### Page 1 of 25 **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

**WA SHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION**



## MEMORANDUM Date: August 30 , 20 1 1 **SUBJECT: Fluopyram**  **:** Occupational and Residential Exposure Assessment for Proposed

U ses on A

## pples, Cherry

( S weet and T art), Dried B eans, P eanut, P otato, S trawberry, S ugar B eets , Tree Nuts, Watermelon, and Viniferous Variety Grapes . **PC Code:** 080302 **DP Barcode:** D389135 **Decision Number:** 402628 **Registration Number :**  264 - 1078 **Petition Number:** 8F7463 **Regulatory Action:** NA **Risk Assessment Type:** NA **Case Number:** NA **T XR Number:**  NA **CAS Number:** 658066 - 35 - 4 **MRID Numbers:** NA **40 CFR**  **:** NA **FROM:** Barry O’Keefe, Senior Biologist Risk Assessment Branch 3 Health Effects Division (7509P) **THROUGH:** Paul a Deschamp, Branch Chief

Risk Assessment Branch 3 Health Effects Division (7509P) **TO:** Sheila Heal y, Risk Assessor

Risk Assessment Branch 3 Health Effects Division (7509P) The Registration Division (RD) requested that Health Effects Division (HED) conduct an occupational exposure and risk assessment for new proposed uses of the new active ingredient fluopy ram on apples, cherry

(sweet and tart), cucurbit vegetables , dried beans, peanut, potato , stone fruit s (except cherry) , strawberry, sugar beets, tree nuts, and wine grapes . This memo was reviewed b y the Exposure Science Advisory Council (ExpoSAC) on 10/0 7/201 0 .

### Page 2 of 25



## 1.0 **EXECUTIVE SUMMARY** The active ingredient, f

luopy ram ( N - [2 - [3 - chloro - 5 - (trifluoromethyl) - 2 -py ridinyl]ethyl] - 2 - (trifluoromethyl )benzamide) is a new py ridylethylamide SDH (succinate - dehydrogenase inhibitor, complex II) fungicide with broad spectrum of activity against fungal diseases in a wide range of crops . A Section 3 registration is being requested for the proposed new uses of fluopy ram on a vari ety of agricultural food crops , including apple, cherry (sweet and tart), dried beans, peanut, potato , strawberry, sugar beets, tree nuts , watermelon, and viniferous variety grapes . The proposed formulated end-use product evaluated in this assessment is LUNA ® 

## PRIVILEGE , a liquid formulation containing 41.5 % ai (4.16 lb /gal) fluop yram . Proposed Use Profile : Broadcast f

oliar applications of fluopy ram may be applied to agricultural crops at a maximum single rate s ranging from 0.092 to 0.2 2 lb ai/A . Multiple applications may be made per season , up to a maximum of 0.45 lb ai/season. Applications may be made in greenhouses of 10 acres or larger for strawberries, or watermelon s. Handlers may apply fluopy

ram using a variety of equipment, including aerial, chemigation, groundboom sprayers, airblast sprayers, low pressure handwand sprayers , and backpack sprayers. The proposed label requires handlers to wear chemical resistant gloves. Hazard Concerns: There is a potential for short- and intermediate - term occupational exposure to fluopy ram during mixing, loading, application, and other handling tasks and for short - and intermediate - term occupational exposure during postapplication activities . Long - term occupational exposure is not expected for the proposed use patterns associated with fluopy ram . Fluopy ram has low acute toxicity by the oral and dermal routes of exposure (Toxicity Category III) and also b y the inhalation route of exposure (Toxicity Category IV) . It is not a dermal or eye irritant and is not a dermal sensitizer. Short- and intermediate term dermal risks are based on increased cholesterol in females, increased prothrombin time in males, increased liver weight (both sexes) and liver hy pertrophy effects observed at the Lo west Observe d Adverse Effect Level ( LOAEL) of 1000 mg/kg/day (No Observe d Adverse Effect Level (NOAEL) of 3 00 mg/kg/day) from a 28 - day dermal toxicity

study in rats . Short- and intermediate - term inhalation risks are based on decreased pup body weight and body weight gain , and decrease in spleen and thy mus weight effects observed at the LOAEL of 82.8 mg/kg/day (NOAEL of 14 . 5 mg/kg/day) from a 2 - generation reproduction study in rats. Since the dermal and inhalation end points are not based on developmental effects, the average body weight of an adult (70 kilograms) was used in the exposure assessment s. Further, s ince the toxicological effects for dermal and inhalation routes are not similar, the risks from both routes are not combined together . Short- and intermediate - term incidental oral risks are based on decreased pup body weight and body weight gain , and decrease in spleen and thy mus weight effects observed at the LOAEL of 82.8 mg/kg/day

(NOAEL of 14 . 5 mg/kg/day) from a 2 - generation reproduction study in rats.

### Page 3 of 25



## The cancer classification is “like ly to be carcinogenic to humans. ” There is no mutagenic concern for fluop yram. The available data do not support the proposed modes of action for the thy roid or liver tumors. The CARC recommended the use of a linear low dose extrapolation model applied to the animal data ( Q 1 * 

## ) for quantitative estimation of human risk. The unit risk, Q 1 * 

## (mg/kg/day) - 1 

## , of f

luopy ram based upon female rat liver combined adenoma and carcinoma tumor rates is 1.55x10 - 2 

## in human equivalents. Occupational Exposure: Occupational Handlers: No chemical - specific handler exposure data were submitted in support of this Section 3 registration. To assess handler exposures for regulatory actions when chemical - specific monitoring data are not available, HED relie d on the most scientifically- reliable surrogate data currentl y available from various sources such as the Pesticide Handler Exposure Database (PHED), and the Agricultural Handler Exposure Task Force (AHETF) . Some of this data, such as the industry

task force data, is compensatory, subject to the data protection provisions of FIFRA. Non- cancer risk estimates for dermal (with gloves) and inhalation short- and intermediate - term occupational handler exposures all resulted in MOE ≥ 100, and therefore, do not exc eed HED’s level of concern. Handler c ancer risk estimate s for private growers and commercial applicators were calculated for different exposure scenarios at different levels of personal protection. Handler cancer risk estimates for combined inhalation and dermal (with gloves) exposures f or private growers ranged from 1.0 x 10 - 8 

## to 5.6 x 10 - 7 

## and for commercial workers ranged from 3.1 x 10 - 8 

## to 8.8 x 10 - 7



## . Occupational Postapplication: Proposed uses include applications in greenhouses. The Worker Protection Standard (WPS) for Agricultural Pesticides contains requirements for protecting workers and bystanders from inhalation exposures during and after greenhouse applications through the use of ventilation requirements. For these reasons, greenhouse postapplication inhalation exposures and risks were not quantitatively

assessed for the proposed uses. Short- and intermediate - term dermal postapplication exposures and risks to occupational workers were estimated using standard values established by HED since no chemical - specific data were submitted. The transfer coefficients (T C ) used for all postapplication activities were the TC s established by

ExpoSAC in the revised SOP No. 3.1. The dislodgeab le foliar residue (DFR) levels for agricultural crops were estimated using HED standard values where it is assumed that the initial residue on treated foliage is 20 % of the application rate and the residues degrade at a rate of 10 % per day . The occupational postapplication non- cancer MOEs do not exceed HED’s level of concern (MOEs ≥ 100) with dermal MOEs ranging from 5,600 to 530 . Worker postapplicati on cancer risk estimates were assessed for individuals employed b y multiple establishments (i.e., commercial or migratory farm workers) and were assumed to be exposed 30

### Page 4 of 25



## days per year. Additionally, private growers were assumed to be exposed 10 days per year. D FRs were estimated using the method described above in the non- cancer postapplication section (i.e., assuming 20% of the active ingredient is available initially and a dissipation of 10% per day thereafter). HED used the average DFR residue (μg/cm2 

## ) over the minimum re treatment interval for each crop or crop group to estimate cancer risk. F or private growers the cancer risks estimates ranged from 1. 6 x 10 - 7 

