliar Sulfoxaflor Residues from Treated Broccoli” was

submitted by Dow AgroSciences LLC, in support of the registration of sulfoxaflor.

This study was designed to determine the dissipation of dislodgeable foliar residues (DFR) of sulfoxaflor formulated as a 22.5% active ingredient (ai) suspension concentrate (XDE

- 2 40 SC) from treated broccoli at two trial sites: Porterville, CA and Omega, GA. Each trial site consisted of one control plot and one treatment plot. The treatment plots received three groundboom broadcast spray applications of the test substance to the foliage. The single application rate was 100 g ai/ha (0.0892 lb ai/A/application), for a total application rate of 300 g/ha (0.27 lb ai/A) for the three applications. The re

- treatment interval between each application was 7 days. Applications were made a s foliar broadcast spray applications at a spray volumes of approximately 19.9

- 20.9 gallons per acre and an adjuvant was added to the spray mixture for all applications.

Samples were collected from: 1) one control and three treated samples prior to each application, 2) as soon as the spray dried after each application (0 to 8 hours), and 3) at intervals of 1, 2, 3/4, 7, 10, 14, 20/21, 27, and 35 days after the final treatment (27 and 35 day samples were only collected at the GA site). Field

- fortified sam ples using samples from the untreated control plot were prepared on Days 1 and 14 after the last application at the California site and on Days 1, 14, and 27 after the last application at the Georgia site.

The Registrant provided DFRs in μg/cm 2 

## , correcte d for an average procedural recovery of 93%. Versar also calculated DFRs in μg/cm 2 

## , but did not correct the results for either procedural

recoveries or field fortification recoveries as average recoveries were >90%. For calculation purposes, DFR values r eported as between the limit of quantization (LOQ) and the limit of detection (LOD) were assigned a value of 1⁄2 LOQ, and DFR values less than the LOD were assigned a value of 1⁄2 LOD. The LOQ was 0.20 ng/mL (0.0001 μg/cm 2 

## ) and the LOD was 0.075 ng/mL (0.0000 38 μg/cm 2 

## ).

For the California site, the maximum average DFR values occurred after the 0

- day sampling interval: 0.147 μg/cm 2 

## (14.8% of application) at 0

- day after first treatment (0 DAT1 ) , 0.120 μg/cm 2 

## (11.9% of application) at 0DAT2, and 0.147 μg/cm 2 

## (14.4% of application) at 0DAT3.

## Page 33 of 39

Residues were still above the LOQ prior to the third application (0.0067 μg/cm 2 

## ). After the third application, the average DFR declined to 0.0017 μg/cm 2 

## by 21DAT3.

For the Georgia site, the maximum average DFR values af ter each treatment occurred at the 0

- day sampling interval: 0.319 μg/cm 2 

## (31.9% of application) at 0DAT1, 0.191 μg/cm 2 

## (19.1% of application) at 0DAT2, and 0.139 μg/cm 2 

## (13.9% of application) at 0DAT3. Residues were still above the LOQ prior to the third application (0.00057 μg/cm 2 

## ). After the third application, the average DFR declined rapidly to 0.13 μg/cm 2 

## at 1DAT3 and residues were <LOQ by 10DAT3.

Versar assumed first

- order dissipation kinetics to generate dissipation curves for sulfoxaflor.

Versar conducted the linear regression analysis using the natural logarithm of the individual foliar residue values collected immediately after the third application through the last day of sampling or when all residues <LOQ (21DAT3 for California trial and 10DA T3 for Georgia trial). Based on linear regression of the natural log transformed data, Versar’s calculated half

lives for sulfoxaflor treated broccoli leaves were 2.9 days (R 2 

## = 0.917) for the California site and 1.2 days (R 2 

## = 0.93) for the Georgia site. A comparison of the actual and predicted values determined after the third application shows that the actual values were higher than the predicted values for the 0DAT3, 1DAT3, 2DAT3, and 4DAT3 sampling intervals at the California site and

at the 0DAT3 in terval for the Georgia site.

