Date:

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

01-SEP-2015 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

Flutriafol. Occupational and Residential Exposure Assessment for a Proposed Use on Hops

PC Code: 1 28940 D ecis ion No.: 492995 Petition No

. : N I A DP Barcode: 0426919 Registration No.: 67760-75 Regulatory Action : Sec tion 3 Case No.: 7060 Risk Assessment Type: Occupational/Residential Expos ur e Assessment TXRNo.: NA MRIDNo.: NA CAS No.: 76674-21-0 40 CFR: § 180.629

From:

Through:

To:

Introduction Kelly M. Lowe, Environmental Scientist

### /;\(**~('.'.:' .~**  Risk Assessment Branch 1 (RAB 1) · Health Effects Division (7509P)

T hurston Morton
, Acting Branch C hi ef Health Effects Divi s ion (7509P)

and

Kristin Rury
, ExpoSAC Reviewer

# V;--~ Ivan Nieves, Ex poSAC Reviewer /

## ~ .. ' 

# J--d---

Expos ure Science Advisory

### Committe**ExpoSAC)** I HED

Tamue Gibson, RM21 Fungicide Branch Registration Division (7505P)

The Registration Di v ision (RD) requested t h at the Health Effects Di vision (HED) conduct an exposure and risk assessment for a propo sed use of flutriafol on hops. A quantitati ve assessme nt of occupational handler ex posur e h as not b ee n conducted s ince a previous assessme nt (D416213)

covers handl e r ex posure from the proposed u se. How eve r , post-applic at ion exposure from the
propo se d u se is not covered by th e previous assessme nt and has been included here.

Page I of 1 5Page 2 of 15 It is HED policy to use the best av ailable 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 the Agricultural Reentry Task Force (ARTF) database . 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 30

- APR

- 201 5

.Page 3 of 15 T able of Contents

1.0 Executive Summary

................................ ................................ ................................ ............. 4 2.0 Risk Assessment Conclusions and Recommendations

................................ ........................ 5 2.1 Summary of Risk Estimates

................................ ................................ ............................. 5 2.2 Label Recommendations

................................ ................................ ................................ .. 5 2.3 Data Deficiencies and Requirements

................................ ................................ ............... 6 3.0 Hazard Characterization

................................ ................................ ................................ ....... 6 4.0 Exposure and Use Profile

................................ ................................ ................................ ..... 7 5.0 Residential Exposure and Risk Estimates

................................ ................................ ............ 8 5.1 Spray Drift

................................ ................................ ................................ ........................ 8 5.2 Residential Bystander Post

- Application Inhalation Exposure

................................ ......... 8 6.0 Occupational Exposure and Risk Estimates

................................ ................................ ........ 9 6.1 Occupational Handler Exposure/Risk Estimates

................................ .............................. 9 6.2 Occupational Post

- application Exposure/Risk Estimates

................................ ................ 9 6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

........................ 9 6.2.2 Occupational Post

- application Dermal Exposure/Risk Estimates

.......................... 10 Appendix A. Summary of Occupational Non

- cancer Algorithms

................................ ............... 14Page 4 of 15 1.0 Executive Summary

Flutriafol [(±)

- α

- (2

- fluorophenyl)

- α

- (4

- fluorophenyl)

- 1 H

- 1 , 2,4

- triazole

- 1

- ethanol] is a systemic, triazole fungicide tha t can be used as a systemic eradicant and a protectant. It has a post

infection activity that can stop pathogen establishment in the early phases of disease development. It is currently registered for use on a variety of agricultural c rops

. Exposure and Proposed U se Profile The proposed use on hops is to be added to the TopGuard® Fungicide ( EPA Reg. #: 67760

- 75) label. The proposed maximum single application rate is 0.114 lb ai/A

, and is to be made to the foliage via aerial or airblast appli cations. The product cannot be applied via chemigation. The foliar applications are allowed for up to four times per season, with a retreatment interval of 7 days. The r estricted entry interval for the proposed use is 12 hours. Personal protective equi pment (PPE) listed on the proposed label includes long

- sleeved shirt and long pants, chemical

- resistant gloves, and shoes plus socks. Based on the proposed use pattern , it has been determined that the potential exposure scenarios are short

- and intermedia te

- term handler and post

- application occupational exposures

.