## to 1 . 3 x 10 - 6



## . For commercial workers the cancer risks estimates ranged from 5 . 1 x 10 - 7 

## to 4 . 0 x 10 - 6



## . Restricted Entry

Interval: When postapplication risks are not a concern on day 0 (12 hours following application), the restricted entry interval (REI) is based on the acute toxicity of fluopy ram technical material. Fluop yram is classified as T oxicity C ategory III by the acute oral and dermal route s of exposure , and Toxicity C ategory IV for acute inhalation, eye irritation potential , and skin irritation potential. Under the WPS for Agricultural Pesticides, active ingredients classified as acute toxicity categories III or IV for these routes are assigned a 12 -hour REI . Therefore, the 12 -hour REIthat appears on the proposed label would be adequate. Residential Exposure: Based on product label, the product is not intended for use by homeowners , or by

occupational handlers in residential settings. Therefore, non- occupational/residential risk assessments have not been completed. 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 studies, which comprise the Pesticide Handlers Exposure Database (PHED) and the Agricultural Re - entry Task Force (ARTF) have been determined to require a review of their ethical conduct and have received that review. **2.0 HAZARD CHARACTERIZATION**  The acute toxicity

for fluopy

ram is summarized in Table 1 . Fluop yram has l ow acute toxicity by the oral and dermal route s of exposure (Toxicity Category III) and b y the inhalation route of exposure (Toxicity

Category IV). It is not a dermal or eye irritant and is not a dermal sensitizer. **TABLE 1**  **. Acute Toxicity Profile** 

**– Fluopyram**  **Technical** Guideline No. Study T ype MRID(s) Results Toxicity Category 870.1100 Ac ute Oral 47372430 LD 50 

### > 2000 mg/kg in females III 870.1200 Ac ute Dermal 47372432 LD 50 

### > 2000 mg/kg in males &, females III

### Page 5 of 25

**TABLE 1**  **. Acute Toxicity Profile** 

**– Fluopyram**  **Technical** Guideline No. Study T ype MRID(s) Results Toxicity Category 870.1300 Ac ute Inhalation (4 hr) 47372434 LC 50 

### > 5 . 112 mg/L in males & females IV 870.2400 Primary Eye Irritation 47372436 No positive scores at 24 hr; not irritating IV 870.2500 Primary Skin Irritation 47723701 N ot irritating IV 870.2600 Dermal Sensitization 47372440 N ot sensitizing N/A 870.2600 Dermal Sensitization 47753403 N ot sensitizing N/A 

## A summary

of the toxicological doses and endpoints for occupational human health risk assessment is provided in Table 2 . **Table 2**  **. Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Hum**  **an Health Risk Assessments.**  Exposure/ Scenario Point of

Departure Uncertainty

Factors Level of Concern

for Risk Assessment Study and Toxicological Effects Short- (1 - 30 days) & Intermediate Term Dermal (1 - 6 mo nths) NOAEL =

300 mg/kg/day UF A 

### = 10x

UF H 

### = 10x LOC =

MOE ≤ 100 28 - day dermal toxicity study in the rat

LOAEL of 1000 mg/kg/day based on increased cholesterol in females, increased prothrombin time in males, increased liver weight (both sexes) and liver hypertrophy. (low dermal absorption, <1%) Short- (1 - 30 days) & Intermediate Term (1 - 6 mo nths) Inhalation NOAEL =

14.5 mg/kg/day UF A 

### = 10x

UF H 

### = 10x LOC =

MOE ≤ 100 2 - generation reproduction study in rats

LOAEL = 82.8 mg/kg/day based on decreased pup body weight and body weight gain and decrease in spleen and thymus weight. Short- (1 - 30 days) & Intermediate Term (1 - 6 mo nths) Oral NOAEL =

14.5 mg/kg/day UF A 

### = 10x

UF H 

### = 10x UF DB 

### = 10x LOC =

MOE ≤ 1000 2 - generation reproduction study in rats

LOAEL = 82.8 mg/kg/day based on decreased pup body weight and body weight gain and decrease in spleen and thymus weight.

### Page 6 of 25

**Table 2**  **. Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Hum**  **an Health Risk Assessments.**  Exposure/ Scenario Point of

Departure Uncertainty

Factors Level of Concern

for Risk Assessment Study and Toxicological Effects Cancer (oral, dermal, inhalation) **Classification: Likely to be carcinogenic to hum**  **ans** based on tumors in two species and two

sexes: a treatment related increase in thyroid follicular cell adenomas in high dose male mice and liver tumors in female rats at the high dose, with incidences exceeding that of the laboratory’s historical controls. The CARC recommended the use of a linear low dose extrapolation model applied to the animal data (Q1*) for quantitative estimation of human risk. The unit risk, Q 1 * 

### (mg/kg/day) - 1 

### , of f

luopy ram based upon female rat liver combined adenoma and carcinoma t umor rates is 1.55 x 10 - 2 

### in human equivalents. 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 amo ng members of the human population (intraspecies). UF DB 

### = database uncertainty factor for lack of a comparative thyroid study. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

## 3.0 **PROPOSED USE PATTERNS** Table 3 provide s a summary of the proposed uses of fluopy ram for agricultural and occupational uses . **TABLE 3. Occupational Use Profile for Fluopyram**  **.** Crop 1 Target of

Application Treatment

Type Application Equipment Maximum Single Application Rate (lb ai/A) Re Treatment Interval Preharvest

Interval Maximum

Seasonal Application Rate (lb ai/A) Apple Foliar Broadcast Chemigation , Airblast 0.22 7 - 14 days 7 days 0.45 Cherry Foliar Broadcast Aerial, Chemigation , Airblast 0. 092 5 - 7 days 0 days 0. 18 Dried Beans Foliar Broadcast Aerial, Chemigation , Groundboom 0.13 7 - 10 days 14 days 0. 27 Peanut Foliar Broadcast Aerial, Chemigation , Groundboom 0.22 14 days 7 days 0.45 Potato Foliar Broadcast Chemigation , Groundboom 0. 18 5 - 7 days 7 days 0. 36 Potato Foliar Broadcast Aerial 0. 092 5 - 7 days 7 days 0. 27 Strawberry Foliar Broadcast Aerial, Chemigation , Groundboom 0.22 5 - 7 days Spray Uses: 0 days 0.45 Strawberry (greenhouse ) Foliar,

Soil, Soil less Mix Broadcast Chemigation , Groundboom, H andwand , Backpack 0.22 5 - 7 days 1 day 0.45 Sugar Beet Foliar Broadcast Chemigation , Groundboom 0.11 5 - 7 days 7 days 0. 22 Tree Nuts Foliar Broadcast Aerial, Chemigation , Airblast 0.22 7 - 14 days 14 days 0.45

### Page 7 of 25

**TABLE 3. Occupational Use Profile for Fluopyram**  **.** Crop 1 Target of

Application Treatment

Type Application Equipment Maximum Single Application Rate (lb ai/A) Re Treatment Interval Preharvest

Interval Maximum

Seasonal Application Rate (lb ai/A)

Watermelon ( field) Foliar Broadcast Chemigation , Groundboom 0.22 5 - 14 days Spray uses: 0 days Drip application use: 7 days 0.45

Watermelon (greenhouse ) Foliar,

Soil, Soil less Mix Broadcast Chemigation , Groundboom, H andwand , Backpack 0.22 5 - 14 days 3 days 0.45 Wine Grapes Foliar Broadcast Chemigation , Groundboom, Airblast 0.22 12 - 21 days 7 days 0.45 Footnotes: 1. Specific crops listed on the label under each crop group above are provided below. **Dried Beans :**  Dried Shelled Bean, Bean ( Lupinus spp., includes grain lupin, sweet lupin, white lupin, and white sweet lupin), Bean ( Phaseolus spp., includes field bean, kidney bean, lima bean (dry) , navy bean, pinto bean, tepary bean), Bean ( Vigna spp., includes adzuki bean, blackeyed pea, catjang, Crowder pea, moth bean, mung bean, rice bean, Southern pea, Urd bean), Other Beans [Broad bean (dry), chickpea , Guar, Lablab bean , Lentil]. **Tree nuts:** Almond, Beech nut, Brazil nut, Butternut, Cashew, Chestnut, Chinquapin, Filbert (hazelnut), Hickory nut, Macadamia nut (bush nut), Pecan, Pistachio, Walnut [including B lack and English (Persian) walnuts]. 

