                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460      

                                                     	OFFICE OF CHEMICAL SAFETY
                                                      	AND POLLUTION PREVENTION
	


Date:	December 18, 2015

Subject:	Fluopyram.  Occupational and Residential Exposure Assessment for New Uses on artichoke (globe), Brassica (cole) leafy vegetables, Brassica (cole) leafy vegetables head and stem subgroup, bulb vegetables, canola, carrot, cereal grains (except rice), citrus, corn (including field, sweet, popcorn, and field corn grown for seed)cotton, cucurbit vegetables, fruiting vegetables, ginseng, grapes and small vines fruits (except fuzzy kiwifruit), herbs and spices (except black pepper), hops, leafy vegetables, legume vegetables (including soybean), peanut, pome fruits, potato and other root, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit, strawberry and other low growing berries, sugar beet, sunflower subgroup, tree nuts; use as a seed treatment to peanuts; turf grass (golf courses, sod farms, sports fields, residential, industrial, municipal, commercial, and other turf grass areas), ornamentals (in residential and commercial settings), and Christmas trees.

PC Code: 080302
DP Barcode: D426622 
Decision No.: 492321
File Symbols and Registration No.: 432-RLGI; 432-RLGT; 432-RLGA; 432-RLGL; 432-RLUG; 264-1078; 264-1084; 264-1085; 264-1090; 264-1091
Petition No.: 4F8284
Regulatory Action: Section 3
Risk Assessment Type: Occupational/Residential Exposure Assessment
Case No.: NA
TXR No.: NA
CAS No.: 658066-35-4
MRID No.: NA
40 CFR: §180.661

From:	Barry O'Keefe, Senior Biologist
	Risk Assessment Branch III
	Health Effects Division (7509P)

Through:	Christine Olinger, Branch Chief
	Risk Assessment Branch III
	Health Effects Division (7509P)

	and

	Matthew Lloyd, CIH, ExpoSAC Reviewer
	Cassi Walls, Ph.D., ExpoSAC Reviewer
	Exposure Science Advisory Committee (ExpoSAC) / HED
	
To:	Barry O'Keefe, Risk Assessor
	Risk Assessment Branch III
	Health Effects Division (7509P)

	and

      Tamue Gibson, Risk Management Team #20
		Fungicide Herbicide Branch
      Registration Division (7505P)

Introduction

The Health Effects Division (HED) of the Office of Pesticide Programs (OPP) is charged with estimating the risk to human health from exposure to pesticides.  The Registration Division (RD) of OPP has requested that HED evaluate the hazard and exposure data and conduct occupational and residential exposure assessments, as needed, to estimate the risk to human health that will result from the proposed uses of fluopyram; the other active ingredients in the combination products have been addressed in separate assessments.  This memorandum serves as HED's assessment of the occupational and residential exposure and risk from these proposed uses.  

It is HED policy to use the best available data to assess exposure.  Several sources of generic data were used in this assessment as surrogate data in the absence of chemical-specific data, including Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force (ORETF) database; ExpoSAC Policy 14, 15, and 15.1 (SOPs for Seed Treatment), The Reviewer's Aid to Calculating Occupational Exposure from Activities Related to Agricultural Seed Treatment, the Agricultural Reentry Task Force (ARTF) database; and the Residential SOPs (turf, gardens and trees).  Some of these data are proprietary, and subject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  

Note:  This memorandum was reviewed by the Exposure Science Advisory Committee (ExpoSAC) on August 27, 2015.  

                               Table of Contents

1.0	Executive Summary	4
2.0	Risk Assessment Conclusions and Recommendations	7
2.1	Summary of Risk Estimates	7
2.2	Data Deficiencies and Requirements	7
2.3	Label Recommendations	7
3.0	Hazard Characterization	7
4.0	Use Profile	10
5.0	Residential Exposure and Risk Estimates	28
5.1	Residential Handler Exposure/Risk Estimates	28
5.2	Residential Post-application Exposure/Risk Estimates for Proposed Uses	30
5.3	Combined Residential Risk Estimates (Multiple Exposure Scenarios)	32
5.4	Residential Risk Estimates for Use in Aggregate Assessment	32
5.5	Spray Drift	33
5.6	Residential Bystander Post-Application Inhalation Exposure	33
6.0	Occupational Exposure and Risk Estimates	34
6.1	Occupational Handler Exposure/Risk Estimates	34
6.2	Occupational Post-application Exposure/Risk Estimates	43
6.2.1	Occupational Post-application Inhalation Exposure/Risk Estimates	44
6.2.2	Occupational Post-application Dermal Exposure/Risk Estimates	44
Appendix A.  Summary of Occupational and Residential Non-cancer Algorithms	51

1.0	Executive Summary

The active ingredient, fluopyram (N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide) is a pyridylethylamide SDH (succinate-dehydrogenase-inhibitor, complex II) fungicide with broad spectrum of activity against fungal diseases in a wide range of crops.  

Use Profile
The registrant, Bayer CropScience, is requesting numerous new uses on agricultural field crops and crop groups be added to the Luna[(R)] Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264-1078] that contains the sole active ingredient (ai) fluopyram.  Additionally, Bayer CropScience is requesting to add numerous agricultural field crops and crop groups to the following multi-active ingredient labels: 1) Propulse[TM] (1.67 lb ai/gal) [EPA Reg. No. 264-1084] which contains fluopyram and prothioconazole; 2) Luna[(R)] Tranquility (1.04 lb ai/gal) [EPA Reg. No. 264-1085] which contains fluopyram and pyrimethanil; 3) Luna[(R)] Sensation (2.1 lb ai/gal) [EPA Reg. No. 264-1090] which contains fluopyram and trifloxystrobin; and 4) Luna[(R)] Experience (1.67 lb ai/gal) [EPA Reg. No. 264-1091] which contains fluopyram and tebuconazole.  

In addition, Bayer CropScience is requesting a new seed treatment use on peanut seeds to be added to the Luna[(R)] Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264-1078]. 

Bayer CropScience, is also requesting new non-food uses of fluopyram on several newly proposed labels, including turf grass (golf courses, sod farms, sports fields, residential, industrial, municipal, commercial, and other turf grass areas), ornamentals (in residential and commercial landscapes, interiorscapes, field grown and container ornamentals, in nurseries, and greenhouses, lathhouses, shadehouses, containers and other enclosed structures), fruit and nut trees (including citrus, grapes, pome fruits, stone fruits, and tree nuts), ornamental sunflower, and Christmas trees.  The proposed labels are as follows: 1) Fluopyram 500 SC (4.16 lb ai/gal) [EPA File Symbol 432-RLGI] which contains fluopyram; 2) FLU+TFS SC 500 (2.1 lb ai/gal) [EPA File Symbol 432-RLGT] which contains fluopyram and trifloxystrobin; 3) FLU+TFS SC 32.5 (0.104 lb ai/gal) [EPA File Symbol 432-RLGA] which contains fluopyram and trifloxystrobin; 4) FLU+TFS SC 25 (0.104 lb ai/gal) [EPA File Symbol 432-RLGL] which contains fluopyram and trifloxystrobin; and 5) 13ESP715 3.3 SC (3.34 lb ai/gal) [EPA File Symbol 432-RLUG] which contains fluopyram.  

Most of the proposed labels require occupational handlers to wear the following personal protective equipment (PPE): long sleeved shirts, long pants, shoes, socks, and chemical resistant gloves.  However, the FLU+TFS SC 32.5 and FLU+TFS SC 25 labels do not require the use of gloves.  Additionally, for the Luna[(R)] Privilege label requires water proof gloves for seed treatment activities and no gloves for baggers and bag sewers.

On all registered and proposed labels the restricted entry interval (REI) is 12 hours.

Fluopyram is currently registered on a variety of agricultural food crops, including apple, cherry (sweet and tart), cotton, dried beans, peanut, potato, strawberry, sugar beets, tree nuts, watermelon, viniferous variety grapes, and for seed treatment to cotton and soybean.  There are no existing residential uses of fluopyram.

Exposure Profile
There is a potential for short- and intermediate-term occupational dermal and inhalation exposure to fluopyram during handling tasks (mixing, loading, and application) and during post-application activities.  Long-term occupational exposure is not expected for the proposed use patterns associated with fluopyram.  There is a potential for residential short-term dermal and inhalation exposure to fluopyram to adults during handling tasks.  During residential post-application activities there is a potential for short-term dermal exposure to adults, youths, and children and incidental oral exposure to children 1 to <2 years old.

Hazard Concerns
There have been no changes in the hazard characterization, toxicity endpoints, or points of departure (PODs) since the last risk assessment for fluopyram.  The toxicity database is considered complete for risk assessment.  The liver was the target organ across species and exposure durations.  Treatment-related thyroid effects were also observed at dose levels causing adverse liver perturbations in rats and mice.  Decreased body weight was a common clinical finding throughout the toxicology database.  Liver tumors were observed in female rats and thyroid tumors were observed in male mice in chronic feeding studies.  

Short- and intermediate-term dermal endpoints were chosen from a dermal toxicity study in rats in which increased prothrombin time and altered cholesterol levels were seen at the limit dose (NOAEL = 300 mg/kg/day).  Short- and intermediate-term inhalation and short-term incidental oral risks are based on clinical chemistry and kidney effects in the parental generation 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 subchronic inhalation study data requirement was waived by the Hazard and Science Policy Council (HASPOC, K. Rury, 1/30/13, TXR No. 0056523).  Since the dermal and inhalation endpoints are not based on developmental effects, the average body weight of an adult (80 kg) was used in the exposure assessments.  Since the toxicological effects for dermal and inhalation routes are not similar, the risk estimates from both routes are not combined together.  Also, since the toxicological effects for dermal and incidental oral routes are not similar, the risk estimates from both routes are not combined together.

HED recommends that the Food Quality Protection Act (FQPA) safety factor be reduced to 1x because there are no residual uncertainties with regard to pre- and postnatal susceptibility, the toxicology database is complete, and there is no evidence of neurotoxicity.

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. 

The cancer classification is "not likely to be carcinogenic to humans."  There is no mutagenic concern for fluopyram.  

Occupational Exposure
No chemical-specific handler exposure data were submitted in support of these Section 3 registrations.  To assess handler exposures for regulatory actions when chemical-specific monitoring data are not available, HED used the most scientifically-reliable surrogate data currently available from various sources such as the PHED and the AHETF.  Some of this data, such as the industry task force data, is compensatory, subject to the data protection provisions of FIFRA.  

For occupational handlers for agricultural crops, turf, and Christmas trees, all short- and intermediate-term risk estimates resulted in margins of exposure (MOEs) >=100, and therefore, do not exceed HED's level of concern at any level of protection.  For dermal exposures at baseline personal protective equipment (PPE), MOEs range from 410 to 1,500,000.  For dermal exposures with gloves, MOEs range from 2,400 to 1,100,000.  For inhalation exposures, MOEs range from 7,400 to 5,400,000.  For the seed treatment use on peanut seeds, risk estimates for dermal and inhalation short-term occupational handler exposures all resulted in MOEs >=100, and therefore, do not exceed HED's level of concern, with MOEs ranging from 1,400 to 9,200 for dermal exposures and from 1,700 to 17,000 for inhalation exposures.

Short- and intermediate-term dermal post-application exposures and risks to occupational workers were estimated using standard values established by HED, since no chemical-specific data were submitted.  For all occupational post-application scenarios the dermal MOEs, at day zero following application, do not exceed HED's level of concern (MOEs >=100), with dermal MOEs ranging from 270 to 23,000.  Additionally, several post-application worker scenarios involved with the mechanical harvesting of cotton were assessed.  The dermal exposures to these harvesters of cotton resulted in risk estimate MOEs ranging from 3,100,000 to 17,000,000, which also do not exceed HED's level of concern (MOEs >=100).

Based on the Agency's current practices, a quantitative occupational post-application inhalation exposure assessment was not performed for fluopyram at this time.  If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post-application inhalation exposure assessment for fluopyram.

Restricted Entry Interval:  The 12-hour REI that appears on the registered and proposed labels is adequate to protect for worker exposure to fluopyram.  

Residential Exposure
All residential handler risk estimates are not of concern to HED (all MOEs >=100), with MOEs ranging from 8,900 to 190,000 for dermal exposures and 260,000 for inhalation exposures.

For treated lawns and turf, all residential post-application risk estimates are not of concern to HED (all MOEs >=100), with dermal post-application MOEs for all life stages ranging from 1,000 to 97,000 and incidental oral post-application MOEs for children 1 to <2 years old ranging from 2,400 to 1,100,000.  For treated gardens, ornamental trees and shrubs, and fruit trees, the dermal post-application MOEs for all life stages range from 2,100 to 33,000 and are not of concern to HED (MOEs >=100).

Human Studies Review
This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These data, which include studies from PHED 1.1; the AHETF database; the ARTF database; the ORETF database, and ExpoSAC Policies 14, 15, and 15.1 (SOPs for Seed Treatment), and The Reviewer's Aid to Calculating Occupational Exposure from Activities Related to Agricultural Seed Treatment are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements.  For certain studies, the ethics review may have included review by the Human Studies Review Board.  Descriptions of data sources, as well as guidance on their use, can be found at the Agency website.  

2.0	Risk Assessment Conclusions and Recommendations

2.1	Summary of Risk Estimates

There are no occupational or residential risk estimates of concern associated with the proposed uses of fluopyram.  

2.2	Data Deficiencies and Requirements

There are no data deficiencies or requirements missing from the fluopyram database at this time.

2.3	Label Recommendations

Some of the proposed products for fluopyram are intended for use by residential applicators on home lawns or residential areas, but require certain clothing and/or PPE to be worn.  Generally, the Agency does not consider PPE and clothing requirements to be enforceable on consumer lawn products.  If products containing fluopyram are meant to be marketed towards and applied by residential handlers on residential turf, ornamentals, fruit trees, or gardens, HED recommends that the label requirements for clothing and/or PPE be reevaluated or separate consumer-specific labels be developed.

3.0	Hazard Characterization

Acute Toxicity
The acute toxicity for fluopyram is summarized in Table 3.1.  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 3.1.  Acute Toxicity Profile of 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

Toxicological PODs Used for Risk Assessment
Short- and intermediate-term dermal endpoints were chosen from a dermal toxicity study in rats in which increased prothrombin time and altered cholesterol levels were seen at the limit dose (NOAEL = 300 mg/kg/day).  Short- and intermediate-term inhalation and short-term incidental oral risks are based on clinical chemistry and kidney effects in the parental generation 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 subchronic inhalation study data requirement was waived by the HASPOC (K. Rury, 1/30/13, TXR No. 0056523).  Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure.  Since the dermal and inhalation endpoints are not based on developmental effects, the average body weight of an adult (80 kg) was used in the exposure assessments.  Further, since the toxicological effects for dermal and inhalation routes are not similar, the risk estimates from both routes are not combined together.  

For small children (1 to <2 years old), the risk estimates from the incidental oral and dermal routes should not be combined.  The common effects seen in the dermal tox study (used for establish dermal endpoint) and the 2-generation reproduction study (used to establish the incidental oral endpoint) appeared to be increases in liver weights and hepatocellular hypertrophy, but these effects are adaptive effects.  For the dermal toxicity study, the other endpoints at the LOAEL included increased prothrombin time (which is hematological effect).  In contrast, the other endpoints for establishing the LOAEL were a host of effects including decreases in body weights with decreases in spleen and thymus weights and slight delay in preputial separation in the offsprings.  Therefore, the adverse effects at LOAEL for establishing the tox endpoints in these two studies are different.

HED recommends that the Food Quality Protection Act (FQPA) safety factor be reduced to 1x because there are no residual uncertainties with regard to pre- and postnatal susceptibility, the toxicology database is complete, and there is no evidence of neurotoxicity.

There is no mutagenic concern for fluopyram.  HED classified fluopyram as "Not Likely to be Carcinogenic to Humans" at doses that do not induce cellular proliferation in the liver or thyroid glands (TXR# 0056961, CARC Report, 05/08/2014).  This classification was based on convincing evidence that non-genotoxic modes of action for liver tumors in rats and thyroid tumors in mice have been established and that the carcinogenic effects have been demonstrated as a result of a mode of action dependent on activation of the CAR/PXR receptors.  HED has determined that quantification of risk is not required (TXR# 0056961, CARC Report, 05/08/2014).

A summary of the toxicological doses and endpoints for occupational and residential human health risk assessment is provided in Table 3.2.

Table 3.2.  Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Occupational and Residential Human Health Risk Assessments.
Exposure/
Scenario
Point of Departure
Uncertainty Factors
Level of Concern for Risk Assessment
Study and Toxicological Effects
Incidental Oral Short-Term (1-30 days) and Intermediate-Term (1-6 months)
NOAEL= 14.5 mg/kg/day
UFA= 10X
UFH=10X
FQPA SF=1X

Residential LOC for MOE = 100
2-Generation reproduction study in rats

The LOAEL of 82.8 mg/kg/day is based clinical chemistry changes and increased kidney weight in parents, and decreased body weight and body weight gain with decreases in spleen and thymus weights in offspring.
Dermal Short-Term (1-30 days) and Intermediate-Term (1-6 months)
NOAEL= 300 mg/kg/day
UFA= 10X
UFH=10X
FQPA SF=1X
Residential and Occupational LOC for MOE = 100
A 28-day dermal study in rats

The LOAEL of 1000 mg/kg/day is based on increased cholesterol (F), increased prothrombin time (M).
Inhalation Short- Term (1-30 days) and Intermediate-Term (1-6 months)
NOAEL= 14.5 mg/kg/day
UFA= 10X
UFH=10X
FQPA SF=1X
Residential and Occupational LOC for MOE = 100
2-Generation reproduction study in rats

The LOAEL of 82.8 mg/kg/day is based clinical chemistry changes and increased kidney weight in parents, and decreased body weight and body weight gain with decreases in spleen and thymus weights in offspring.
Cancer (oral, dermal, inhalation)
Classification: The CARC classified fluopyram as "Not Likely to be Carcinogenic to Humans" at doses that do not induce cellular proliferation in the liver or thyroid glands.
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).  MOE = margin of exposure.  LOC = level of concern.