Hazard Profile The short

- (1

- 30 days), and intermediate

- (1

- 6 months) term dermal and inhalation toxicological points of departure (PODs) were identified from a prenatal developmental toxicity study in the rabbit where the effects were based on decreased number of live fetuses, complete litter resorptions

, and increased post

- implantation loss. The no

- observed adverse

- effect level ( NOAEL ) w as 7.5 mg/kg /day . Flutriafol was classified as a “not likely” human carcinogen based on carcinogenicity studies in rats and mice. The total uncertainty factor (UF) that was applied to occupational and residential risk assessments is 1 00 for short

- and in termediate

- term risks (10x interspecies factor, 10x intraspecies factor) . Since the POD for the dermal and inhalation routes of exposure are based on the same effect , the exposures from these routes can be combined to estimate total risk

. Since the derma l and inhalation PODs are based on developmental and/or fetal effects, the body weight appropriate for dermal and inhalation assessments is 69 kg.

Residential Exposure and Risk There are no residential uses proposed or currently registered for flutriafol. Therefore, residential handler and post

- application exposure/risk were not assessed.

Occupational Exposure and Risk A new occupational handler assessment was not conducted si nce the anticipated exposure scenarios (mixing/loading and applying via aerial and airblast equipment ) , m aximum application rate (0.114 lb ai/A) , and recommended level of PPE have been assessed in a previous assessment (D416213 )

. The combined occupational dermal plus inhalation handler exposure and risk estimates were not of concern in those assessments ( i.e., MOE > 1 00) at baseline and with the use of gloves, as is required on the proposed label

. Although the anticipated occupational handl er scenarios for hops have been covered by a previous assessment (D416213 ) that included the same maximum application rate andPage 5 of 15 equipment, the anticipated post

- application scenarios have been assessed for the proposed use because the worker activities are u nique to the proposed crop. The occupational post

- application dermal exposure and risk estimates are greater than the level of concern ( LOC ) of 1 00 on the day of application , ranging from 510 to 4, 2 00

. Since the post

- application assessment is not a conce rn on Day 0 (12 hours following application), the restricted entry interval (REI) is based on the acute toxicity of flutriafol technical material. Flutriafol has low acute toxicity via the oral, dermal and inhalation routes (Toxicity Categories III and IV)

, is minimally irritating to the eyes (Toxicity Category III)

, and is not a dermal irritant (Toxicity Category IV). Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs (Buehler method). Therefore, the acute toxicity categories for this chemical require a 12 hour REI under 40 CFR 156.208 (c) (2) (iii). The 12

- hour REI, which currently appears on the proposed label , is adequate for the proposed

use

. Based on the Agency's current practices, a quantitative non

- cancer occupational post

- application inhalation exposure assessment was not performed for flutriafol 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 assessmen t for flutriafol

.

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 the ARTF database are (1) su bject 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 dat a sources, as well as guidance on their use, can be found at the Agency website 1

.

2.0 Risk Assessment Conclusions and Recommendations

2.1 Summary of Risk Estimates

Based on a previous assess ment for flutriafol (D416213 ) which included an occupational handler assessment that covers the proposed use , t here are no occupational handler risk estimates of concern for the proposed use on hops

. In addition, there are no occupational post

- application risk estimates of concern ba sed on the current assessment

.

• In the previous assessment , occupational handler MOEs ranged from 280 to 30,000 for aerial and airblast applications.

• The occupational post

- application dermal exposure and risk estimates rang e from 510 to 4

, 2 00 depending on the activity on the day of application

.

2.2 Label Recommendations

There are no label recommendations based on the proposed uses.

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

- exposure

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

- app

- exposure

- data.htmlPage 6 of 15 2.3 Data Deficiencies and Requirements

None.

3 .0 Hazard Characterization

Flutriafol has low acute toxicity via the oral, dermal and inhalation routes (Toxicity Categories III and IV). Flutriafol is minimally irritating to the eyes (Toxicity Category III) and is not a dermal irritant (Toxicity Category IV). Flutriafol was not shown to be a skin sensitizer when
tes ted in guinea pigs (Buehler method). Table 3 .1 presents a summary of the acute toxicity information for flutriafol.

Table 3 .1. Acute Toxicity Profile

– Flutriafol. Guideline No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute oral (rat) 47090336 LD 50 = 1140 mg/kg (M); 1480 mg/kg (F) III

870.1200 Acute dermal (rat) 47090337 LD 50 > 2000 mg/kg III 870.1300 Acute inhalation (rat) 47090338 LC 50 > 5.20 mg/L IV

870.2400 Primary eye irritation (rabbit) 47090339 Minimally irritating III

870.2500 Primary dermal irritation (rabbit) 47090341 Not a dermal irritant IV

870.2600 Dermal sensitization (guinea pigs) 47090343 Not a sensitizer

-

Flutriafol appears to be generally equally toxic to rats, mice, and dogs with all three species having similar (within one order of magnitude) NOAELs /lowest

- observed adverse

- effect levels (LOAELs). The target organ is the liver in dogs, rats

, and mice. H epatotoxicity occurred at similar dose levels across several species and durations of exposure. Flutriafol is considered to be “Not likely to be Carcinogenic to Humans” based on the results of the carcinogenicity studies in rats and mice.

