### Date :

Subject: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON

, D

. C

. 20460



### Decembe r 4

, 20 1 5 OFFIC E OF C H EMICAL SAFETY

AND POLLUTION PREVENTION



### Azoxyst robin. 

### Occ up at i onal a nd Residential Registration Re v i ew Ri sk

Assessme nt for the Exi s tin g Uses of Azoxystrobin.

P C Co d e: 1 288 1 0

D ecis ion No. : 511551 DP Bar co de : 0430444

R eg ul a t o r y Action: Regi s t ration Review

Case No.: 7020 Ri s k A ssess ment 

### T y p e : Occ u pa tion al/Reside nti a l Exposu r e Assessmen t

T X R No.: NA CAS No. : 131860

- 33-8

40 C FR: § 180.507 MRIO No.: NA



### From :

Through:

To : 

### Kristin Rur y, Bi o l ogist 

# Y--

# ~ Ri sk Assess ment Bran c h Ill 

# ( Mihrd

H ealth E ffects Di v i s i on (7509 P )

A nd

# r,-**~ C~**  r:=7,.P

T im o th y C. Dol e, In dustrial Hygi e ni s t 

## I J..AJ 

# 'I

R i sk Assessment and Sc i ence Support Branch ( RASS )

A ntimi crob i a ls Di visio n ( 751 OP)

Barry O'Kecfe, Senio r Biologist

Risk Assess ment B r anch III (RA B III )

Health Effects Di vis ion (7509P) 

# 13,**o~**

and 

# (), JJ 

# ¥

---

Shalu Shela t

, Environmen t al H ealt h Sc i entist

# t:/**vfl-(f.~** Cass i Walls

, Se ni or Bi o l og i s t**~>~** 

# l Ur.MU:>

E xposure Scie n ce Advisory Co mmittee (ExpoSAC) I 

### HED

Veronica Dutch

, Chemical R ev iew Manager (C RM )

Jill Bl oo m
, Team Lead e r Risk Management and I mple m enta ti on Branch V (RM IB V)

D i v i s i o n (750 8P )

Page I of64

### Intr o du c ti o n



### The Health Effec t s Di vis ion ( H E D ) a nd th e A ntimi crobials D i v i s i on (AD) of the Office of

Pesticide P rograms (O PP ) i s charged with estimating th e ri sk to hum a n h ea l t h from expos ur e to pesticides. As p a rt of Re g i s trat i on R ev i ew, the P es ticide Re-e va luati on Di v i s i o n ( PRO ) of O PP

ha s requested that HEO and AO eva lu ate the hazard and expos ur e data and conduct occupatio n a l

and residential expos ur e assessments

, as n ee d e d

, t o es timat e the risk t o human heal t h that will

re s ult from th e r egis ter e d u ses of azoxystrobin. This memorandum se r ves as HED·s Registration

Review exposure and risk assess m ent of the registered conven ti o nal and a ntimi c r ob ial uses of

azoxys t rob in

.

Azoxystrobin is curre n tly registered fo r use on a l arge numb e r of agricultural cro p s
, for see d

tr ea tment and post-ha r vest use s o n ag ricultur a l commod i tie s
, as well as fo r u se in ind oo r a n d

o utd oor r esidentia l areas

.



### It i s H E O polic y t o u se the best ava il able data to assess exposu r e. Seve r al sources of gene ri c
data were u s e d in thi s assessme nt as surroga t e d a t a in th e absence of c hemic a l- s p ec ific data

, in c ludin g: P es ticid e H a ndl e rs Expo s ure Datab ase Version 

### I.I ( PHED I.I ); and th e Agr i c ultural

Handler Expos ur e Task Force (A H ETF) database; the A ntimic robia l Expos ur e Assessme nt Task

Force (AEATF); ExpoSAC P o licie s 14

, 15

, and 1 5. 1 (S OP s for S eed Treatment); and the

R es idential SOPs ( Re s i dential Handl e r s)

. Some of these d a ta are pr opr iet a r y
, and s ubj ect to the

data protection provisions of th e Federal In sec ticid e
, Fun g i c id e, a nd Rodenticide Act ( FIFRA ).

N ot e : 

### T his m e m o randum was r ev i ewed by th e Expos ure Science Adv i so r y Commi tt ee (ExpoSAC) on D ecember 3

, 20 15

.

Pa g e 2 of64Page 3 of 64 

### 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 Label Recommendations from Occupational Assessment

................................ .................... 9

2.3 Label Recommendations from Residential Assessment

................................ ....................... 9

3.0 Hazard Characterization

................................ ................................ ................................ .......... 10

4.0 Use Profile

................................ ................................ ................................ .............................. 13

5.0 Resident ial Exposure and Risk Estimates

................................ ................................ ............... 17 5.1 Residential Handler Exposure/Risk Estimates

................................ ................................ .... 17

5.2 Residential Post

- application Exposure/Risk Estimates

................................ ...................... 21 5.3 Residential Risk Estimates for Use in Aggregate Assessment

................................ .......... 25

6.0 Non

- Occupational Spray Drift Exposure and Risk Estimates

................................ ................ 26

7.0 Non

- Occupational Bystander Post

- Application Inhalation Exposure and Risk Estimates

..... 27 8.0 Occupational Exposure and Risk Estimates

................................ ................................ ........... 27 8.1 Occupational Handler Exposure/Risk Estimates

– Conventional Azoxystrobin Uses

....... 27 8.2 Occupational Handler Exposure/Risk Estimates

– Antimicrobial Uses

............................. 43 8.3 Occupational Post

- application Exposure/Risk Estimates

................................ ................... 44 8.3.1 Occupational Post

- application In halation Exposure/Risk Estimates

........................... 44 8.3.2 Occupational Post

- application Dermal Exposure/Risk Estimates

............................... 46 Appendix A. Summary of Occupational and Residential Non

- cancer Algorithms

..................... 48 Appendix B. TTR and DFR Data Requirements

................................ ................................ ......... 58 Appendix C. Exposure Inputs and Inhalation Doses for Registered Conventional Uses of Azoxystrobin.

................................ ................................ ................................ ................................ 60Page 4 of 64



### 1.0 Executive Summary

HED and AD h ave conducted an occupational and residential exposure assessment for Registration Review of the active ingredient (ai), azoxystrobin. Azoxystrobin is a β

methoxyacrylate fungicide currently registered for use on a variety of field, vegetable, fruit, and

nut crops as well as on ornamental plants and turf. It is also used to control mold on indoor surfaces. Its biochemical mode of action is inhibition of electron transport.

This memorandum contains HED’s and AD’s occupational exposure and risk estimates t o pesticide handlers (i.e., mixers, loaders, applicators) and to agricultural workers conducting post

application activities. The residential scenarios for aggregate risk assessment have not changed since the previous azoxystrobin exposure assessment whic h reflect s HED’s 2012 Residential

SOPs 1 

### ( (K. Rury, D418012 and D423847, 12/17/2014). However, the inhalation point of departure (POD) ha s been revised by the risk assessment team since the previous assessment ; therefore, the conventional and antimicrobia l inhalation scenarios have been reevaluated to incorporate changes to the azoxystrobin toxicity database. This assessment also contains a non

occupationa l post

- application assessment evaluating the exposure resulting from azoxystrobin drift from agricult ural applications onto residential areas.

Use Pattern Azoxystrobin is currently formulated as liquid, dry flowable, granul e , and dust end

- use products (EUPs) containing between 0.31% and 50% ai. Azoxystrobin is registered for agricultural use on numerous fruit and vegetable crops growing in both fields and greenhouses. Azoxystrobin is also registered as a post

- harvest treatment for use on bananas, plantains, citrus, and tuberous and corm vegetables. It may also be used on golf course turf, lawns , sports fields, ornamentals, conifers, roses, cut flowers , interior plantscapes, and sod. Seed treatment uses of azoxystrobin

include the following commodities: barley; Brassica (cole) leafy vegetables, crop group 5; bulb vegetables, crop group 3; canola ; corn (field, pop, sweet); cotton; cucurbit vegetables, crop group 9; eggplant; leafy vegetables, crop group 4; leaves of root and tuber vegetables, crop group 2; legume vegetables (succulent or dried), crop group 6; okra, peanut; peppers; potato; rice; r oot vegetables, crop subgroup 1A; soybean; sunflower; tomato; triticale; tuberous and corm vegetables (except potato), crop subgroup 1D; turf; watercress; and wheat.

The antimicrobial uses of azoxystrobin for mold control on indoor surfaces include material preservati on in paints and coatings, rubber and plastics, textiles, paper and paperboard products and drywall, and as a mold spray inside residential areas including structural wood, subflooring, drywall and carpet

.

Azoxystrobin may be applied to agricultural commodities using ground (groundboom and airblast) , aerial, chemigation, and handheld equipment. Handheld application equipment is used

inside /around residential areas. Seed treatment is expected to occur in commercial treatment

facilities only. All registered labels require occupational handlers to wear baseline attire (long sleeved shirt, long pants, shoes/socks) and chemical resistant gloves. Some labels require

addition al personal protective equipment (PPE) such as protective eyewear, dust / mist respirators,

1 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

residential

- pesticidePage 5 of 64



### coveralls, and aprons. Those EUPs requiring PPE beyond baseline attire and chemical resistant gloves are co

- formulations with other active ingredients. The restricted entry intervals (REIs) range from 4 hours to 24 hours; those labels requiring REIs longer than 12 hours are all co

formulations with other active ingredients.