4.0	Use Profile 

Fluopyram is currently registered on a variety of agricultural food crops, including apple, cherry (sweet and tart), cotton, dried beans, peanut, potato, strawberry, sugar beets, tree nuts, watermelon, viniferous variety grapes, and for seed treatment to cotton and soybean.  There are currently no existing residential uses of fluopyram.

The registrant, Bayer CropScience, is requesting the addition of new uses of fluopyram on registered liquid formulation product labels, as follows: 

      1) The Luna[(R)] Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264-1078] contains only the active ingredient fluopyram.  New uses are proposed on artichoke (globe), Brassica (cole) leafy vegetables, bulb vegetables, canola, carrot, cereal grains (except rice), citrus, cotton, cucurbit vegetables, fruiting vegetables, ginseng, grapes and small vines fruits (except fuzzy kiwifruit), herbs and spices (except black pepper), hops, leafy vegetables, legume vegetables (including soybean), peanut, pome fruits, potato and other root, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit, strawberry and other low growing berries (except cranberries), sugar beet, sunflower subgroup, and tree nuts.  Additionally, the Luna Privilege label is also proposed for use as a seed treatment to peanuts.

      2) The Propulse[TM] label (1.67 lb ai/gal) [EPA Reg. No. 264-1084] contains the active ingredients fluopyram and prothioconazole.  New uses are proposed on barley, buckwheat, bushberry subgroup, canola, corn, crambe, cucurbit vegetables, field mustard, Indian rapeseed, low growing berries (except strawberries and cranberries), millet (pearl and proso), oats, rapeseed, rye, soybean, triticale, and wheat (spring, durum, and winter).
      
      3) The Luna[(R)] Tranquility label (1.04 lb ai/gal) [EPA Reg. No. 264-1085] contains the active ingredients fluopyram and pyrimethanil.  New uses are proposed on bulb vegetables, ginseng, lemons, pome fruit, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit (except cherries), strawberries and other low-growing berries (except cranberries), and tomato.
      
      4) The Luna[(R)] Sensation label (2.1 lb ai/gal) [EPA Reg. No. 264-1090] contains the active ingredients fluopyram and trifloxystrobin.  New uses are proposed on artichoke (globe), Brassica (head and stem subgroup), Brassica (leafy greens subgroup), carrot, citrus, cucurbit vegetables, fruiting vegetables, ginseng, grapes and small vines fruits (except fuzzy kiwifruit), herbs and spices (except black pepper), hops, leafy vegetables (leafy greens subgroup), leafy vegetables (leaf petioles subgroup), pome fruits, potato and other root, tuberous and corm vegetables, soybean, stone fruit, strawberry and other low growing berries (except cranberries), and wheat.
      
      5) The Luna[(R)] Experience label (1.67 lb ai/gal) [EPA Reg. No. 264-1091] contains the active ingredients fluopyram and tebuconazole.  New uses are proposed on barley, bean (fresh and dry, except succulent shelled), bulb vegetable, corn (sweet corn, field corn, field corn grown for seed, and popcorn), cotton, cucurbit vegetables, fruiting vegetables, grapes and small vines fruits (except fuzzy kiwifruit), hops, leafy Brassica greens, okra, pome fruits, soybean, stone fruit, sunflower, and wheat.

Bayer CropScience, is also requesting the registration of several new end-use products containing the following new non-food uses of fluopyram: turf grass (golf courses, sod farms, sports fields, residential, industrial, municipal, commercial, and other turf grass areas), ornamentals (in residential and commercial landscapes, interiorscapes, field grown and container ornamentals, in nurseries, and greenhouses, lathhouses, shadehouses, containers and other enclosed structures), and Christmas trees.  These new end-use product labels also include proposed uses on citrus, grapes and small vine fruits, pome fruits, stone fruits, sunflower, and tree nuts.  All of these uses can be used by occupational, as well as residential, handlers.  The proposed end-use product labels are as follows: 1) Fluopyram 500 SC (4.16 lb ai/gal) [EPA File Symbol 432-RLGI] which contains the active ingredient fluopyram; 2) FLU+TFS SC 500 (2.1 lb ai/gal) [EPA File Symbol 432-RLGT] which contains the active ingredients fluopyram and trifloxystrobin; 3) FLU+TFS SC 32.5 (0.104 lb ai/gal) [EPA File Symbol 432-RLGA] which contains the active ingredients fluopyram and trifloxystrobin; 4) FLU+TFS SC 25 (0.104 lb ai/gal) [EPA File Symbol 432-RLGL] which contains the active ingredients fluopyram and trifloxystrobin; and 5) 13ESP715 3.3 SC (3.34 lb ai/gal) [EPA File Symbol 432-RLUG] which contains the active ingredient fluopyram.  

The proposed labels require occupational handlers to wear the following attire and PPE: long sleeved shirts, long pants, shoes, socks, and chemical resistant gloves.  However, the FLU+TFS SC 32.5 and FLU+TFS SC 25 labels do not require the use of gloves.  Additionally, for seed treatment of peanuts, the Luna[(R)] Privilege label requires water proof gloves for seed treatment activities and no gloves for baggers and bag sewers.

On all registered and proposed labels the proposed REI for new uses is 12 hours.

The proposed uses and application rates are described in detail in Table 4.1.



Table 4.1.  Summary of Proposed Directions for Use of Fluopyram.
Application Timing, Type, and Equip.
                                  Formulation
                                [EPA Reg. No.]
                                     Crops
                               Application Rate 
                                   (lb ai/A)
                          Max. No. Applic. per Season
                          Max. Seasonal Applic. Rate
                                   (lb ai/A)
                                      PHI
                                    (days)
                        Use Directions and Limitations
                            Agricultural Use Sites
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                               Artichoke (globe)
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 10 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                       
                                       
                                       

Ground, aerial or chemigation
Luna Sensation
(2.1 lb ai/gal) [264-1090]
Brassica Leafy Vegetables Head and Stem Subgroup: Broccoli, Chinese broccoli (Gai Lon), Brussels sprouts, Cabbage, Chinese cabbage (Napa), Chinese cabbage (Bok choy), Chinese mustard cabbage (Gai choy), Cauliflower, Cavalo broccolo, Kohlrabbi.  Including all cultivars and/or hybrids of these.
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 10 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Brassica (cole) Leafy Vegetables: Broccoli, Broccoli raab (Rapini), Brussels sprouts, Cabbage, Cauliflower, Cavalo broccoli, Chinese broccoli (Gai Lon), Chinese cabbage (Bok choy), Chinese cabbage (Napa), Chinese mustard cabbage (Gai choy), Collards, Kale, Mizuna, Mustard greens, Mustard spinach, Rape greens, and Turnip greens.  Including all cultivars and/or hybrids of these.
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 5 to 10 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
Brassica Leafy Vegetables Leafy Greens Subgroup: Broccoli raab (Rapini), Chinese cabbage, Collards, Kale, Mizuna, Mustard greens, Mustard spinach, Rape greens, and Turnip greens.  Including all cultivars and/or hybrids of these.
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 14 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
Leafy Brassica Greens (Crop Subgroup 5B):  Broccoli raab (rapini), Chinese cabbage (bok choy), Collards, Kale, Mizuma, Mustard greens, Mustard spinach, Rape greens, and Turnip greens,
                                0.0783 to 0.112
                             (6.0 to 8.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Bulb Vegetables: Chive fresh leaves, Chive fresh leaves (Chinese), Daylily bulb, Elegans hosta, Fritillaria (bulb and leaves), Garlic bulb, Garlic bulb (Great headed and Serpent), Kurrant, Leek, Leek (Lady's and Wild), Lily bulb, Onion (Beltsville bunching, Bulb, Chinese bulb, Fresh, Green, Macrostem, Pearl, Potato bulb, Tree tops, and Welsh), Shallot (bulb and fresh leaves).  Including all cultivars and/or hybrids of these.
                                 0.13 to 0.222
                             (4.0 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 5 to 7 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
Bulb Vegetables: Chive fresh leaves, Chive fresh leaves (Chinese), Daylily bulb, Elegans hosta, Fritillaria (bulb and leaves), Garlic bulb, Garlic bulb (Great headed and Serpent), Kurrant, Leek, Leek (Lady's and Wild), Lily bulb, Onion (Beltsville bunching, Bulb, Chinese bulb, Fresh, Green, Macrostem, Pearl, Potato bulb, Tree tops, and Welsh), Shallot (bulb and fresh leaves).
                                0.104 to 0.167
                             (8.0 to 12.8 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 10 to 14 days.

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
Bulb Vegetables: Dry Bulb Onion, Eschalots, Green Onion, Garlic, Leeks, Japanese Bunching Onion, Scallions, Shallot, and Spring Onion.
                                0.130 to 0.219
                            (16.0 to 27.0 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Canola subgroup: Borage, Crambe, Cuphea, Echium, Flax seed, Gold of pleasure, Hare' ear mustard, Lesquerella, Lunaria, Meadowfoam, Milkweed, Mustard seed, Oil radish, Poppy seed, Rapeseed, Sesame, and Sweet rocket. Including cultivars, varieties, and/or hybrids of these.
                                     0.222
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 12 to 14 days.
Ground, aerial or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
            Canola Rapeseed, Indian Rapeseed, Field Mustard, Crambe
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                      36
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                                    Carrot
                                0.156 to 0.222
                             (4.8 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 5 to 7 days.  Tops or greens from this crop may be utilized for food or feed.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                       
                                       
                                       7
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Cereal Grains (except Rice): Barley, Buckwheat, Corn (Sweet Corn, Field Corn, Field Corn Grown for Seed, and Popcorn), Millet, (Pearl and Proso), Oats, Rye, Sorghum, Sudan Grass, Teosinte, Triticale, and Wheat.
                                     0.222
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 14 days.  Do not allow livestock to graze treated area for 14 days and do harvest for food or feed within 14 days of application.
Ground, aerial or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
                                    Barley
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                      32
Retreatment interval of 14 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
                                    Barley
                                     0.112
                                 (8.6 fl oz/A)
                                      NS
                                     0.446
                                      30
Retreatment interval not specified.  Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application.
Ground or aerial
Propulse
(1.67 lb ai/gal) [264-1084]
                Buckwheat, Millet (Pearl and Proso), Oats, Rye
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                      30

Ground, aerial or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
                                     Wheat
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                      30
Retreatment interval of 14 days.  

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                     Wheat
                                     0.112
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                      35
Retreatment interval of 14 to 21 days.  If two applications or 0.224 lb ai/A/yr are applied, do not allow livestock to graze within the treated area and do not harvest the treated crop for forage or hay.  If one application or 0.112 lb ai/A/yr are applied, do not allow livestock to graze within the treated area within 30 days after application, and do not harvest the treated crop for forage within 30 days after application or for hay within 45 days after application.

Luna Experience
(1.67 lb ai/gal) [264-1091]
                                     Wheat
                                     0.112
                                 (8.6 fl oz/A)
                                      NS
                                     0.446
                                      30
Retreatment interval not specified.  Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed for 14 days of application.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Forage, Fodder or Straw from Cereal Grains: Barley, Buckwheat, Corn (Sweet Corn, Field Corn, Field Corn Grown for Seed, and Popcorn), Millet, (Pearl and Proso), Oats, Rye, Sorghum, Sudan Grass, Teosinte, Triticale, and Wheat.
                                     0.222
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 14 days.  Do not allow livestock to graze treated area for 14 days and do harvest for food or feed within 14 days of application.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Citrus: Australian desert lime, Australian finger-lime, Brown River finger lime, Calamondin, Citron, Citrus hybrids, Grapefruit, Japanese summer grapefruit, Kumquat, Lemon, Lime, Mediterranean mandarin, Mount white lime, New Guinea wild lime, Orange (sour and sweet), Pummelo, Russell River lime, Satsuma mandarin, Sweet lime, Tachibana orange, Tahiti lime, Tangelo, Tangerine (Mandarin), Tangor, Trifoliate orange, Uniq fruit, White sapote (Casimiroa spp.) and cultivars, varieties, and/or hybrids of these.
                                0.156 to 0.222
                             (4.8 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 21 days.  Minimum 30 day interval between soil applications.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
Citrus: Calamondin, Citrus Citron, Citrus hybrids (Citrus spp., includes Chironja, Tangelo and Tangor), Grapefruit, Grapefruit, Kumquat, Lemon, Lime, Mandarin (Tangerine), Orange (Sweet and Sour), Pummelo, Tangelo, Satsuma Mandarin, White Sapote (Casimiroa spp.), and other cultivars and/or hybrids of these.
                                     0.125
                                 (7.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 21 days.

Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                                    Citrus
                        0.156 to 0.221 lb ai/100 gal/A
                          4.8 to 6.8 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 13.7 fl oz/A
                                       7
Retreatment interval of 7 to 21 days.  Retreatment interval for nematode control is 30 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                             0.125 lb ai/100 gal/A
                              7.6 fl oz/100 gal/A
                                       
                                 0.446 lb ai/A
                                 27.3 fl oz/A
                                       


FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                             0.125 lb ai/100 gal/A
                              154 fl oz/100 gal/A
                                       
                                 0.445 lb ai/A
                                  548 fl oz/A
                                       


13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                        0.157 to 0.446 lb ai/100 gal/A
                          6.0 to 17.1 fl oz/100 gal/A
                                       
                                 0.446 lb ai/A
                                 17.1 fl oz/A
                                       

Ground, aerial or chemigation
Luna Tranquility
(1.04 lb ai/gal) [264-1085]
                                     Lemon
                                     0.219
                                (27.0 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval not specified.  The use of adjuvants is prohibited.
Ground, aerial or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
Corn (including Field Corn, Sweet Corn, Popcorn, and Field Corn grown for seed) 
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                      14
                                       0
Retreatment interval of 7 to 14 days.  For field corn, field corn grown for seed, and popcorn, do not apply within 14 days of harvest for grain or fodder.  For sweet corn, do not apply within 14 days of harvest for fodder.  Sweet corn ears and forage may be harvested the same day of application.

Luna Experience
(1.67 lb ai/gal) [264-1091]
     Corn (Sweet Corn, Field Corn, Field Corn Grown for Seed, and Popcorn)
                                     0.167
                                (12.8 fl oz/A)
                                      NS
                                     0.446
                                  See Limits
Retreatment interval of 14 days.  For field corn, field corn grown for seed, and popcorn, may be applied up to 21 days before harvest of forage, and 36 days before the harvest of grain or fodder.  For sweet corn, may be applied within 7 days before harvest of ears or forage, and 49 days before the harvest of fodder.  Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Cotton Subgroup (20C):  Includes cultivars, varieties and other hybrids of these.
                                0.156 to 0.222
                             (4.8 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                      30
Retreatment interval not specified.

Luna Experience
(1.67 lb ai/gal) [264-1091]
                                    Cotton
                                     0.222
                                (17.0 fl oz/A)
                                      NS
                                     0.446
                                      30
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Cucurbit Vegetables: Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin (edible, includes Hyotan, Cucuzza, Hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (hybrids and/or cultivars of Cucumis melo including True cantaloupe, Cantaloupe, Casaba, Crenshaw melon, Golden Pershaw melon, Honeydew melon, Honey balls, Mango melon, Persian melon, Pineapple melon, Santa Claus melon, Snake melon), Pumpkin, Squash (includes Summer Squash types such as: Crookneck squash, Scallop squash, Straight neck squash, Vegetable marrow, Zucchini, and Winter squash types such as Acorn squash, Butternut squash, Calabaza, Hubbard squash, Spaghetti squash), and Watermelon (includes hybrids and/or varieties of Citrullus lanatus).
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 5 to 14 days; except for soil applications with minimum 5 day interval between soil applications.
Ground or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
Cucurbit Vegetables: Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin, Edible gourd (includes hyotan, cucuzza, hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (includes cantaloupe), Pumpkin, Squash (summer and winter, includes Butternut squash, Calabaza, Hubbard squash, Acorn squash, Spaghetti squash), and Watermelon.
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 5 to 10 days.  Only 1 soil application allow; up to two foliar applications allowed.
Ground, aerial or chemigation
Luna Sensation
(2.1 lb ai/gal) [264-1090]
Cucurbit Vegetables: Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin (edible, includes Hyotan, Cucuzza, Hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (hybrids and/or cultivars of Cucumis melo including True cantaloupe, Cantaloupe, Casaba, Crenshaw melon, Golden Pershaw melon, Honeydew melon, Honey balls, Mango melon, Persian melon, Pineapple melon, Santa Claus melon, Snake melon), Pumpkin, Squash (includes Summer Squash types such as: Crookneck squash, Scallop squash, Straight neck squash, Vegetable marrow, Zucchini, and Winter squash types such as Acorn squash, Butternut squash, Calabaza, Hubbard squash, Spaghetti squash), and Watermelon (includes hybrids and/or varieties of Citrullus lanatus).
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                       4
                                     0.446
                                       0
Retreatment interval of 7 to 14 days; except for soil applications with minimum 7 day interval between soil applications.