The Hazard and Science Policy Council (HASPOC) met on December 12, 2013 to discuss the need for a subchronic inhalation toxicity study for flutriafol. Based on a weight of evidence approach, the HASPOC concluded that a subchronic inhalation toxicity study was not neede d for flutriafol at this time for the following reasons: (1) f lutriafol is category IV for acute toxicity through the inhalation route and the effects in that study were seen at a very high concentration of 5.2 mg/L; (2 ) f ollowing the ORE inhalation risk assessment at the time

, the lowest inhalation MOE was 17,000 ; and (3) the HAPSOC waived the requirement for an inhalation study for

c yproconazole, a similar broad spectrum triazole fungicide.

A summary of the toxicological endpoints and doses chosen for the relevant exposure scenarios for human risk assessment are found in Table 3.2. The short

- (1

- 30 days), and intermediate

- (1

- 6 months) term dermal and inhalation toxicological PODs were identified from a prenatal developmental toxicity study in the rabb it where the effects were based on decreased number of live fetuses, complete litter resorptions and increased post

- implantation loss. The NOAEL was 7.5 mg/kg.Page 7 of 15 The Agency’s LOC for risks (i.e., target level for Margins of Exposure) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a factor of 10X to account for interspecies extrapolation to humans from the animal test species and anoth er factor of 10X to account for intra

- species sensitivity. The total uncertainty factor that has been applied to occupational risk assessments is 100 for short

- and intermediate

- term dermal and inhalation
exposures.

Absorption Since an oral study was used, a dermal absorption factor of 21% was used for the dermal risk
assessment derived from a dermal pe netration study (MRID 47090415) . 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.

Body Weight Since the dermal and inhalation PODs are based on developmental and/or fetal effects, the body weight appropriate for dermal and inhalation assessments is 69 kg.

Table 3 .2: Summary of To xicological Dos es and Endpoints for Flutriafol

.

Exposure/ Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects

Dermal Short (1

- 30 days)

- and Intermediate (1

- 6 months)

- Term NOAEL=7.5 mg/kg/day

Dermal Absorption Factor = 21% UF A = 10X UF H = 10X Occupational LOC for MOE = 100 Developmental toxicity

– rabbit

LOAEL = 15mg/kg, based on decreased number of live fetuses, complete litter resorptions and increased post

- implantation loss.

Inhalation Short (1

- 30 days)

- and Intermediate (1

- 6 months)

- Term NOAEL = 7.5 mg/kg/day

Inhalation toxicity assumed to be equivalent to oral toxic ity. UF A = 10X UF H = 10X Occupational LOC for MOE = 100 Developmental toxicity

– rabbit

LOAEL = 15 mg/kg, based on decreased number of live fetuses, complete litter resorptions and increased post

- implantation loss.

Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans” based on the carcinogenicity studies in rats and mice.

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 adver se effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from anima l to human (intraspecies). UF H = potential variation in sensitivity among members of the human population (interspecies). MOE = margin of exposure. LOC = le vel of concern.

4 .0 Exposure and Use Profile

Flutriafol is registered for use on a number of agricultural crops, and is being proposed for a use on hops

. Based on the proposed new use , it has been determined that the potential exposurePage 8 of 15 scenarios include short

- and intermediate

- term occupational handler and post

- application
exposures

. A summary of the proposed use directions are included in Table 4.1 below.

Table 4.1. Summary of Proposed Use Directions for Flutriafol.

Applic. Timing, Type, and Equip. Formulation [EPA Reg. No.] Application Rate Max No. Applications per Season Max Seasonal Application Rate Use Directions and Limitations

TopGuard® Fungicide 1 (67760

- 75) 1.04 lb ai/gal (11.8% ai) Hops Apply preventatively or when conditions are favorable for disease development. Repeat

as necessary if conditions are favorable for disease development.

Airblast or Aerial. Liquid (67760

- 75) 0.114 lb ai/A 4 apps/growing

season 0.455 lb ai/A Do not apply via chemigation. REI = 12 hours. RTI = 14 days. PHI = 7 days.

5 .0 Residential Exposure and Risk Estimates

There are no residential uses proposed or currently registered for flutriafol. Therefore, residential handler and post

- application exposure/risk were not assessed.