Irrigation was applied at the rate of 3 inches per acre to the broccoli plots on days 7 and 14 following the third application at the California site. Rain in excess of one inch (1.22 inches) occurred at the Georgia site on 2 DAT3, following the sampling on this day. This rainfall event may have affected the amount of residue available for dislodging on subsequent sampling days. Residues had declined significantly by the 2DAT3 interval (13.9% at 0DAT3 to 0.67% at 2DAT3). Sig nificant rainfall (2.58 inches) also occurred at the Georgia site on 28DAT3.

HED concurs with Versar’s primary review of the sulfoxaflor DFR Study on broccoli. This study review was presented and discuss at the HED Science Advisory Council for Exposure o n June 30, 2011. The council agreed that foliar residue values (California = 0.147 ug/cm 2 

## , and Georgia = 0.139 ug/cm 2 

## ) collected immediately after the third application (0DAT3) at each test site, would be used for calculating predicted day 0 residue valu es using first

- order dissipation kinetics and decay model. The predicted day 0 residue value of 0.115 ug/cm 2 

## (from California) should be used to estimate occupational postapplication exposure and risk. A summary of the key inputs/results is presented in the table below.

Table A .2

. Summary of DFR Values and Linear Regression Analysis Results for Treated Broccoli with Sulfoxaflor.

Parameter 240 SC Formulation

California Georgia

Application Rate (lb ai/A) Target Appl. Rate = 0.0892 lb ai/A 0.0889 (first application) 0.0900 (second application) 0.0911 (third application) 0.0892 (first application) 0.0892 (second application) 0.0892 (third application)

Measured Actual Average Day 0 Residue (μg/cm 2 ) 0.147 (first application 0DAT1) 0.120 (second application 0DAT2) 0.147 (third application 0DAT3) 0.319 (first application 0DAT1) 0.191 (second application 0DAT2) 0.139 (third application 0DAT3) Predicted Day 0 Residue (μg/cm 2 ) 0.115 0.0329 Slope

- 0.236

- 0.591

Half

- life (days) 2.9 1.2

## Page 34 of 39

Table A .2

. Summary of DFR Values and Linear Regression Analysis Results for Treated Broccoli with Sulfoxaflor.

Parameter 240 SC Formulation

California Georgia

R 2 0.917 0.935

Note: Linear r egression analysis based on DFRs collected after the third application.

## Page 35 of 39

Appendix B. Anticipated Post

- Application Activities and Dermal Transfer Coefficients.

Table B.1

. Anticipated Post

- A pplication Activities and Dermal Transfer Coefficients. † Proposed Crop Crop Group Transfer Coefficients Activities EPA MRID No.
Field / row crop,

low / medium Barley, Wheat 70 cm 2 /hr Hand weeding 42851302

, 42689103

, 42689104
1,100 cm 2 /hr Scouting 45005904

, 45005908

Canola (Subgroup 20A) 1,100 cm 2 /hr Scouting 45005904

, 45005908

Cotton 70 cm 2 /hr Hand weeding 42851302, 42689103,

42689104

210 cm 2 /hr Scouting 42851302

900 g cotton/hr Harvesting Mechanical

(Module Builder) 42701601

2400 g cotton/hr Harvesting Mechanical

(Picker Operator; Raker) 42701601

5050 g cotton/hr Harvesting Mechanical

(Tramper) 42701601

Soybean 70 cm 2 /hr Hand weeding 42851302

, 42689103

, 42689104
1,100 cm 2 /hr Scouting 45005904

, 45005908

Succulent Edible Podded and Dry

Beans 70 cm 2 /hr Hand weeding 42851302

, 42689103

, 42689104

210 cm 2 /hr Scouting 42851302

, 42974501

1100 cm 2 /hr Scouting 45005904

, 45005908

1900 cm 2 /hr Irrigation (hand set) 45224801 Vegetable, head and

stem Brassica Brassica (Cole) Leafy Vegetables 230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

