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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

OFFICE OF

CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: August 30, 2011

SUBJECT: Fluopyram: Occupational and Residential Exposure Assessment for Proposed 

Uses on Apples, Cherry (Sweet and Tart), Dried Beans, Peanut, Potato, 

Strawberry, Sugar Beets, 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

TXR 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: Paula Deschamp, Branch Chief

Risk Assessment Branch 3

Health Effects Division (7509P)

TO: Sheila Healy, 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 

fluopyram on apples, cherry (sweet and tart), cucurbit vegetables, dried beans, peanut, potato,

stone fruits (except cherry), strawberry, sugar beets, tree nuts, and wine grapes. This memo was 

reviewed by the Exposure Science Advisory Council (ExpoSAC) on 10/07/2010.
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1.0 EXECUTIVE SUMMARY

The active ingredient, fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-

(trifluoromethyl)benzamide) is a new pyridylethylamide SDH (succinate-dehydrogenaseinhibitor, 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

fluopyram on a variety 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) fluopyram.

Proposed Use Profile:

Broadcast foliar applications of fluopyram may be applied to agricultural crops at a maximum 

single rates ranging from 0.092 to 0.22 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 watermelons. Handlers may apply fluopyram 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 fluopyram 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 fluopyram. 

Fluopyram has low acute toxicity by the oral and dermal routes of exposure (Toxicity Category

III) and also by 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 hypertrophy effects observed 

at the Lowest Observed Adverse Effect Level (LOAEL) of 1000 mg/kg/day (No Observed Adverse 

Effect Level (NOAEL) of 300 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 thymus 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 

endpoints are not based on developmental effects, the average body weight of an adult (70 kilograms) 

was used in the exposure assessments. Further, since 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 thymus 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. 
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The cancer classification is “likely to be carcinogenic to humans.” There is no mutagenic 

concern for fluopyram. The available data do not support the proposed modes of action for the 

thyroid or liver tumors. 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, 

Q1

*

(mg/kg/day)

-1

, of fluopyram based upon female rat liver combined adenoma and carcinoma 

tumor rates is 1.55x10-2in 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 relied on the most scientifically-reliable surrogate data 

currently 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 exceed HED’s level of concern.

Handler cancer risk estimates 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 for private growers ranged 

from 1.0 x 10-8to 5.6 x 10-7and for commercial workers ranged from 3.1 x 10-8to 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 (TC) used for all postapplication activities were the TCs 

established by ExpoSAC in the revised SOP No. 3.1. The dislodgeable 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 postapplication cancer risk estimates were assessed for individuals employed by multiple 

establishments (i.e., commercial or migratory farm workers) and were assumed to be exposed 30 
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days per year. Additionally, private growers were assumed to be exposed 10 days per year. 

DFRs 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 retreatment interval for each crop or crop group to estimate cancer risk. For private growers the

cancer risks estimates ranged from 1.6 x 10-7to 1.3 x 10-6. For commercial workers the cancer 

risks estimates ranged from 5.1 x 10-7to 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 

fluopyram technical material. Fluopyram is classified as Toxicity Category III by the acute oral 

and dermal routes of exposure, and Toxicity Category 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 REI that 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 fluopyram is summarized in Table 1. Fluopyram has low acute toxicity by

the oral and dermal routes of exposure (Toxicity Category III) and by 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 Type MRID(s) Results Toxicity 

Category

870.1100 Acute Oral 47372430 LD50 > 2000 mg/kg in females III

870.1200 Acute Dermal 47372432 LD50 > 2000 mg/kg in males 

&, females

III
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TABLE 1. Acute Toxicity Profile – Fluopyram Technical

Guideline No. Study Type MRID(s) Results Toxicity 

Category

870.1300 Acute Inhalation (4 hr) 47372434 LC50 > 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 Not irritating IV

870.2600 Dermal Sensitization 47372440 Not sensitizing N/A

870.2600 Dermal Sensitization 47753403 Not 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 Human Health Risk 

Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty 

Factors

Level of Concern 

for Risk 

Assessment

Study and Toxicological Effects

Short- (1-30 days) 

& IntermediateTerm Dermal (1-6 

months)