Luna Experience
(1.67 lb ai/gal) [264-1091]
Cucurbit Vegetables: Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin (edible, includes Hyotan, Cucuzza, Hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (hybrids and/or cultivars of Cucumis melo including True cantaloupe, Cantaloupe, Casaba, Crenshaw melon, Golden Pershaw melon, Honeydew melon, Honey balls, Mango melon, Persian melon, Pineapple melon, Santa Claus melon, Snake melon), Pumpkin, Squash (includes Summer Squash types such as: Crookneck squash, Scallop squash, Straight neck squash, Vegetable marrow, Zucchini, and Winter squash types such as Acorn squash, Butternut squash, Calabaza, Hubbard squash, Spaghetti squash), and Watermelon (includes hybrids and/or varieties of Citrullus lanatus).
                                0.0783 to 0.222
                             (6.0 to 17.0 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 10 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Fruiting Vegetables: African eggplant, Bush Tomato, Cocona, Currant tomato, Eggplant, Garden huckleberry, Goji berry, Martynia, Naranjilla, Okra, Pea eggplant, Pepino, Pepper (Capsicum spp., including Bell, Chili, Cooking, Pimento and Sweet), Roselle, Scarlet eggplant, Sunberry, Tomatillo, Tomato, Tree tomato, and cultivars, varieties, and/or hybrids of these.
                                0.117 to 0.222
                            (3.60 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
Fruiting Vegetables: Eggplant, Groundcherry, Okra, Pepinos, Pepper (Capsicum spp., including Bell, Chili, Cooking, Pimento and Sweet), Tomatillo, and Tomato.
                                0.0825 to 0.125
                             (5.0 to 7.6 fl oz/A)
                                       5
                                     0.446
                                       3
Retreatment interval of 7 to 14 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
Fruiting Vegetables: African eggplant, Bush Tomato, Cocona, Currant tomato, Eggplant, Garden huckleberry, Goji berry, Martynia, Naranjilla, Pea eggplant, Pepino, Non Bell Pepper, Roselle, Scarlet eggplant, Sunberry, Tomatillo, Tomato, Tree tomato, and cultivars, varieties, and/or hybrids of these.
                                0.0783 to 0.222
                             (6.0 to 17.0 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Experience
(1.67 lb ai/gal) [264-1091]
                                     Okra
                                     0.167
                                (12.8 fl oz/A)
                                      NS
                                     0.446
                                       3
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Tranquility
(1.04 lb ai/gal) [264-1085]
                                    Tomato
                                    0.0910
                                 (11.2 fl oz/A
                                      NS
                                     0.446
                                       1
Retreatment interval of 7 to 14 days.  For greenhouse uses apply only in well-ventilated plastic tunnel houses or glass houses.  Ventilate for at least 2 hours after application.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                                    Ginseng
                                     0.222
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 5 to 7 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                     0.125
                                 (7.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 14 days.

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
                                       
                                0.130 to 0.219
                            (16.0 to 27.0 fl oz/A)
                                      NS
                                     0.446
                                      30
Retreatment interval of 7 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Grapes and Small Vine Fruits (except fuzzy kiwifruit): Amur River grape, Gooseberry, Grape, Kiwifruit, Hardy, Maypop, Schisandra berry, and cultivars, varieties, and/or hybrids of these varieties.
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 12 to 21 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                       6
                                     0.446
                                      14
Retreatment interval of 12 to 21 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
                                       
                                0.0783 to 0.112
                             (6.0 to 8.6 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 12 to 21 days.

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
                                       
                                0.130 to 0.219
                            (16.0 to 27.0 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 12 to 14 days.
Ground, Drench or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                         Grapes and Small Vine Fruits
                        0.104 to 0.221 lb ai/100 gal/A
                          3.2 to 6.8 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 13.7 fl oz/A
                                       7
Retreatment interval of 12 to 21 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                        0.0656 to 0.125 lb ai/100 gal/A
                          4.0 to 7.6 fl oz/100 gal/A
                                       6
                                 0.446 lb ai/A
                                 27.3 fl oz/A
                                      14
Retreatment interval of 12 to 21 days.

FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                        0.0821 to 0.125 lb ai/100 gal/A
                          101 to 154 fl oz/100 gal/A
                                       6
                                 0.445 lb ai/A
                                  548 fl oz/A
                                      14
Retreatment interval of 12 to 21 days.

13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                        0.112 to 0.223 lb ai/100 gal/A
                         4.28 to 8.56 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 17.1 fl oz/A
                                       7
Retreatment interval of 12 to 21 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Herbs and Spices (except black pepper): Allspice, Angelica, Anise (anise seed), Anise (star), Annatto, (seed), Balm (lemon balm), Basil (fresh and dried), Borage, Bumet, Camomile, Caper buds, Caraway, Caraway (black), Cardamom, Cassia (bark and buds), Catnip, Celery seed, Chervil (dried), Chinese chive, Chive, Cinnamon, Clary, Clove (buds), Coriander (cilantro or Chinese parsley leaves), Corinader seed (cilantro seed), Costmary, Cilantro (leaf and seed), Cumin, Curry leaf, Dill (seed), Dillweed, Fennel [common and Florence (seed)], Fenugreek, Grains of paradise, Horehound, Hyssop, Juniper berry, Lavender, Lemongrass, Lovage (leaf and seed), Mace, Marigold, Mustard (seed), Nasturtium, Nutmeg, Parsley (dried), Pennyroyal, Poppy (seed), Rosemary, Rue, Saffron, Sage, Savory (summer and winter), Sweet bay (bay leaf), Tansy, Tarragon, Thyme, Vanilla, Wintergreen, Woodruff, and Wormwood.
                                 0.13 to 0.222
                             (4.0 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 10 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 10 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                                     Hops
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 14 days.
NS
Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                0.0495 to 0.125
                             (3.0 to 7.6 fl oz/A)
                                       4
                                     0.446
                                      14
Retreatment interval of 14 days.  Do not replant areas within 30 days of the last application.  Do not graze cover crops within the treated area.  Do not harvest cover crops within the area treated for silage and hay.  Do not apply using aerial application.  Do not apply using low volume applicators.  Do not apply through any type of irrigation system.  Do not apply on hops in California.
Ground, aerial or chemigation
Luna Experience
(1.67 lb ai/gal) [264-1091]
                                       
                                0.104 to 0.222
                             (8.0 to 17.0 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Leafy Vegetables (except Watercress): Amaranth (Leafy amaranth, Chinese spinach, Tampala), Arugula (Roquette), Cardoon, Celery, Celtuce, Chervil, Chinese celery, Chrysanthemum, (Edible-leaved and Garland), Cilantro, Corn salad, Cress (Garden), Cress (Upland, Yellow rocket, Winter cress), Dandelion, Dock (Sorrel), Endive (Escarole), Florence fennel (Sweet anise, Sweet fennel, Finocchio), Lettuce (Head and Leaf), Orach, Parsley, Purslane (Garden and Winter), Radicchio (Red Chicory), Rhubarb, Spinach [including New Zealand and vine (Malabar spinach, Indian spinach)], and Swiss chard.
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
                                       
                                       3
Retreatment interval of 7 to 10 days.  For lettuce greenhouse uses the PHI is 3 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
Leafy Greens Vegetables (except Watercress): Amaranth (Leafy amaranth, Chinese spinach, Tampala), Arugula (Roquette), Chervil, Chrysanthemum, (Edible-leaved and Garland), Cilantro, Corn salad, Cress (Garden), Cress (Upland, Yellow rocket, Winter cress), Dandelion, Dock (Sorrel), Endive (Escarole), Lettuce (Head and Leaf), Orach, Parsley, Purslane (Garden and Winter), Radicchio (Red Chicory), Rhubarb, and Spinach [including New Zealand and vine (Malabar spinach, Indian spinach)]. 
                                     0.125
                                 (7.6 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Sensation
(2.1 lb ai/gal) [264-1090]
Leafy Petiole Vegetables: Cardon, Celery, Chinese celery, Florence fennel (including Sweet anise, Sweet fennel, Finocchio), Rhubarb, Swiss chard.
                               0.0660 to 0.0957
                             (4.0 to 5.8 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Legume Vegetables (including Soybean): Edible Podded Legume Vegetables: Bean (Phaseolus spp.) (includes Runner Bean, Snap Bean, Wax Bean); Bean (Vigna spp.) (includes Asparagus Bean, Chinese Longbean, Moth Bean, Yardlong Bean); Jackbean; Pea (Pisum spp.) (includes Dwarf Pea, Edible-pod Pea, Snow Pea, Sugar Snap Pea); Pigeon Pea; Soybean (immature seed); Sword Bean.  Succulent Shelled Pea and Bean: Bean (Phaseolus spp.) (includes Lima Bean (green); Broad Bean (succulent); Bean (Vigna spp.) ( except Cowpea, Southpea); Pea (Pisum spp.) (includes English Pea, Garden Pea, Green Pea); Pigeon Pea.  Dried Shelled Pea and Bean.  Dried Cultivars of Bean (Lupinus spp.) (includes Grain Lupin, Sweet Lupin, White Lupin, White Sweet Lupin); (Phaseolus spp.) (includes Field Bean, Kidney Bean, Lime Bean Dry), Navy Bean, Pinto Bean; Tepary Bean; Bean (Vigna spp.) (includes Adzuki Bean, Blackeyed Pea, Catjang, Moth Bean, Mung Bean, Rice Bean, Southern Pea, Urd Bean; except Cowpea & Crowder Pea); Broad Bean (Dry); Chickpea; Guar; Lablab Bean; and Lentil.
                                0.156 to 0.222
                             (4.8 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Do not apply to cultivars that are to be grazed, cut for forage or hay, or used as livestock feed.
Ground, aerial or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
Dried Beans: Bean (Lupinus spp., includes Grain lupin, Sweet lupin, White lupin, and White sweet lupin), Bean (Phaseolus spp., includes Field bean, Kidney bean, Lima bean, Navy bean, Pinto bean, and Tepary bean), Bean (Vigna spp., includes Adzuki bean, Blackeyed pea, Catjang, Crowder pea, Moth bean, Mung bean, Rice bean, Southern pea, and Urd bean), Broad Bean (dry), Chickpea, Guar, Lablab Bean, and Lentil.
                                0.134 to 0.177
                            (10.3 to 13.6 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 7 to 14 days.  Allow 7 days from the last application until cutting or swathing the crop for harvest. Do not feed hay or threshings or allow livestock to graze in treated areas.
Ground, aerial or chemigation
Luna Experience
(1.67 lb ai/gal) [264-1091]
                Beans (Fresh and Dry, except Succulent Shelled)
                                0.104 to 0.167
                             (8.0 to 12.8 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 10 to 14 days.  Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application. 
Ground, aerial or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
                                    Soybean
                                     0.133
                                (10.2 fl oz/A)
                                      NS
                                     0.446
                                      21
Retreatment interval of 10 to 14 days.  Do not allow livestock to graze soybean and do not harvest soybean hay for food or feed.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                     0.125
                                 (7.6 fl oz/A)
                                      NS
                                     0.446
                                      21
Retreatment interval of 14 days.  Do not allow livestock to graze soybean and do not harvest soybean hay for food or feed.

Luna Experience
(1.67 lb ai/gal) [264-1091]
                                       
                                     0.112
                                 (8.6 fl oz/A)
                                      NS
                                     0.446
                                      21
Retreatment interval of 10 to 14 days.  Do not allow livestock to graze soybean and do not harvest soybean hay for food or feed. 
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Pome Fruits: Apple, Azarole, Crabapple, Loquat, Mayhaw, Medlar, Pear, Pear (Asian), Quince, Quince (Chinese and Japanese), Tejocote, and cultivars, varieties, and/or hybrids of these.
                                0.078 to 0.222
                             (2.4 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 14 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
                                       
                                0.0652 to 0.130
                             (5.0 to 10.0 fl oz/A)
                                      NS
                                     0.446
                                      75
Retreatment interval of 7 to 14 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
  Pome Fruits: Apple, Crabapple, Loquat, Mayhaw, Pear, Oriental Pear, Quince.
                               0.0660 to 0.0957
                             (4.0 to 5.8 fl oz/A)
                                       4
                                     0.446
                                      14
Retreatment interval of 7 to 14 days.

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
                                       
                                0.0975 to 0.130
                            (12.0 to 16.0 fl oz/A)
                                      NS
                                     0.446
                                      72
Retreatment interval of 7 to 10 days.
Ground, Drench or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                                  Pome Fruits
                        0.0780 to 0.221 lb ai/100 gal/A
                          2.4 to 6.8 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 13.7 fl oz/A
                                       7
Retreatment interval of 7 to 14 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                       0.0656 to 0.0952 lb ai/100 gal/A
                          4.0 to 5.8 fl oz/100 gal/A
                                       4
                                 0.345 lb ai/A
                                 21.0 fl oz/A
                                      14
Retreatment interval of 7 to 14 days.

FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                       0.0650 to 0.0951 lb ai/100 gal/A
                           80 to117 fl oz/100 gal/A
                                       4
                                 0.345 lb ai/A
                                  425 fl oz/A
                                      14
Retreatment interval of 7 to 14 days.

13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                        0.0783 to 0.223 lb ai/100 gal/A
                          3.0 to 8.56 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 17.1 fl oz/A
                                       7
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Potato and Other Root, Tuberous, and Corm Vegetables: Arracacha, Arrowroot, Artichoke (Chinese and Jerusalem), Beet (Garden), Burdock (Edible), Canna (Edible, Queensland arrowroot), Cassava (Bitter & Sweet), Celeriac (Celery root), Chayote (root), Chervil (Turnip-rooted), Chickory, Chufa, Dasheen (Taro), Ginger, Horseradish, Leren, Parsley (Turnip-rooted), Parsnip, Potato, Radish, Oriental radish (Daikon), Rutabaga, Salsify (Black), Salsify (Oyster plant), Salsify (Spanish), Skirret, Sweet potato, Tanier (Cocoyam), Turmeric, Turnip, Yam bean (Jicama, Manoic pea) and Yam (True).
                                 0.13 to 0.222
                             (4.0 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 5 to 7 days.  The grazing of livestock in treated areas within 7 days of application is prohibited.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                               0.0825 to 0.0957
                             (5.0 to 5.8 fl oz/A)
                                       4
                                     0.446
                                       7
Retreatment interval of 14 days.  