330 cm 2 /hr Scouting 42974501

1400 cm 2 /hr Hand Weeding 45530102

1900 cm 2 /hr Irrigation (hand set) 45224801

4200 cm 2 /hr Weeding, Hand 45005906

, 45005907

, 45191701 Vegetable, " R oot" Bulb Vegetables (Crop Group 3

- 07) 330 cm 2 /hr Scouting 42974501

1400 cm 2 /hr Hand Weeding 45530102

1900 cm 2 /hr Irrigation (hand set) 45224801

4200 cm 2 /hr Weeding, Hand 45005906

, 45005907

, 45191701

Leaves of Root

and Tuber Vegetables (Crop Group 2) 70 cm 2 /hr Weeding, Hand 42851302

, 42689103

, 42689104

210 cm 2 /hr Scouting 42851302

, 42974501

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

1100 cm 2 /hr Harvesting, Hand 43013003

, 40966503

, 40966502

, 45530103

1900 cm 2 /hr Irrigation (hand set) 45224801

Root and Tuber Vegetables (Crop Group 1) 70 cm 2 /hr Weeding, Hand 42851302

, 42689103

, 42689104

210 cm 2 /hr Scouting 42851302

, 42974501

1100 cm 2 /hr Harvesting, Hand 43013003

, 40966503

, 40966502

, 45530103

1900 cm 2 /hr Irrigation (hand set) 45224801 Tree Fruit, Evergreen Citrus (Crop Group 10) 10 0 cm 2 /hr Hand weeding 43297602

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

580 cm 2 /hr Hand Pruning 45175102

, 45480302

1400 cm 2 /hr Hand Harvesting 42830002

, 40975308

, 40966501

, 45138202

, 45175101

, 45432301

, 45432302

3600 cm 2 /hr Thinning Fruit 42428101 Vegetable, C ucurbit Cucurbits Vegetables (Crop Group 9) 9 0 cm 2 /hr Scouting 45005909

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

550 cm 2 /hr Turning 45480301

, 45491902

1900 cm 2 /hr Irrigation (hand set) 45224801 Vegetable, Fruting Fruiting Vegetables (Crop 70 cm 2 /hr Weeding, Hand 42851302

, 42689103

, 42689104

9 0 cm 2 /hr Scouting 45005909

## Page 36 of 39

Table B.1

. Anticipated Post

- A pplication Activities and Dermal Transfer Coefficients. † Proposed Crop Crop Group Transfer Coefficients Activities EPA MRID No.
Group 8) 210 cm 2 /hr Scouting 42851302

, 42974501

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

550 cm 2 /hr Tying/Training , Hand

Harvesting 45480301

, 45491902

1100 cm 2 /hr Harvesting, Hand 43013003

, 40966503

, 40966502

, 45530103

1900 cm 2 /hr Irrigation (hand set) 45224801 Vegetable, Leafy Leafy Vegetables except Brassica

– (Crop Group 4) &

Watercress 70 cm 2 /hr Weeding, Hand 42851302

, 42689103

, 42689104

210 cm 2 /hr Scouting 42851302

, 42974501

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

1100 cm 2 /hr Harvesting, Hand 43013003

, 40966503

, 40966502

, 45530103

1900 cm 2 /hr Irrigation (hand set) 45224801 Nursery/Greenhouse (Unassigned) Ornamentals 230 cm 2 /hr Harvesting, Hand 45344501

, 45469501

, 45469502

1900 cm 2 /hr Irrigation (hand set) 45224801
Tree, "F ruit",

D eciduous Pome Fruits (Crop Group 11) 100 cm 2 /hr Orchard M aintenance

, Propping, Hand Weeding 43297602

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

580 cm 2 /hr Scouting, Hand Pruning,

Training 45175102

, 45480302

1400 cm 2 /hr Harvesting, Hand 42830002

, 40975308

, 40966501

, 45138202

, 45175101

, 45432301

, 45432302

3600 cm 2 /hr Thinning Fruit 42428101 Stone Fruits (Crop Group 12) 100 cm 2 /hr Orchard M aintenance

, Propping, Hand Weeding, Thinning Fruit, Bird Control 43297602

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

580 cm 2 /hr Scouting, Hand Pruning,

Training 45175102

, 45480302

1400 cm 2 /hr Harvesting, Hand 42830002

, 40975308

, 40966501

, 45138202

, 45175101

, 45432301

, 45432302

3600 cm 2 /hr Thinning Fruit 42428101

Vine /T rellis Small Fruit Vine Climbing (except fuzzy kiwifruit

– Subgroup 13

- 07F) 230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

640 cm 2 /hr Scouting, Hand Pruning,

Hand Weeding, Propagating, Bird Control, Trellis Repair, Tying/Training 45005910

1900 cm 2 /hr Irrigation (hand set) 45224801

5500 cm 2 /hr Leaf Pulling

,

T ying/Training , Hand Harvesting 43223907

, 40985601

10100 cm 2 /hr Leaf Pulling

,

Tying/Training , Hand Harvesting 45491901

19300 cm 2 /hr Turning, Girdling 40975304 Berry, L ow Low Growing Berry (Subgroup