NOAEL = 

300 

mg/kg/day

UFA = 10x 

UFH = 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) 

& IntermediateTerm (1-6 

months) 

Inhalation

NOAEL = 

14.5 

mg/kg/day

UFA = 10x 

UFH = 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) 

& IntermediateTerm (1-6 

months) Oral

NOAEL = 

14.5 

mg/kg/day

UFA = 10x 

UFH = 10x 

UFDB = 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. 
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Table 2. Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Human 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 humans 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, Q1

*

(mg/kg/day)-1, of fluopyram based upon female rat liver combined adenoma and carcinoma tumor 

rates is 1.55 x 10-2in 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. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFDB = 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 provides a summary of the proposed uses of fluopyram for agricultural and occupational 

uses.

TABLE 3. Occupational Use Profile for Fluopyram.

Crop1 Target of 

Application

Treatment 

Type Application Equipment

Maximum 

Single 

Application 

Rate

(lb ai/A)

ReTreatment 

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, Soilless MixBroadcast

Chemigation, 

Groundboom,

Handwand, 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
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TABLE 3. Occupational Use Profile for Fluopyram.

Crop1 Target of 

Application

Treatment 

Type Application Equipment

Maximum 

Single 

Application 

Rate

(lb ai/A)

ReTreatment 

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, Soilless MixBroadcast

Chemigation, 

Groundboom,

Handwand, 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 Black and English (Persian) walnuts].

4.0 OCCUPATIONAL EXPOSURE/RISK PATHWAY

The new proposed uses of fluopyram 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 Fluopyram 500 SC Fungicide, a liquid formulation containing 

41.5% ai (4.16 lb /gal) fluopyram.

4.1 Occupational Handler Exposure

Fluopyram 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,
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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/applying sprays with low pressure handwand equipment,

10. Mixing/loading/applying sprays with high pressure handwand equipment, and

11. Mixing/loading/applying sprays with backpack sprayer equipment.

4.1.1 Data and Assumptions for Occupational Handler 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 

currently 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 tables 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 generally 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, by 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 systems, 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 rates ranged from 0.092 to 0.22 lb ai/acre and are

proposed for broadcast foliar application to the agricultural crops.

Body Weight:

70 kg

Absorption Factors:

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 (μg 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 exposure 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 by 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:
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Average Daily Dose = Absorbed dose received from exposure to a pesticide in a given 

scenario (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

assessment.

Margin of Exposure (MOE): The daily dermal dose and daily inhalation dose received by 

occupational handlers were compared to the appropriate point of departure (i.e., NOAEL) 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 = NOAEL (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

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(A/day) 

Unit Exposured Daily Exposuree(mg/kg/day) MOEf

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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

0.00550 No Data 0.0000748 55,000 No Data 190,000

Dried Beans 0.13 0.00325 No Data 0.0000442 92,000 No Data 190,000

Cherry, Potato 0.092 0.00230 No Data 0.0000313 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 0.0786 0.0161 0.34

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

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(A/day) 

Unit Exposured Daily Exposuree(mg/kg/day) MOEf

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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 

Liquid 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 

Liquid 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 

Liquid 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 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. 

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 fluopyram as “likely to be 

carcinogenic to humans” by all routes of exposure 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. To estimate the risk from exposure to fluopyram, the Q1* of 1.55x10-2

(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 fluopyram 

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 fluopyram 

products 10 days a year, and a commercial applicator applies fluopyram 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 Daily Dose (LADD) is calculated and compared with a Q1* that has been calculated for 

fluopyram based on dose response data in the appropriate toxicology study (Q1* = 1.55 x 10-2

(mg/kg/day)

-1

). Absorbed average daily 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 populations 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. Finally, a 35 year career and a 70 year 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 daily 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 lifetime that an individual spends engaged in a career 

involving pesticide exposure (35 years)

Lifetime = The average life expectancy of an individual (70 years)

Cancer Risks: Finally, cancer risk calculations were completed by comparing the LADD values 

calculated above to the Q1* for fluopyram (Q1* = 1.55.x 10-2(mg/kg/day)-1). The Agency

considered more typical 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 

year). Cancer risk values were calculated using the following equation:

All of the cancer risk calculations for occupational fluopyram handlers completed in this 

assessment are included in Tables 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 cancer risk estimates for combined 

inhalation and dermal (with gloves) exposures for private growers ranged from 1.0 x 10-8to 5.6 x 

10-7and for commercial workers ranged from 3.1 x 10-8to 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

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(acres/day) 

Unit Exposured Average Daily Dosee(mg/kg/day) LADD f(mg/kg/day) Cancer Riskg

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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 

Liquid Concentrates 

for Aerial 

Applications

Peanut, Strawberry, 

Tree Nuts 0.22

350 0.22 0.0376 0.219

4.60E-3 7.87E-4 2.41E-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 1.42E-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 1.01E-4 2.63E-5 4.50E-6 1.38E-6 4.3E-7 9.1E-8

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

4.60E-3 7.87E-4 2.41E-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 1.97E-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 

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

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 

Liquids 

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 0.0000442 8.46E-7

No 

Data 5.75E-7 2.2E-8 No Data

Cherry, Potato 0.092 4.37E-5 No Data 0.0000313 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

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(acres/day) 

Unit Exposured Average Daily Dosee(mg/kg/day) LADD f(mg/kg/day) Cancer Riskg

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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 0.0786 0.0161 0.34

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 6.99E-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 5.05E-5 3.04E-6 6.22E-7 6.92E-7 5.8E-8 2.0E-8

Sugar Beet 0.11 1.88E-4 3.84E-5 4.27E-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 3.57E-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 5.66E-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 2.37E-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 3.85E-4 3.15E-6 NA 5.27E-6 1.3E-7 NA

Dried Beans 0.13 1.36E-4 NA 2.28E-4 1.86E-6 NA 3.12E-6 7.7E-8 NA

Cherry, Potato 0.092 9.61E-5 NA 1.61E-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 4.71E-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 1.89E-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 4.71E-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 Inhalation: 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) * Absorption 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 

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(acres/day) 

Unit Exposured Average Daily Dosee(mg/kg/day) LADD f(mg/kg/day) Cancer Riskg

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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 

Liquid Concentrates 

for Aerial 

Applications

Peanut, Strawberry, 

Tree Nuts 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

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

Cherry, Potato 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 

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

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 

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

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 

Liquids 

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 7.48E-5 4.29E-6 No 3.07E-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 

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(acres/day) 

Unit Exposured Average Daily Dosee(mg/kg/day) LADD f(mg/kg/day) Cancer Riskg

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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 0.0786 0.0161 0.34

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 5.66E-4 3.54E-5 2.36E-5 2.33E-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 3.85E-4 9.45E-6 NA 1.58E-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 4.71E-4 1.23E-3 5.28E-6 1.94E-5 1.9E-5 3.8E-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 1.89E-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 4.71E-4 3.08E-5 3.07E-5 1.94E-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 

Ratea

(lb ai/A)

Area 

Treated 

Dailyb

(acres/day) 

Unit Exposured Average Daily Dosee(mg/kg/day) LADD f(mg/kg/day) Cancer Riskg

Baseline 

Dermalc

(mg/lb ai)

PPE-G 

Dermalc

(mg/lb ai)

Baseline 

Inhalationc

(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 (30 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 routes. Based 

on the Agency's current practices, a quantitative post-application inhalation exposure assessment 

was not performed for fluopyram at this time primarily because of the low acute inhalation 

toxicity (Toxicity Category IV), low vapor pressure (1.2x10-6Pa at 20oC), 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-application activities in previously treated 

fields. These potential sources include volatilization of pesticides and resuspension of dusts 

and/or particulates that contain pesticides. The Agency sought expert advice and input on issues 

related to volatilization of pesticides from its Federal Insecticide, 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 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 fluopyram.

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 

fluopyram 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 bodyweight values discussed above in the handler

exposure section, the following assumptions were made in assessing short- and intermediateterm dermal postapplication risks:

Dislodgeable foliar residues:

There were no chemical-specific dislodgeable foliar residue data to assess postapplication risks 

to workers while performing tasks related to crops treated with fluopyram. For agricultural 

crops, occupational 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 Coefficients:

HED uses a concept known as the transfer coefficient to numerically represent the 

postapplication exposures one would receive (generally 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 Dermal Exposure: 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 (cm2/hour), 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)tx 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 530 to 5,600. 