Exposure Profile

– Conventional Residential & Agricultural Uses Based on the currently registered uses of azoxystrob in, the durations of exposure are expected to

be both short

- (1 to 30 days) and intermediate

- term (1 to 6 months) for agricultural occupational

handlers. Although there is potential for long

- term exposures to re

- entry workers because cut flowers may be gr own year

- round, long

- term exposures were not assessed because the registered labels explicitly state concerns for resistance and outline approaches for integrated pest management strategies. Exposures in residential settings and from spray drift are expec ted to be

short

- term only.

Exposure Profile

– Antimicrobial Uses Based on the currently registered antimicrobial uses of azoxystrobin, the durations of exposure are expected to be intermediate

- to long

- term for the occupational incorporation of materia l preservatives into paints and short

- to intermediate

- term for occupational use of preserved

materials in paints

. The residential handler exposure duration is anticipated to be short

- term for both the material preservation and mold spray uses. The resid ential post

- application exposure duration is anticipated to be short

- term only.

Hazard Characterization The azoxystrobin database is complete for risk assessment, with the exception of a subchronic inhalation toxicity study on technical azoxystrobin . In repeat

- dose oral studies, the liver and bile ducts were consistently the target organs of azoxystrobin toxicity. Developmental effects were not seen in rabbit or rat developmental toxicity studies. In the rat reproduction study, offspring and paren tal effects (decreased body weight and increased adjusted liver weight) were observed at the same dose in both offspring and parental animals. Therefore, the azoxystrobin toxicity data show no increased susceptibility in the young. Because there were no effects seen

in a route

- specific subchronic dermal study in the rat, and there was no concern for developmental or reproductive effects, a dermal risk assessment is not applicable at this time. For episodic ingestion of azoxystrobin granules , the point of departure ( POD ) ( level of concern; LOAEL = 200 mg/kg/day) was selected based on diarrhea at two

- hours post dose at all dose

levels tested. For assessing acute risk, EPA is retaining a Food Quality Protection Act ( FQPA ) safety factor (SF) of 3X to account for the use of a LOAEL from the acute neurotoxicity study

to derive an acute reference dose. For short

- and intermediate

- term incidental oral exposures, the POD was based on decreased pup weights in both males and females. This LOAEL will be protective of effects seen in the developmental toxicity study and in the 90

- day oral toxicity study. A 100

- fold uncertainty factor (10X for interspecies extrapolation, and 10X for intraspecies extrapolation) will be applied to the short

- and intermediate

- term incid ental oral

risk assessments

. Since there was no concern for susceptibility of offspring and effects on offspring viability in the in the developmental or reproductive studies, the FQPA SF was reduced from 10X to 1X. Since the previous assessment, a route

- specific 28

- day inhalation toxicity study with the SC formulation was submitted and reviewed, and now provides the basis for the inhalation POD for azoxystrobin. The POD is based on adverse histopathologicalPage 6 of 64



### changes in the larynx (squamous metaplasia) an d nasal cavity (metaplasi a of the respiratory epithelium

. The standard interspecies extrapolation UF is reduced from 10X to 3X due to the calculation of HECs accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. For intraspecies variation, 10X is applied. A n a dditional 10 X is applied for a

database uncertain ty factor to account for the requirement for an inhalation toxicity study on the technical active ingredient (a.i.) because the available 28

- day inhalation study was test ed on only approximately 8% a.i., whereas most of the marketed p roducts contained 30

- 50% a.i

. Therefore, the LOC for inhalation exposures is a margin of exposure ( MOE ) less than 300 (3X for interspecies extrapolation, 10X for intraspecies variation, and 10X f or database uncertainty

/FQPA SF ).

Residential Exposure and Risk Assessment

– Conventional Uses There is potential residential exposure from the existing conventional uses of azoxystrobin. Some of the residential handler inhalation risk estimates for the registered conventional uses of azoxystrobin are of concern (MOE < 300). However, the registered conventional residential uses of azoxystrobin do not result in any risks of concern for post

- application incidental oral or inhalation exposures.

Residential Exposure and Risk Assessment

– Antimicrobial Uses There is potential residential exposure from the existing antimicrobial uses of azoxystrobin. T he inhalation PODs have changed since th e previous assessment. Therefore, the antimicrobial inhalation scenarios have been reevaluated to incorporate changes to the azoxystrobin toxicity

database. Residential handler inhalation exposures were assessed for applying azoxystrobin

treated paint an d for applying mold spray. The M OE s are of concern (MOE < 300) for the mold spray scenario, and the airless sprayer and brush/roller painting scenarios for applying azoxystrobin treated paints

.

There is the potential for residential post

- application exposure to vinyl flooring made from azoxystrobin treated vinyl, contact with plastic toys manufactured from azoxystrobin treated plastic

, and carpets treated with the azoxystrobin mold spray. Incidental oral MOEs for treated/impregnated vinyl flooring

, treated plastic toys, and object

- to

- mouth exposures from treatments on hard surfaces and carpets were not of concern

. Residential post

- application inhalation MOEs were also not of concern for adults or children 1 to < 2 years old following

surface directe d mold sprays.

Occupational Exposure

– Conventional Agricultural uses Some occupational handler risk estimates resulted in inhalation MOEs of concern with baseline

PPE ; some scenarios result ed in MOEs of concern using maximum levels of PPE or engineering

controls for agricultural, post

- harvest, and seed treatment uses (MOEs < 300)

.

Because no dermal POD was selected for azoxystrobin, an occupational post

- application exposure assessment was not completed. P ost

- application inhalation expo sure following the planting of azoxystrobin

- treated seeds is unlikely because sustained levels of contact with treated seed after placement in soil or other growing media is not expected; therefore post

- application exposure is expected to be negligible and a quantitative post

- application assessment wa s not required for the seed treatment uses of azoxystrobin. Based on the Agency's current practices, aPage 7 of 64



### quantitative non

- cancer occupational post

- application inhalation exposure assessment was not performed for the agricultural uses azoxystrobin 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 azoxystrobin

. However, there is the pot ential for occupational post

- application inhalation exposures in post

- harvest treatment facilities. There are some occupational post

- application inhalation risk estimates of concern for the registered post

harvest uses of azoxystrobin at baseline and maxim um PPE mitigation (MOE < 300).

Occupational Exposure

- Antimicrobial Uses Occupational handler inhalation exposures were assessed for open pouring during paint preservation and for airless spray and brush/roller application of preserved paint and resulted in a risk estimate of concern (MOE < 300) at baseline . If a PF10 elastomeric half face respirator is worn, the MOE is increased to 300 and is no longer of concern. Application of preserved pain using an airless sprayer and brush/rollers resu lt in risk estimates of concern (MOE < 300). These risks cannot be mitigated with respiratory protection because only the materials preservatives to preserve paints are EPA registered pesticide products; preserved paints themselves are not EPA registered pesticide products and thus do not have labels that could include PPE requirements.

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 AEATF database; ExpoSAC Policy 14 (SOPs for Seed Treatment); and the Residential SOPs ( Treated Paints, Lawns/Turf, and Indoor Environments ); 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 o n their use, can be found at the Agency website 2



### .

2.0 Risk Assessment Conclusions and Recommendations

2.1 Summary of Risk Estimates

 As no systemic dermal toxicity was identified, occupational and residential dermal exposure/risk assessments were not c onducted.

 Residential handler inhalation risk estimates were of concern for some scenarios:

o Mixing/loading/applying liquids using a hose

- end sprayer to turf,

o Mixing/loading/applying liquids using a backpack sprayer to turf,

o Mixing/loading/applying dry flowable formulations using a manually pressurized handwand to turf,

o Mixing/loading/applying a dry flowable formulation using a hose

- end sprayer to turf,

o Mixing/loading/applying dry flowable formulations using a backpack spray er to turf,

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

- exposure

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

- app

- exposure

- data.htmlPage 8 of 64 

### o Hand dispersal of granules to gardens/trees

,

o Application of paint containing azoxystrobin with airless sprayers and brush rollers, and

o Mixing/loading/applying azoxystrobin with a low pressure handwand indoors for mold spray treatment.