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
Potato and Other Root, Tuberous, and Corm Vegetables: Arracacha, Arrowroot, Artichoke (Chinese and Jerusalem), Canna (Edible), Cassava (Bitter & Sweet), Chayote (root), Chufa, Dasheen (Taro), Ginger, Leren, Potato, Sweet Potato, Tanier (Cocoyam), Turmeric, Yam bean, and Yam (True).
                               0.0650 to 0.0910
                             (8.0 to 11.2 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                 Small Berries (caneberries and bushberries): 
Blackberry Rubus spp. (including Andean blackberry, Artic blackberry, Bingleberry, Black blackberry, Boysenberry, Brombeere, California blackberry, Chesterberry, Cherokee blackberry, Cheyenne blackberry, Common blackberry, Coryberry, Darrowberry, Dewberry, Dirksen thornless berry, Evergreen blackberry, Himalayaberry, Hullberry, Lavacaberry, Loganberry, Lowberry, Lucretiaberry, Mammoth blackberry, Marionberry, Mora, Mures deronce, Nectarberry, Northern dewberry, Olallieberry, Oregon evergreen berry, Phenomenalberry, Rangeberry, Ravenberry, Rossberry, Shawnee blackberry, Southern dewberry, Tayberry, Youngberry, Zarzamora, and cultivars, varieties, and/or hybrids of these.
Raspberry Rubus spp. (Rubus occidentalis, Rubus strigosus, Rubus idaeus) (including Bababery, Black raspberry, Blackcap, Framboise, Frambueso, Himbeere, Keriberry, Mayberry, Purple raspberry, Red raspberry, Thimblberry, Tulameen, Wild raspberries, Yellow raspberry) and cultivars, varieties, and/or hybrids of these.
Bushberry (including Berry (Aronia), Blueberry (Highbush and Lowbush), Currant (Buffalo), Guava (Chilean), Currant (Black and Red), Barberry (European), Elderberry, Gooseberry, Cranberry (Highbush), Honeysuckle, Huckleberry, Jostaberry, Juneberry, Currant (Native), Salal, Sea buckthorn, and cultivars, varieties, and/or hybrids of these.
                                0.156 to 0.222
                             (4.8 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 10 days.
Ground, aerial or chemigation
Luna Tranquility
(1.04 lb ai/gal) [264-1085]
                 Small Berries (caneberries and bushberries): 
Blackberry Rubus spp. (including Andean blackberry, Artic blackberry, Bingleberry, Black Satin berry, Boysenberry, Brombeere, California blackberry, Chesterberry, Cherokee blackberry, Cheyenne blackberry, Common blackberry, Coryberry, Darrowberry, Dewberry, Dirksen thornless berry, Evergreen blackberry, Himalayaberry, Hullberry, Lavacaberry, Loganberry, Lowberry, Lucretiaberry, Mammoth blackberry, Marionberry, Mora, Mures deronce, Nectarberry, Northern dewberry, Olallieberry, Oregon evergreen berry, Phenomenalberry, Rangeberry, Ravenberry, Rossberry, Shawnee blackberry, Southern dewberry, Tayberry, Youngberry, Zarzamora, and cultivars, varieties, and/or hybrids of these.
Raspberry Rubus spp. (Rubus occidentalis, Rubus strigosus, Rubus idaeus) (including Bababery, Black raspberry, Blackcap, Framboise, Frambueso, Himbeere, Keriberry, Mayberry, Purple raspberry, Red raspberry, Thimblberry, Tulameen, Wild raspberries, Yellow raspberry) and cultivars, varieties, and/or hybrids of these.
Bushberry (including Berry (Aronia), Blueberry (Highbush and Lowbush), Currant (Buffalo), Guava (Chilean), Currant (Black and Red), Barberry (European), Elderberry, Gooseberry, Cranberry (Highbush), Honeysuckle, Huckleberry, Jostaberry, Juneberry, Currant (Native), Salal, Sea buckthorn, and cultivars, varieties, and/or hybrids of these.
                                0.111 to 0.219
                            (13.6 to 27.0 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 14 days.
Ground or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
Bushberry subgroup: Aronia berry, Blueberry (Highbush and Lowbush), Chilean Guava, Currant (Black, Buffalo, and Red), Highbush Cranberry, Elderberry, European Barberry, Gooseberry, Edible Honeysuckle, Huckleberry, Jostaberry, Juneberry (Saskatoon berry), Ligonberry, Native Currant, Salal, Sea buckthorn, and cultivars, varieties, and/or hybrids of these.
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 7 to 10 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Stone Fruit: Apricot, Apricot (Japanese), Capulin, Cherry (Black, Nanking, Canada, Sweet, Tart), Jujube (Chinese), Nectarine, Peach, Plum, Plum (American, Beach, Canada, Cherry, Chickasaw, Damson, Japanese, Klamath), Prune, Plumcot, Sloe, and cultivars, varieties, and/or hybrids of these.
                                 0.13 to 0.222
                             (4.0 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 5 to 7 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
Stone Fruit: Apricot, Cherry (Sweet and Tart), Nectarine, Peach, Plum (including Chickasaw, Damson, Japanese), Plumcot, and Prune (Fresh and Dried).
                                0.0825 to 0.125
                             (5.0 to 7.6 fl oz/A)
                                       4
                                     0.446
                                       1
Retreatment interval of 7 to 14 days.

Luna Experience
(1.67 lb ai/gal) [264-1091]
Stone Fruit: Apricot, Cherry (Sweet, Tart), Nectarine, Peach, Plum (all varieties including Chickasaw, Damson, Japanese, and Stanley), Plumcot, and Prune (fresh and dried).
                                0.0783 to 0.130
                             (6.0 to 10.0 fl oz/A
                                      NS
                                     0.446
                                       0
Retreatment interval of 5 to 7 days.

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
Stone Fruit: Apricot, Nectarine, Peach, Plum (all varieties including Chickasaw, Damson, Japanese, and Stanley), Plumcot, and Prune (fresh and dried).
                                0.0975 to 0.219
                             (12.0 to 27.0 fl oz/A
                                      NS
                                     0.446
                                       2
Retreatment interval of 7 to 14 days.  Do not make more than two applications of a group 9 fungicide within 30 days of harvest.
Ground, Drench or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                                 Stone Fruits
                        0.130 to 0.221 lb ai/100 gal/A
                          4.0 to 6.8 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 13.7 fl oz/A
                                       0
Retreatment interval of 5 to 7 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                        0.0820 to 0.125 lb ai/100 gal/A
                          5.0 to 7.6 fl oz/100 gal/A
                                       4
                                 0.251 lb ai/A
                                 15.3 fl oz/A
                                       1
Retreatment interval of 7 to 14 days. 

FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                        0.0821 to 0.125 lb ai/100 gal/A
                          101 to 154 fl oz/100 gal/A
                                       4
                                 0.251 lb ai/A
                                  309 fl oz/A
                                       1
Retreatment interval of 7 to 14 days.

13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                        0.157 to 0.223 lb ai/100 gal/A
                          6.0 to 8.56 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                  17.1 fl oz/
                                       0
Retreatment interval of 5 to 7 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Strawberry and Other Low-Growing Berries (except Cranberries): Bearberry, Bilberry, Blueberry (Low-bush), Cloudberry, Ligonberry, Muntries, Partridgeberry, and Strawberry.
                                0.104 to 0.222
                             (3.2 to 6.84 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 days.
Ground or chemigation
Propulse
(1.67 lb ai/gal) [264-1084]
Low Growing Berry subgroup, except Strawberry and Cranberries: Bearberry, Bilberry, Cloudberry, Muntries, Partridgeberry, and cultivars, varieties, and/or hybrids of these.
                                     0.134
                                (10.3 fl oz/A)
                                      NS
                                     0.446
                                      45
Retreatment interval of 7 to 10 days.
Ground, aerial or chemigation
Luna Sensation
(2.1 lb ai/gal) [264-1090]
Strawberry and Other Low-Growing Berries (except Cranberries): Bearberry, Bilberry, Blueberry (Low-bush), Cloudberry, Ligonberry, Muntries, Partridgeberry, and Strawberry.
                                0.0660 to 0.125
                             (4.0 to 7.6 fl oz/A)
                                      NS
                                     0.446
                                       0
Retreatment interval of 7 to 14 days.

Luna Tranquility
(1.04 lb ai/gal) [264-1085]
Strawberry and Other Low-Growing Berries (except Cranberries): Bearberry, Bilberry, Blueberry (Low-bush), Cloudberry, Ligonberry, Muntries, Partridgeberry, and Strawberry.
                                0.130 to 0.219
                            (16.0 to 27.0 fl oz/A)
                                      NS
                                     0.446
                                       1
Retreatment interval of 7 to 14 days.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                                  Sugar beet
                                     0.222
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 5 to 7 days.

Propulse
(1.67 lb ai/gal) [264-1084]
                                       
                                     0.177
                                (13.6 fl oz/A)
                                      NS
                                     0.446
                                       7
Retreatment interval of 14 days.

Luna Sensation
(2.1 lb ai/gal) [264-1090]
                                       
                                0.0924 to 0.125
                             (5.6 to 7.6 fl oz/A)
                                      NS
                                     0.446
                                      21
Retreatment interval of 10 to 14 days.  Tops or greens from this crop may be utilized for food or feed.
Ground, aerial or chemigation
Luna Privilege
(4.16 lb ai/gal) [264-1078]
Sunflower Subgroup: Calendula, Castor oil plant, Chinese tallowtree, Euphorbia, Evening primrose, Jojoa, Niger seed, Rose hib, Safflower, Stokes aster, Sunflower, Tallowwood, Tea oil plant, Veronia, and cultivars, varieties and/or hybrids of these.
                                     0.222
                                (6.84 fl oz/A)
                                      NS
                                     0.446
                                      14
Retreatment interval of 14 days.
Ground, aerial or chemigation
Luna Experience
(1.67 lb ai/gal) [264-1091]
                                   Sunflower
                                0.117 to 0.167
                             (9.0 to 12.8 fl oz/A
                                      NS
                                     0.446
                                      50
Retreatment interval of 14 days.
Ground, Drench or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                                   Sunflower
                             0.221 lb ai/100 gal/A
                              6.8 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                 13.7 fl oz/A
                                      14


13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                             0.223 lb ai/100 gal/A
                             8.56 fl oz/100 gal/A
                                      NS
                                 0.446 lb ai/A
                                  17.1 fl oz/
                                      14

Ground or Chemigation
FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                   Tree Nuts
                        0.0820 to 0.125 lb ai/100 gal/A
                          5.0 to 7.6 fl oz/100 gal/A
                                      NS
                                 0.251 lb ai/A
                                 15.3 fl oz/A
                                      60
Retreatment interval of 7 to 21 days.

FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                        0.0821 to 0.125 lb ai/100 gal/A
                          101 to 154 fl oz/100 gal/A
                                      NS
                                 0.251 lb ai/A
                                  309 fl oz/A
                                      60

                                Seed Treatment
Seed treatment with commercial slurry mixture equipment only.
Luna Privilege
(4.16 lb ai/gal) [264-1078]
                                    Peanut
                             0.049725  to 0.124475
                               lb ai/100 lb seed
                              (1.53 to 3.83 fl oz
                                 per 100 lb of
                                 peanut seeds)
                                       1
                             0.446 (from all uses)
                                      NA
Do not use treated seed for food, feed, or oil purposes.
                          Non Agricultural Use Sites
Ground or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
Turf Grass: Golf Courses, Sod Farms, Sports Fields, Industrial, Municipal, Commercial, and other Turf Grass areas.
                       0.0013 to 0.0101 lb ai/1000 ft[2]
                        (0.04 to 0.31 fl oz/1000 ft[2])
                           (0.0566 to 0.439 lb ai/A)
                                      NS
                            0.3145 fl oz/1000 ft[2]
                                 13.7 fl oz/A
                                 0.446 lb ai/A
                                      NA
Retreatment interval of 7 to 28 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                     0.000820 to 0.00984 lb ai/1000 ft[2]
                        (0.05 to 0.6 fl oz/1000 ft[2])
                           (0.0557 to 0.429 lb ai/A)
                                       
                            0.6267 fl oz/1000 ft[2]
                                 27.3 fl oz/A
                                 0.446 lb ai/A
                                       


FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                      0.00121 to 0.0102 lb ai/1000 ft[2]
                        (1.5 to 12.6 fl oz/1000 ft[2])
                           (0.0531 to 0.446 lb ai/A)
                                       
                             12.6 fl oz/1000 ft[2]
                                  549 fl oz/A
                                 0.446 lb ai/A
                                       


FLU+TFS SC 32.5
(0.104 lb ai/gal) [264-RLGA]
                                       
                      0.00121 to 0.0102 lb ai/1000 ft[2]
                        (1.5 to 12.6 fl oz/1000 ft[2])
                           (0.0531 to 0.446 lb ai/A)
                                       
                             12.6 fl oz/1000 ft[2]
                                  549 fl oz/A
                                 0.446 lb ai/A
                                       


13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                       0.0013 to 0.0102 lb ai/1000 ft[2]
                        (0.05 to 0.39 fl oz/1000 ft[2])
                           (0.0566 to 0.444 lb ai/A)
                                       
                            0.393 fl oz/1000 ft[2]
                                 17.1 fl oz/A
                                 0.446 lb ai/A
                                       

Ground
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                            Residential Turf Grass
                      0.0013 to 0.00912 lb ai/1000 ft[2]
                        (0.04 to 0.28 fl oz/1000 ft[2])
                           (0.0566 to 0.396 lb ai/A)
                                      NS
                            0.2847 fl oz/1000 ft[2]
                                 12.4 fl oz/A
                                 0.403 lb ai/A
                                      NA
Retreatment interval of 7 to 28 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                     0.000820 to 0.00919 lb ai/1000 ft[2]
                        (0.05 to 0.56 fl oz/1000 ft[2])
                           (0.0557 to 0.400 lb ai/A)
                                       
                            0.5647 fl oz/1000 ft[2]
                                 24.6 fl oz/A
                                 0.404 lb ai/A
                                       


FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                      0.00121 to 0.00926 lb ai/1000 ft[2]
                        (1.5 to 11.4 fl oz/1000 ft[2])
                           (0.0531 to 0.404 lb ai/A)
                                       
                             11.4 fl oz/1000 ft[2]
                                497 fl oz/A[2]
                                 0.404 lb ai/A
                                       


FLU+TFS SC 32.5
(0.104 lb ai/gal) [264-RLGA]
                                       
                      0.00121 to 0.00926 lb ai/1000 ft[2]
                        (1.5 to 11.4 fl oz/1000 ft[2])
                           (0.0531 to 0.404 lb ai/A)
                                       
                             11.4 fl oz/1000 ft[2]
                                  497 fl oz/A
                                 0.404 lb ai/A
                                       


13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                      0.0013 to 0.009285 lb ai/1000 ft[2]
                       (0.05 to 0.3558 fl oz/1000 ft[2])
                           (0.0566 to 0.404 lb ai/A)
                                       
                            0.3558 fl oz/1000 ft[2]
                                 15.5 fl oz/A
                                 0.404 lb ai/A
                                       

Ground, Drench or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
Ornamentals: in Residential and Commercial Landscapes, Interiorscapes, Field Grown and Container Ornamentals, in Nurseries, and Greenhouses, Lathhouses, Shadehouses, Containers and Other Enclosed Structures.
                             0.221 lb ai/100 gal/A
                              6.8 fl oz/100 gal/A
                                      NS
                                 13.7 fl oz/A
                                 0.446 lb ai/A
                                      NA
Retreatment interval of 7 to 21 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                        0.0164 to 0.131 lb ai/100 gal/A
                          1.0 to 8.0 fl oz/100 gal/A
                                       
                                 27.3 fl oz/A
                                 0.446 lb ai/A
                                       
Retreatment interval of 7 to 28 days.

FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                        0.0163 to 0.130 lb ai/100 gal/A
                           20 to 160 fl oz/100 gal/A
                                       
                                 0.445 lb ai/A
                                  548 fl oz/A
                                       
Retreatment interval of 7 to 28 days.

13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                             0.223 lb ai/100 gal/A
                             8.56 fl oz/100 gal/A
                                       
                                 0.446 lb ai/A
                                 17.1 fl oz/A
                                       
Retreatment interval of 7 to 21 days.
Ground or Chemigation
Fluopyram 500 SC
(4.16 lb ai/gal) [264-RLGI]
                                Christmas Trees
                             0.221 lb ai/100 gal/A
                              6.8 fl oz/100 gal/A
                                      NS
                                 13.7 fl oz/A
                                 0.446 lb ai/A
                                      NA
Retreatment interval of 7 to 21 days.

FLU+TFS SC 500
(2.10 lb ai/gal) [264-RLGT]
                                       
                             0.220 lb ai/100 gal/A
                             13.4 fl oz/100 gal/A
                                       
                                 27.1 fl oz/A
                                 0.445 lb ai/A
                                       


FLU+TFS SC 25
(0.104 lb ai/gal) [264-RLGL]
                                       
                             0.220 lb ai/100 gal/A
                              271 fl oz/100 gal/A
                                       
                                      NS
                                       


13ESP715 3.3 SC
(3.34 lb ai/gal) [432-RLUG]
                                       
                             0.223 lb ai/100 gal/A
                             8.56 fl oz/100 gal/A
                                       
                                 0.446 lb ai/A
                                 17.1 fl oz/A
                                       





5.0	Residential Exposure and Risk Estimates

Based on the proposed product labels, several products are intended for use by homeowners, or by occupational handlers in residential settings.  Therefore, non-occupational/residential risk assessments have been completed.

5.1	Residential Handler Exposure/Risk Estimates

HED uses the term "handlers" to describe those individuals who are involved in the pesticide application process.  HED believes that there are distinct tasks related to applications and that exposures can vary depending on the specifics of each task.  Residential handlers are addressed somewhat differently by HED as homeowners are assumed to complete all elements of an application without use of any protective equipment.

The quantitative exposure/risk assessment developed for residential handlers is based on the following residential handler scenarios:  

 Mixing/Loading/Applying liquids for manually pressurized handwand for gardens, ornamentals, fruit trees, and turf;
 Mixing/Loading/Applying liquids for hose-end sprayers for gardens, ornamentals, fruit trees, and turf;
 Mixing/Loading/Applying liquids for backpack for gardens, ornamentals, fruit trees, and turf; and
 Mixing/Loading/Applying liquids for sprinkler cans for gardens, ornamentals, fruit trees, and turf.

Residential Handler Exposure Data and Assumptions

Short-term dermal and inhalation exposures were assessed for residential handlers.  A series of assumptions and exposure factors served as the basis for completing the residential handler risk assessments.  Each assumption and factor is detailed below.

Application Rate: 

For flower gardens, ornamentals, and fruit trees, the proposed maximum single application rate is 0.223 lb ai/A.  Applications to residential turf have a proposed maximum single application rate of 0.446 lb ai/A for occupational handlers and 0.404 lb ai/A for residential handlers.  

Unit Exposures and Area Treated or Amount Handled:
Unit exposure values and estimates for area treated or amount handled were taken from HED's 2012 Residential SOPs. 


Exposure Duration:

Residential handler exposure is expected to be short-term in duration.  Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners.

Residential Handler Exposure and Risk Estimate Equations

The algorithms used to estimate exposure and dose for residential handlers can be found in Appendix A and/or the 2012 Residential SOPs.

Summary of Residential Handler Non-Cancer Exposure and Risk Estimates

Dermal and inhalation exposures were not combined, since different endpoints and PODs are used for both routes of exposure.  Table 5.1 summarizes the residential handler exposures and risk estimates for fluopyram.  All residential handler risk estimates are not of concern to HED (all MOEs >=100), with MOEs ranging from 8,900 to 190,000 for dermal exposures and 260,000 for inhalation exposures.