## 4.0 **OCCUPATIONAL EXPOSURE/RISK PATHWAY** The new proposed uses of fluopy ram are for control of fungal diseases in a wide range of agricultural food crops . This document assesses occupational exposures and risks from the proposed uses of the product Fluop yram 500 SC Fungicide, a liquid formulation containing 41.5 % ai (4.16 lb /gal) fluopy ram . **4.1 Occupational**  **Handler Exposure** Fluopy ram can be applied to agricultural crops using aerial, chemigation, groundboom , airblast, backpack, and low -pressure sprayer application equipment. Application methods, maximum application rates, and use sites are summarized in Table 3 . Handler exposure is expected to be short- or intermediate - term in duration based on information provided on proposed labels. The quantitative exposure/risk assessment developed for occupational handlers is based on the following exposure scenarios: Mixer/Loaders 1. Mixing/loading liquid concentrates to support aerial applications , 2. Mixing/loading liquid concentrates to support chemigation applications , 3. Mixing/loading liquid concentrates to support groundboom applications , 4. Mixing/loading liquid concentrates to support airblast applications ,

### Page 8 of 25



## Applicators 5. Applying sprays with aircraft (enclosed cockpit) , 6. Applying sprays with groundboom equipment , 7. Applying sprays with airblast equipment , Flaggers 8. Flagging to support aerial spray applications, Mixer/Loader/Applicators 9. Mixing/loading/appl ying sprays with low pressure handwand equipment , 10. Mixing/loading/appl ying sprays with high pressure handwand equipment , and 11. Mixing/loading/appl ying sprays with backpack sprayer equipment .

**4.1.1 Data and Assumptions for**  **Occupational Han**  **dler Exposure Scenarios Unit Exposures:**  No chemical - specific handler exposure data were submitted in support of this Section 3 registration. To assess handler exposures for regulatory actions when chemical - specific monitoring data are not available, HED relies on the most scientifically- reliable surrogate data currentl y available from various sources such as the Pesticide Handler Exposure Database (PHED), the Agricultural Handler Exposure Task Force (AHETF), and the Outdoor Residential Exposure Task Force (ORETF). Some of this data, such as the industry task force data, is compensatory, subject to the data protection provisions of FIFRA. HED policy on use of surrogate data is described in more detail on the Agency's website (http://www.epa.gov/pesticides/science/handler- exposure - data.html). Scenario - specific surrogate exposure data, including their sources, are presented in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (http://www.epa.gov/pesticides/science/handler- exposure - table.pdf ). HED has developed a series of tabl es of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure. **Mitigation Approaches:** There are three basic risk mitigation approaches considered appropriate for controlling occupational exposure. These include administrative controls, use of PPE, and the use of engineering controls. Occupational handler exposure assessments were completed by HED using baseline, PPE, and engineering controls. The baseline clothing level for occupational exposure scenarios is generall y an individual wearing long pants, a long - sleeved shirt, shoes, socks, no chemical -resistant gloves, and no respirator. The first level of mitigation generally applied is PPE, which may include addition of chemical resistant- gloves, an additional layer of clothing, and/or a respirator. The next layer of mitigation considered in the risk assessment process is the use of appropriate engineering controls, which, b y design, attempt to eliminate the possibility of human exposure . Examples of

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## commonly

used engineering controls include enclosed cockpits or tractor cabs, closed mixing/loading s ys tems, and water- soluble packets. **Gallons Applied or Acres Treated:** The gallons applied per day or acres treated per day

for each scenario are shown in Table 4 . The values are based on the equipment used and HED Exposure Science Advisory Committee SOP No. 9.1 or professional judgement . **Application Rate:** As shown in Table 3 , a maximum application rate s ranged from 0.092 to 0.2 2 lb ai/acre and are proposed for broadcast foliar application to the agricultural crops. **Body Weight:** 70 kg **Absorption Factor s**  **:** None for dermal, 100% for inhalation. **Equations and Calculations: Daily Exposure:**  Daily

handler exposures are estimated for each applicable handler task with the application rate, the amount of acres treated or amount applied in a day, and the applicable unit exposure using the following formula: Daily Exposure (mg ai/day) = Unit Exposure ( μ g ai/lb ai handled) * Application Rate (lbs ai/A or gal) * Daily Amount Handled (A or gal/day) * Conversion Factor (mg/1,000 μg) Where: Daily Exposure = Amount (mg ai/day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption, Unit Exposure = Unit e xposure value (μg ai/day), Application Rate = Normalized application rate based on a logical unit treatment, such as acres or gallons ; maximum values are used (lb ai/acre , lb ai/gal), and Daily Amount Handled = Normalized application area based on a logical unit treatment such as acres or gallons (A/day, gal/day). 

## Daily Dose: Daily

dose (inhalation or dermal) was calculated b y normalizing the daily dermal or inhalation exposure value by body weight and accounting for dermal and inhalation absorption. Average Daily

Dose (mg/kg/day) = Daily Exposure (mg ai/day) x { Absorption Factor (%/100) } Body Weight (kg) Where:

### Page 10 of 25 Average Daily Dose = Absorbed dose received from exposure to a pesticide in a given s cenario (mg pesticide active ingredient/kg body weight/day) , Daily Exposure = Amount (mg ai/day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption, Absorption Factor = A measure of the amount of chemical that crosses a biological boundary such as the skin or lungs, and Body Weight = Body weight determined to represent the population of interest in a risk a ssessment. 

## Margin of Exposure (MOE): The dail y dermal dose and dail y inhalation dose received b y occupational handlers were compared to the appropriate point of departure ( i.e., N OAEL) to assess the risk to occupational handlers for each exposure route. All MOE values were calculated separately for dermal and inhalation exposure levels using the following formula: MOE = N OAEL (mg/kg/day)

Average Daily Dose (mg/kg/day) Where: MOE = Margin of exposure value used by HED to represent risk or how close a chemical exposure is to being a concern (unitless), ADD = Average daily dose (ADD) is absorbed dose received from exposure to

pesticide, and NOAEL = Dose level in a toxicity study, where no observed adverse effects occurred in the

study. 

## Combined Risks: Dermal and inhalation risks for short- term and intermediate - term exposures were not combined in this assessment, since the toxicological effects for the dermal and inhalation routes were different .

**4.1.2 Occupational**  **Handlers Exposure and Risk Estimates for Non**  **- Cancer**  Non- cancer short- and intermediate - term occupational handler exposures and risk estimates are shown in Table 4 . Risk estimates for dermal (with gloves) and inhalation exposures all resulted in MOE ≥ 100, and therefore, do not exceed HED’s level of concern.

