Document ID: EPA-HQ-OPP-2009-0364-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-12-22T05:00Z

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.

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-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 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[(R)] 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.  

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[-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 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[-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 (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 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 (ug/cm[2]) 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[-][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 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
                                   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) & Intermediate-Term 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) & Intermediate-Term (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) & Intermediate-Term (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. 
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[-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.  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.
                                       
                                    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, 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
                              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, 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,
      
   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 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 (ug ai/lb ai handled) * Application Rate (lbs ai/A or gal) * Daily Amount Handled (A or gal/day) * Conversion Factor (mg/1,000 ug)

	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 (ug 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:

	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.  

Table 4. Non-Cancer Occupational Short- and Intermediate-Term Dermal and Inhalation Exposures and Risk Estimates For Fluopyram
                               Exposure Scenario
                                Crop or Target
                              ApplicationRate[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] (ug/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

                                    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.	

      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 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:

Total Risk = LADD x Q1*

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[-][8] to 5.6 x 10[-][7] and for commercial workers ranged from 3.1 x 10[-][8] to 8.8 x 10[-][7].

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 Risk[g]

Baseline Dermal[c] (mg/lb ai)
PPE-G Dermal[c] (mg/lb ai)
Baseline Inhalation[c] (ug/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
                   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.  
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 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 Risk[g]

Baseline Dermal[c] (mg/lb ai)
PPE-G Dermal[c] (mg/lb ai)
Baseline Inhalation[c] (ug/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 Aerial Equipment
                         Peanut, Strawberry, Tree Nuts
                                     0.22
                                      350
                             0.005 (Eng. Control)
                                    No Data
                             0.068 (Eng. Control)
                            1.05E-4 (Eng. Control)
                                    No Data
                            7.48E-5 (Eng. Control)
                                    4.29E-6
                                    No Data
                                    3.07E-6
                                    1.1E-7
                                    No 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 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
                                    3.08E-5
                                    3.07E-5
                                    1.94E-5
                                    7.8E-7
                                    7.8E-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.  
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).

	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[-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-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 intermediate-term 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 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 cm[2]/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) (ug/cm[2]) x TC (cm[2]/hr) x Hr/Day)/1,000 (ug/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" (ug/cm[2]),
	TC	=	Transfer Coefficient (cm[2]/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:

	Default DFR (ug/cm[2]) = 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 ug/lb, and
      	CF2 = 2.47E-8 A/cm[2].
   
		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 application[a]
                                   (μg/cm2)
                             Work Activity & 
                  Maximum Transfer Coefficient[b] (cm[2]/hr)
                                 Daily Dose[c]
                                  (mg/kg/day)
                                    MOE[d]
                                  (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 (ug/cm[2]) = application rate (lb ai/A) x (1- daily dissipation rate) [t] x 4.54E+8 ug/lb x 24.7E-9 A/cm[2] x 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 ug) x ET (8 hr/day) / body weight (70 kg)
   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 (ug/cm[2]) 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[-][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 employed.

Table 8.  Summary of Occupational Postapplication Cancer Risks with HED Default Assumptions.
                                 Crop Grouping
                       Average DFR after application[a] 
                                  (μg/cm2) 
                             Work Activity & 
                  Maximum Transfer Coefficient[b] (cm[2]/hr)
                   Dermal Average Daily Dose[c] (mg/kg/day)
                          Dermal LADD[d] (mg/kg/day)
                                Cancer Risk[e]
                                    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 (ug/cm[2]).
   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 ug) 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).

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