Table 5.1.  Residential Handler Short-term Exposure and Risk Estimates for Fluopyram.
                                   Use Site
                                  Equipment/
                              Application Method
                              Application Rate[1]
                    Area Treated or Amount HandledDaily[2]
                                Exposure Route
                           Unit Exposure (mg/lb ai)
                           Daily Dose[3] (mg/kg/day)
                                    MOE[4]
                                Gardens / Trees
                         Manually-Pressurized Handwand
                               0.00223 lb ai/gal
                                     5 gal
                                    Dermal
                                      63
                                    0.0088
                                    34,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.018
                                   0.0000025
                                   5,800,000
                                Gardens / Trees
                         Manually-Pressurized Handwand
                            0.000005119 lb ai/ft[2]
                                  1200 ft[2]
                                    Dermal
                                      63
                                    0.0048
                                    62,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.018
                                   0.0000014
                                  10,000,000
                                Gardens / Trees
                               Hose-End Sprayer
                               0.00223 lb ai/gal
                                    11 gal
                                    Dermal
                                      58
                                     0.018
                                    17,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                    0.0014
                                  0.00000043
                                  34,000,000
                                Gardens / Trees
                               Hose-End Sprayer
                            0.000005119 lb ai/ft[2]
                                  1200 ft[2]
                                    Dermal
                                      58
                                    0.0045
                                    67,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                    0.0014
                                  0.00000011
                                  130,000,000
                                Gardens / Trees
                                   Backpack
                               0.00223 lb ai/gal
                                     5 gal
                                    Dermal
                                      130
                                     0.018
                                    17,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.14
                                   0.000020
                                    740,000
                                Gardens / Trees
                                   Backpack
                            0.000005119 lb ai/ft[2]
                                  1200 ft[2]
                                    Dermal
                                      130
                                     0.010
                                    30,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.14
                                   0.000011
                                   1,300,000
                                Gardens / Trees
                                 Sprinkler Can
                               0.00223 lb ai/gal
                                     5 gal
                                    Dermal
                                      58
                                    0.0081
                                    37,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                    0.0014
                                  0.00000020
                                  74,000,000
                                Gardens / Trees
                                 Sprinkler Can
                            0.000005119 lb ai/ft[2]
                                  1200 ft[2]
                                    Dermal
                                      58
                                    0.0045
                                    67,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                    0.0014
                                  0.00000011
                                  130,000,000
                                 Lawns / Turf
                         Manually-Pressurized Handwand
                               0.00404 lb ai/gal
                                     5 gal
                                    Dermal
                                      63
                                     0.016
                                    19,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.018
                                   0.0000045
                                   3,200,000
                                 Lawns / Turf
                               Hose-End Sprayer
                                 0.404 lb ai/A
                                     0.5 A
                                    Dermal
                                     13.4
                                     0.034
                                     8,900
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.022
                                   0.000056
                                    260,000
                                 Lawns / Turf
                                   Backpack
                               0.00404 lb ai/gal
                                     5 gal
                                    Dermal
                                      130
                                     0.033
                                     9,100
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.14
                                   0.000035
                                    410,000
                                 Lawns / Turf
                                 Sprinkler Can
                           0.000009285 lb ai / ft[2]
                                  1000 ft[2]
                                    Dermal
                                     13.4
                                    0.0016
                                    190,000
                                       
                                       
                                       
                                       
                                  Inhalation
                                     0.022
                                   0.0000026
                                   5,700,000
[1] Maximum Single Application Rate.
[2] Units Treated taken from Science Advisory Council for Exposure, Standard Operating Procedure 9.1, Standard Values for Daily Acres Treated in Agriculture, Rev. 25 SEP 2001.
[3] Daily Dose = Unit Exposure x Application Rate x Units Treated  Body Weight (80 kg).
[4] Margin Of Exposure (MOE) = NOAEL (mg/kg/day)  Daily Dose (mg/kg/day); where the NOAEL = 300 mg/kg/day for dermal exposure & 14.5 mg/kg/day for inhalation exposure.

5.2	Residential Post-application Exposure/Risk Estimates for Proposed Uses

There is the potential for post-application exposure to fluopyram for individuals exposed as a result of being in an environment that has been previously treated with fluopyram.  

The quantitative exposure/risk assessment for residential post-application exposures includes the following scenarios:  

 Adults and children (1 to <2 years old) dermal exposure to treated turf during high contact lawn activities,
 Children (1 to <2 years old) incidental oral exposure as a result of contacting treated turf,
 Adults and youths (11 to <16 yr old) dermal exposure to treated turf during mowing and golfing activities,
 Children (6 to <11 years old) dermal exposure to treated turf during golfing activities, and
 Adults and children (6 to <11 years old) dermal exposure to treated gardens.

The exposure assessment for dermal exposure to treated gardens is protective of exposure to treated ornamental and fruit trees.

The lifestages selected for each post-application scenario are based on an analysis provided as an Appendix in the 2012 Residential SOPs.  These lifestages are not the only lifestages that could be potentially exposed for these post-application scenarios; however, the assessment of these lifestages is health protective for the exposures and risk estimates for any other potentially exposed lifestages.

Residential Post-application Exposure Data and Assumptions
A series of assumptions and exposure factors served as the basis for completing the residential post-application risk assessment.  Each assumption and factor is detailed in the 2012 Residential SOPs[4].  The algorithms used to estimate exposure and dose for residential post-application exposures can be found in Appendix A and/or the 2012 Residential SOPs.

TTR data for Fluopyram
Because turf transferable residue data were not available for fluopyram, turf residues were estimated using default assumptions.  A TTR study is not required for fluopyram at this time.  Refer to Section 6.2.2 of this document for a detailed rationale.

DFR data for Fluopyram
Because dislodgeable foliar residue data were not available for fluopyram, foliar residues were estimated using default assumptions.  A DFR study is not required for fluopyram at this time.  Refer to Section 6.2.2 of this document for a detailed rationale.

Exposures are expected to be short-term in duration.  Short-term dermal and incidental oral exposure and risk estimates have been assessed.  

Combining Exposure and Risk Estimates
HED combines risk values resulting from separate routes of exposure when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population, and if the hazard associated with the points of departure is similar across routes.  
Since dermal and incidental oral exposure routes do not share a common toxicological endpoint for fluopyram, risk estimates have not been combined for those routes.  

Tables 5.2.1 and 5.2.2 summarize the residential post-application exposure and risk estimates for exposures to treated lawns and turf.  The proposed liquid formulations do not lead to post-application risk estimates of concern.  Residential dermal post-application MOEs for all life stages range from 1,000 to 97,000.  Residential incidental oral post-application MOEs for children 1 to <2 years old range from 2,400 to 1,100,000.

Table 5.2.1.  Residential Post-Application Dermal Short-Term Exposure and Risk Estimates from Turf.
                                   Scenario
                          Application Rate (lb ai/A)
                              TTR[1] (ug/cm[2])
                              Exposure Time (hr)
                                  Population
                                      TC 
                                  (cm[2]/hr)
                           Daily Dose[2] (mg/kg/day)
                                    MOE[3]
                               Golf Course Turf
                                     0.446
                                    0.0496
                                       4
                                    Adults
                                     5,300
                                    0.0131
                                    23,000
                                       
                                       
                                       
                                       
                          Youths 11 to <16 yr old
                                     4,400
                                    0.0153
                                    20,000
                                       
                                       
                                       
                                       
                          Children 6 to <11 yr old
                                     2,900
                                    0.0180
                                    17,000
                            High Contact Activities
                                     0.404
                                    0.0449
                                      1.5
                                    Adults
                                    180,000
                                     0.152
                                     2,000
                                       
                                       
                                       
                                       
                          Children 1 to <2 yr old
                                    49,000
                                     0.300
                                     1,000
                                  Mowing Turf
                                     0.404
                                    0.0449
                                       1
                                    Adults
                                     5,500
                                    0.00309
                                    97,000
                                       
                                       
                                       
                                       
                          Youths 11 to <16 yr old
                                     4,500
                                    0.00355
                                    85,000
[1] TTR derived as follows: 0.446 lb ai/A x 4.54E+8 ug/lb x 2.47E-8 A/cm[2]x 0.01 (fraction of transferable ai) = 0.0496 ug/cm[2] or 0.404 lb ai/A x 4.54E+8 ug/lb x 2.47E-8 A/cm[2]x 0.01 (fraction of transferable ai) = 0.0449 ug/cm[2].
[2] Daily Dose = [TTR (ug/cm[2]) x (0.001 mg/ug) x Dermal Transfer Coefficient x Exposure Time] / [Body weight (80 kg for adults, 57 kg for youths 11 to <16 yr, 32 kg for children 6 to <11 yr, and 11 kg for children 1 to <2 yr old)].
[3] MOE = NOAEL/Daily Dose.  Short-Term NOAEL = 300 mg/kg/day.

Table 5.2.2.  Residential Post-Application Incidental Oral Exposure to 1 to <2 Year Olds from Turf.
                                   Scenario
                               Application Rate 
                                   (lb ai/A)
                            Daily Dose (mg/kg/day)
                                      MOE
                                 Hand-to-Mouth
                                     0.404
                                    0.00615
                                     2,400
                                Object-to-Mouth
                                     0.404
                                   0.000187
                                    78,000
                                Soil Ingestion
                                     0.404
                                   0.000014
                                   1,100,000
[1] TTR derived as follows: 0.404 lb ai/A x 4.54E+8 ug/lb x 2.47E-8 A/cm[2]x 0.01 (fraction of transferable ai) = 0.0449 ug/cm[2].
[2] Based on HED's 2012 Residential SOPs: Lawns/Turf (http://www.epa.gov/pesticides/science/residential-exposure-sop.html).
[3] MOE = NOAEL/Daily Dose.  Short-Term NOAEL = 14.5 mg/kg/day.

Table 5.2.3 summarizes the residential post-application exposure and risk estimates for exposures to treated gardens, ornamental trees and shrubs, and fruit trees.  The proposed liquid formulations do not lead to post-application risk estimates of concern (all MOEs >=100).  Residential dermal post-application MOEs for all life stages range from 2,100 to 33,000.

Table 5.2.3.  Residential Post-Application Dermal Short-Term Exposure and Risk Estimates from Gardens, Ornamentals and Fruit Trees.
                                   Scenario
                          Application Rate (lb ai/A)
                              DFR[1] (ug/cm[2])
                              Exposure Time (hr)
                                  Population
                                      TC 
                                  (cm[2]/hr)
                           Daily Dose[2] (mg/kg/day)
                                    MOE[3]
                                    Gardens
                                     0.223
                                     0.625
                                      2.2
                                    Adults
                                     8,400
                                     0.143
                                     2,100
                                       
                                       
                                       
                                      1.1
                          Children 6 to <11 yr old
                                     4,600
                                    0.0980
                                     3,100
                                     Trees
                                     0.223
                                     0.625
                                      1.0
                                    Adults
                                     1,700
                                    0.0132
                                    23,000
                                       
                                       
                                       
                                      0.5
                          Children 6 to <11 yr old
                                      930
                                    0.0090
                                    33,000
[1] DFR derived as follows: 0.223 lb ai/A x 4.54E+8 ug/lb x 2.47E-8 A/cm[2]x 0.25 (fraction of transferable ai) = 0.625 ug/cm[2]. 
[2] Daily Dose = [DFR (ug/cm[2]) x (0.001 mg/ug) x Dermal Transfer Coefficient x Exposure Time] / [Body weight (80 kg for adults and 32 kg for children 6 to <11 yr)].
[3] MOE = NOAEL/Daily Dose.  Short-Term NOAEL = 300 mg/kg/day.

5.3	Combined Residential Risk Estimates (Multiple Exposure Scenarios)

Residential handler and post-application scenarios should generally not be combined.  Although there is potential for the same individual (i.e., adult) to apply a pesticide in and around the home and be exposed by reentering a treated area in the same day, this is unlikely to occur day after day for 30 days.  Combining both of these exposure scenarios would also be inappropriate because of the conservative nature of each individual assessment.

Since the application rates are different for turf and ornamental plants/trees, and because of the conservative nature of the individual turf and gardens/trees assessments, these scenarios were not combined.

5.4	Residential Risk Estimates for Use in Aggregate Assessment

Table 5.4.1 reflects the residential risk estimates that are recommended for use in the aggregate assessment for fluopyram.

 The recommended residential exposure for use in the adult aggregate assessment reflects inhalation handler exposure from treating lawns from by hose-end sprayer.
 The recommended residential exposure for use in the children (1 to <2 years old) aggregate assessment reflects incidental oral hand-to-mouth post-application exposure to treated lawns.

Table 5.4.1.  Recommendations for the Residential Exposures for the Fluopyram Aggregate Assessment.
                                   Lifestage
                              Dose (mg/kg/day)[4]
                                    MOE[5]
Adults [inhalation handler exposure from treating lawns by hose-end sprayer]
                                   0.000056
                                    260,000
Child (1 to <2 years old) [incidental oral hand-to-mouth post-application exposure to treated lawns]
                                    0.00615
                                     2,400

5.5	Spray Drift

Spray drift is a potential source of exposure to those nearby pesticide applications.  This is particularly the case with aerial application, but, to a lesser extent, spray drift can also be a potential source of exposure from the ground application methods (e.g., groundboom and airblast) employed for fluopyram.  The agency has been working with the Spray Drift Task Force (a task force composed of various registrants which was developed as a result of a Data Call-In issued by EPA), EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the agency's Spray Drift website for more information).   The agency has also developed a policy on how to appropriately consider spray drift as a potential source of exposure in risk assessments for pesticides.  The potential for spray drift will be quantitatively evaluated for each pesticide during the Registration Review process which ensures that all uses for that pesticide will be considered concurrently.  The approach is outlined in the revised (2012) Standard Operating Procedures For Residential Risk Assessment (SOPs) - Residential Exposure Assessment Standard Operating Procedures Addenda 1: Consideration of Spray Drift.  This document outlines the quantification of indirect non-occupational exposure to drift.  

5.6	Residential Bystander Post-Application Inhalation Exposure

Volatilization of pesticides may be a source of post-application inhalation exposure to individuals nearby pesticide applications.  The agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP's final report on March 2, 2010 (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0687-0037).  The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2014-0219).  During Registration Review, the Agency will utilize this analysis to determine if data (i.e., flux studies, route-specific inhalation toxicological studies) or further analysis is required for fluopyram.

In addition to this screen, the Agency has developed a preliminary bystander volatilization inhalation exposure assessment for fluopyram utilizing the currently available inhalation toxicity and air monitoring data.  


6.0	Occupational Exposure and Risk Estimates

6.1	Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individuals who are involved in the pesticide application process.  HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each task.  Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used by a handler can cause exposure levels to differ in a manner specific to each application event.  

Based on the anticipated use patterns and proposed labeling, types of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed uses.  The quantitative dermal and inhalation exposure/risk assessment developed for occupational handlers is based on the following scenarios: 

 Mixing/loading liquids for aerial and chemigation application,
 Mixing/loading liquids for groundboom application,
 Mixing/loading liquids for airblast application, 
 Applying sprays via aerial equipment, 
 Applying sprays via groundboom equipment, 
 Applying sprays via airblast equipment, 
 Flagging for aerial sprays, 
 Mixing, loading, and applying liquids with manually pressurized handwand, 
 Mixing, loading, and applying liquids with mechanically-pressurized handgun, and
 Mixing, loading, and applying liquids with a backpack.

Occupational Agricultural Handler Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments.  Each assumption and factor is detailed below on an individual basis.

Application Rate:  A summary of the maximum application rates for each crop or use site are provided in Table 4.1.

Unit Exposures:  It is the policy of HED to use the best available data to assess handler exposure.  Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, include PHED 1.1, the AHETF database, or other registrant-submitted occupational exposure studies.  Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA.  The standard values recommended for use in predicting handler exposure that are used in this assessment, known as "unit exposures", are outlined in the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table", which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at the Agency website. 

Area Treated or Amount Handled:  The daily areas treated or amounts handled were defined for each handler scenario (in appropriate units) by determining the amount that can be reasonably treated by an individual in a single day.  When possible, the assumptions for daily areas treated or amounts handled are taken from the HED's ExpoSAC Policy 9.1: "Standard Values for Daily Acres Treated in Agriculture".  

Exposure Duration:  HED classifies exposures from 1 to 30 days as short-term and exposures 30 days to six months as intermediate-term.  Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggering the use of the pesticide, and the cultural practices surrounding that use site.  For most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one-month time frame; however, there may be a large agribusiness and/or commercial applicators who may apply a product over a period of weeks (e.g., completing multiple applications for multiple clients within a region).  

For fluopyram, based on the existing labeled use patterns, short- and intermediate-term exposures are expected.  Long-term exposure is not expected based on the proposed use patterns.

Mitigation/Personal Protective Equipment:  Occupational handler exposure assessments are completed by HED using different levels of risk mitigation.  Typically, HED uses a tiered approach.  The lowest tier is designed as the baseline exposure scenario (i.e., long-sleeve shirt, long pants, shoes, socks, no respirator).  If risk estimates are of concern at baseline attire, then increasing levels of PPE (i.e., gloves, respirators) are evaluated.  This approach is used to ensure that the lowest level of risk mitigation that provides adequate protection is selected.  Estimates of dermal and inhalation exposure were calculated for "baseline," defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no protective gloves, and no respirator.  The fluopyram product labels direct mixers, loaders, applicators and other handlers to wear long-sleeved shirt and long pants, and chemical resistant gloves.