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**Table 4. Non**  **- Cancer**  **Occupational Short** **- and Intermediate**  **- Term**  **Dermal and Inhalation Exposures and Risk**  **Estimates For Fluopyram**  Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (A /day) Unit Exposure d Daily Exposure e (mg/kg/day) MOE f Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation **Mixer/Loader** Mixing/Loading Liquid Concentrates for Aerial Applications Peanut, Strawberry, Tree Nuts 0.22 350 0.22 0.0376 0.219 0.242 0.0414 0.000241 1,200 7,300 60,000 Dried Beans 0.13 0.143 0.0244 0.000142 2,100 12,000 100,000 Cherry, Potato 0.092 0.101 0.0173 0.000101 3,000 17,000 140,000 Mixing/Loading Liquid Concentrates for Chemigation Applications Apples, Peanut, Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes 0.22 350 0.22 0.0376 0.219 0.242 0.0414 0.000241 1,200 7,300 60,000 Potato 0.18 0.198 0.338 0.000197 1,500 8,900 74,000 Dried Beans 0.13 0.143 0.0244 0.000142 2,100 12,000 100,000 Sugar Beet 0.11 0.121 0.0207 0.000120 2,500 15,000 120,000 Cherry 0.092 0.101 0.0173 0.000101 3,000 17,000 140,000 Mixing/Loading Liquids Concentrates for Groundboom Applications Apples, Peanut, Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes 0.22 80 0.22 0.0376 0.219 0.0553 0.00945 0.0000551 5,400 32,000 260,000 Potato 0.18 0.0452 0.00773 0.0000451 6,600 39,000 320,000 Dried Beans 0.13 0.0327 0.00559 0.0000325 9,200 54,000 450,000 Sugar Beet 0.11 0.0277 0.00473 0.0000275 11,000 63,000 530,000 Cherry 0.092 0.0231 0.00395 0.0000230 13,000 76,000 630,000 Mixing/Loading Liquids Concentrates for Airblast Applications Apples, Tree Nuts ,

Viniferous variety Grapes 0.22 40 0.22 0.0376 0.219 0.0277 0.00473 0.0000275 11,000 63,000 530,000 Cherry 0.092 0.0116 0.00198 0.0000115 26,000 150,000 1,300,000 **Applicator** Applying Sprays via Aerial Equipment Peanut, Strawberry, Tree Nuts 0.22 350 0.005 No Data 0.068 0.0055 0 No Data 0.0000748 5 5 ,000 No Data 190,000 Dried Beans 0.13 0.00 325 No Data 0.0000 442 92 ,000 No Data 190,000 Cherry, Potato 0.092 0.00 230 No Data 0.0000 313 130 ,000 No Data 190,000 Applying Sprays via Groundboom Equipment Apples, Peanut, Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes 0.22 80 0.0 786 0.01 61 0. 3 4 0.0198 0.00405 0.0000855 15,000 74,000 170,000 Potato 0.18 0.0162 0.00331 0.0000699 19,000 91,000 210,000 Dried Beans 0.13 0.0117 0.00239 0.0000505 26,000 130,000 290,000 Sugar Beet 0.11 0.00988 0.00202 0.0000427 30,000 150,000 340,000

### Page 12 of 25

**Table 4. Non**  **- Cancer**  **Occupational Short** **- and Intermediate**  **- Term**  **Dermal and Inhalation Exposures and Risk**  **Estimates For Fluopyram**  Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (A /day) Unit Exposure d Daily Exposure e (mg/kg/day) MOE f Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Cherry 0.092 0.00826 0.00169 0.0000357 36,000 180,000 410,000 Applying Sprays via Airblast Equipment Apples, Tree Nuts , Viniferous variety Grapes 0.22 40 0.36 0.24 4.5 0.0453 0.0302 0.000566 6,600 9,900 26,000 Cherry 0.092 0.0189 0.0126 0.000237 16,00 24,000 61,000 **Flagger** Flagging for Aerial Sprays Applications Peanut, Strawberry, Tree Nuts 0.22 350 0.011 NA 0.35 0.0121 NA 0.000385 25,000 NA 38,000 Dried Beans 0.13 0.00715 NA 0.000228 42,000 NA 64,000 Cherry, Potato 0.092 0.00506 NA 0.000161 59,000 NA 90,000 **Mixer/Loader/Applicator** Mixing/Loading/Applying Li quid Concentrates with Low Pressure Handwand Greenhouse Only: Strawberries & Watermelon 0.22 5 100 0.43 30 1.57 0.00676 0.000471 190 44,000 31,000 Mixing/Loading/Applying Li quid Concentrates with High Pressure Handwand Greenhouse Only: Strawberries & Watermelon 0.22 5 3.5 2.5 0.12 0.0550 0.0393 0.00189 5,500 7,600 7,700 Mixing/Loading/Applying Li quid Concentrates with a Backpack Greenhouse Only: Strawberries & Watermelon 0.22 5 2.51 2.5 30 0.0394 0.0393 0.000471 7,600 7,600 31,000 a. Application Rates are based on propose d uses from the fluopyram label s (Fluopyram 500 SC) . b. Science Advisory Council Policy No. 9.1 . c . Baseline Dermal: Long - sleeve shirt, long pants, and no gloves . PPE - G Dermal : Baseline plus chemical - resistant gloves. Baseline Inhalation: no respirator. Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit. d . Unit Exposures are based on PHED Version 1.1. e . Daily Exposure (mg/kg/day) = Application Rate (lb ai/A) *Unit Exposure (mg/lb ai) *Area Treated or Amount Applied (acre/day) / 70 kg . f. MOE = NOAEL (mg/kg/day) / Daily Exposure (mg/kg/day); where dermal NOAEL = 300 mg/kg/day and inhalation NOAEL = 14.5 mg/kg/day .

### Page 13 of 25



## 4 **.1. 3**  **Occupational Handler Exposure and Risk Assessment for Cancer** In accordance with the EPA ’s Final Guidelines for Carcinogen Risk Assessment (March, 2005 ), the HED CARC (TXR No. 0055261, J. Kidwell, 11/25/09) classified fluopy ram as “likel y to be carcinogenic to humans” by all routes of exposure based on tumors in two species and two sexes: a treatment related increase in thy roid follicular cell adenomas in high dose male mice and liver tumors in female rats at the high dose, with incidences exceeding that of the laboratory ’s historical controls. To estimate the risk from exposure to f luopy ram , the Q1* of 1 . 55 x10 - 2 

## (mg/kg/day) - 1 

## in human equivalents based on female rat liver combined adenoma and carcinoma tumor rates was calculated. EPA conducted an assessment of the carcinogenic risk estimates associated with fluopy ram following exposures to occupational handlers. The cancer risks, for the handler (dermal plus inhalation) exposures, are based on the assumption that a private farmer applies fluopy ram products 10 days a ye ar, and a commercial applicator applies fluop yram products 30 days a year. The occupational handler exposure and cancer risk calculations are presented in this section. Cancer risks were calculated using a linear low - dose extrapolation approach in which a Lifetime Average Dail y Dose (LADD) is calculated and compared with a Q1* that has been calculated for f luopy ram based on dose response data in the appropriate toxicology study (Q1* = 1 . 55 x 10 - 2 

## (mg/kg/day) - 1 

## ). Absorbed average dail y dose (ADD) levels were used as the basis for calculating the LADD values. Section 4 .1.1 above described how the ADD values were calculated for the non- cancer MOE calculations. These values also serve as the basis for the cancer risk estimates. Dermal and inhalation ADD values were added together to obtain combined ADD values. LADD values were then calculated and compared to the Q1* to obtain cancer risk estimates. **Lifetime Average Daily Dose** : After the development of the ADD values, the next step required to calculate the carcinogenic risk is to amortize these values over the working lifetime of occupational handlers based on use patterns, which results in the LADD for that use. The Agency considered two distinct popul ations in the cancer risk assessment including private growers at 10 use events per year and commercial applicators that would have a more frequent use pattern of 30 days per year. Finall y, a 35 ye ar career and a 70 ye ar lifespan were used to complete the calculations. LADD values were calculated using the following equation:

Where: Lifetime Average Daily Dose = the amount as absorbed dose received from exposure to a pesticide in a given scenario over a lifetime (mg pesticide active ingredient/kg body weight/day, also referred to as LADD) Average Daily Dose = the amount as absorbed dose received from exposure to a pesticide in a given scenario on a dail y basis (mg pesticide active ingredient/kg body weight/day, also referred

### Page 14 of 25



## to as ADD) Treatment Frequency = the annual frequency of an application by

an individual (days/year) Working Duration = The amount of a lif etime that an individual spends engaged in a career involving pesticide exposure (35 ye ars) Lifetime = The average life expectancy of an individual (70 years) **Cancer Risks** : Finall y, cancer risk calculations were completed b y comparing the LADD values cal culated above to the Q1* for f luopy ram (Q1* = 1.55. x 10 - 2 