 So me occupational inhalation handler and post

- application risk estimates were

of concern at baseline and require respiratory protection to mitigate risks. In some cases, standard respiratory protection measures/engineering controls do not appear to

be succe ssful in mitigating inhalation risk estimates of concern. These scenarios

include:

o Mixing/loading dry flowables for aerial, airblast, groundboom, and chemigation application to all registered crops at maximum registered application rates;

o Mixing/loading granules for aerial application to sod;

o Mixing/loading granules for tractor

- drawn spreader applications to sod and golf course fairways, greens, and tees.

o Mixing/loading liquids for aerial application to orchards/vineyards, sod, typical field crops, an d high acreage field crops at maximum registered application rates;

o Mixing/loading liquids for chemigation application to orchards/vineyards, sod, typical field crops, high acreage field crops;

o Mixing/loading liquids for groundboom application to sod an d high acreage field crops;

o Applying sprays with airblast application equipment to nursery ornamentals and orchards/vineyards;

o Applying sprays with groundboom application equipment to sod; golf course fairways, tees, and greens; typical field crops; and high acreage field crops;

o Applying granules with aerial application equipment to sod;

o Applying granules with a tractor

- drawn spreader to sod, and golf course fairways, greens, and tees;

o Flagging for aerial application to sod during liquid and granular a pplications;

o Mixing/loading/applying dry flowable or liquid formulations with a backpack sprayer to orchard/vineyards, Christmas tree farms, and nursery ornamentals;

o Mixing/loading/applying dry flowable or liquid formulations using a manually pressurized handwand to Christmas tree farms, nursery ornamentals, and landscaping;

o Mixing/loading/applying dry flowable or liquid formulations using a mechanically pressurized h andwand to orchard/vineyards, Christmas tree farms, nursery ornamentals, golf courses, landscaping, and typical field crops;

o Mixing/loading/applying liquids with a manually pressurized handwand to greenhouse ornamentals;

o Mixing/loading/applying liquids w ith a mechanically pressurized handwand to orchards/vineyards, Christmas tree farms, nursery ornamentals, greenhouse ornamentals, landscaping, and typical field crops;Page 9 of 64 

### o Loading/applying granule formulations with a rotary spreader to golf courses;

o Mixing/l oading for post

- harvest treatments in a closed system to citrus;

o Mixing/loading dry flowable formulations in an automated system for post

harvest treatment of bananas,

o Mixing/loading liquids in an automated system for post

- harvest treatment fo
citrus;

o A pplying direct post

- harvest sprays using a mechanically pressurized handgun
to citrus and bananas;

o Loading/applying, sewing, bagging, and multiple activities for numerous liquid seed treatment uses of azoxystrobin;

o Planting treated barley, legume vegetab le, peanut, potato, triticale, tuberous and corm vegetable, turf, and wheat seeds with liquid formulations of azoxystrobin;

o Loading/applying, sewing, bagging, multiple activities for dust seed treatment applications to peanuts;

o Planted peanut seeds treat ed with dust formulations;

o Loading/applying, sewing, bagging, and multiple activities for cotton dry flowable seed treatment uses of azoxystrobin;

o Adding azoxystrobin to pain during manufacturing; and

o Sorting and packing following post

- harvest treatment of citrus and bananas.

2.2 Label Recommendations from Occupational Assessment

Labels vary considerably with respect to requirements for work attire and PPE. For example, some labels do not specify any requirements for work attire, while others require respirators and coveralls over long

- sleeve shirt and long pants. Like work attire and PPE, REIs also vary considerably across labels (e.g., 4 hours versus 48 hours). Thus, label corrections/revisions should be consistently made to default to end

- use prod uct and/or technical grade active ingredient acute (ocular, dermal, oral, and inhalation) toxicity requirements. Additional PPE, such as respiratory protection, beyond end

- use product acute toxicity requirements, should be

considered as described in the c ontext of any risks of concern identified in this assessment.

It is recommended that the material preservation labels be amended to include the use of respiratory protection for open pouring.

2.3 Label Recommendations from Residential Assessment

Some azoxystrobin products are intended for use by residential applicators on home lawns or residential areas but require certain clothing and/or PPE to be worn. Thus, standard assumptions for residential/consumer applicator specific assessments, such as wearing shorts and a t

- shirt

without PPE like chemical

- resistant gloves or respirators, would represent non

- compliance with currently registered products. If products containing azoxystrobin are meant to be marketed towards and applied by homeowners on re sidential turf, ornamentals, and in homes, HEDPage 10 of 64



### recommends that the label requirements for clothing and/or PPE be reevaluated or separate

consumer

- specific labels be developed.

Note to PRD: It is recommended that the EPA registered label Reg. No. 100

- 109 3 be split into two separate labels: one label for conventional uses, and one label for antimicrobial uses that would be regulated by AD.

3 .0 Hazard Characterization

Updates have been made to the azoxystrobin endpoints and PODs since the previous risk assessment ( K. Rury, D418012 and D423847, 12/17/2014 ).

Acute Toxicity

Azoxystrobin exhibits low acute mammalian toxicity via oral, dermal, and inhalation routes of exposure (Category III or IV for acute lethality and irritation studies) and is not a de rmal irritant

or sensitizer.

Table 3 .1 . Acute Toxicity Data on Technical Azoxystrobin

. Guideline

No. Study Type MRID # Results Toxicity Category

870.1100 Acute Oral

- Rat 43678122 LD 50 > 5000 mg/kg (Limit Test) in Males &

Females IV

870.1200 Acute Dermal

-

Rat 43678124 LD 50 > 2000 mg/kg (Limit Test) in Males &

Females III

870.1300 Acute Inhalation

-

Rat 43678126 LC 50 Males = 0.962 mg/L (95% C.I. = 0.674) Females = 0.698 mg/L (95% C.I. = 0.509, 2.425)

The combined LC50 was not calculated

due t o mortality pattern III

870.2400 Primary Eye

Irritation

- Rabbit 43678128 Slight to moderate erythema and slight chemosis in all rabbits within one hour, but effects resolved

within 48 hours of treatment. III

870.2500 Primary Skin

Irritation

- Rabbit 43678130 Very slight erythema and edema that persisted for three days on one rabbit and for one hour on

another. IV

870.2600 Dermal

Sensitization

- Guinea Pig 43678132 No erythema or edema were found 38 or 48 hrs after challenge with test material. Not a

dermal

sensitizer



### Toxicological PODs Used for Risk Assessment The azoxystrobin database is complete and adequate for risk assessment. In repeat

- dose oral studies, the liver and bile ducts were consistently the target organs of azoxystrobin toxicity.

De velopmental effects were not seen in rabbit or rat developmental toxicity studies. In the rat reproduction study, offspring and parental effects (decreased body weight and increased adjusted liver weight) were observed at the same dose in both offspring a nd parental animals. Therefore, the azoxystrobin toxicity data show no increased susceptibility in the young.

In a 21

- day repeated dose dermal study in the rat, neither dermal nor systemic toxicity was seen at the limit dose (1,000 mg/kg/day). Further more, there was no concern for developmental orPage 11 of 64



### reproductive effects. Therefore, a hazard was not identified for short

- and intermediate

- term dermal exposure scenarios, and a dermal risk assessment is not applicable at this time.

For short

- and interme diate

- term incidental oral exposures the POD (i.e., no observable adverse effect level (NOAEL) = 35 mg/kg/day) included the results of the 2

- generation reproduction study in rats, the developmental toxicity study in rats, and the 90

- day oral toxicity study in rats. The POD is based on decreased pup weights in both males and females at the lowest observable adverse effect level (LOAEL) of 165 mg/kg/day. This LOAEL is protective of effects seen in the developmental toxicity study and in the 90

- day oral toxi city study. A 100

- fold uncertainty

factor (UF) [ 10X for interspecies extrapolation, 10X for intraspecies extrapolation, and 1X for the Food Quality Protection Act ( FQPA ) Safety Factor ( SF) ] is applied to short

- term incidental

oral risk assessments

.

For s hort

- , intermediate

- , and long

- term inhalation exposure assessment, the POD ( no observed adverse effect level; NOAEL = 3.8 μg/L) was selected based on a route

- specific inhalation toxicity study in rats with the soluble concentrate (SC) formulation of azoxy strobin. The LOAEL of 11.2 μg/L was based on adverse microscopic changes seen in the nasal cavity and the larynx. Human equivalent concentrations (HECs) for residential and occupational scenarios were derived using the NOAEL and the regional deposited

- do se ratio (RDDR). Subsequently,

human

- equivalent doses (HEDs) were calculated from the HECs for residential and occupational

handler scenarios. The standard interspecies extrapolation UF is reduced from 10X to 3X due to the calculation of HECs accounting for pharmacokinetic (not pharmacodynamic) interspecies

differences. The intraspecies variation UF of 10X is retained

. A n a dditional 10 X is applied for a

database UF because the available 28

- day inhalation toxicity study was not conducted using

technical grade active ingredient. Consequently, the LOC for inhalation exposures is an MOE

less than 300 [ 3X for interspecies extrapolation, 10X for intraspecies variation, and 10X for database uncertainty or in the case of residential exposures, FQPA SF].

For episodic ingestion of a zoxystrobin granules , the POD (LOAEL = 200 mg/kg/day) was

selected based on diarrhea at two

- hours post dose at all dose levels tested. For assessing acute risk, EPA is retaining an FQPA factor of 3X to account for the use of a L OAEL from the acute neurotoxicity study to derive an acute reference dose. The Agency believes that a 3X FQPA SF (as opposed to a 10X) will be adequate to extrapolate a NOAEL in assessing acute risk based on the following considerations: (1) The LOAEL is b ased on a transient effect (diarrhea in rats) expected to be relatively insignificant in nature. This effect is also seen in other chemicals of the same class. (2) The diarrhea was only seen in studies using gavage dosing in the rat, but not in

studies us ing repeat dosing through dietary administration in rats or mice, and not through gavage dosing in rabbits. (3) The very high dose level needed to reach the acute oral lethal dose (LD) 50 

### (>5000 mg/kg), and the overall low toxicity of azoxystrobin. Consequ ently, the LOC for acute episodic incidental ingestion is an MOE less than 300 [10 X for interspecies extrapolation, 10X for intraspecies vari ation, and 3X for LOAEL to NOAEL extrapolation].