Occupational Handler Non-Cancer Exposure and Risk Estimate Equations
The algorithms used to estimate non-cancer exposure and dose for occupational handlers can be found in Appendix A.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

For all exposure scenarios the risk estimates do not exceed HED's LOC (i.e., MOEs >=100) at baseline clothing (i.e., long sleeved shirt, long pants, shoes plus socks, without gloves or a respirator).  The MOEs ranged from 410 to 1,500,000 for dermal exposure with baseline clothing, 2,400 to 1,100,000 for dermal exposure with the addition of gloves, and 7,400 to 30,000,000 for inhalation exposure.  See Table 6.1.1 for the summary of occupational handler risk estimates.



Table 6.1.1. Occupational Short- and Intermediate-Term Dermal and Inhalation Exposures and Risk Estimates For Fluopyram
                               Exposure Scenario
                                Crop or Target
                         Maximum Application Rate[a] 
                                   (lb ai/A)
               Area Treated or Amount Handled 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 and Chemigation Applications
Artichoke (globe); Brassica (cole) Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low-Growing Berries
                                     0.222
                                      350
                                     0.22
                                    0.0376
                                     0.219
                                     0.214
                                    0.0365
                                    2.13E-4
                                     1,400
                                     8,200
                                    68,000
                                       
               Brassica Leafy Vegetables Head and Stem Subgroup
                                     0.125
                                      350
                                       
                                       
                                       
                                     0.120
                                    0.0206
                                    1.20E-4
                                     2,500
                                    15,000
                                    120,000
                                       
Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean); Potato; Sugar Beet; Sunflower subgroup
                                     0.222
                                     1200
                                       
                                       
                                       
                                     0.733
                                     0.125
                                    7.29E-4
                                      410
                                     2,400
                                    20,000

           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.131
                                      60
                                       
                                       
                                       
                                    0.0216
                                    0.00370
                                    2.15E-5
                                    14,000
                                    81,000
                                    670,000

                                      Sod
                                     0.446
                                      350
                                       
                                       
                                       
                                     0.429
                                    0.0734
                                    4.28E-4
                                      700
                                     4,100
                                    34,000
        Mixing/Loading Liquids Concentrates for Groundboom Applications
Artichoke (globe); Brassica (cole) Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low-Growing Berries
                                     0.222
                                      80
                                     0.22
                                    0.0376
                                     0.219
                                    0.0489
                                    0.00835
                                    4.86E-5
                                     6,00
                                    36,000
                                    300,000
                                       
               Brassica Leafy Vegetables Head and Stem Subgroup
                                     0.125
                                      80
                                       
                                       
                                       
                                    0.0275
                                    0.00470
                                    2.74E-5
                                    11,000
                                    64,000
                                    530,000

Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean); Potato; Sugar Beet; Sunflower subgroup
                                     0.222
                                      200
                                       
                                       
                                       
                                     0.122
                                    0.0209
                                    1.22E-4
                                     2,500
                                    14,000
                                    120,000

                            Field Grown Ornamentals
                                     0.131
                                      40
                                       
                                       
                                       
                                    0.0144
                                    0.00246
                                    1.44E-5
                                    21,000
                                    120,000
                                    1.0E+6

           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.131
                                      60
                                       
                                       
                                       
                                    0.0216
                                    0.0037
                                    2.15E-5
                                    14,000
                                    81,000
                                    670,000

                                      Sod
                                     0.446
                                      80
                                       
                                       
                                       
                                    0.0981
                                    0.0168
                                    9.76E-5
                                     3,100
                                    18,000
                                    150,000

                                     Turf
                                     0.446
                                      40
                                       
                                       
                                       
                                    0.0490
                                    0.00839
                                    4.89E-5
                                     6,100
                                    36,000
                                    300,000
         Mixing/Loading Liquids Concentrates for Airblast Applications
           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.131
                                      20
                                     0.22
                                    0.0376
                                     0.219
                                    0.00720
                                    0.00123
                                    7.18E-6
                                    42,000
                                    240,000
                                    2.0E+6
                                       
Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Pome Fruit; Stone Fruit; 
                                     0.222
                                      40
                                       
                                       
                                       
                                    0.0244
                                    0.00418
                                    2.43E-5
                                    12,000
                                    72,000
                                    600,000
                                  Applicator
                     Applying Sprays via Aerial Equipment
Artichoke (globe); Brassica (cole) Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low-Growing Berries
                                     0.222
                                      350
                                  0.00208[g]
                                    No Data
                                   0.0049[g]
                                    0.00203
                                    No Data
                                    4.76E-6
                                    150,000
                                    No Data
                                    3.0E+6
                                       
               Brassica Leafy Vegetables Head and Stem Subgroup
                                     0.125
                                      350
                                       
                                       
                                       
                                    0.00114
                                    No Data
                                    2.68E-6
                                    260,000
                                    No Data
                                    5.4E+6

Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean); Potato; Sugar Beet; Sunflower subgroup
                                     0.22
                                     1200
                                       
                                       
                                       
                                    0.00693
                                    No Data
                                    1.64E-5
                                    43,000
                                    No Data
                                    880,000

           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.131
                                      60
                                       
                                       
                                       
                                   0.000204
                                    No Data
                                    4.81E-7
                                    1.5E+6
                                    No Data
                                    3.0E+7

                                      Sod
                                     0.446
                                      350
                                       
                                       
                                       
                                    0.00406
                                    No Data
                                    9.56E-6
                                    74,000
                                    No Data
                                    1.5E+6
                   Applying Sprays via Groundboom Equipment
Artichoke (globe); Brassica (cole) Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low-Growing Berries
                                     0.222
                                      80
                                    0.0786
                                    0.0161
                                     0.34
                                    0.0175
                                    0.00358
                                    7.55E-5
                                    17,000
                                    84,000
                                    190,000
                                       
               Brassica Leafy Vegetables Head and Stem Subgroup
                                     0.125
                                      80
                                       
                                       
                                       
                                    0.00983
                                    0.00201
                                    4.25E-5
                                    31,000
                                    150,000
                                    340,000

Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean); Potato; Sugar Beet; Sunflower subgroup
                                     0.222
                                      200
                                       
                                       
                                       
                                    0.0436
                                    0.00894
                                    1.89E-4
                                     6,900
                                    34,000
                                    77,000

                            Field Grown Ornamentals
                                     0.131
                                      40
                                       
                                       
                                       
                                    0.00515
                                    0.00106
                                    2.23E-5
                                    58,000
                                    280,000
                                    650,000

           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.131
                                      60
                                       
                                       
                                       
                                    0.00773
                                    0.00159
                                    3.34E-5
                                    39,000
                                    190,000
                                    430,000

                                      Sod
                                     0.446
                                      80
                                       
                                       
                                       
                                    0.0175
                                    0.00359
                                    7.59E-5
                                    17,000
                                    84,000
                                    190,000

                                     Turf
                                     0.446
                                      40
                                       
                                       
                                       
                                    0.0350
                                    0.00718
                                    1.51E-4
                                     8,600
                                    42,000
                                    96,000
                    Applying Sprays via Airblast Equipment
           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.222
                                      20
                                     1.77
                                     1.59
                                     4.71
                                    0.0580
                                    0.0521
                                    1.54E-4
                                     5,200
                                     5,800
                                    94,000
                                       
Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Pome Fruit; Stone Fruit 
                                     0.131
                                      40
                                       
                                       
                                       
                                     0.196
                                     0.176
                                    5.23E-4
                                     1,500
                                     1,700
                                    28,000
                                    Flagger
                    Flagging for Aerial Sprays Applications
Artichoke (globe); Brassica (cole) Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low-Growing Berries
                                     0.222
                                      350
                                     0.011
                                     0.012
                                     0.35
                                    0.0107
                                    0.0117
                                    3.40E-4
                                    28,000
                                    26,000
                                    43,000
                                       
               Brassica Leafy Vegetables Head and Stem Subgroup
                                     0.125
                                      350
                                       
                                       
                                       
                                    0.00601
                                    0.00656
                                    1.91E-4
                                    50,000
                                    46,000
                                    76,000
                                       
Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean); Potato; Sugar Beet; Sunflower subgroup
                                     0.22
                                     1200
                                       
                                       
                                       
                                    0.0366
                                     0.040
                                    0.00117
                                     8,200
                                     7,500
                                    12,000
                                       
           Nursery (ornamentals, vegetables, trees, container stock)
                                     0.131
                                      60
                                       
                                       
                                       
                                    0.00108
                                    0.00118
                                    3.44E-5
                                    280,000
                                    250,000
                                    420,000
                                       
                                      Sod
                                     0.446
                                      350
                                       
                                       
                                       
                                    0.0215
                                    0.0234
                                    6.83E-4
                                    14,000
                                    13,000
                                    21,000
                            Mixer/Loader/Applicator
Mixing/Loading/Applying Liquid Concentrates with Manually Pressurized Handwand
                            Greenhouse Ornamentals
                               0.00131 lb ai/gal
                                    40 gal
                                      100
                                     0.43
                                      30
                                    0.0655
                                    2.81E-4
                                    1.96E-5
                                     4,600
                                    1.1E+6
                                    740,000
                                       
           Nursery (ornamentals, vegetables, trees, container stock)
                               0.00131 lb ai/gal
                                       
                                       
                                       
                                       
                                    0.0655
                                    2.81E-4
                                    1.96E-5
                                     4,600
                                    1.1E+6
                                    740,000
                                       
                                Christmas Trees
                               0.00223 lb ai/gal
                                       
                                       
                                       
                                       
                                     0.112
                                    4.80E-4
                                    3.35E-5
                                     2,700
                                    630,000
                                    430,000
                                       
                                     Turf
                               0.0026 lb ai/gal
                                       
                                       
                                       
                                       
                                     0.130
                                    5.59E-4
                                    3.90E-5
                                     2,300
                                    540,000
                                    370,000
Mixing/Loading/Applying Liquid Concentrates with Mechanically-Pressurized Handgun
                            Greenhouse Ornamentals
                               0.00131 lb ai/gal
                                   1000 gal
                                      3.5
                                      2.5
                                      120
                                    0.0574
                                    0.0410
                                    0.00196
                                     5,200
                                     7,300
                                     7,400

           Nursery (ornamentals, vegetables, trees, container stock)
                               0.00131 lb ai/gal
                                   1000 gal
                                      1.3
                                     0.39
                                      3.9
                                    0.0213
                                    0.00639
                                    6.39E-5
                                    14,000
                                    47,000
                                    230,000

                                Christmas Trees
                               0.00223 lb ai/gal
                                   1000 gal
                                       
                                       
                                       
                                    0.0363
                                    0.0109
                                    1.09E-4
                                     8,300
                                    28,000
                                    130,000

                            Pome Fruit; Stone Fruit
                               0.0222 lb ai/gal
                                   1000 gal
                                       
                                       
                                       
                                     0.361
                                     0.108
                                    0.00108
                                      830
                                     2,800
                                    13,000

                               Golf Course; Turf
                                     0.446
                                       5
                                     1.14
                                     0.88
                                      1.9
                                    0.0318
                                    0.0245
                                    5.30E-5
                                     9,400
                                    12,000
                                    270,000
          Mixing/Loading/Applying Liquid Concentrates with a Backpack
           Nursery (ornamentals, vegetables, trees, container stock)
                               0.00131 lb ai/gal
                                    40 gal
                                     13.2
                                     11.2
                                      140
                                    0.00865
                                    0.00734
                                    1.98E-5
                                    35,000
                                    41,000
                                    160,000
                                       
                                Christmas Trees
                               0.00223 lb ai/gal
                                       
                                       
                                       
                                       
                                    0.0148
                                    0.0125
                                    1.56E-4
                                    20,000
                                    24,000
                                    93,000
                                       
                            Pome Fruit; Stone Fruit
                               0.0222 lb ai/gal
                                       
                                     8.26
                                     8.26
                                     2.58
                                    0.0916
                                    0.0916
                                    2.86E-5
                                     3,300
                                     3,300
                                    510,000
                                       
                                     Turf
                               0.0026 lb ai/gal
                                       
                                       
                                       
                                       
                                    0.0107
                                    0.0107
                                    3.35E-6
                                    28,000
                                    28,000
                                    4.3E+6
a. Application Rates are based on proposed uses from the proposed fluopyram labels.
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.
d. Unit Exposures are based on "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table". 
e. Daily Exposure (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) * Area Treated or Amount Applied (acre/day) / 80 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.	
g. Engineering control unit exposure for applying sprays via aerial equipment = enclosed cockpit.



Seed Treatment Use on Peanut Seeds
Based on the anticipated use patterns and labeling, types of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed seed treatment of peanuts.  The quantitative exposure/risk assessment developed for occupational handlers is based on the following scenarios: 

 Mixing/loading liquids for commercial seed treatment,
 Bagging treated seed,
 Sewing bags,
 Multiple activities, and
 Planting treated seed.

Occupational seed treatment handlers may experience short- and intermediate-term exposure to fluopyram while performing seed treatment activities in commercial settings.  In addition, occupational secondary handlers may experience short- and intermediate-term exposure while planting fluopyram-treated seeds.  No chemical-specific handler exposure data were submitted in support of this use pattern.  For assessing commercial seed treatment and seed planting activities, unit exposure data were taken from HED ExpoSAC Policy 14: SOPs for Seed Treatment.  The amount of ai handled depends on the application rate (lb ai/lb seed) and the pounds of seed treated in a day (or the pounds of seed that can be planted in a day), all of which vary depending upon the seed type.  Values for the amount of seed treated and planted per day were obtained from HED ExpoSAC Policy 15 and 15.1.

Treating Seed (Primary Handler)
Potential occupational exposure scenarios from the use of fluopyram as a commercial seed treatment include: mixing, loading, applying liquid formulations; bagging treated seed; sewing bags; and multiple activities.  Typically, for large-scale commercial seed treatments, workers perform only those specific individual tasks listed above; however, it is assumed that workers also may perform multiple activities throughout the day.  As a result a "multiple activities" scenario (i.e. where one worker performs all seed treatment tasks such as loading/applying, sewing, bagging, cleaning, calibration, repair, forklift driver, etc.) was addressed.

Planting Treated Seed (Secondary Handler)
Potential occupational exposure scenarios from the use of fluopyram as a commercial seed treatment include planting treated seed (secondary handler).  Planting treated seed consists of the farmer purchasing bags of treated seed, placing the seed in the hopper and applying seed to fields (considered a secondary handler exposure scenario).

Occupational Handler Exposure Data and Assumptions
A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments.  Each assumption and factor is detailed below on an individual basis.

Application Rate:  
Refer to the proposed use pattern table in Section 4.0 for a detailed description.

Unit Exposures:  It is the policy of HED to use the best available data to assess handler exposure.  Chemical-specific data for assessing exposure during commercial seed treatment and seed planting were not submitted to the Agency in support of these applications.  Unit exposures are from ExpoSAC Policy 14: SOPs for Seed Treatment (May 1, 2003) and are based on data for open mixing/loading/application systems.

Amount Handled:  
HED is currently in the process of revising ExpoSAC Policy 15: Amount of Seed Treated or Planted per Day (March 2, 2004) in efforts to update the daily amount of seed treated in commercial seed treatment facilities.  With the increasing demand for hybridized treated seeds, there have been modifications not only in the seed treatment equipment, but in the market shares of new and currently registered pesticide products.  HED understands that due to the high cost of producing hybrid seeds, direct seeding is done in a precision manner which requires lower volumes of seed per acre.  However, this does not provide a direct correlation to the amount of seed which is treated in the commercial seed treatment facilities.

The amount of seed handled (for both primary/treater and secondary/planter handlers) is based on HED ExpoSAC Policy 15, HED ExpoSAC Policy SOP 15.1, and the BEAD memo: "Acres Planted Per Day and Seeding Rates of Crops Grown in the United States."

 The amount of peanut seed treated per day at a commercial facility for short-term exposure durations is 339,500 lb.

 Amount of seed planted per acre (ASP, lb seed/A) for peanut is 228 lb seed/A (105,000 seeds/A x lb peanut seeds/460 peanut seeds).

 The amount of seed planted per acre per day for peanut is 18,260 lb (228 lb seed/A x 80 A/day).

Exposure Duration: 
HED classifies exposures from 1 to 30 days as short-term and exposures 30 days to six months as intermediate-term.

Mitigation/Personal Protective Equipment:  Results are presented for PPE (gloves); defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, protective gloves, and no respirator for all scenarios, except bagging and sewing, for which "baseline" attire was evaluated.

Occupational Handler Non-Cancer Exposure and Risk Estimate Equations
The algorithms used to estimate non-cancer exposure and dose for occupational handlers can be found in Appendix A.

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates
The results of the occupational handler exposure and risk assessment indicate that short-term dermal and inhalation risk estimates do not exceed HED's LOC (i.e., an MOE < 100 for short-term exposures).  Short-term exposure risk estimates are protective of intermediate-term exposure risk estimates because the throughput (amount of seed treated) of short-term exposure is greater than, or equal to, the throughput of intermediate-term exposure.  The dermal MOEs range from 1,400 to 9,200 for handlers (treaters and planters).  The inhalation MOEs range from 1,700 to 15,000 for handlers (treaters and planters).  Because the short- and intermediate-term dermal and inhalation PODs are the same, and the intermediate-term exposure inputs are less conservative than the short-term exposure inputs for seed treatment, short-term exposure risk estimates are protective of intermediate-term exposure risk estimates.