## (mg/kg/day) - 1 

## ). The Agency considered more ty

pical users in these calculations (i.e., private growers at 10 events per year) as well as more frequent users that might represent commercial applicators (i.e., 30 events per ye ar). Cancer risk values were calculated using the following equation: All of the cancer risk calculations for occupational fluopy ram handlers completed in this assessment are included in Table s 5 (Private Growers) and 6 (Commercial Applicators) . Cancer risks for private growers and commercial applicators were calculated for different exposure scenarios at different levels of personal protection. Handler c ancer risk estimates for combined inhalati on and dermal (with gloves) exposures f or private growers ranged from 1 . 0 x 10 - 8 

## to 5 . 6 x 10 - 7 

## and f or commercial workers ranged from 3 .1 x 10 - 8 

## to 8 . 8 x 10 - 7



## . Total Risk = LADD x Q1*

### Page 15 of 25 **Table 5**  **. Occupational Handler Estimated Cancer Risks for Private**  **Growers.** Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (acres/day) Unit Exposure d Average Daily Dose e (mg/kg/day) LADD f (mg/kg/day) Cancer Riskg

Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal + Inhalation PPE - G

Dermal + Inhalation **Mixer/Loader** Mixing/Loading Li quid Concentrates for Aerial Applications Peanut, Strawberry, Tree Nuts 0.22 350 0.22 0.0376 0.219 4.60E - 3 7.87E - 4 2 . 41 E - 4 6.30E - 5 1.08E - 5 3.30E - 6 1.1E - 6 2.2E - 7 Dried Beans 0.13 2.72E - 3 4.64E - 4 1 . 42 E - 4 3.72E - 5 6.35E - 6 1.95E - 6 6.1E - 7 1.3E - 7 Cherry, Potato 0.092 1.92E - 3 3.29E - 4 1 . 01 E - 4 2.63E - 5 4.50E - 6 1.38E - 6 4.3E - 7 9.1E - 8 Mixing/Loading Li quid Concentrates for Chemigation Applications Apples, Peanut,

Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes 0.22 350 0.22 0.0376 0.219 4.60E - 3 7.87E - 4 2 . 41 E - 4 6.30E - 5 1.08E - 5 3.30E - 6 1.1E - 6 2.2E - 7

Potato 0.18 3.76E - 3 6.42E - 4 1 . 97 E - 4 5.15E - 5 8.80E - 6 2.70E - 6 8.4E - 7 1.8E - 7 Dried Beans 0.13 2.72E - 3 4.64E - 4 1.42E - 4 3.72E - 5 6.35E - 6 1.95E - 6 6.1E - 7 1.3E - 7 Sugar Beet 0.11 2.30E - 3 3.93E - 4 1.20E - 4 3.15E - 5 5.39E - 6 1.64E - 6 5.1E - 7 1.1E - 7 Cherry 0.092 1.92E - 3 3.29E - 4 1.01E - 4 2.63E - 5 4.50E - 6 1.38E - 6 4.3E - 7 9.1E - 8 Mixing/Loading Li quids Concentrates for Groundboom Applications Apples, Peanut,

Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes 0.22 80 0.22 0.0376 0.219 1.05E - 3 1.80E - 4 5.51E - 5 1.44E - 5 2.46E - 6 7.55E - 7 2.3E - 7 5.0E - 8

Potato 0.18 8.59E - 4 1.47E - 4 4.51E - 5 1.18E - 5 2.01E - 6 6.18E - 7 1.9E - 7 4.1E - 8 Dried Beans 0.13 6.21E - 4 1.06E - 4 3.25E - 5 8.51E - 6 1.45E - 6 4.45E - 7 1.4E - 7 2.9E - 8 Sugar Beet 0.11 5.26E - 4 8.99E - 5 2.75E - 5 7.21E - 6 1.23E - 6 3.77E - 7 1.2E - 7 2.5E - 8 Cherry 0.092 4.39E - 4 7.51E - 5 2.30E - 5 6.01E - 6 1.03E - 6 3.15E - 7 9.8E - 8 2.1E - 8 Mixing/Loading Li quids Concentrates for Airblast Applications Apples, Tree Nuts ,

Viniferous variety Grapes 0.22 40 0.22 0.0376 0.219 5.26E - 4 8.99E - 5 2.75E - 5 7.21E - 6 1.23E - 6 3.77E - 7 1.2E - 7 2.5E - 8 Cherry 0.092 2.20E - 4 3.76E - 5 1.15E - 5 3.02E - 6 5.15E - 7 1.58E - 7 4.9E - 8 1.0E - 8 **Applicator** Applying Sprays via Aerial Equipment Peanut, Strawberry, Tree Nuts 0.22 350 0.005 (Eng. Control) No Data 0.068 (Eng. Control) 1.04E - 4

(Eng. Control) No Data 0.0000748 (Eng. Control) 1.43E - 6 No Data 1.02E - 6 3.8E - 8 No Data Dried Beans 0.13 6.18E - 5 No Data 0.0000 442 8.46E - 7 No Data 5.75E - 7 2.2E - 8 No Data Cherry, Potato 0.092 4.37E - 5 No Data 0.0000 313 5.99E - 7 No Data 4.29E - 7 1.6E - 8 No Data

### Page 16 of 25 **Table 5**  **. Occupational Handler Estimated Cancer Risks for Private**  **Growers.** Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (acres/day) Unit Exposure d Average Daily Dose e (mg/kg/day) LADD f (mg/kg/day) Cancer Riskg

Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal + Inhalation PPE - G

Dermal + Inhalation Applying Sprays via Groundboom Equipment Apples, Peanut,

Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes 0.22 80 0.0 786 0.01 61 0. 3 4 3.76E - 4 7.70E - 5 0.0000855 5.15E - 6 1.05E - 6 1.17E - 6 9.8E - 8 3.4E - 8

Potato 0.18 3.08E - 4 6.29E - 5 6 . 99 E - 5 4.22E - 6 8.62E - 7 9.58E - 7 8.0E - 8 2.8E - 8 Dried Beans 0.13 2.22E - 4 4.54E - 5 5 . 05 E - 5 3.04E - 6 6.22E - 7 6.92E - 7 5.8E - 8 2.0E - 8 Sugar Beet 0.11 1. 88 E - 4 3.84E - 5 4 . 27 E - 5 2.57E - 6 5.26E - 7 5.85E - 7 4.9E - 8 1.7E - 8 Cherry 0.092 1.57E - 4 3.21E - 5 3 . 57 E - 5 2.15E - 6 4.40E - 7 4.89E - 7 4.1E - 8 1.4E - 8 Applying Sprays via Airblast Equipment Apples, Tree Nuts ,

Viniferous variety Grapes 0.22 40 0.36 0.24 4.5 8.61E - 4 5.74E - 4 5 . 66 E - 4 1.18E - 5 7.86E - 6 7.75E - 6 3.0E - 7 2.4E - 7 Cherry 0.092 3.59E - 4 2.39E - 4 2 . 37 E - 4 4.92E - 6 3.28E - 6 3.25E - 6 1.3E - 7 1.0E - 7 **Flagger** Flagging for Aerial Sprays Applications Peanut, Strawberry, Tree Nuts 0.22 350 0.011 NA 0.35 2.30E - 4 NA 3 . 85 E - 4 3.15E - 6 NA 5.27E - 6 1.3E - 7 NA Dried Beans 0.13 1.36E - 4 NA 2 . 28 E - 4 1.86E - 6 NA 3.12E - 6 7.7E - 8 NA Cherry, Potato 0.092 9.61E - 5 NA 1 . 61 E - 4 1.32E - 6 NA 2.21E - 6 5.5E - 8 NA **Mixer/Loader/Applicator** Mixing/Loading/ Applying Liquid Concentrates with Low Pressure Handwand Greenhouse Only:

Strawberries & Watermelon 0.22 5 100 0.43 30 2.98E - 2 1.28E - 4 4 . 71 E - 4 4.09E - 4 1.76E - 6 6.45E - 6 6.4E - 6 1.3E - 7 Mixing/Loading/ Applying Liquid Concentrates with High Pressure Handwand Greenhouse Only: Strawberries & Watermelon 0.22 5 3.5 2.5 120 1.05E - 3 7.47E - 4 1 . 89 E - 3 1.43E - 5 1.02E - 5 2.59E - 5 6.2E - 7 5.6E - 7 Mixing/Loading/ Applying Liquid Concentrates with a Backpack Greenhouse Only:

Strawberries & Watermelon 0.22 5 2.51 2.5 30 7.49E - 4 7.47E - 4 4 . 71 E - 4 1.03E - 5 1.02E - 5 6.45E - 6 2.6E - 7 2.6E - 7 a. Application Rates are based on proposed uses from the fluopyram labels (Fluopyram 500 SC) . b. Science Advisory Council Policy No. 9.1 . c. Baseline Dermal: Long - sleeve shirt, long pants, and no gloves . PPE - G Dermal: Baseline plus chemical -resistant gloves. Baseline I nhalation: no respirator. Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit.