Table 7. Summary of Occupational Non-Cancer Postapplication Risks (Short- and Intermediate-Term) with 

HED Default Assumptions.

Crop Grouping

Application 

rate

(lb ai/acre)

Default DFR on 0 

days (12 hrs) after 

applicationa

(μg/cm2)

Work Activity & 

Maximum Transfer 

Coefficientb(cm

2

/hr)

Daily Dosec

(mg/kg/day)

MOEd

(LOC = 100)

Apples 0.22 0.493 3,600 - Thinning 0.203 1,500

Cherry 0.092 0.206 3,600 - Thinning 0.0848 3,500

Dried Beans 0.13 0.292 1,900 - Irrigation 0.0634 4,700

Peanuts 0.22 0.493 1,900 - Irrigation 0.107 2,800

Potatoes 0.18 0.404 1,900 - Irrigation 0.0877 3,400

Strawberries 0.22 0.493 1,100 – Hand Harvest 0.0620 4,800

Sugar Beets 0.11 0.247 1,900 - Irrigation 0.0536 5,600

Tree Nuts 0.22 0.493 3,600 - Thinning 0.203 1,500

Watermelon 0.22 0.493 1,900 - Irrigation 0.107 2,800

Viniferous variety

Grapes 0.22 0.493 10,100 - Harvest (hand), Training, Tying, Leaf Pulling 0.569 530

a. Default DFR (μg/cm2) = application rate (lb ai/A) x (1- daily dissipation rate) tx 4.54E+8 μg/lb x 24.7E-9 A/cm2x 

20% DFR after initial treatment.

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

c. Daily Dose = DFR x TC 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 REI is based on the acute toxicity of fluopyram technical material. 

Fluopyram is classified as Toxicity Category III by the acute oral and dermal routes of exposure

and Toxicity Category 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 

REI that 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.

Postapplication cancer 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. For private 

growers the cancer risks estimates ranged from 1.6 x 10-7to 1.3 x 10-6. For commercial workers 

the cancer risks estimates ranged from 5.1 x 10-7to 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 employed.
Page 24 of 25

Table 8. Summary of Occupational Postapplication Cancer Risks with HED Default Assumptions.

Crop Grouping

Average DFR after 

applicationa

(μg/cm2)

Work Activity & 

Maximum Transfer Coefficientb(cm2/hr)

Dermal Average Daily 

Dosec(mg/kg/day)

Dermal LADDd

(mg/kg/day) Cancer Riske

Apples 0.351 3,600 - Thinning 2.74E-3 1.13E-4 1.7E-6

Cherry 0.161 3,600 - Thinning 1.26E-3 5.18E-5 8.0E-7

Dried Beans 0.208 1,900 - Irrigation 8.59E-4 3.53E-5 5.5E-7

Peanuts 0.261 1,900 - Irrigation 1.08E-3 4.44E-5 6.9E-7

Potatoes 0.315 1,900 - Irrigation 1.30E-3 5.34E-5 8.3E-7

Strawberries 0.385 1,100 – Hand Harvest 9.20E-4 3.78E-5 5.9E-7

Sugar Beets 0.193 1,900 - Irrigation 7.96E-4 3.27E-5 5.1E-7

Tree Nuts 0.351 3,600 - Thinning 2.74E-3 1.13E-4 1.7E-6

Watermelon 0.385 1,900 - Irrigation 1.59E-3 6.53E-5 1.0E-6

Viniferous variety Grapes 0.283 10,100 - 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 by homeowners, or by occupational 

handlers in residential settings. Therefore, non-occupational/residential risk assessments have 

not been completed.

Spray Drift

Spray 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 fluopyram. The Agency has been working with the Spray Drift Task Force, 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 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 practices to reduce off-target drift 

and risks associated with aerial as well as other application types 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 fluopyram at this time primarily because of the low acute 

inhalation toxicity (Toxicity Category IV), low vapor pressure (1.2x10-6Pa at 20oC), 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 policies 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 post-application inhalation exposure assessment 

for fluopyram.