Azoxystrobin is characterized as "not likely" to be a human carcinogen. The FQPA SF has been

reduced to 1X for all non

- acute exposure durations. Azoxystrobin exhibits low acute mammalian toxicity via oral, dermal, and inhalation routes of exposure (Categ ory III or IV for acute lethality and irritation studies) and is not a dermal irritant or sensitizer.Page 12 of 64

Table 3.2

. Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Non

- Occupational

Human Health Risk Assessments. 1

Exposure/

Scenari o Point of Departure Uncertainty/ FQPA Safety

Factors Level of

Concern for

Risk

Assessment Study and Toxicological

Effects

Episodic Granule Ingestion ( Children 1 to < 2 years old ) LOAEL = 200

mg/kg/day UF A = 10X

UF H = 10X FQPA SF =

3X Residential

LOC for MOE

= 3 00 Acute Neurotoxicity

- Rat.

LOAEL = 200 mg/kg/day based

on diarrhea at two

- hours post

dose at all dose levels tested.

Incidental Oral

Short

- Term (1

- 30 days) &

Intermediate

- term (1

- 6 months) NOAEL = 35

mg/kg/day UF A = 10X

UF H = 10X FQPA SF =

1X Residential

LOC for MOE

= 100 2

- generation reproduction study

– rats LOAEL = 165 mg/kg/day based on decreased pup weights in both males and females (↓8

-

21%).

Dermal (All Durations) No hazard was identified for this exposure scenario. 21

- Day Repeated Dose Dermal Study

– Rat. No dermal or systemic toxicity was seen at the limit dose (1,000 mg/kg/day).

Inhalatio n 2
( All Durations) Rat inhalation

NOAEL=3.8 μg/L

UF A =3

UF H =10

UF DB = FQPA

SF = 10 X + LOC = 300 28

- Day inhalation toxicity study

in rats on SC formulation + LOAEL = 12.2 μg/L based on adverse histopathological changes in the larynx (squamous metaplasia) and nasal cavity (metaplasia of the respiratory epithelium.). There was an increase severity with increases

in the test concentrations. Conventional

Residential Uses : HEC 3 = 0.688 mg/ cubic meter

HED 4 =0.02 mg/kg/day (16.7 L/min)
Antimicrobial

Residential

Uses++ : HEC 3 = 0.516 mg/ cubic meter

HED 4
= 0.059 mg/kg/day (16.7 L/min)

Cancer (oral, dermal, inhalation) Azoxystrobin is classified as "Not Likely" to be carcinogenic to humans.

1. 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. UF A = extrapolation from animal to human (interspecies). UF H = potential v ariation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = le vel of concern. N/A = not app licable.

2. To protect for the body weight decreases seen in the pups, a 69 kg body weight was used for estimating short

- and intermediate

- term inhalation doses because the pup body weight decrease also influenced by the maternal health.

3. HEC = rat NOAEL*(da ily duration adjustment)*weekly daily duration adjustment *RDDR*

4. HED = HEC*human specific conversion factor*daily durationPage 13 of 64

+: An inhalation study on active ingredient (a.i.) is re commend ed. This safety factor is to account for lack of a study with the a.i.

++ AD assumes that the exposure duration for residential painting and mold spraying is 8 hours per day (ventilation rate = 16.7 LPM).

Table 3.3. Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in O ccupational Human

Health Risk Assess ments. 1

Exposure/

Scenario Point of Departure Uncertainty/ FQPA Safety

Factors RfD, PAD,

Level of

Concern for

Risk

Assessment Study and Toxicological Effects

Dermal (All Durations) No hazard was identified for this exposure scenario. 21

- Day Repeated Dose Dermal Study

– Rat. No dermal or systemic toxicity was seen at the limit dose (1,000 mg/kg/day).

Inhalation 2

Short

- Term (1

- 30 days) &

Intermediate

Term (1

- 6 months) Rat inhalation

NOAEL=3.8 μg/L

UF A =3

UF H =10

UF DB =10 + LOC = 300 28

- Day inhalation toxicity study in

rats on SC formulation LOAEL = 12.2 μg/L based on adverse histopathological changes in the larynx (squamous metaplasia) and nasal cavity (metaplasia of the respiratory epithelium.). There was an increase severity with increases in

the tes t concentrations. Occupational handler

HEC 3 = 0.516 mg/ cubic meter

HED 4 ( mg/kg /day): 0.029 (8.3 L/min) ++ 0.059 (16.7 L/min) ++ 0.103 (29 L/min) ++

Cancer (oral, dermal, inhalation) Azoxystrobin is classified as "Not Likely" to be carcinogenic to humans.

1. 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. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (in traspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = le vel of concern. N/A = not applicable.

2. To protect for the body weight decreases seen in the pup s, a 69 kg body weight was used for estimating short

- and intermediate

- term inhalation doses because the pup body weight decrease also influenced by the maternal health.

3. HEC = rat NOAEL*(daily duration adjustment)*weekly daily duration adjustment *RDDR*

4. HED = HEC*human specific conversion factor*daily duration +: An inhalation study on active ingredient (a.i.) is re commend ed. This safety factor is to account for lack of a study with the a.i.

++: Three v entilation rate s corresponding to three HEDs used for assessing occupational inhalation exposures

.



### Absorption

The inhalation POD is based on a route

- specific inhalation toxicity study; therefore

, an inhalation absorption factor is not applicable

. A dermal absorption factor is not applicable because a dermal hazard was not identified for azoxystrobin.

Body Weight The standard body weight s for adults (80 kg) and children (1 to < 2 years old, 11 kg ; 6 to < 11 years old, 32 kg; and 11 to < 16 year s old, 57 kg) w ere used for all exposure scenarios covered in this risk assessment since the endpoints selected were not developmental and/or fetal effects.

4 .0 Use Profile

Azoxystrobin is currently formulated as liquid, dry flowable, granule, and dust end

- use products (EUPs) containing between 0.31% and 50% ai. Azoxystrobin is registered for agricultural use on numerous fruit and vegetable crops growing in both fields and greenhouses. Azoxystrobin isPage 14 of 64



### also registered as a post

- harvest treatment for use on bananas, plantains, citrus, and tuberous and corm vegetables. It may also be used on golf course turf, lawns, sports fields, ornamentals, conifers, roses, cut flowers , interior plantscapes, and sod. Seed treatment uses of azoxystrobin

include the fol lowing commodities: barley; Brassica (cole) leafy vegetables, crop group 5; bulb vegetables, crop group 3; canola; corn (field, pop, sweet); cotton; cucurbit vegetables, crop group 9; eggplant; leafy vegetables, crop group 4; leaves of root and tuber veget ables, crop group 2; legume vegetables (succulent or dried), crop group 6; okra, peanut; peppers; potato; rice; root vegetables, crop subgroup 1A; soybean; sunflower; tomato; triticale; tuberous and corm vegetables (except potato), crop subgroup 1D; turf; watercress; and wheat.

The antimicrobial uses of azoxystrobin for mold control on indoor surfaces include material preservation in paints and coatings, rubber and plastics, textiles, paper and paperboard products and drywall, and as a mold spray inside residential areas including structural wood, subflooring, drywall and carpet.

Table 4.1. Summary of Directions for the Agricultural Uses of Azoxystrobin 1

.

Formulation Applic.

Timing, Type, and Equip. Use Site Applic. Rate (lb ai/A) Max. Seasonal

Applic. Rate (lb ai/A) RTI (days) 2

Liquid Ground, Aerial,

Chemigation Almonds; Artichoke, globe;

Asparagus; Canberries; Brassica Head and Stem Subgroup; Bulb vegetables; Celery; Citrus; Cranberry; Cucurbits; Grapes 13

- 07F; Leafy vegetables; Legume vegetables; Pistachios; Soybean; Stone fruit; Tropical fruit; Wasabi;

Watercress 0.25 1.5 B ulb vegetables, C ucurbits, Leafy vegetables, Vegetables

root and tuber tuberous and

corm = > 5 Soybean = N S Tropical fruit = 10

- 14 All other crops = > 7

Bananas/plantains 0.135 1.08 12

- 14
Cereal grains (Barley, Oats, Rye); Wheat; Triticale 0.2 0.4 N A (m ax 2 applications )

Bushberry Subgroup 13

- 07B;

Brassica leafy greens; 0.25 0.75 7

- 14

Low growing berries; Fruiting vegetables; 0.25 1.0 > 7

Canola 0.25 0.45 Make one application at early bud, one at 45 days pre harvest, and one at 30 days pre harvest Carrots, Potatoes; Vegetables, leaves of root and tuber group and root subgroup; Vegetables, tuberous

and corm group 0.33 2.0 7

- 14

Liquid Ground, Aerial,

Chemigation Chickpeas 0.18 N/S N S

Christmas Trees; Corn (field, pop, sweet seed); Conifers; Roses; 0.25 2.0 > 7

Cotton 0.15 0.4 14

- 21

Air and ground Filberts 0.2 N/S N S

Ground, Aerial, Chemigation Grasses grown for seed; Mint 0.25 0.8 Grasses = 10

- 14

Mint = 7

- 10
Ground only Herbs and spices 0.25 1.5 7Page 15 of 64 Table 4.1. Summary of Directions for the Agricultural Uses of Azoxystrobin 1

.

Formulation Applic.

