### FLUOXASTROBIN Human Health Risk Assessment DP No. 0421420


### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D

. C

. 204 6 0



### MEMORANDUM DATE: July 9, 2014 OFFICE OF CHEMICA L SAFETY A N D POLLUTIO N PREVENTION



### SUBJECT: Addendum: Fluoxastrobin. Revised Aggregate Human Health Risk Estimate for Children 1 to <2 Years Old in Response to Review of Turf Transferable Residue Study (Previously Required Data Deficiency) Submitted by Registrant. 

### PC Code: 028869 

### DP Barcode: D421420 , D405370, D404179 

### Decision No.: 489469**'/~77'/.** f'ttf/IJ 

### Registration Nos.: 66330-64, 66330

-65 

### Petition No.: 2F8047 , 9F7567 

### Regulatory Action: Section 3 

### Case No.: NA 

### Risk Assessment Type: Single Chemical /Aggregate 

### TXRNo.: NA 

### CAS No.: 361377-29-9 

### MRID No
. : 49341901 40 

### CFR: §180.609 

### FROM: Nancy J. 

### Keller, Chemist, Risk Assessor Risk Assessment Branch 3 Health Effects Division (7509P) 

### THROUGH: Christine Olinger, Branch Chief

# /)~ 

# h Risk Assessment Branch 3

### ~/'/ • Health Effects Division (7509P) 

### TO: Heather Garvie/Shaja Joyner, RM #20 Fungicides Branch (FB) Registration Division (7505P) The Registration Division (RD) requested that the Health Effects Division (HED) provide an evaluation of the turf transferable residue (TTR) study submitted by Arysta LifeScience North America, LLC (Arysta) to satisfy a data deficiency listed in the most recent risk assessment (DP405370 , N. Tsaur, 03 /27/2013). This addendum incorporates the TTR study results and provides updated revisions to the human health risk assessment that result from the changes to residential turf exposure (primarily children, 1 to <2 

### years old). The TTR data evaluation record (DER ) and the updated aggregate human health risk estimates were conducted by Nancy Keller. The results ofthe study indicate a slight increase (

- 2X) in the TTR value when compared to the default assumption used in the previous risk assessments (DP419228 , N. Keller, 06/06/2014). Thus , this document highlights the direct changes in risk estimates that result from the new data, including the chi ldren's postapplication incidental oral risk estimates, and the children's aggregate risk estimates. Page 1 of4FLUOXASTROBIN Human Health Risk Assessment DP No. D421420 

### 1.0 Introduction Fluoxastrobin is a strobilurin-class fungicide that controls foliar fungal diseases and soilborne/seedling fungal diseases
. It works by interrupting mitochondrial respiration in plantpathogenic fungi, thus inhibiting spore germination and mycelial growth. The two most recent fluoxastrobin risk assessments invo lved the product Fluoxastro bin 480 SC Fungicide (EPA Reg. No. 66330-64), a suspension concentrate (SC) formulation containing 40.3% active ingredient (ai) by weight (3.98 lb ai per gallon). In PP#2F8047, Arysta submitted a label amendment to add melon subgroup 9A and sorghum to the master label for Fluoxastrobin 480 SC Fungicide, thus petitioning for the associated tolerances (DP405370, N. Tsaur, 03/27/2013). Prior to the most recent petition, Arysta submitted a label amendment to remove the homeowner use rest riction from the turf and ornamentals sec t ion ofthe master label for Fluoxastrobin 480 SC Fungicide, thus proposing a new residential use (DP404179, N. Tsaur, 11113/2012). Based on previous results ofthe residential turfpostapplication risk assessment, a TTR study was required for fluoxastrobin, and listed as a data deficiency. The incidental oral hand-tomouth margin of exposure (MOE) for young children (1 to <2 years old) was less than 1,000 (MOE= 390, LOC 

### = 1 00) based on default values for t he fraction of application rate available for transfer after a liquid application to turf(N. Tsaur, 0406106, 10/25/2012). Arysta has since submitted a TTR study for review. The predicted initial residue values (and percent of application rate) at ODAT1 were: 0.124 J..l.g/cm2 (2.2%) at the Pennsylvania site; 0.066 J..l.g/cm 2 (1.2%) at the Georgia site; and 0.034 J..l.g/cm2 (0.61%) at the California site (DP419228 , N. Keller, 06/06/2014). The results ofthe study indicate a slight increase**(~2X)** in the TTR value when compared to the default assumption used in the previous ri sk assessments. Thus, this document highlights the direct changes in risk estimates that result from the new data. Since the TTR data only affect the residential exposure component and dermal hazard is not of concern, the TTR data only affect children's incidental oral risk estimates, which thus translates to a change in children's aggregate risk estima tes . Aside from a slight increase in the incidental oral exposure of young children from fluoxastrobin use on residential turf, and the associated aggregate changes, all other assumptions and risk estimates remain unchanged from the previous risk assessments. All ofthe following topics of interest can be found in detail in th e two previous risk assessments: the hazard characterization and toxicity endpoints for risk assessment, th e rationale to support the Food Quality Protection Act (FQPA) safety factor, the proposed use profile, the exposure profile, the dietary exposure profile, the drinking water profile, and the occupational exposure profile. 