### Page 17 of 25

d. Unit Exposures are based on PHED Version 1.1 , or AHETF data . e. Average Daily Dose (ADD) (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) * Area Treated or Amount Applied (acre/day) * Ab sorption Factor (1.9% dermal, 100% inhalation)/ 70 kg . f. Lifetime Average Daily Dose (LADD) = ADD (mg/kg/day) x (10 days per year treated by Private Growers / 365 days per year) x (35 years working duration / 70 years per lifetime). g. Cancer Risk = Q1* ( 1.55E - 2 (mg/kg/day) - 1 ) x LADD mg/kg/day). 

### Table 6. Occupational Handler Estimated Cancer Risks for Commercial **Applicators .**  Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (acres/day) Unit Exposure d Average Daily Dose e (mg/kg/day) LADD f (mg/kg/day) Cancer Riskg

Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal + Inhalation PPE - G

Dermal + Inhalation **Mixer/Loader** Mixing/Loading Li quid Concentrates for Aerial Applications Peanut, Strawberry, Tree Nuts 0.22 350 0.22 0.0376 0.219 4.60E - 3 7.87E - 4 2 . 41 E - 4 1.89E - 4 3.23E - 5 9.90E - 6 3.1E - 6 6.5E - 7 Dried Beans 0.13 2.72E - 3 4.64E - 4 1 . 42 E - 4 1.12E - 4 1.91E - 5 5.84E - 6 1.8E - 6 3.9E - 7 Cherry, Potato 0.092 1.92E - 3 3.29E - 4 1 . 01 E - 4 7.89E - 5 1.35E - 5 4.15E - 6 1.3E - 6 2.7E - 7 Mixing/Loading Li quid Concentrates for Chemigation Applications Apples, Peanut,

Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes , 0.22 350 0.22 0.0376 0.219 4.60E - 3 7.87E - 4 2.41E - 4 1.89E - 4 3.23E - 5 9.90E - 6 3.1E - 6 6.5E - 7

Potato 0.18 3.76E - 3 6.42E - 4 1.97E - 4 1.55E - 4 2.64E - 5 8.10E - 6 2.5E - 6 5.3E - 7 Dried Beans 0.13 2.72E - 3 4.64E - 4 1.42E - 4 1.12E - 4 1.91E - 5 5.84E - 6 1.8E - 6 3.9E - 7 Sugar Beet 0.11 2.30E - 3 3.93E - 4 1.20E - 4 9.45E - 5 1.62E - 5 4.93E - 6 1.5E - 6 3.3E - 7 Cherry 0.092 1.92E - 3 3.29E - 4 1.01E - 4 7.89E - 5 1.35E - 5 4.15E - 6 1.3E - 6 2.7E - 7 Mixing/Loading Li quids Concentrates for Groundboom Applications Apples, Peanut,

Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes , 0.22 80 0.22 0.0376 0.219 1.05E - 3 1.8E - 4 5.51E - 5 4.32E - 5 7.38E - 6 2.26E - 6 7.1E - 7 1.5E - 7

Potato 0.18 8.59E - 4 1.47E - 4 4.51E - 5 3.53E - 5 6.04E - 6 1.85E - 6 5.8E - 7 1.2E - 7 Dried Beans 0.13 6.21E - 4 1.06E - 4 3.25E - 5 2.55E - 5 4.36E - 6 1.34E - 6 4.2E - 7 8.8E - 8 Sugar Beet 0.11 5.26E - 4 8.99E - 5 2.75E - 5 2.16E - 5 3.69E - 6 1.13E - 6 3.5E - 7 7.5E - 8 Cherry, Stone Fruit 0.092 4.39E - 4 7.51E - 5 2.30E - 5 1.80E - 5 3.08E - 6 9.45E - 7 2.9E - 7 6.2E - 8 Mixing/Loading Li quids Concentrates for Airblast Applications Apples, Tree Nuts ,

Viniferous variety Grapes 0.22 40 0.22 0.0376 0.219 5.26E - 4 8.99E - 5 2.75E - 5 2.16E - 5 3.69E - 6 1.13E - 6 3.5E - 7 7.5E - 8 Cherry 0.092 2.20E - 4 3.76E - 5 1.15E - 5 9.06E - 6 1.55E - 6 4.73E - 7 1.5E - 7 3.1E - 8 **Applicator** Applying Sprays via Peanut, Strawberry, 0.22 350 0.005 No Data 0.068 1.05E - 4 No Data 7 . 48 E - 5 4.29E - 6 No 3. 07 E - 6 1.1E - 7 No Data

### Page 18 of 25 **Table 6. Occupational Handler Estimated Cancer Risks for Commercial Applicators**  **.** Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (acres/day) Unit Exposure d Average Daily Dose e (mg/kg/day) LADD f (mg/kg/day) Cancer Riskg

Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal + Inhalation PPE - G

Dermal + Inhalation Aerial Equipment Tree Nuts (Eng. Control) (Eng. Control) (Eng.

Control) (Eng. Control) Data Dried Beans 0.13 6.18E - 5 No Data 4.42E - 5 2.54E - 6 No Data 1.82E - 6 6.8E - 8 No Data Cherry, Potato 0.092 4.37E - 5 No Data 3.13E - 5 1.80E - 6 No Data 1.29E - 6 4.8E - 8 No Data

Applying Sprays via Groundboom Equipment Apples, Peanut,

Strawberry, Tree Nuts , Watermelon (field and greenhouse), Viniferous variety Grapes , 0.22 80 0.0 786 0.01 61 0. 3 4 3.76E - 4 7.70E - 5 8.55E - 5 1.55E - 5 3.16E - 6 3.51E - 6 2.9E - 7 1.0E - 7

Potato 0.18 3.08E - 4 6.29E - 5 6.99E - 5 1.26E - 5 2.58E - 6 2.87E - 6 2.4E - 7 8.5E - 8 Dried Beans 0.13 2.22E - 4 4.54E - 5 5.05E - 5 9.14E - 6 1.87E - 6 2.08E - 6 1.7E - 7 6.1E - 8 Sugar Beet 0.11 1.88E - 4 3.84E - 5 4.27E - 5 7.71E - 6 1.58E - 6 1.75E - 6 1.5E - 7 5.2E - 8 Cherry 0.092 1.57E - 4 3.21E - 5 3.57E - 5 6.45E - 6 1.32E - 6 1.47E - 6 1.2E - 7 4.3E - 8 Applying Sprays via Airblast Equipment Apples, Tree Nuts , Viniferous variety Grapes 0.22 40 0.36 0.24 4.5 8.61E - 4 5.74E - 4 5 . 66 E - 4 3.54E - 5 2.36E - 5 2.3 3 E - 5 9.1E - 7 7.3E - 7 Cherry 0.092 40 0.36 0.24 4.5 3.59E - 4 2.39E - 4 2.37E - 4 1.48E - 5 9.84E - 6 9.74E - 6 3.8E - 7 3.0E - 7 **Flagger** Flagging for Aerial Sprays Applications Peanut, Strawberry, Tree Nuts 0.22 350 0.011 NA 0.35 2.30E - 4 NA 3 . 85 E - 4 9.45E - 6 NA 1. 58 E - 5 3.9E - 7 NA Dried Beans 0.13 1.36E - 4 NA 2.28E - 4 5.58E - 6 NA 9.34E - 6 2.3E - 7 NA Cherry, Potato 0.092 9.61E - 5 NA 1.61E - 4 3.95E - 6 NA 6.62E - 6 1.6E - 7 NA **Mixer/Loader/Applicator** Mixing/Loading/ Applying Liquid Concentrates with Low Pressure Handwand Greenhouse Only:

Strawberries & Watermelon 0.22 5 100 0.43 30 2.98E - 2 1.28E - 4 4 . 71 E - 4 1.2 3 E - 3 5.28 E - 6 1.9 4 E - 5 1.9E - 5 3.8 E - 7 Mixing/Loading/ Applying Liquid Concentrates with High Pressure Handwand Greenhouse Only: Strawberries & Watermelon 0.22 5 3.5 2.5 120 1.05E - 3 7.47E - 4 1 . 89 E - 3 4.29E - 5 3.07 2.59E - 5 1.1E - 6 8.8E - 7 Mixing/Loading/ Applying Liquid Greenhouse Only: Strawberries & 0.22 5 2.51 2.5 30 7.49E - 4 7.47E - 4 4 . 71 E - 4 3.08E - 5 3.07E - 5 1.9 4 E - 5 7.8E - 7 7.8E - 7

### Page 19 of 25 **Table 6. Occupational Handler Estimated Cancer Risks for Commercial Applicators**  **.** Exposure Scenario Crop or Target Application Rate a (lb ai/A) Area

Treated Daily b (acres/day) Unit Exposure d Average Daily Dose e (mg/kg/day) LADD f (mg/kg/day) Cancer Riskg

Baseline Dermal c (mg/lb ai) PPE - G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal PPE - G

Dermal Baseline

Inhalation Baseline

Dermal + Inhalation PPE - G

Dermal + Inhalation Concentrates with a Backpack Watermelon a. Application Rates are based on proposed uses from the fluopyram labels (Fluopyram 500 SC) . b. Science Advisory Council Policy No. 9.1 . c. Baseline Dermal: Long - sleeve shirt, long pants, and no gloves . PPE - G Dermal: Baseline plus chemical -resistant gloves. Baseline Inhalation: no respirator. Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit. d. Unit Exposures are based on PHED Version 1.1 , or AHETF data . . e. Average Daily Dose (ADD) (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) * Area Treated or Amount Applied (acre/day) * Absorption Factor (1.9% dermal, 100% inhalation)/ 70 kg . f. Lifetime Average Daily Dose (LADD) = ADD (mg/kg/day) x ( 3 0 days per year treated by Commercial Growers / 365 days per year) x (35 years working duration / 70 years per lifetime). g. Cancer Risk = Q1* (1.55E - 2 (mg/kg/day) - 1 ) x Dermal LADD mg/kg/day).

### Page 20 of 25



## 4.2 **Occupational Postapplication Exposure**  Occupational postapplication exposure can occur via the dermal and/or inhalation route s . Based on the Agency's current practices, a quantitative post- application inhalation exposure assessment was not performed for fluopy ram at this time primarily because of the low acute inhalation toxicity (Toxicity Category IV), low vapor pressure (1.2x10 - 6 

## Pa at 20 o 

## C), and the low proposed use rate (0.22 lb ai/A). However, there are multiple potential sources of post- application inhalation exposure to individuals performing post- a pplication activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and input on issues related to volatil ization 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/scipol y/ SAP/meetings/2009/120109meeting.html). Th e Agency is in the process of evaluating the SAP report as well as available post- application inhalation exposure data generated by the Agricultural Reentry Task Force and may, as appropriate, develop policies and procedures, to identify the need for and, subsequently, the way to incorporate occupational post- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post- application inhalation exposure assessment for fluop yram. Proposed uses include applications in greenhouses. The WPS for Agricultural Pesticides contains requirements for protecting workers and bystanders from inhalation exposures during and after greenhouse applications through the use of ventilation requirements. For these reasons, postapplication inhalation exposures and risks were not quantitatively assessed for the proposed greenhouse uses. Since, there is the possibility for agricultural workers to have postapplication dermal exposure to fluopy ram following its proposed agricultural crop and turf uses, occupational postapplication short- and intermediate - term dermal exposure and risks were assessed.

**4.2.1 Data and Assumptions for**  **Occupational Postapplication Exposure Scenarios**  In addition to the application rate and body weight values discussed above in the handler exposure section , the following assumptions were made in assessing short- and intermediate term dermal postapplication risks : **Dislodgeable foliar residue s:**  There were no chemical - specific dislodgeable foliar residue data to assess postapplication risks to workers while performing tasks related to crops treated with fluop yram . For agricultural crops, o ccupational postapplication exposures and risks were assessed using HED’s default

### Page 21 of 25



## assumptions that 20 % of the initial application is available for transfer on day 0 (i.e., 12 hours after application) and that the residue dissipates at a rate of 10 % per day . **Transfer C**  **oefficient s:**  HED uses a concept known as the transfer coefficient to numerically represent the postapplication exposures one would receive (generall y presented as cm2

## /hour). A transfer coefficient is a measure of the residue transferred from a treated surface to a person who is doing a task or activity

in a treated area. These values are the ratio of an exposure for a given task or activity to the amount of pesticide residue on treated surfaces available for transfer. HED has developed a series of standard transfer coefficients that are unique for variety of job tasks or activities that are used in lieu of chemical - and scenario - specific data. No post- application data were submitted in support of this registration action; therefore, dermal exposures during post- application activities were estimated for the various tasks that postapplication workers might perform on each crop grouping using dermal transfer coefficients from the Science Advisory Council for Exposure Policy Number 3 (http://www.epa.gov/pesticides/science/exposac_policy3.pdf). This policy reflects adoption of all Agricultural Re - Entry Task Force (ARTF) data. Use of the data in this policy requires compensation to the ARTF under FIFRA. The transfer coefficients (TCs) used in this assessment were taken from the Agency ’s revised Agricultural Transfer Coefficient SOP. Many of the TCs in this SOP are based on work of the ARTF. **Workday :**  HED assumes an 8 hour workday for postapplication workers . **Equations and Calculations:** Daily Dermal Exposure and default DFR calculations are presented below. Daily Dermal Dose and MOE calculations are the same as presented above in Section 4.1.1. **Daily D ermal**  **E**

**xposure:** Daily

dermal exposures were calculated on each postapplication day after application using the following equation: DE (t) 

### (mg/day) = (DFR(t) 

### (μg/cm2 

### ) x TC (cm2

### /hr) x Hr/Day)/1,000 (μg/mg) Where: DE(t) = Daily exposure or amount deposited on the surface of the skin at time (t) attributable for activity

in a previously treated area, DFR(t) = Dislodgeable foliar residue (or transferable turf residue) at time “t” (μg/cm2 

### ), TC = Transfer Coefficient (cm 2

### /ho ur), and Hr/day = Exposure duration meant to represent a typical workday (8 hours). 

## Default DFR: Default dislodgeable foliar residue (DFR) values were calculated on each postapplication day

after application using the following equation:

### Page 22 of 25 Default DFR (μg/cm2 

### ) = AR (lb ai/A) x F x (1 - D) t 

### x CF1 x CF2 Where: AR = Maximum application rate , F = Fraction of ai retained on the foliage , D = Fraction of residue that dissipates daily , t = Postapplication day, CF1 = 4.54E+8 μg/lb , and CF2 = 2.47E - 8 A/cm2