Timing, Type, and Equip. Use Site Applic. Rate (lb ai/A) Max. Seasonal

Applic. Rate (lb ai/A) RTI (days) 2

Ground, Aerial, Chemigation Non

- grass animal feeds, forage,

fodder, straw, and hay 0.25 0.25 NS

Oilseeds, Crop Group 20 0.25 0.4 NS

Onion (green, dry, and bunching) 0.23 N/S N/S

Peanuts 0.4 0.8 NS (ground directed )

10

- 14 (foliar)

Pecans; Tree nuts; 0.20 1.2 7

- 21

Rice; Wild rice 0.3 0.7 7

- 14

Sorghum 0.25 0.75 NS

Sugarcane 0.2 0.8 14

- 28

Tobacco 0.2 0.52 7

- 14

Tomato, subgroup 8

- 10A 0.1 0.6 7

- 21

Post

- harvest bananas/plantains 0.00034 lb ai/gal NA NA

Post

- harvest citrus 0.148 lb ai/gal NA NA

Post

- harvest tuberous and corm

vegetables 0.00000049

lb ai/lb NA NA

Golf course turf; Lawns; Sports

Fields 0.99 NS > 10

Ornamentals 0.24 NS 7

- 14

Cut flowers 0.06 NS > 7

Greenhouse ornamentals 0.26 NS > 7

Greenhouse vegetables 0.18 NS > 7

Greenhouse tomatoes 0.10 NS 7

- 10

Liquid Commercial

Seed Treatment Equipment Barley, Bell Pepper, Brassica, Bulb

Vegetables, Corn (field, pop, sweet), Cotton, Cucurbits, Eggplant, Leafy Vegetables, Legume Vegetables, Non

- Bell Pepper, Okra, Ornamental Bulbs, Ornamental Seed, Peanuts, Potato,

Root Vegetables, Sunflower, Sorghum, Tomato, Triticale, Tuberous and Corm Vegetables, Turf, Watercress, Wheat 0.000244 (lb ai/lb seed) NA NA

Rice 0.000070 (lb

ai/lb seed) NA NA

Soybean 0.00003 (lb ai/lb seed) NA NA

Cotton 0.00018 (lb ai/lb seed) NA NA

Dry Flowable Ground, Aerial,

Chemigation, Handheld (if applicable) Almonds; Artichoke, globe;

Asparagus; Caneberries; Brassica Head and Stem Subgroup; Bulb vegetables; Celery; Legume Vegetables, dry and succulent; 0.25 1.5 Bulb vegetables, cucurbits, leafy v egetables, = > 5 Grapes, Tropical fruit = > 10 Soybeans = NS All other crops = > 7Page 16 of 64 Table 4.1. Summary of Directions for the Agricultural Uses of Azoxystrobin 1

.

Formulation Applic.

Timing, Type, and Equip. Use Site Applic. Rate (lb ai/A) Max. Seasonal

Applic. Rate (lb ai/A) RTI (days) 2

Citrus; Cranberry; Cucurbits; Grapes 13

- 07F; Leafy Vegetables; Pistachios; Soybean; Stone fruit; Tropical Fruit; Watercress

Bananas/Plantains 0.135 1.08 12

- 14

Dry Flowable Cereal Grains; Wheat; Triticale 0.2 0.4 NS
Bushberry Subgroup 13

- 07B;

Brassica leafy greens; Mint 0.25 0.75 > 7

Strawberry; Fruiting Vegetables

except tomatoes 0.25 1.00 > 7

Canola 0.125 0.86 NS

Carrots 0.33 0.48 7

- 14
Christmas trees; Corn (field, pop, seed, sweet); Conifers; Roses 0.25 2.00 > 7

Cotton 0.15 NA One application per season

Dry Flowable Ground, Aerial,

Chemigation Grasses grown for seed 0.25 0.8 10

- 14

Ground only Herbs and Spices 0.25 1.5 7

Ground, Chemigation Wasabi 0.25 NS NS

Ground, Aerial, Chemigation Oilseeds crop group 20 0.25 0.45 NS

Peanuts

– soilborne 0.4 8.0 NS

Peanuts

– foliar 0.3 10

- 14
Potatoes; Vegetables, leaves of root and tuber; Vegetables, tuberous and

corm 0.33 2.0 > 5

Rice 0.3 0.7 7

- 14

Tomatoes 0.1 0.8 > 5

Tree Nuts 0.2 1.2 7

- 21

Turf 0.95 NS NS

Ornamentals 0.04 0.0125 NS

Post

- Harvest Spray Equipment Post

- Harvest Bananas/Plantains 400 (ppm) NA NA

Seed Treatment Equipment Cotton 0.0002 lb

ai/lb seed NA NA

Granul e s Ground, Aerial,

Handheld Turf, Lawn and Golf course 0.95 5.0 14

- 28

Dust Seed Treatment

Equipment Peanuts 0.00008 lb

ai/lb seed NA NA

1 NS = Not specified, NA = Not applicable

2 RTIs are based on the following representative labels:

a. Liquid: EPA Reg. No. 89442

- 21

b. Liquid greenhouse: EPA Reg. No. 100

- 1506

c. Dry Flowable: EPA Reg. No. 100

- 1093

d. Granul e s: EPA Reg. No. 100

- 1275Page 17 of 64

Table 4.2. Azoxystrobin Antimicrobial Uses

.

Use Application Rate Application

Method Comment

Material Preservation Uses

Ceiling Tiles 0.048 to 0.33% ai i n wet slurry Open Pour Liquid N/A

Latex Caulks, Sealants, Adhesives

and Binders 0.015 to 0.305% ai Open Pour Liquid N/A

Textiles, Fabrics, Canvas and

Cordage 0.015 to 0.23% ai Open Pour Liquid Not for apparel

Rubber and Plastic Products 0.076 to 0.23% ai Open Pour Liquid Not for use in food and beverage containers including plastic piping carrying water or beverages and piping for food processing equipment

Paints , Stains and Coatings 0.029 to 0.305% ai Open Pour Liquid N/A Paper, Wallboard and Paperboard

Products 48 to 190 ppm ai in dry

paper Open Pour Liquid N/A

Residential and Public Access Premises

Indoor Residential Mold Spray 0.00 7 8 lb ai per gallon Handwand Sprayer 100

- 1093

1 Not for use in food and beverage containers including plastic piping carrying water or beverages and piping for food proces sing equipment



### 5 .0 Residential Exposure and Risk Estimates

There is potential residential exposure from the existing conventional and antimicrobial uses of azoxystrobin. All existing conventional residential uses were previously reassessed to reflect

HED’s 2012 Residential SOPs 3 

### ( K. Rury, DP394287, 03/30/2012 ; K. Rury, D418012 and
D423847, 12/17/2014 ) . However, the inhalation PODs have changed since the previous assessment. Therefore, the conventional and antimicrobial inhalation scenarios have been reevaluated to incorporate changes to t he azoxystrobin toxicity database.

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

scenarios listed in Table 5.1 .1

.

Conventional Uses

Residential Handler Exposure Data and Assumptions

–

3 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

residential

- pesticidePage 18 of 64



### 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: The registered application rates of azoxystrobin quantitative exposure/risk assessment developed for residential handler s is based on the scenarios listed in Table 4 .1.

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 4



### .

Exposure Duration: Residential han dler 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 Non

- Cancer Exposure and Risk Estimate Equations

- Conventional Uses The algorithms used to estimate exposure and dose for residential handlers can be found in Appendix A and the 2012 Residential SOPs 5



### .

Summary of Residential Handler Non

- Cancer Exposure and Risk Estimates

– Conventional Uses For residential handlers, expos ures from application to turf were not combined with exposures from treating gardens/trees because concurrent use of separate pesticide products that contain the same active ingredient to treat the same or different pests does not typically occur. Additio nally, combining exposures to these uses is not considered appropriate in light of the already conservative assumptions inherent in the assessment. For example, wh en assessing individual

short

- term residential handler exposure scenarios, EPA assumes expos ure occurs to the highest registered application rate, day after day , for the same amount of time each day, for up to 30 days

for short

- term exposures. E xposure estimates are then compared to points of departure that are typically based on weeks of dosing in test animals. Therefore, although the same products allow treatment of gardens/trees and turf, these exposures were not combined for residential handlers.

Some of the residential handler inhalation risk estimates for the registered uses of azoxystrobin

are of concern. The individual scenarios of concern include:

 Mixing/loading/applying liquids using a hose

- end sprayer to turf,

 Mixing/loading/applying liquids using a backpack sprayer to turf,

 Mixing/loading/applying dry flowable formulati ons using a manually pressurized handwand to turf,

 Mixing/loading/applying a dry flowable formulation using a hose

- end sprayer to turf,

and

 Mixing/loading/applying dry flowable formulations u sing a backpack sprayer to turf.

 Hand dispersal of granul es to gardens/trees

.

All other scenarios are not of concern for the registered conventional uses of azoxystrobin in

residential areas.

4 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/s tandard

- operating

- procedures

residential

- pesticide

5 Available: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

residential

- pesticidePage 19 of 64

Table 5.1.1. Residential Handler Non

- cancer Exposure and Risk Estimates for Azoxystrobin

.