Table 6.1.2.  Summary of Short- and Intermediate-Term Handler Exposures and Risk Estimates for Fluopyram Seed Treatment of Peanut Seed.[a]
                          Maximum Application Rate[b]
                                 lb ai/lb seed
                            Amount of Seed Treated 
                             or Planted Per Day[d]
                                  lb seed/day
                                    Dermal
                               Unit Exposure[c]
                                     mg/lb
                                  Inhalation
                               Unit Exposure[c]
                                     mg/lb
                                Dermal Dose[e]
                                   mg/kg/day
                              Inhalation Dose[f]
                                   mg/kg/day
                                 Dermal MOE[f]
                                   LOC = 100
                               Inhalation MOE[h]
                                   LOC = 100
                               Loader/Applicator
                                   0.001245
                                    339,500
                                     0.023
                                    0.00034
                                    0.1215
                                   0.001796
                                     2,500
                                     8,100
                                     Sewer
                                   0.001245
                                    339,500
                                    0.0062
                                    0.00023
                                    0.03276
                                   0.001215
                                     9,200
                                    12,000
                                    Bagger
                                   0.001245
                                    339,500
                                    0.0091
                                    0.00016
                                    0.04808
                                   0.0008454
                                     6,200
                                    17,000
                              Multiple Activities
                                   0.001245
                                    339,500
                                     0.042
                                    0.0016
                                    0.2219
                                   0.008454
                                     1,400
                                     1,700
                                   Planters
                                   0.001245
                                    18,260
                                     0.25
                                    0.0034
                                    0.07104
                                   0.0009662
                                     4,200
                                    15,000
a	Seed treatment rate calculations are based on the following assumptions:
	Peanut: 460 seeds per lb; 228 lb of seed planted per acre, 80 acres planted per day.
b	Application Rate based on proposed label for fluopyram (Luna Privilege, EPA Reg. No. 264-1078).
c	Unit Exposures from HED Exposure Science Advisory Council Policy 14: Standard Operating Procedures for Seed Treatment (baseline inhalation = no respirator; dermal unit exposure includes PPE with gloves for loading/applicator, multiple activities and planter scenarios).
d	HED default for lb seed treated/planted per day from HED Exposure Science Advisory Council Interim Policy 15.1 and the BEAD memo "Acres Planted Per Day and Seeding Rates of Crops Grown in the United States" (J. Becker, March 2011).
e	Daily Dermal Dose (mg/kg/day) = daily dermal unit exposure (mg/ - lb ai) x application rate (lb ai/lb seed) x amount planted (lb seed/day) / body weight (80 kg adult).
f	Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/ - lb ai) x application rate (lb ai/lb seed) x amount planted (lb seed/day) / body weight (80 kg adult).
g	Dermal MOE = NOAEL (300 mg/kg/day for short- and intermediate-term exposure) / Dermal Dose (mg/kg/day). Level of concern = 100.
h	Inhalation MOE = NOAEL (14.5 mg/kg/day for short- and intermediate-term exposure) / Inhalation Dose (mg/kg/day). Level of concern = 100.

6.2	Occupational Post-application Exposure/Risk Estimates

HED uses the term post-application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re-entry exposure).  Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting.  Post-application exposure levels vary over time and depend on such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide application, and the chemical's degradation properties.  In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post-application exposure.

6.2.1	Occupational Post-application Inhalation Exposure/Risk Estimates

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 has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2014-0219).  During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux studies, route-specific inhalation toxicological studies) or further analysis is required for fluopyram.

In addition, the Agency is continuing to evaluate the available post-application inhalation exposure data generated by the Agricultural Reentry Task Force.  Given these two efforts, the Agency will continue to identify the need for and, subsequently, the way to incorporate occupational post-application inhalation exposure into the agency's risk assessments.

Although a quantitative occupational post-application inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers.  Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post-application exposure.  Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post-application inhalation exposure scenarios.

6.2.2	Occupational Post-application Dermal Exposure/Risk Estimates

Use on Agricultural Field Crops

Occupational Post-application Dermal Exposure Data and Assumptions
In addition to the application rate and body weight values discussed above in the handler exposure section, the following assumptions were made in assessing short- and intermediate-term dermal post-application risks:

Dislodgeable Foliar Residues:
There were no chemical-specific dislodgeable foliar residue data to assess post-application risks to workers while performing tasks related to crops treated with fluopyram.  For agricultural crops, occupational post-application exposures and risks were assessed using HED's default assumptions that 25% 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.  

In accordance with 40 CFR §158, DFR data are required for all occupational (e.g., crop, nursery, greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own farms, retail tree farms) uses that could result in post-application exposure to foliage.  In the absence of chemical-specific DFR data, EPA uses default values.  The 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an analysis of a number of DFR studies, which resulted in the selection of a revised default values for the fraction of the application rate available for transfer after a foliar application (FAR).  These values are based on an analysis of 19 DFR studies.  Since that time, the Agricultural Re-entry Task Force has submitted information (MRID 49299201) that corrects an application rate error made in the original submission of "ARF039  -  Determination of Dermal and Inhalation Exposure to Reentry Workers During Chrysanthemum Pinching in a Greenhouse" (EPA MRID 45344501).  As a result, the range of FAR values was revised from 2% - 89% to 2% - 47%.  In the data, a large range of transferability is observed and this variability can potentially be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e.g., humidity); or many other difficult to quantify factors.  Although witnessed across multiple chemicals, this range in FAR values is not expected when considering DFR data for a single chemical.  At this time, the ARTF submission did not alter the selection of 25% as the reasonable, high-end default value.  Because DFR data are not available for fluopyram, EPA is using the default value of 25%.  Although there may be a small degree of uncertainty in the use of the default DFR value for fluopyram (i.e., there is a small chance that the FAR value may exceed the applicable default value), it is likely that the health-protective aspects of EPA's occupational post-application assessment methodology will more than compensate for this potential uncertainty.  For example,  when assessing residential and occupational post-application exposure to gardens and ornamentals, EPA assumes the following:  exposures occur to zero-day (i.e., day of application ) residues every day of the assessed exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn't rain, etc); individuals perform the same post-application activities performed in the transfer coefficient study day after day (e.g., weeding, harvesting, pruning, etc.); and individuals engage in these post-application activities for a high-end amount of time every day (represented by data reflecting time spent gardening based on survey data).

Given the conservatisms discussed above and the potential compounding nature of these conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that exposure is not being underestimated. 

Since the highest estimated residential and occupational post-application exposures using default DFR values for fluopyram are minimal in comparison to the level of concern (i.e., the calculated MOE is greater than 2 times higher than the level of concern, residential MOE = 2,100 and occupational MOE = 250 compared to the LOC of 100); EPA is waiving the 40 CFR §158 DFR data requirement.  In this instance, it is unlikely that chemical-specific DFR data would be needed to further refine exposure assessments or would add appreciably to our overall understanding of the availability of dislodgeable foliar pesticide residues for fluopyram.  


Turf Transferrable Residues
A turf transferrable residue study has not been submitted for fluopyram.  Therefore, HED's standard operating procedures and assumptions were used to determine an estimate of day zero fluopyram residues on treated turf.  

In accordance with 40 CFR §158, TTR data are required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses that could result in post-application exposure to turf.  In the absence of chemical-specific TTR data, EPA uses default values.  The 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an analysis of all TTR data, available at the time, which resulted in the selection of revised liquid and granular default values for the fraction of the application rate available for transfer after a turf application (FAR).  These values are based on an analysis of 59 TTR studies performed with the Modified California Roller Method (36 studies using liquids, 11 studies using wettable powders/water dispersible granules, and 12 studies using granules).  The liquid results (N=131) indicate a range of FAR values from 0.0005% to 6.1% and the granular results (N=37) indicate a range of 0.00064% to 0.69%.  In both the liquid and granular data, a large range of transferability is observed and this variability can potentially be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e.g., humidity); or many other difficult to quantify factors.  Although witnessed across multiple chemicals, this range in FAR values is not expected when considering TTR data for a single chemical.  HED selected 1% and 0.2% as high-end default values for liquid and granular products, respectively.  Because TTR data are not available for fluopyram, EPA is using the default value of 1%.  Although there may be a small degree of uncertainty in the use of the default TTR value for fluopyram (i.e., there is a small chance that the FAR value may exceed the applicable default value), it is likely that the health-protective aspects of EPA's residential and occupational post-application turf assessment methodology will more than compensate for this potential uncertainty (i.e., the methodology is likely to overestimate exposure by a factor greater than the factor than the highest measured FAR values exceed the defaults).  For example, when assessing residential post-application turf exposure, EPA assumes the following:  exposures occur to zero-day (i.e., day of application ) residues every day of the assessed exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn't rain, the grass is not mowed, etc.); individuals perform the same post-application activities performed in the turf transfer coefficient study day after day (e.g., tumbling, playing on turf with toys, etc.); and individuals engage in these post-application activities for a high-end amount of time every day that is represented by data reflecting time children spend outdoors and not specifically engaged in activities on turf, when in actuality children do not spend all of their outdoor time on turf and high-end levels of activity will not occur every day.

Given the conservatisms discussed above and the potential compounding nature of these conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that exposure is not being underestimated.

Since the estimated residential turf post-application exposure from high contact activities on lawns and the occupational post-application activities on golf course turf using default TTR values for fluopyram are minimal in comparison to the level of concern (i.e., the calculated MOEs are greater than 10 times higher than the level of concern, residential MOE = 1,000 and occupational MOE = 9,000, compared to the LOC of 100); EPA is waiving the 40 CFR §158 TTR data requirement.  In this instance, it is unlikely that chemical-specific TTR data would be needed to further refine exposure assessments or would add appreciably to our general understanding of the availability of turf transferable pesticide residues.

Transfer Coefficients:
HED uses a concept known as the transfer coefficient to numerically represent the post-application 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 post-application 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 ARTF data.  Use of the data in this policy requires compensation to the ARTF under FIFRA.  The transfer coefficients used in this assessment were taken from the Agency's revised Agricultural Transfer Coefficient SOP.  Many of the transfer coefficients in this SOP are based on work of the ARTF.  

Workday:
HED assumes an 8 hour workday for post-application workers.

Equations and Calculations:
Daily Dermal Exposure and default DFR calculations are presented below.  The algorithms used to estimate dermal post-application exposure and dose can be found in Appendix A.

The post-application dermal exposure and risk estimates associated with agricultural crops, Christmas trees, and nursery ornamentals are summarized in Table 6.2.2.  For each crop or crop group the post-application activities with the highest transfer coefficient and highest exposure contact are presented.  The occupational post-application MOEs for all crops and crop groups and scenarios shown below do not exceed HED's level of concern (MOEs >=100) on day 0 (i.e., 12 hours following application) with dermal MOEs ranging from 250 to 23,000.  All other scenarios involving lesser contact activities would have higher MOEs and are also not of concern.

Table 6.2.2.  Summary of Occupational Non-Cancer Post-application Risks (Short- and Intermediate-Term) with HED Default Assumptions.
                             Crops or Crop Groups
                               Application Rate
                                 (lb ai/acre)
              Default DFR on 0 days (12 hr) after application[a]
                                   (ug/cm2)
                             Work Activity & 
                       Maximum Transfer Coefficient[b] 
                                  (cm[2]/hr)
                                 Daily Dose[c]
                                  (mg/kg/day)
                                    MOE[d]
                                  (LOC = 100)
                                   Artichoke
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
              Brassica Leafy Vegetables Head & Stem Subgroup
                                     0.125
                                     0.350
     4200 Hand Harvesting, Hand Weeding, Scouting, Topping, Tying/Training
                                     0.147
                                     2,000
                           Brassica Leafy Vegetables
                                     0.222
                                     0.622
                               4200 Hand Weeding
                                     0.261
                                     1,100
                                Bulb Vegetables
                                     0.222
                                     0.622
                               4200 Hand Weeding
                                     0.261
                                     1,100
                                Canola Subgroup
                                     0.222
                                     0.622
                                 1100 Scouting
                                    0.0684
                                     4,400
                                    Carrot
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                  Sweet Corn
                                     0.222
                                     0.622
                   17,600 Hand Detasseling, Hand Harvesting
                                     1.09
                                      270
                                 Cereal Grains
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                  Forage, Fodder or Straw from Cereal Grains
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                    Citrus
                                     0.222
                                     0.622
                             1400 Hand Harvesting
                                    0.0871
                                     3,400
                                    Cotton
                                     0.222
                                     0.622
                                 210 Scouting
                                    0.0131
                                    23,000
                                   Cucurbits
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                              Fruiting Vegetables
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                     Okra
                                     0.167
                                     0.468
                          1900 Irrigation (Hand Set)
                                    0.0889
                                     3,400
                                    Ginseng
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                               Small Vine Fruits
                                     0.222
                                     0.622
                            10,100 Hand Harvesting
                                     0.628
                                      480
                              Herbs & Spices
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                     Hops
                                     0.222
                                     0.622
                   19,300 Harvesting, Mechanically Assisted
                                     1.20
                                      250
                               Leafy Vegetables
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                               Legume Vegetables
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                    Soybean
                                     0.222
                                     0.622
                                 1100 Scouting
                                    0.0684
                                     4,400
                                  Pome Fruit
                                     0.222
                                     0.622
                              3600 Thinning Fruit
                                     0.224
                                     1,300
                     Root, Tuberous & Corm Vegetables
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                 Small Berries
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                  Stone Fruit
                                     0.222
                                     0.622
                              3600 Thinning Fruit
                                     0.224
                                     1,300
                              Low Growing Berries
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                  Sugar Beet
                                     0.222
                                     0.622
                             1100 Hand Harvesting
                                    0.0684
                                     4,400
                                   Sunflower
                                     0.222
                                     0.622
                          1900 Irrigation (Hand Set)
                                     0.118
                                     2,500
                                Christmas Trees
                                     0.223
                                     0.625
                          1900 Irrigation (Hand Set)
                                     0.119
                                     2,500
                              Nursery Ornamentals
                                     0.131
                                     0.367
                          1900 Irrigation (Hand Set)
                                    0.0697
                                     4,300
 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 25% DFR after initial treatment.
 Crops were assessed using the highest transfer coefficient (TC) available.
 Daily Dose = DFR x TC x (1 mg/1000 ug) x ET (8 hr/day) / body weight (80 kg)
 MOE = NOAEL (300 mg/kg/day) / Daily Dose (mg/kg/day)

For use on cotton, HED has also assessed the post-application dermal exposure and risk estimates for workers involved in harvesting cotton bolls.  Although most of cotton harvesting is done mechanically, there are still some activities, with the potential for exposure, that are associated with the harvesting of cotton.  The anticipated post-application activities and dermal transfer coefficients for these activities are presented in Table 6.2.3.  The recommended transfer coefficients are derived from EPA's Science Advisory Council for Exposure (ExpoSAC) Policy 3 (http://www.epa.gov/pesticides/science/exposac-policy3-march2013.pdf).  No chemical specific data are available for the amount of residue available on the cotton bolls; i.e., dislodgeable boll residue (DBR) data.  Such data are available from a study with the active ingredient tribufos; i.e., MRID 42701601.  Note to RD:  These data may be proprietary, and subject to the data protection provisions of FIFRA, and therefore, may trigger a data compensation issue between registrants.  Since the proposed fluopyram labels include a 30 day pre-harvest interval, the best fit residue data used from MRID 42701601 was chosen from 30 days after harvest and then adjusted for the difference in application rates.  All of the cotton harvesting activities resulted in MOEs ranging from 3,100,000 to 17,000,000, which do not exceed the LOC, and are therefore not of concern; see Table 6.2.4.

Table 6.2.3.  Anticipated Post-Application Activities and Transfer Coefficients for Cotton Harvesters.
                                     Crop
                          Policy Crop Group Category
                                  Crop Height
                                Foliage Density
                             Transfer Coefficients
                                  Activities
                                    Cotton
                        Field / row. crop, low / medium
                                     High
                                      Min
                             900 g cotton boll/hr
                Mechanical Harvesting (Module Builder Operator)
                                       
                                       
                                       
                                       
                            2,400 g cotton boll/hr
               Mechanical Harvesting (Picker Operator and Raker)
                                       
                                       
                                       
                                       
                            5,050 g cotton boll/hr
                        Mechanical Harvesting (Tramper)

Table 6.2.4.  Occupational Post-application Exposure and Risk Estimates for Cotton Harvesting Activities.
                        Mechanical Harvesting Activity
                                  Appl. Rate
                                   (lb ai/A)
                                      DBR
                                  (ug/g)[1]
                             Transfer Coefficient
                                   (g/hr)[2]
                                Dermal Dose[3]
                                  (mg/kg/day)
                                 Dermal MOE[4]
                            Module Builder Operator
                                     0.222
                                   0.000194
                                      900
                                   0.0000175
                                  17,000,000
                           Picker Operator and Raker
                                       
                                       
                                     2,400
                                   0.0000466
                                   6,400,000
                                    Tramper
                                       
                                       
                                    5,0500
                                   0.0000981
                                   3,100,000
1. Cotton Harvesting Dislodgeable Boll Residue (DBR) = (Best fit DBR at 30 days MRID# 42701601 (0.082 ug/50g = 0.00164 ug/g) x Application Rate (0.222 lb ai/A)) / Study Application Rate (1.875 lb ai/A) = 0.000194 ug/g
2. From Non-Foliar Transfer Coefficient Table: http://epa.gov/pesticides/science/exposac-policy-3-march2013.pdf  
3. Daily Dose (mg/kg/day) = [DBR x Transfer Coefficient x Conv. Factor (0.001 mg/ug) x 8 hr/day] / Body Weight (80 kg). 
4: Short- & Intermediate-term Margin of Exposure (MOE) = Short-term Dermal NOAEL (300 mg/kg/day) / Daily Dose (mg/kg/day).