### Residential Exposure and Risk Estimates Upon incorporating the new TTR data, all existing registered uses do not result in any residential handler or post-application ri sk estimates of concern. The lowest and most protective incidental
Page 2 of4FLUOXASTROBIN Human Health Risk Assessment DP No. D421420
oral post-application MOE for children (1 to <2 years old) is 180 based on hand to mouth activities on turf treated with a liquid formulation of fluoxastrobin. 

### Aggregate Exposure Risk Estimates Upon incorporating the new TTR data, the aggregate MOE for children (1 to <2 years old) is greater than 100, which indicates tha t exposure and risk estimates do not exceed HED's LOC. The children's short-term aggregate (dietary + residential) MOE is 110. Acute exposures were not considered because an adverse effect attributable to a single dose was not identified. Since there are neither intermediate-term nor chronic residential exposure scenarios, the aggregate risk estimates are expected to be equivalent to chronic dietary (food and drinking water) risk estimate. Fluoxastrobin is classified as "not likely to be carcinogenic to humans;" therefore, an aggregate cancer assessment was not conducted. 

### 2.0 Residential (Non-Occupational) Exposure/Risk Estimates for Children Young children (1 to <2 years old) may receive incidental oral post-application exposure to fluoxastrobin from treated turf. Although residential dermal exposure is expected following the treatment ofturf, short-term dermal hazard was not identified for fluoxastrobin. Therefore, a quantitative post-application dermal risk assessment was not conducted; Only short-term incidental oral exposure and risk estimates have been assessed for the physical activities of children 1 to <2 years old on turf, following liquid and granular application of fluoxastrobin at maximum registered application rates. Intermedia te
-term incidental oral exposure is not expected for post-applica tion activities to turf because residues are unlikely to persist for longer than one month due to turf maintenance (e.g. mowing) and climate (e.g. rain). Table 1 presents the most protective post-application incidental oral MOE value calculated for liquid applications offluoxastrobin to turf. The post-application risk estimates is not of concern to HED (MOE= 180). Table 1. Short-Term Residential Post-Application Exposure and Risk Estimates for Fluoxastrobin on Turf" Post-Application Exposure Scenariob Dose Lifestage mg/kglday MOEC Child 1 to < 2 years old Hand to Mouth 0.0170 180

.. a Based on regtstered product label for Fluoxastrobm 480 SC Fungtctde (EPA Reg. No. 66330-64); SC Ltqutd

Formulation; 3.69lb ai/gallon ; max single application rate = 0.46 lb ai/A. b Hand-to-Mouth Dose = hand residue loading (mg/cm2) x fraction ofhand mouthed (0
. 127) x surface area of 1

hand (150 cm2) x exposure time (1.5 hrs/day) x #ofreplenishment intervalslhr ( 4 intlhr) x ( 1-((1 -saliva extraction factor (0.5))1'(Number ofhand-to -mouth events per hour (13.9 eventslhr) +# ofreplenishment intervalslhr)) + body weight (11 kg)
. TTR = 0
. 124 j.lg/cm 2 (DP419228 , N. Keller, 06 /06 /20 14) c MOE= NOAEL +Daily Dose (mg/kg/day)
. Incidental Oral NOAEL= 3.0 mgfkg/day. Level ofconcern= 100. 

### 3.0 Short-Term Aggregate Exposure/Risk Estimates for Children HED must consider and aggregate (add) pesticide exposures and risks from three major sources : food, drinking water, and residential exposures. In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative estimates ofhazard (e.g. a Page 3 of4

### FLUOXASTROBIN Human Health Risk Assessment DP No. D421420
NOAEL or PAD), or the risks themselves can be aggregated. When aggregating exposures and risks from various sources, HED considers both the route and duration of exposure. For fluoxastrobin, potential exposures from food , drinking water, and residential scenarios were aggregated
. Short-Term Aggregate Risk There is potential short-term exposure to fluoxastrobin via the dietary (which is considered background exposure) and residential (which is considered primary) pathways. For children, these pathways lead to exposure via the oral (background) and incidental oral (primary) routes. The most protect ive residential exposure risk estimates are included in the aggregate exposure assessment. The recommended residential exposure for use in the children 1 <2 years old aggregate assessment reflects hand

-to-mouth exposures from post
- application exposure to liquid applications to turf (MOE 

### = 180). Aggregate MOEs are greater than 100, which indicates that exposure and risk do not exceed HED's level of concern. The children short-term aggregate (dietary 

### + residential) MOE is 110, as shown in Table 2.
Table 2. Short-T e r m Aggregate Risk Calculations Max Average Food and Residential Population NOAEL 

### Loca Allowable Water Exposurec Exposureb Exposure mg!kg!day mglkg!day mg/kg/day mg/kglday Children 3.0 100 0.030 0
.009516 0.0170 1-2 years old a LOC = 100 (based on mter- and mtra- spec1es uncertamty factors totalmg IOOX). b Maximum Allowable Exposure (mglkg/day) = NOAEL 7 LOC. c Residential Exposure= Incidental Oral Only for children (See Table 1). d Total Exposure = Average Food and Water Exposure + Residential Exposure
. e Aggregate MOE = NOAEL + Total Exposure. NOAEL = 3 mg/kg/day
. LOC = 100
.



### Page 4 of4 Aggregate Total Exposured MOE(food, water, and mg!kglday residential)e 0.026516 110