Exposure Scenario Formulation Inhalation Unit Exposure (mg/lb ai) Maximum

Application Rate 1 Area Treated

or Amount

Handled Daily 2 Inhalation

Dose (mg/kg/day) 3 MOE

(LOC = 300) 4

Mixer/Loader/Applicator

Manually Pressurized Handwand

to Gardens/Trees

Liquid 0.018 0.0013 lb ai/gal 5 gal 0.0000015 14,000

Manually Pressurized Handwand

to Turf 0.018 0.01 lb ai/gal 5 gal 0.000011 1,800

Hose

- end Sprayer to

Gardens/Trees 0.0014 0.0013 lb ai/gal 11 gal 0.00000025 80,000

Hose

- end Sprayer to Turf 0.022 0.99 lb ai/A 0.5 acres 0.00014 150

Backpack Sprayer to

Gardens/Trees 0.14 0.0013 lb ai/gal 5 gal 0.000011 1,800

Backpack Sprayer to Turf 0.14 0.01 lb ai/gal 5 gal 0.000088 230

Sprinkler Can to Gardens/Trees 0.0014 0.0013 lb ai/gal 5 gal 0.00000011 180,000

Sprinkler Can to Turf 0.022 0.000013 lb ai/ft 2 1000 ft 2 0.0000036 5,600

Manually Pressurized Handwand

to Gardens/Trees

Dry Flowable 1.1 0.000125 lb ai/gal 5 gal 0.0000086 2,300

Manually Pressurized Handwand

to Turf 1.1 0.119 lb ai/gal 5 gal 0.0082 2.4

Hose

- end Sprayer to

Gardens/Trees 0.0014 0.000125 lb ai/gal 11 gal 0.000000024 830,000

Hose

- end Sprayer to Turf 0.022 0.95 lb ai/A 0.5 acres 0.00013 150

Backpack Sprayer to

Gardens/Trees 1.1 0.000125 lb ai/gal 5 gal 0.0000086 2,300

Backpack Sprayer to Turf 1.1 0.119 lb ai/gal 5 gal 0.0082 2.4

Sprinkler Can to Gardens/Trees 0.0014 0.000125 lb ai/gal 5 gal 0.000010 1,900

Sprinkler Can to Turf 0.022 0.0000218 lb ai/ft 2 1000 ft 2 0.0000060 3,300

Belly Grinder to Turf

Granules 0.039

0.0000218 lb ai/ft 2 1200 ft 2 0.000013 1,600

Spoon around Gardens/Trees 0.087 1200 ft 2 0.000028 700

Spoon to Turf 0.087 100 ft 2 0.0000024 8,400

Cup around Gardens/Trees 0.013 1200 ft 2 0.000043 4,700

Cup to Turf 0.013 100 ft 2 0.00000035 56,000

Hand Dispersal around

Gardens/Trees 0.38 1200 ft 2 0.00012 160

Hand Dispersal to Turf 0.38 100 ft 2 0.000010 1,900

Shaker Can around

Gardens/Trees 0.013 1200 ft 2 0.0000043 4,700

Shaker Can to Turf 0.013 100 ft 2 0.00000035 56,000

1 Based on registered azoxystrobin products

. Shaded MOEs indicated risk estimates of concern (MOE < 300).

2 Based on HED’s 2012 Residential SOPs ( http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

operating

- procedures

- residential

- pesticide ).

3 Inha lation Dose = Inhalation Unit Exposure (mg/lb ai) × Application Rate (lb ai/acre

, gal , or ft 2 ) × Area Treated or Amount Handled (A

/day

, gallons/day , or ft 2 /day ) ÷ BW ( 80 kg).

4 Inhalation MOE = Inhalation HED ( 0.02 mg/kg/day) ÷ Inhalation Dose (mg/kg/day)

. LOC = 300. Shaded MOEs indicate risks of concern (LOC < 300).Page 20 of 64



### Antimicrobial Uses

Residential Handler Exposure

– – Treated Paint All three of the antimicrobial end use products that are used for material preservation are added

to paints . There is potential for residential handler exposure during the application of paints treated with azoxystrobin as a preservative

. The exposure duration is assumed to be short term

because it is likely that a residential painter would apply paints for a few days at a time.

The following assumptions were used:

 The use rate is 0.31% a.i. by weight.

 The amount of paint handled per day is 2 gallons for brush/roller applications and 15 gallons for airless sprayer applications. These are standard AD and HED assumptions.

 The body weight of an adult handler is 80 kg.

 The daily task duration is 8 hours.



### The MOEs for residential handlers of azoxystrobin preserved paints are summarized in Table

5.1.2 . The MOE s are less than the LOC of 300 for both the airless sprayer and brush/roller

scenarios , which means that the risks are of concern. These risks cannot be mitigated with respiratory protection because only the materials preservatives to preserve paints are EPA registered pesticide products; preserved paints themselves are not EPA registered pesticide products and thus do not have labels that could include PPE requirements.

Residential Handler Exposure

– Antimicrobial Mold Spray

There is one label product ( EPA Reg. No. 100

- 1093) registered for indoor residential mold spray

use. Th e label indicates that the product can only be used by residential applicators as a preventative treatment on up to 800 square feet and for remediation of areas of 10 square feet or less. This product is not for use by professional or commercial applicator s. There is the potential for residential handler inhalation exposure during mold remediation treatments that are applied as a spray to wood, drywall, carpets, and non

- food hard non

- porous surfaces.

The following assumptions were used:

 The application rate is 2.6 ounces of product per ten gallons of water. This rate is from page 84 of label

100

- 1093.

 The amount of spray applied by low pressure handwand sprayer is 10 gallons per day based on the label Table 5.1.2

. Azoxystrobin Residential Handler Inhalation Exposure and Risk Estimates for Preserved Paint

.

Scenario Application

Rate 1 Amount Paint

Applied (lb/day) 2 Amount a i

Handled (lb/day) Unit Exposure 3

(mg/lb ai) Daily Dose 4

(mg/kg/day) Inhalation

MOE 5
(LOC =300) Application of Paint Containing Azoxystrobin

Airless sprayer 0.31% ai by wt 150 (15 ga l x 10 lb/ga l ) 0.47 0.56 0.0033 18

Brush/Roller 20 (2 ga l x 10 lb/ga l ) 0.047 0.20 0.00012 170

1 Based upon maximum rate listed on label #39967

- 86.

2 HED Standard Operating Procedures (SOPs) for Residential Exposure Assessment (October 22, 2012).

3 HED Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (March, 2013)

. 4 Daily Dose = [Amount ai Handled (lb) * Unit Exposure (mg/lb)] ÷ Body Weight (80 kg)

. 5 MOE = HED (0.059 mg/kg/day for an 8 hour exposure at 16.7 liters/minute) ÷ D aily Dose (mg/kg/day) . Shaded MOEs represent risk estimates of concern (MOE < 300).Page 21 of 64 directions above for the use dilution and the label recommendation to “Prepare no more mixture than is necessary for immediate use

.

 The task duration is eight hours per day given the amount of spray applied

.

 The body weight of an adult handler is 80 kg.



### The unit exposures, application rates and amo unts of products applied per day were used to

calculate the MOE as shown in Table 5.1.3

. The MOE is less than 3 00 and the risk is of concern.

5 .2 Residential Post

- application Exposure/Risk Estimates

5. 2. 1 Residential Post

- Application Exposure/Risk Estimates

– Conventional Uses

There is the potential for post

- application exposure for individuals exposed as a result of being in an environment that has been previously treated with azoxystrobin. The quantitative exposure/risk assessment for residential post

- application exposures ha s been updated here for the purposes of the aggregate risk assessment because the inhalation POD has changed since the previous full assessment of all the existing residential uses ( K. Rury , D394287, 03/30/2012 ). The quantitative exposure/risk assessment for residential post

- application exposures is based on

the scenarios listed in Table 5.2 .1

. The lifestages selected for each post

- application scenario are based on an analysis provided as an Appendix in the 2012 Residential SOPs 6



### . While not the only

life stage potentially exposed for these post

- application scenarios, the lifestage that is included in the quantitative assessment is health protective for the exposures and risk estimates for any other potentially exposed lifestage. There was no dermal hazard identified for azoxystrobin; therefore only incidental oral and inhalation post

- application exposures were assessed for the residential uses of azoxystrobin.

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 6



### .

Application Rate: The registered application rates of azoxystrobin on treated turf , ornamentals and golf courses are listed in Table 4.1.

6 Available : http://www2.epa.gov/pesticide

- science

- and

- assessing

- pestici de

- risks/standard

- operating

- procedures

residential

- pesticide Table 5.1.3. Azoxystrobin Residential Handler Inhalation MOEs for Mold Spray Treatment

.

Scenario Application

Rate 1
(% a.i.) Amount Product

Applied per Day 2 Amount Ai

Handled 3 (lb/day) Unit

Exposure 4 (mg/lb ai) Daily Dose 5

(mg/kg/day) Inhalation

MOE (LOC = 300) 6

L ow Pressure

H andwand in

Indoor

Environments 0.0078 lb ai per gallon 10 gallons 0.0 78 1.1 0.0011 54

1 Based on the label directions (2. 6 solid ounces of product added to 10 gallons of water) and 50% a.i. in the product.

2 Based on the label directions. 3 Amount ai handled = Application Rate (lb ai/gallon) *Gallons Applied

4 Unit Exposure Value for Mix Lo ad Apply Wettable Powder Using a Low Pressure Handwand ( 2012 Residential SOPs )

. 5 Daily Dose = [Amount ai Handled (lb) * Unit Exposure (mg/lb ai)] ÷ Body Weight (80 kg)

. 6 Inhalation MOE = HED (0.0 59 mg/kg/day for 8 hour exposures ) ÷ Daily Dose (mg/kg/day)

.Page 22 of 64



### Exposure Duration: Residential exposure is expected to be short

- term in duration. Intermediate

term exposures are not likely because of the intermittent nature of applications by homeowners.