For use on turf, the exposure/risk assessment for the proposed uses results in a post-application occupational MOE of 9,000, which is above the dermal LOC (MOE >=100); and therefore is not of concern.


Table 6.2.5.  Exposure and Risk Assessment for Occupational Post-Application Activities on Turf.
                               Application Rate
                                   (lb ai/A)
          Dermal Transfer Coefficient (cm[2]/hr) & Activities[1]
                               Post Application
                                    Day (t)
                 Turf Transferable Residue (TTR)[2](ug/cm[2])
                           Daily Dose[3] (mg/kg/day)
                 Short- & Intermediate-Term Dermal MOE[4]
                                     0.446
       6,700 (Maintenance, Transplanting/Planting, & Harvesting Sod)
                                       0
                                     0.05
                                    0.0335
                                     9,000
[1] The transfer coefficient is the arithmetic mean value taken from MRID 46734001.  It should be noted that a previous study on golf course maintenance (MRID 45530101) had been submitted, but had been determined to be unacceptable.  Data from MRID 46734001 are believed to be more appropriate.
[2] TTR derived as follows: 0.446 lb ai/A x 4.54E+8 ug/lb x 2.47E-8 A/cm[2]x 0.01 (fraction of transferable ai) = 0.05 ug/cm[2].
[3] Daily Dose = [TTR (ug/cm[2]) x (0.001 mg/ug) x Dermal Transfer Coefficient x Exposure Time (8 hr)] / [Body Weight (80 kg)] = 0.0335 mg/kg/day.
[4] MOE = LOAEL/Daily Dose.  Short-/Intermediate-Term LOAEL = 300 mg/kg/day.

Restricted Entry Interval
Since post-application risk estimates 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 dermal route of exposure and Toxicity Category IV for acute 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 labels is adequate to protect agricultural workers from post-application exposures to fluopyram.

Seed Treatment Use on Peanut Seeds
With regard to seed treatment, the potential for post-application exposures following the planting of fluopyram-treated seeds is unlikely because sustained levels of contact with treated seed after it has been placed in the soil or other planting media would not be expected because no routine cultural practice required for the production of agricultural commodities involves such an activity, as defined in the no/low contact criteria in the Worker Protection Standard (WPS) in 40 CFR §170.112.  Therefore, no quantitative post-application assessment is required for exposure to treated seeds that have already been planted.


Appendix A.  Summary of Occupational and Residential Non-cancer Algorithms

Occupational Handler Non-Cancer Algorithms

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

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

where:

E	=	exposure (mg ai/day),
UE	=	unit exposure (ug ai/lb ai),
AR	=	maximum application rate according to proposed label (lb ai A or lb ai/gal), and
A	=	area treated or amount handled (e.g., A/day, gal/day).
 
The daily doses are calculated using the following formula:

ADD=  E * AFBW

where:

ADD	= 	average daily dose absorbed in a given scenario (mg ai/kg/day),
E	=	exposure (mg ai/day),
AF	=	absorption factor (dermal and/or inhalation), and
BW 	= 	body weight (kg).

Margin of Exposure:  Non-cancer risk estimates for each application handler scenario are calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose of concern.  The daily dermal and inhalation dose received by occupational handlers are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational handlers for each exposure route.  All MOE values are calculated using the following formula:

MOE= PODADD

where:

MOE	=	margin of exposure: value used by HED to represent risk estimates (unitless),
POD	=	point of departure (mg/kg/day), and
ADD	=	average daily dose absorbed in a given scenario (mg ai/kg/day).


Occupational Post-application Algorithms
Exposure resulting from contacting previously treated turf while working is calculated as follows:

	E = TTRt * CF1 * TC * ET 	

where:

E = exposure (mg/day); 
TTRt  = turf transferable residue on day "t" (ug/cm[2]);
CF1 = weight unit conversion factor (0.001 mg/ug);
TC  = transfer coefficient (cm[2]/hr); and
ET  = exposure time (hr/day).

and

                      TTRt = AR * F * (1-FD)t * CF2 * CF3

where:

TTRt = turf transferable residue on day t (μg/cm[2]);
AR = application rate (lbs ai/ft[2] or lb ai/acre);
F = fraction of ai as transferable residue following application (unitless);
FD = fraction of residue that dissipates daily (unitless);
t = post-application day on which exposure is being assessed;
CF2 = weight unit conversion factor (4.54 x 10[8] μg/lb); and
CF3 = area unit conversion factor (1.08 x 10[-3] ft[2]/ cm[2] or 2.47 x 10[-8] acre/cm[2]).

Absorbed dose, normalized to body weight, is calculated as:

	 
where:
      D	= dose (mg/kg-day);
      E	= exposure (mg/day); 
      AF	= absorption factor (dermal); and
      BW	= body weight (kg).


Residential Post-application Algorithms

Post-application Dermal Exposure Algorithm  -  Physical Activities on Turf
Exposure resulting from contacting previously treated turf while performing physical activities is calculated as shown below.  Residential post-application exposure assessment must include calculation of exposure on the day of application.  Therefore, though an assessment can present exposures for any day "t" following the application, it must include "day 0" exposure.

                           E = TTRt * CF1 * TC * ET

where:

E = exposure (mg/day);
TTRt = turf transferable residue on day t (μg/cm[2]);
CF1 = weight unit conversion factor (0.001 mg/μg);
TC = transfer coefficient (cm[2]/hr); and
ET = exposure time (hr/day).

If chemical-specific TTR data are available, then surface residues from the day of application should be used (assume that individuals could be exposed to residues immediately after application). However, if data are not available, then TTRt can be calculated using the following formula:

                      TTRt= AR * F * (1-FD)t * CF2 * CF3

where:

TTRt = turf transferable residue on day t (μg/cm[2]);
AR = application rate (lbs ai/ft[2] or lb ai/acre);
F = fraction of ai as transferable residue following application (unitless);
FD = fraction of residue that dissipates daily (unitless);
t = post-application day on which exposure is being assessed;
CF2 = weight unit conversion factor (4.54 x 10[8] μg/lb); and
CF3 = area unit conversion factor (1.08 x 10[-3] ft[2]/ cm[2] or 2.47 x 10[-8] acre/cm[2]).

Dermal absorbed doses are calculated as:

	 	

where:
      D	= dose (mg/kg-day);
      E	= exposure (mg/day);
      AF	= absorption factor (dermal); and
      BW	= body weight (kg).

Table A-1: Turf (Physical Activities) -- Inputs for Residential Post-application Dermal Exposure
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                      AR
                               Application rate
                    (mass active ingredient per unit area)
                              0.446 or 0.404 lb/A
                                       F
Fraction of AR as TTR following application (if chemical-specific data is unavailable)
                                   L/WP/WDG
                                     0.01
                                       
                                       
                                   Granules
                                     0.002
                                      FD
     Daily residue dissipation (if chemical-specific data is unavailable)
                                  (fraction)
                                   L/WP/WDG
                                      0.1
                                       
                                       
                                   Granules
                                      0.1
                                      TC
                        Transfer Coefficient (cm[2]/hr)
                                   L/WP/WDG
                                    Adults
                                    180,000
                                       
                                       
                                       
                          Children 1 < 2 years old
                                    49,000
                                       
                                       
                                   Granules
                                    Adults
                                    200,000
                                       
                                       
                                       
                          Children 1 < 2 years old
                                    54,000
                                      ET
                                 Exposure Time
                                (hours per day)
                                    Adults
                                      1.5
                                       
                                       
                          Children 1 < 2 years old
                                      1.5
                                      BW
                                  Body Weight
                                     (kg)
                                    Adults
                                      80
                                       
                                       
                          Children 1 < 2 years old
                                      11
L/WP/WDG = Liquids/Wettable Powders/Water-dispersible Granules

Post-application Hand-to-Mouth Exposure Algorithm -  Physical Activities on Turf
Exposure from hand-to-mouth activity is calculated as follows (based on the algorithm utilized in the SHEDS-Multimedia model):

  E = [HR * (FM * SAH) * (ET * N_Replen) * (1- (1- SE)[(Freq_HtM/N-Replen)])]

where:

E = exposure (mg/day);
HR = hand residue loading (mg/cm[2]);
FM = fraction hand surface area mouthed / event (fraction/event);
SAH = typical surface area of one hand (cm[2]);
ET = exposure time (hr/day);
N_Replen = number of replenishment intervals per hour (intervals/hour);
SE = saliva extraction factor (i.e., mouthing removal efficiency); and
Freq_HtM = number of hand-to-mouth contacts events per hour (events/hour).

and

		
                                       
where:

HR = hand residue loading (mg/cm[2]);
Faihands	 = fraction ai on hands compared to total surface residue from dermal transfer coefficient study (unitless);
DE = dermal exposure (mg); and
SAH = typical surface area of one hand (cm[2]).

Dose, normalized to body weight, is calculated as:

	 	

where:
      D	= dose (mg/kg-day);
      E	= exposure (mg/day); and
      BW	= body weight (kg).
Table A-2: Turf (Physical Activities)  -  Inputs for Residential Post-application Hand-to-Mouth Exposure 
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                   Faihands
        Fraction of ai on hands from dermal transfer coefficient study
                                  (unitless)
                              Liquid formulations
                                     0.06
                                       
                                       
                             Granular formulations
                                     0.027
                                      DE
                             Dermal exposure (mg)
                                  Calculated
                                      SAH
     Typical surface area of one hand (cm[2]), children 1 < 2 years old
                                      150
                                      AR
                               Application rate
                    (mass active ingredient per unit area)
                                  0.404 lb/A
                                      HR
                   Residue available on the hands (mg/cm[2])
                      Calculated via (DE * Faihands)/SAH
                                      FM
                      Fraction hand surface area mouthed
                               (fraction/event)
                                     0.127
                                   N_Replen
                       Replenishment intervals per hour
                                (intervals/hr)
                                       4
                                      ET
                                Exposure time 
                                   (hrs/day)
                                      1.5
                                      SE
                           Saliva extraction factor
                                  (unitless)
                                     0.48
                                   Freq_HtM
                         Hand-to-mouth events per hour
                                  (events/hr)
                                     13.9
                                      BW
                                  Body Weight
                                     (kg)
                          Children 1 < 2 years old
                                      11

Post-application Object-to-Mouth Exposure Algorithm -  Physical Activities on Turf
Exposure from object-to-mouth activity is calculated as follows (based on the algorithm utilized in SHEDS-Multimedia):
                                       	
	E = [OR* CF1 * SAMO * (ET * N_Replen) * (1- (1- SEO)(Freq_OtM/N_Replen))]	

where:

E = exposure (mg/day);
OR = chemical residue loading on the object on day "t" (ug/cm[2]);
CF1 = weight unit conversion factor (0.001 mg/ug);
SAMO = area of the object surface that is mouthed (cm[2]/event);
ET = exposure time (hr/day);
N_Replen = number of replenishment intervals per hour (intervals/hour);
SEO  = saliva extraction factor (i.e., mouthing removal efficiency); and
Freq_OtM  = number of object-to-mouth contact events per hour (events/hour).

and

	OR = AR * FO * CF2 * CF3 	

where:

OR = chemical residue loading on the object (μg/cm[2]);
AR = application rate (lbs ai/ft[2] or lb ai/acre);
FO = fraction of residue available on the object (unitless);
CF2 = weight unit conversion factor (4.54 x 10[8] ug/lb); and
CF3 = area unit conversion factor (1.08 x 10[-3] ft[2]/cm[2] or 2.47 x 10[-8] acre/cm[2]).

Dose, normalized to body weight, is calculated as:

	 	

where:
      D	=	dose (mg/kg-day);
      E	=	exposure (mg/day); and
      BW	=	body weight (kg).

Table A-3: Turf (Physical Activities)  -  Inputs for Residential Post-application Object-to-Mouth Exposure 
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                      AR
                          Application rate (to turf)
                    (mass active ingredient per unit area)
                                  0.404 lb/A
                                      FO
                Fraction of AR as OR following application [1]
                                     0.01
                                     SAMO
                        Surface area of object mouthed 
                                 (cm[2]/event)
                                      10
                                   N_Replen
               Replenishment intervals per hour (intervals/hour)
                                       4
                                      SEO
                           Saliva extraction factor
                                  (fraction)
                                     0.48
                                      ET
                                Exposure time 
                                (hours per day)
                                      1.5
                                   Freq_OtM
                  Object-to-mouth events per hour (events/hr)
                                      8.8
                                      BW
                               Body Weight (kg)
                          Children 1 < 2 years old
                                      11
1 This SOP assumes that all of the residue on the turf could be transferred to the object (e.g., object residue is equal to turf transferable residue).

Post-application Incidental Soil Ingestion Exposure Algorithm -  Physical Activities on Turf
Exposure from incidental soil ingestion is calculated as follows:

	E = SRt * SIgR * CF1 	

where:
E = exposure (mg/day);
SRt = soil residue on day "t" (ug/g);
SIgR = ingestion rate of soil (mg/day); and
CF1 = weight unit conversion factor (1 x 10[-6] g/ug).

and

	SRt = AR * FS * (1-FD)t * CF2 * CF3 * CF4 	

where:

SRt = soil residue on day "t" (ug/g);
AR = application rate (lbs ai/ft[2] or lb ai/acre);
FS = fraction of ai available in uppermost cm of soil (fraction/cm);
FD = fraction of residue that dissipates daily (unitless);
T = post-application day on which exposure is being assessed;
CF2 = weight unit conversion factor (4.54 x 10[8] ug/lb);
CF3 = area unit conversion factor (1.08 x 10[-3] ft[2]/cm2 or 2.47 x 10[-8] acre/cm[2]); and
CF4 = soil volume to weight unit conversion factor (0.67 cm[3]/g soil).

Dose, normalized to body weight, are calculated as:

	 	

where:
	D	=	dose (mg/kg-day);
	E	=	exposure (mg/day); and
	BW	=	body weight (kg).

Table A-4: Turf (Physical Activities)  -  Inputs for Residential Post-application Incidental Soil Ingestion Exposure 
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                      AR
                               Application rate
                    (mass active ingredient per unit area)
                                  0.404 lb/A
                                      FS
              Fraction of AR available in uppermost 1 cm of soil
                                  (unitless)
                                       1
                                      FD
                           Daily residue dissipation
                                  (fraction)
                                      0.1
                                     SIgR
                         Soil ingestion rate (mg/day)
                                      50
                                      BW
                               Body weight (kg)
                          Children 1 < 2 years old
                                      11

Post-application Dermal Exposure Algorithm  -  Mowing
Exposure resulting from contacting previously treated turf while mowing is calculated as follows:

	E = TTRt * CF1 * TC * ET 	

where:

E = exposure (mg/day);
TTRt  = turf transferable residue on day "t" (ug/cm[2]);
CF1 = weight unit conversion factor (0.001 mg/ug);
TC  = transfer coefficient (cm[2]/hr); and
ET  = exposure time (hr/day).

and

	TTRt = AR * FAR * (1-FD)t * CF2 * CF3 	

where:

TTRt  = turf transferable residue on day "t" (ug/cm[2]);
AR = application rate (lbs ai/ft[2] or lb ai/acre);
FAR = fraction of ai retained on turf (unitless);
FD = fraction of residue that dissipates daily (unitless);
t = post-application day on which exposure is being assessed;
CF2= weight unit conversion factor (4.54 x 10[8] ug/lb); and
CF3 = area unit conversion factor (1.08 x 10[-3] ft[2]/cm[2] or 2.47 x 10[-8] acre/cm[2]).

Absorbed dose, normalized to body weight, are calculated as:

	 	
where:
      D	= dose (mg/kg-day);
      E	= exposure (mg/day); 
      AF	= absorption factor (dermal); and
      BW	= body weight (kg).

Table A-5: Turf (Mowing)  -  Inputs for Residential Post-application Dermal Exposure 
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                      AR
                               Application rate
                     mass active ingredient per unit area
                                  0.446 lb/A
                                      FAR
                  Fraction of AR as TTR following application
                                   L/WP/WDG
                                     0.01
                                       
                                       
                                   Granules
                                     0.002
                                      FD
                           Daily residue dissipation
                                   L/WP/WDG
                                      0.1
                                       
                                       
                                   Granules
                                      0.1
                                      TC
                             Transfer Coefficient
                                  (cm[2]/hr)
                                     Adult
                                     5,500
                                       
                                       
                         Children 11 < 16 years old
                                     4,500
                                      ET
                                Exposure time 
                                (hours per day)
                                       1
                                      BW
                                 Body Weight 
                                     (kg)
                                    Adults
                                      80
                                       
                                       
                         Children 11 < 16 years old
                                      57
L/WP/WDG = liquid/wettable powder/water dispersible granule