13

- 07G) 70 cm 2 /hr Hand Weeding, Hand Pruning (shears)

, Canopy Management 42851302

, 42689103

, 42689104

210 cm 2 /hr Scouting 42851302

, 42974501

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

1100 cm 2 /hr Hand Harvesting

(ranking)

, Scouting 43013003

, 40966503

, 40966502

45530103

, 45005904

, 45005908

1900 cm 2 /hr Irrigation (hand set) 45224801

## Page 37 of 39

Table B.1

. Anticipated Post

- A pplication Activities and Dermal Transfer Coefficients. † Proposed Crop Crop Group Transfer Coefficients Activities EPA MRID No.
Tree, “Nut” Tree Nuts (Crop Group 14 & Pistachio) 100 cm 2 /hr Orchard M aintenance

, Poling, Hand Weeding 43297602

190 cm 2 /hr Harvesting, Mechanical

(shaking) 41848604

230 cm 2 /hr Transplanting 45344501

, 45469501

, 45469502

580 cm 2 /hr Scouting 45175102

, 45480302

1400 cm 2 /hr Harvesting, Hand (net) 42830002

, 40975308

, 40966501

45138202

, 45175101

, 45432301

45432302

Turf/Sod Turfgrass,

Sodfarm s 6700 cm 2 /hr Maintenance

, Harvesting, Slab Transplanting/Planting 45432303



### † The information in the table is based on proprietary and non

- proprietary data.



## Appendix C . Summary of Residue Data from Cotton Field Trials with Sulfoxaflor.

Table C.1

. Summary of Residue Data from Cotton Field Trials with Sulfoxaflor

. a

Commodity EP b Total appl. rate

lb a.i./A PHI

(day) n Sulfoxaflor Residue (ppm)

Min Max HAFT c Median (STMdR) Mean

(STMR) Std. Dev.

Cotton, ( gin byproducts) 240

SC 0.346

- 0.375 14

- 15 42 0. 037 4.20 4.03 0. 476 0.869 1. 12

Cotton, ( undelinted

seed ) 240

SC 0.346

- 0.375 14

- 15 44 <0.010 0. 182 0. 176 0. 019 0. 037 0. 038

a 

### The LOQ (0.010 ppm) was used for all residue values reported as < LOQ in all calculations (mean, median, etc.). Data are on a per

- sample basis and do not reflect per

- trial averaging.

b 

### EP = End

- use Product; Test item was GF

- 2032 240 g/L SC formulation.

c 

### HAFT = Highest Average Field Trial.

## Page 38 of 39

Appendix D . Crop Groupings.

• Brassica (Cole) Leafy Vegetables

- crop group 5 includes broccoli, broccoli raab, Brussels sprouts, cabbage, cauliflower, cavalo, Chine broccoli (gai lon), Chinese cabbage (bok choy), Chinese cabbage (napa), Chinese mustard cabbage (gai choy), collards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, rape greens, white flowering broccoli.

• Bulb Vegetables

- crop group 3

- 07 includes beltsville bunching onion, bulb daylily, bulb fritillaria, bulb garlic, bulb lily, bulb onion, bulb shallot, Chinese bulb onion, Chinese fresh leaf chive, elegans hosta, fresh leaf chive, fresh leaf shallot, fresh onion, garlic, great

- headed bulb garlic, green onion, kurrat, lady's leek, leek, leaf fritillaria, macrostem onion, pearl on ion, potato bulb onion, serpent bulb garlic, tree onion tops, Welsh onion, wild leek and cultivars, varieties, and/or hybrids of these.

• Canola (Rapeseed)

- subgroup 20A includes borage, canola, crambe, cuphea, echium, flax seed, gold of pleasure, hare' s ear mustard, lesquerella, lunaria, meadowfoam, milkweed, mustard seed, oil radish, poppy seed, rapeseed, sesame, sweet rocket, and cultivars, varieties, and/or hybrids of these.