Granule ingestion following treatment of turf is considered episodic in duration. Because the

soil half

- life is relatively short, intermediate

- te rm exposures are not expected.

Residential Post

- application Non

- Cancer Exposure and Risk Equations The algorithms used to estimate residential post

- application exposure and dose can be found in Appendix A and the 2012 Residential SOPs 7



### .

Combining Exposure and Risk Estimates The incidental oral scenarios (i.e., hand

- to

- mouth and object

- to

- mouth) should be considered

inter

- related and it is likely that they occur interspersed amongst each other across time. Combining these scenarios would be overly

- conservative because of the conservative nature of each individual assessment. This assessment should be considered a protective estimate of potential post

- application exposure for children 1 to < 2 years old

.

Characterization Granul e Ingestion Ingestion of granules is considered an episodic event and not a routine behavior. Because HED does not believe that this would occur on a regular basis, our concern for human health is related to acute poisoning rather than short

- term residue exposure. T herefore, an acute dietary dose is used to estimate exposure and risk resulting from episodic ingestion of granules.

Summary of Residential Post

- application Non

- Cancer Exposure and Risk Estimates The registered residential uses of azoxystrobin do not re sult in any risks of concern for post

application incidental oral exposures.

Table 5.2.1. Residential Post

- application Non

- cancer Exposure and Risk Estimates for the Conventional Uses of Azoxystrobin

.

Lifestage Post

- application Exposure Scenario Application Rate 1 Dose (mg/kg/day) 2 MOEs 3 Use Site Route of Exposure

Child ren 1 to < 2 years old Turf (Liquid/Sprays) Hand

- to

- Mouth

0.99 lb ai/A 0.0151 2,300
Object

- to

- Mouth 0.0046 76,000
Soil Ingestion 0.000034 1,00,000

Turf ( Granul e s ) Hand

- to

- Mouth

0.95 lb ai/A 0.0014 24,000
Object

- to

- Mouth 0.000088 400,000
Soil Ingestion 0.000032 1,100,000

Granul e Ingestion 0.31% ai 0.085 2,400

1 Based on registered or proposed label s (Reg. No. 89442

- 21, and 100

- 1275 ).

2 Dose (mg/kg/day) algorithms provided in 2012 Residential SOPs ( http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/standard

- operating

- procedures

- residential

- pesticide ).

3 MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day). Incidental oral POD = 35 mg/kg/day where LO C = 100 ; Incidental episodic oral POD = 200 mg/kg/day, where LOC = 300



### 5. 2. 2 Residential Post

- Application Exposure/Risk Estimates

– Antimicrobial Azoxystrobin Uses

7 http://www2.epa.gov/pesticide

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- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

- residential

pesticidePage 23 of 64



### T here is the potential for residential post

- application incidental oral exposure s to vinyl flooring made from azoxystrobin treated /impregnated vinyl and plastic toys manufactured from azoxystrobin treated plastic . There is the potential for residential post

- application incidental oral and inhalation exposures from indoor mold spray treat ment and indoor carpet and hard surface

treatment for mold.

5. 2. 2. 1 Incidental Oral Exposure from Treated /Impregnated Vinyl Flooring

Vinyl tiles used for flooring can be treated with azoxystrobin during the manufacturing process.

Therefore

, post

- appl ication incidental oral exposures to treated /impregnated vinyl flooring may

occur. Children (1 to < 2 years old) are the index lifestage for this scenario. Because the Residential SOPs deal primarily with conventional pesticides that are applied to surfaces, rather than antimicrobials that are incorporated into materials, modifications were made to the surface residue equations to include an availability factor (AF) of 0.5 percent 8 

### to account for the fact that only a small portion of the antimicrobia l ingredient incorporated into plastic is at the surface and available for exposure. See Appendix A for the equations and assumptions to estimate the incidental oral exposures from treated vinyl flooring.

Treated Vinyl Risk Summary

The MOE for incident al oral hand to mouth exposure to azoxystrobin treated vinyl flooring is

summarized in Table 5.2

. 2. 1

. T he MOE is 610 and the risk is not of concern.

Table 5.2

. 2.1

. Incidental Oral Hand to Mouth MOE for Azoxystrobin Treated Vinyl Flooring

. Application Rate (percent by weight) Surface

Residue 1 (mg/cm 2 ) Transfer

Factor Hand

Residue 2 (mg/cm 2 ) Exposure 3

(mg/day) Dose 4

(mg/kg/day) Incidental

Oral MOE (LOC = 100) 5

0.225 0.0044 1.0 0.0044 0.65 0.057 610

1

. Surface Residue (SR) = Density (1300 mg/cm 3 ) * Vinyl Thickness (0.3 cm) * W eight F raction (AR/100) * A vailability F actor (0.5/100)

2

. Hand Residue (HR) = SR (mg/cm 2 ) * Transfer Factor (1.0)

3

. Exposure = HR (mg/cm 2 ) * F M (0.13) * Surface Area Hand ( SA H ) (150 cm 2 ) * E xposure Time (E T ) (2 hr s ) * NR (4/hr) * [1

– (1

- SE (0.48) FHtM

(20/hr)/NR(4) ]}

4

. Dose = Exposure (mg/day) / BW (11 kg)

5

. MOE = NOAEL / Dose where the NOAEL is 35 mg/kg/day and the target MOE is 100.



### 5 .2. 2 .2 Post

- Application Exposure from Indoor Spray Antimicrobial Applications

There is potential for incidental oral exposures for children ’s hand

- to

- mouth contact with carpe t
and hard surfaces treated with azoxystrobin mold spray

, as well as

, post

- application inhalation exposure from indoor applications of surface sprays for adults and children

.

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 6



### .

Application Rate: The registered application rates of azoxystrobin are listed in Table 4.1. The

8 The availability factor is based on migration calculations using Fick’s 1 st and 2 nd laws of diffusion as programmed in the Arthur D. Little Polymer Migration Estimation Model (AMEM) model.Page 24 of 64



### treatment solution ai density is 0.0078 lb ai per gallon based on the label. The spray volume is 0.004 gallons per square foot based on the label coverage recommendation of 250 square feet per gallon

Exposure Duration: Residential 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 Post

- application Non

- Cancer Exposure and Risk Equations The algorithms used to estimate residential post

- application expo sure and dose can be found in Appendix A and the 2012 Residential SOPs 9



### .

Indoor Antimicrobial Spray Uses of Azoxystrobin Risk Summary

The MOE s for post

- application exposure to the indoor uses of azoxystrobin are summarized in

Table 5.2.2. Incidental oral exposures were not combined from both treated hard surfaces and carpets because of the already conservative assumptions inherent in the assessment. When assessing individual short

- term residential post

- application exposure scenarios, EPA a ssumes exposure occurs to zero

- day residues (i.e., day of application residues) day after day , for the same amount of time every day (i.e., no day to day variation)

. T hese exposure estimates are then compared to points of departure that are typically based on weeks of dosing in test animals. For azoxystrobin, the short

- term risk assessment has the additional conservatism of basing the level

of concern for short

- term ex posure (30

- days) on a toxicity study involving continuous exposure over 10 weeks for parental animals; and at least 21 days for pups while also being exposed in

utero

.

Table 5.2.2.2. Residential Post

- application Non

- cancer Exposure and Risk Estimat es for the Indoor Antimicrobial Uses of Azoxystrobin.

Lifestage Post

- application Exposure Scenario Application Rate 1 Dose (mg/kg/day) 2 MOEs
(LOC = 100) 3 Use Site Route of Exposure

Adult Indoor Mold Surface Directed

Sprays Inhalation 0.0078 lb ai/gal 0.0000000023 8,800,000

Children 1 to < 2 years old Indoor Mold Surface Directed Sprays Inhalation

0.0078 lb ai/gal or

0.000031 lb ai/ft 2 0.0000000084 2,400,000

Indoor Surface Directed Sprays

–

Carpets Hand

- to

- Mouth 0.0902 390

Indoor Surface Directed Sprays

– Hard Surfaces Hand

- to

- Mouth 0.0301 1,100

Indoor Surface Directed Sprays

–

Carpets Object

- to

- Mouth 0.013 2,700

Indoor Surface Directed Sprays

– Hard Surfaces Object

- to

- Mouth 0.0087 4,000

1 Based on registered or proposed label s (Reg. No. 89442

- 21, 100

- 1275, and 100

- 1093 ).

2 Dose (mg/kg/day) algorithms provided in 2012 Residential SOPs ( http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/standard

- operating

- procedures

- residential

- pesticide ).

3 MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day). Incidental oral POD = 35 mg/kg/day, i nhalation HED ( 0.02 mg/kg/day)

.



### 5 .2. 2. 3 Incidental Oral Exposure from Plastic Toys

Plastics and polymers can be treated with an azoxystrobin during production and these plastics

9 http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

- procedures

- residential

pesticidePage 25 of 64



### and polymers ca n be subsequently used to manufacture toys. Therefore, unless the label specifically prohibits use in plastics and polymers used to manufacture toys, it is assumed

children’s post

- application incidental oral exposures to treated toys may occur. It is ass umed that not all plastic toys are treated with azoxystrobin and the toys that are treated will not be used every day, therefore, exposure would occur intermittently. Thus, only short

- term exposures
durations were assessed. Children (1 to < 2 years old) are the index lifestage for this scenario. See Appendix A for the assumptions and equations for calculating incidental exposure from plastic toys.