5

. 1 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 flutriafol. The agency h as 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 devel op the best spray drift management practices (see the agency’s Spray Drift website for more information). 2 The agency has also developed a policy on how to appropriately consider spray drift as a potential source of exposure in risk assessments for pesti cides. 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

. 2 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 is sues 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

2 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htmPage 9 of 15 March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/1 20109meeting.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 Revi ew, 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 flutriafol

.

6 .0 Occupational Exposure and Risk Estimates

6 .1 Occupational Handler Exp osure/Risk Estimates

Based on the anticipated use patterns

, and the current labeling regarding types of equipment and techniques that can be used, occupation al handler exposure is expected . The following exposure scenarios would be expected: (1) Mix ing/loading liquids for aerial and airblast applications; (2)

a pplying sprays via aerial and airblast equipment; and (3) f lagging for aerial applications.

These scenarios have already been assessed at the proposed maximum application rate in a previous as sessment (D416213 3 ), and no risk estimates of concern were identified. The dermal and inhalation combined MOEs were not of concern to HED (i.e., MOE > 100) at baseline and with the use of gloves as recommended by the proposed label

. Combined o ccupational handler MOEs ranged from 280 to 30,000 for aerial and airblast applications with the use of gloves by mixers/loaders

.

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 relate d to crop production, such as scouting for pests or harvesting. Post

- application exposure levels vary over time and depend o n such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide application, and th e 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

3 Memo, K. Lowe, D416213, 1/24/14, Flutriafol. Occupational and Residential Exposure Assessment for Proposed Uses on Cucurbit Vegetables, Fruiting Vegetables, Strawberries, Tree Nuts, Wheat/Triticale, Brassica (cole) Leafy Vegetables, Celery, Leafy Vegetables, Cotton, SorghumPage 10 of 15 ( 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 flutriafol.

In addition, the Agency is continuing to evaluate the available post

- application inhalation exposure data generated by the Agricultural Reentry Task Force. G iven 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 previously for occupational/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure t han 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

Occupational Post

- application Dermal Exposure Data and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational post

- application risk assessments. Each assumption and factor is detailed belo w on an individual basis.

Exposure Duration: HED classifies exposures from 1 to 30 days as short

- term and exposures 30 days to six mo nths as intermediate

- term. For flutriafol

, short

- and intermediate

- term exposures are expec ted for the following reasons: (1) flutriafol is a fungicide that is recommended to be applied preventatively or when conditions favor disease ; and (2) up to 4 foliar applications can be made per season 14 days apart

. In addition, the short

- and intermedi ate

- term PODs are the same; therefore, the assessment is protective of both durations

. Transfer Coefficients : It is the policy of HED to use the best available data to assess post

application exposure. Sources of generic post

- application data, used as su rrogate data in the absence of chemical

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

- applicat ion exposure that are used in this assessment, known as “transfer coefficients”, are presented in the ExpoSAC Policy 3 4 ” which, along with additional information about the ARTF data, can be found at the Agency website 5

.

It should be noted that the tran sfer coefficient used for asses sing exposure from mechanical ly

assisted harvesting is different from ExpoSAC Policy 3. For this proposed action on hops, the

4 Available: http://www.epa.gov/pesticides/science/exposac_policy3.pdf

5 Available: http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.htmlPage 11 of 15 Registrant submitted an occupational post

- application exposure assessment (MRID 49421701) which used a revised transfer coefficient for mechanically

- assisted harvesting , citing an ARTF report (MRID 49157401) that evaluated current harvesting practices in hops

, and recommended

a different transfer coefficient from what is currently recommended in Expo SAC Policy 3. HED has reviewed the ARTF report, and has revised the transfer coefficient for harvesting of hops based on the available information ( D 41 3084 ).

Table 6

. 2 .2

. 1

. Summary of Post

- Application Activities and Dermal Transfer Coefficients.

Crop Policy Crop Group Category Crop Height Foliage Density Transfer Coefficients

(cm 2 /hr ) Activities

Hops Bunch/bundle Low/High Full/Minimum 0 Irrigation (non

- hand set)

, Mechanical weeding, Ditching

, Mechanical harvesting

Low Minimum 230 Transplanting

Low/High Full/Minimum 640 Hand weeding, Stripping, Scouting, Tying/Training
High Full 1 ,4 00 Mechanically

- assisted harvesting High Full 1,900 Irrigation (hand

- set)

Application Rate: The application rates used in this assessment are provided in Table 4.1.

Exposure Time : The average occupational workday is assumed to be 8 hours.

Dislodgeable Foliar Residues : Chemical

- specific dislodgeable foliar residue data have not been submitted for flutriafol. Therefore, this assessment uses HED’s default assumption that 25% of the application is available for transfer on day 0 following the application and the residues dissipate at a rate of 10% each following day.