### . 

## 4.2.2 **Occupational Non**  **- Cancer**  **Postapplication Exposure and Risk**  The postapplication exposure associated with agricultural crops is summarized in Table 7 **.** The occupational postapplication MOEs do not exceed HED’s level of concern (MOEs ≥ 100) with dermal MOEs ranging from 53 0 to 5,600 . **T able**  **7 . Summary of Occupational**  **Non -**  **Cancer Postapplication Risks**  **(Short -**  **and Interm ediate**  **- Term)**  **with HED Default Assumptions**  **.** Crop Grouping Application

rate (lb ai/acre) Default DFR on 0

days (12 hrs) after applicationa 

### ( μg/cm

2 

### ) Work Activity &

Maximum Transfer Coefficient

b 

### (c m 2

### /hr) Daily Dose c



### (mg/kg/day) MOE d



### (L OC = 100) Apples 0.22 0.493 3, 6 00 - Thinning 0.203 1,500 Cherry 0.092 0.206 3, 6 00 - Thinning 0.0848 3,500 Dried Beans 0. 13 0.292 1 , 9 00 - Irrigation 0.0634 4,700 Peanut s 0.22 0.493 1 , 9 00 - Irrigation 0.107 2,800 Potato es 0. 18 0.404 1 , 9 00 - Irrigation 0.0877 3,400 Strawberries 0.22 0 .493 1, 1 00

– Hand Harvest 0.0620 4,800 Sugar Beets 0.11 0.247 1 , 9 00 - Irrigation 0.0536 5,600 Tree Nuts 0.22 0.49 3 3 , 6 00 - Thinning 0.203 1,500 Watermelon 0.22 0.493 1 , 9 00 - Irrigation 0.107 2,800 Viniferous variety Grapes 0.22 0.493 10 , 1 00 - Harvest (hand), Training, Tying, Leaf Pulling 0. 569 530 a. Default DFR (μg/cm 2 ) = application rate (lb ai/A) x (1 - daily dissipation rate) t x 4.54E+ 8 μg/lb x 24.7E - 9 A/cm2 x 20% DFR after initial treatment. b. 

### Crops were assessed using the highest transfer coefficient (TC) available . c. 

### Daily Dose = DFR x T C x (1 mg/1000 μg) x ET (8 hr/day) / body weight (70 kg)

### Page 23 of 25 d. 

### MOE = NOAEL ( 300 mg/kg/day) / Daily Dose (mg/kg/day) 

## Restricted Entry Interval: Since postapplication risks were not a concern on day 0 (12 hours following application), the REIis based on the acute toxicity of fluop yram technical material. Fluopy ram is classified as T oxicity C ategory I II by the acute oral and dermal route s of exposure and Toxicity

C ategory IV for acute inhalation, eye irritation potential and skin irritation potential. Under the WPS for Agricultural Pe sticides, active ingredients classified as acute toxicity categories III or IV for these routes are assigned a 12 -hour REI. Therefore, the 12 -hour REIthat appears on the proposed label is adequate.

**4.2. 3**  **Occupational Cancer Postapplication**  **Exposure and Risk**  The occupational exposure and cancer risk calculations for postapplication workers are presented in this section. The use dissipation data and the manner in which daily postapplication dermal exposures were calculated are inherently different than with handler exposures. However, once daily exposures are calculated, the calculation of lifetime average daily doses (LADD) and the resulting cancer risk estimates use the same algorithms that are described above for the handler exposures. Postapplic ation c ancer risk estimates are summarized below in Table 8 . Occupational postapplication exposure scenarios were assessed for individuals employed by multiple establishments (i.e., commercial or migratory farm workers) and were assumed to be exposed 30 days per year. Additionally, private growers were assumed to be exposed 10 days per year. Dislodgeable foliar residues were estimated using the method described above in the non- cancer postapplication section (i.e., assuming 20% of the active ingredient is available initially and a dissipation of 10% per day thereafter). HED used the average DFR residue (μg/cm2 

## ) over the minimum re - treatment interval for each crop or crop group to estimate cancer risk. F or private growers the cancer risks estimates ranged from 1 . 6 x 10 - 7 

## to 1 . 3 x 10 - 6



## . For commercial workers the cancer risks estimates ranged from 5 . 1 x 10 - 7 

## to 4 . 0 x 10 - 6



## . These estimates are considered conservative, since the maximum application rate and shortest retreatment intervals were used to calculate the estimates. In reality, lower application rates and longer retreatment intervals may often be emplo yed.

### Page 24 of 25

**T able**  **8 . Summary of Occupational Postapplication**  **Cancer Risks**  **with HED Default Assumptions .**  Crop Grouping Average DFR after applicationa 

### ( μg/cm

2 

### ) Work Activity &

Maximum Transfer Coefficient b 

### (cm 2

### /hr) Dermal Average Daily Dose c 

### (mg/kg/day) Dermal LADD d 

### (mg/kg/day) Cancer Riske Apples 0.351 3, 6 00 - Thinning 2.74E - 3 1.13E - 4 1.7E - 6 Cherry 0.161 3, 6 00 - Thinning 1.26E - 3 5.18E - 5 8.0E - 7 Dried Beans 0.208 1 , 9 00 - Irrigation 8.59E - 4 3.53E - 5 5.5E - 7 Peanut s 0.261 1 , 9 00 - Irrigation 1.08E - 3 4.44E - 5 6.9E - 7 Potato es 0.315 1 , 9 00 - Irrigation 1.30E - 3 5.34E - 5 8.3E - 7 Strawberries 0 .385 1, 1 00

– Hand Harvest 9.20E - 4 3.78E - 5 5.9E - 7 Sugar Beets 0.193 1 , 9 00 - Irrigation 7.96E - 4 3.27E - 5 5.1E - 7 Tree Nuts 0. 351 3 , 6 00 - Thinning 2.74E - 3 1.13E - 4 1.7E - 6 Watermelon 0 .385 1 , 9 00 - Irrigation 1.59E - 3 6.53E - 5 1.0E - 6 Viniferous variety Grapes 0. 283 10 , 1 00 - Harvest (hand), Training, Tying, Leaf Pulling 6.21E - 3 2.55E - 4 4.0E - 6 a . Average DFR residue averaged over the shortest number of re - treatment days for each crop or crop group (μg/cm2 ) . b . Crops were assessed using the highest transfer coefficient (TC) available. c . Dermal Average Daily Dose (ADD) = Average DFR x TC x (1 mg/1000 μg) x ET (8 hr/day) x Dermal Absorption Factor (1.9%)/ body weight (70 kg) . d . Dermal Lifetime Average Daily Dose (LADD) = Dermal ADD (mg/kg/day) x ( 30 days per year treated / 365 days per year) x (35 years working duration / 70 years per lifetime) . e . Cancer Risk = Q1*(1.55E - 2 (mg/kg/day) - 1 ) x Dermal LADD mg/kg/day) .

### Page 25 of 25



## 5.0 **RESIDENTIAL (NON -**  **OCCUPATIONAL) EXPOSURE/RISK PATHWAY** Based on product label, the product is not intended for use b y homeowners, or by occupational handlers in residential settings. Therefore, non- occupational/residential risk assessments have not been completed. **Spray Drift** S pray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly

the case with aerial application , but to a lesser extent, could also be a potential source of exposure from the airblast and groundboom application methods additionally employed for fluopy

ram . The Agency

has been working with the Spray Drift Task F orce, EPA Regional Offices , and State Lead Agencies for pesticide regulation and other parties to develop the best spray

drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on pro duct 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 appropriatel y apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast , and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off - target drift and risks associated with aerial as well as other application ty pes where appropriate. **Residential Bystander Post** **- Application Inhalation Exposure**  Based on the Agency's current practices, a quantitative post- application inhalation exposure assessment was not performed for fluop yram at this time primarily because of the low acute inhalation toxicity

(Toxicity Category IV), low vapor pressure ( 1.2x10 - 6 

## Pa at 20 o 

## C ), and the low proposed use rate (0.22 lb ai/A). However, volatilization of pesticides may be a source of postapplication inhalation exposure to individuals nearby pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html). The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policie s and procedures to identify the need for and, subsequently, the way to incorporate post- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are developed, the Agency may revisit the need for a quantitative po st- application inhalation exposure assessment for fluop yram.