• Citrus

- crop group 10 includes citrus citron, grapefruit, kumquat, lemo n, lime, orange, tangelo, tangerine, and hybrids of these.

• Cucurbit Vegetables

- crop group 9 includes balsam apple, balsam pear, bitter melon, casaba, chayote, Chinese cucumber, Chinese okra, crenshaw melon, crookneck squash, cucumber, cucuzza, edible gourds, golden pershaw melon, hechima, honey balls, honeydew melon, hyotan, mango melon, muskmelons (cantaloupe, honeydew, etc.), Persian melon, pineapple melon, pumpkin, Santa Claus melon, scallop squash, snake melon, spaghetti squash, straightneck

squas h, summer squash, true cantaloupe, vegetable marrow, watermelon, winter squash, and other varieties and/or hybrids of these.

• Fruiting Vegetables

- crop group 8

- 10 includes bell pepper, eggplant, groundcherry, hot pepper, pepino, pepper (except black), pimento, sweet pepper, tomatilo, tomato.

• Leafy Vegetables, except Brassica

- crop group 4 & Watercress includes amaranth, arugula, cardoon, celery, celtuce, chervil, Chinese celery, Chinese spinach, corn salad, cos (romaine), dandelion, dock, edible

- le aved chrysanthemum, endive (escarole), finochio, Florence fennel, garden cress, garden purslane, garland chrysanthemum, head lettuce, leaf lettuce, leafy amaranth, New Zealand spinach, orach, parsley, radicchio (red chicory) rhubarb, spinach, sweet anise, sweet fennel, Swiss chard, tampala, upland cress, vine spinach, winter cress, winter purslane, yellow rocket

.

• Leaves of Root and Tuber Vegetables

- crop group 2 includes bitter cassava, black salsify,

broccoli raab , carrot, celeriac (celery root), chicory, dasheen (taro), edible burdock, garden beet, hanover salad, oriental radish (daikon), parsnip, raab, raab salad, radish, rutabaga, sugar beet, sweet cassava, sweet potato, tanier, true yam, turnip, turnip

- rooted c hervil.

## Page 39 of 39

• Pome Fruits

- crop group 11 includes apples, crabapple, loquat, quince, mayhaw, pears, quince.

• Root and Tuber Vegetables

- crop group 1 includes arracacha, arrowroot, bitter black salsify, bitter cassava, carrot, celeriac, chayote (root), c hicory, Chinese artichoke, chufa, daikon, dasheen, edible burdock, edible, canna, garden beet, ginger, ginseng, horseradish, Jerusalem artichoke, leren, lobok, lo pak, oriental radish, parsnip, potato, radish, red Chinese radish, red Japanese radish, rutab aga, salsify, skirret, Spanish salsify, sugar beet, sweet cassava, sweet potato, tanier, true yam, turmeric, turnip, turnip

- rooted chervil, turnip

- rooted parsley, yam, yam bean, white Chinese radish, white Japanese radish, winter radish, and other cultivar s or hybrids of these).

• Small Fruit Vine Climbing, except Fuzzy Kiwifruit

- subgroup 13

- 07F includes amur river grape, gooseberry, grape, hardy kiwifruit, maypop, schisandra berry, and cultivars, varieties, and/or hybrids of these.

• Low Growing Berry

- subgroup 13

- 07G includes bearberry, bilberry, lowbush blueberry, cloudberry, cranberry, lingonberry, muntries, partridgeberry, strawberry, and cultivars, varieties, and/or hybrids of these.

• Stone Fruits

- crop group 12 includes apricot , nectarine, peach, plum, prune, sweet cherry, tart cherry.

• Succulent, Edible Podded, and Dry Beans includes adzuki bean, asparagus bean, bean, blackeyed pea, broad bean, chickpea, Chinese longbean, cowpea, fava bean, field bean, garbanzo bean, grain l upine, green lima bean, jackbean, kidney bean, lablab bean, lima bean, moth bean, mung bean, navy bean, pinto bean, rice bean, runner bean, snap bean, soybean (immature seed), sweet lupine, sword bean, tepary bean, wax bean, white lupine, white sweet lupin e, yardlong

bean.

• Tree Nuts

- crop group 14 & Pistachio includes almonds, cashew, chestnut, filbert (hazelnut), macadamia nut, pecan, walnut.