Occupational Post

- application Non

- Cancer Dermal Exposure and Risk Estimate Equation s The algorithms used to estimate non

- cancer exposure and dose for occupational post

- application workers can be found in Appendix A

. Occupational Post

- application Non

- Cancer Dermal Risk Estimates The short

- and intermediate

- term post

- application exposure scenarios a ssociated with the proposed use for flutriafol are summarized in Table 6.2.2.2. All scenarios resulted in MOEs greater than the LOC of 1 00 (ranging from 510 to 4,200 ) on day 0 (12 hours after application) and, therefore, are not of concern to H ED.Page 12 of 15 Table 6

. 2 .2.2

. Occupational Post

- application Non

- Cancer Exposure and Risk Estimates for Flutriafol

.
Crop/Site Activities Transfer Coefficient

(cm 2 /hr) Proposed Application Rate (lb ai/A) DFR 1 Dermal Dose (mg/kg/day) 2 MOE 3 (LOC =

1 00)
Short

- and Intermediate

- term

Hops Transplanting 230

0.114 0.32 0.00 18 4,200 Hand weeding, Stripping, Scouting,

Tying/Training 640 0. 00498 1,500

Mechanically

- assisted harvesting 1,400 0.011 690
Irrigation (hand

- set) 1,900 0.015 510

1 DFR = Application Rate × F × (1

- D) t × 4.54E8 μg/lb × 2.47E

- 8 acre/cm 2 ; where F = 0.25 and D = 0.10 per day

. 2 Daily Dermal Dose = [DFR (μg/cm 2 ) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption ( 2 1 %)] ÷ BW ( 69 kg). 3 MOE = POD ( 7.5 mg/kg/day) / Daily Dermal Dose.
Dislodgeable Foliar Residue (DFR): In accordance with 40CFR158, 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

- sp ecific 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 (F AR ). 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 appl ication 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 F AR 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 diff icult to quantify factors. Although witnessed across multiple chemicals, this range in F AR 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, hig h

- end default value. Because DFR data are not available for flu triafol , 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 flutriafol (i.e., there is a small chance that the F AR 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 reside ntial 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 acti vities for a high

- end amount of time every day (represented by data reflecting time spent gardening based on survey data).Page 13 of 15 Given the conservatisms discussed above and the potential compounding nature of these conservatisms, EPA is able to rely upon the ca lculated exposure estimates with confidence that exposure is not being underestimated.

Since the highest estimated occupational post

- application exposure using default DFR values for flutriafol is minimal in comparison to the level of concern (i.e., the calculated MOE is greater than 2 times higher than the level of concern, MOE = 510 compared to the LOC of 100 ); EPA is waiving the 40CFR DFR data requirement. In this instance, it is unlikely that chemical

- specific DFR data would be needed to further refi ne exposure assessments or would add appreciably to our overall understanding of the availability of dislodgeable foliar pesticide residues for flutriafol

. Restricted Entry Interval The REI specified on the proposed label is based on the acute toxicity of flutriafol

. Flutriafol has low acute toxicity via the oral, dermal and inhalation routes (Toxicity Categories III and IV). Flutriafol is minimally irritating to the eyes (Toxicity Category III) and is not a dermal irritant (Toxicity Category IV). Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs (Buehler method). Short

- and intermediate

- term post

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

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

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

- application exposures to flutriafol

.Page 14 of 15 Appendix A. Summary of Occupational Non

- cancer Algorithms

Occupational Non

- cancer Post

- application Algorithms

Potential daily exposures for occupational post

- applicatio n workers are calculated using the following formulas:

DFR t =AR * F* (1

- D) t * � 4.54E8 ug lb � * � 2.47E

- 8 A

cm 2 �

where:

DFR t = dislodgeable foliage residue on day "t" (μg/cm 2 ), AR = application rate (lb ai/acre), F = fraction of ai retained on foliage or 25% (unitles s), D = fraction of residue that dissipates daily or 10% (unitless), and
t = number of days after application day (days).

E=TC * DFR t * ET * 0.001 mg
ug

where: E = exposure (mg ai/day), TC = transfer coefficient (cm 2 /hr), DFR t = dislodgeable foliar residue on day “t” (μg/cm 2 ), and ET = exposure time (hours/day).

The daily doses are calculated using the following formula:

ADD= E * AF
BW

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 scenario are calculated using a Margin of Exposure (MOE), which is a ratio of the toxicological endpoint to the daily dose o f concern. The daily dermal dose received by occupational post

- application workers is compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational post

- application workers. All MOE values are calculated using the following formula:Page 15 of 15 M OE= POD
ADD

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).