Treated Toys Risk Summary

The MOE for incidental oral hand to mouth exposure to azoxystrobin treated toys is summarized

in Table 5.2.3

. T he MOE is 2,500 and the risk is not of concern.

Table 5.2. 2. 3. Incidental Oral Object to Mouth MOE for Azoxystrobin Treated Toys

. Weight Fraction Surface

Residue 1 (mg/cm 2 ) Object Residue 2

(mg/cm 2 ) Exposure 3

(mg/day) Dose 4

(mg/kg/day) Incidental Oral

MOE (LOC = 100) 5

0.00225 0.0011 0.0011 0.16 0.014 2,500

1 Surface Residue (SR) = WF (0.00225) * Toy Weight (50 grams) * 1000 mg/gm * Availability Factor (0.5/100) Toy Surface Area (500 cm 2 )

2 Object Residue (OR) = SR (mg/cm 2 ) * Transfer Factor (1.0)

3 Exposure = OR (mg/cm 2 ) * Surface Area Mouthed ( SAM ) (10 cm 2 ) * Exposure Time ( E T ) (4 hr) * NR (4/hr) * [1

– (1

- SE (0.48) FHtM (14/hr)/NR(4) ]}

4 Dose = Exposure (mg/day) / BW (11 kg)

5 MOE = NOAEL / Dose where the NOAEL is 35 mg/kg/day and the target MOE is 100.



### 5. 3 Residential Risk Estimates for Use in Aggregate Assessment

Table 5. 3 reflects the residential risk estimates that are recommended for use in the aggregate

assessment for azoxystrobin

. An adult aggregate assessment including residential handler inhalation exposures will not be conducted because effects seen in the route

- specific inhalation toxicity study differ from those seen via the oral route; therefore residential exposures will not be aggregated with dietary exposures for adults. The recommended residential exposure for use

in the children 1 to <2 years old a ggregate assessment reflects hand

- to

- mouth incidental oral exposures from treated carpets.

Ingestion of granules is considered an episodic event and not a routine behavior. Because HED does not believe that this would occur on a regular basis, our conc ern for human health is related to acute poisoning rather than short

- term residue exposure. Therefore, an acute dietary dose is used to estimate exposure and risk resulting from episodic ingestion of granules. For these same reasons, the episodic ingesti on scenario is not recommended for inclusion in the aggregate

assessment.Page 26 of 64 Table 5. 3 . Recommend ed Scenarios for the Residential Exposures for the Azoxystrobin Aggregate Assessment. 1

Lifestage Post

- application Exposure (mg/kg/day) Residential Post

application Total Exposure (mg/kg/day) 2 Residential

Post

application

MOE 3 Inhalation Oral

Short

- Term

Child 1 to <2 years old N/A 0.0902 (Hand

- to

- Mouth exposure from treated

carpets) 0.0902 390

1 N/A = not applicable. C hildren handler exposures are not expected. For children 1 to < 2 years old, total residential exposure

represents high

- end post

- application incidental oral exposure (Table s 5.2

. 2.2 ).

2 Post

- application exposure represents high

- end or incidental oral exposure f or the relevant exposure duration.

3 Total MOE = NOAEL (35 mg/kg/day) ÷ (Incidental Oral Exposure).



### Since the estimated residential turf post

- application exposure for residential turf using default

TTR values for azoxystrobin is minimal in comparison to the level of concern (i.e., the calculated MOE is greater than 10 times higher than the level of concern, MOE = 2,300 compared to the

LOC of 100 ); EPA is recommending that 40CFR TTR data are not needed

. 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.

Because no dermal hazard was identified f or azoxystrobin, a residential post

- application assessment on ornamentals was not conducted; therefore a DFR study is not needed for azoxystrobin at this time.

6.0 Non

- Occupational Spray Drift Exposure and Risk Estimates

Off

- target movement of pesticides can occur via many types of pathways and it is governed by a variety of factors. Sprays that are released and do not deposit in the application area end up off

target and can lead to exposures to those it may directly con tact. They can also deposit on surfaces where contact with residues can eventually lead to indirect exposures ( e.g. , children playing on lawns where residues have deposited next to treated fields). The potential risk

estimates from these residues can be calculated using drift modeling coupled with methods employed for residential risk assessments for turf products.

The approach to be used for quantitatively incorporating spray drift into risk assessment is based on a premise of compliant applications whi ch, by definition, should not result in direct exposures to individuals because of existing label language and other regulatory requirements intended to prevent them. 10 

### Direct exposures would include inhalation of the spray plume or being sprayed directly. Rather, the exposures addressed here are thought to occur indirectly through contact with impacted areas, such as residential lawns, when compliant applications are conducted. Given this premise, exposures for children (1 to 2 years old) and adults who have contact with turf where residues are assumed to have deposited via spray drift thus resulting in an indirect exposure are the focus of this analysis analogous to how exposures to turf products are

considered in risk assessment.

10 This approac h is consistent with the requirements of the EPA’s Worker Protection Standard which, when included on all labels, precludes direct exposure pathways.Page 27 of 64



### Several azoxystrobin products have existing labels for use on turf, thus it was considered whether the risk assessment for that use may be considered protective of any type of exposure that would be associated with spray drift. It should be noted that t he registered resident ial uses on turf result in exposure greater than potential exposure from spray drift; therefore, no new

residential assessment needs to be completed. If the maximum application rate on crops adjusted by the amount of drift expected is less than or equal t o existing turf application rates, the existing turf assessment is considered protective of spray drift exposure. The currently registered maximum single application rate of azoxystrobin is 0.33 lb ai/A

. The highest degree of spray drift noted for any ap plication method immediately adjacent to a treated field (Tier 1 output from the aerial application using fine to medium spray quality) results in a deposition fraction of 0.26 of the application rate. A quantitative spray drift assessment for azoxystrobi n is not required

because the max imum application rate to a crop/ta rget site multiplied by the adjustment factor

for drift of 0.26 is less than the maximum direct spray residential turf application rate of 0.99 lb

ai/A 11 

### for any azoxystrobin products . The turf post

- application MOEs have been previously assessed and are based on the revised SOPs for Residential Exposure Assessment (i.e., see above in Section 5.2).

7.0 Non

- Occupational Bystander Post

- Application Inhalation Exposure and Risk Estimates

Vola tilization 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, Fungic ide, 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, additional route

- specific inhalation toxicological studies) or further analysis is needed

for azoxystrobin

.

Per the Residential SOPs, a quantitativ e residential post

- application inhalation exposure

assessment was performed in the residential post

- application section of the ORE chapter. There were no risks of concern identified for residential post

- application inhalation exposures using

conservative inputs and assumptions. T here are no post

- application inhalation residential risk

estimates of concern at this time.

8 .0 Occupational Exposure and Risk Estimates

8 .1 Occupational Handler Exposure/Risk Estimates

– Conventional Azoxystrobin Uses

HED u ses 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

11 0.33 lb ai/A x 0.26 ≤ 0.99 lb ai/APage 28 of 64



### 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 current labeling, types of equipment and techniques that can potentially be used, occupational handler exposure is expected from the proposed uses. The quantitative exposure/risk assessment developed for occupatio nal handlers is based on the

scenarios listed in Table s 8.1.1

– 8.1 .6

.

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 : The registered application rates for azoxystrobin are listed in Table 4.1.

Unit Exposures: It is the policy of HED to use the best available data to assess handler expos ure. Sources of generic handler data, used as surrogate data in the absence of chemical

- specific data, include PHED 1.1, the Policy 14 for Seed Treatment, AHETF database, the ORETF database,

the Post

- Harvest SOP, 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 expo sures”, are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 12 

### ”, which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at the Agenc y website 13



### .

Area Treated or Amount Handled : The area treated/amount handled are based on ExpoSAC Policy 9.1 , the Post

- Harvest SOP, and the SOPs for Seed Treatment. Inputs may be found in Appendix C

.

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 la rge 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 azoxystrobin, based on the existing uses, both short

- and intermediate

- term exposures are expected for occupational handlers because it could be applied multiple times per season to many

12 Available: http://www.epa.gov/opp00001/science/handler

- exposure

- table.pdf

13 Available: http://www.epa.gov/pes ticides/science/handler

- exposure

- data.htmlPage 29 of 64



### registered crops. However, the occupational inhalation POD is applicable to both durations; therefore the assessment is protective of both short

- and intermediate

- term exposures.

Mitigation/Personal Protective Equipment: Estimates of dermal and inhalation exposure were calculated for various levels of PPE. Results are presented 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, as well as baseline with various levels of PPE as necessary (e.g., gloves, respirator, etc). The registered azoxystrobin labels require baseline attire (long sleeved shirts, long pants, shoes, and socks) and in addition to PPE including chemical resistant gloves; and in some cases, protective eyewear, a respirator, or double layer clothing. Only liquid

formulation labels that are co

- formulated with other active ingredients require respirators , and no dry flowable products require the use of r espirators when handling azoxystrobin

.

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

.

Combining Exposures/ Risk Estimates There was no dermal hazard identified for azoxystrobin; therefore a dermal exposure assessment was not conducted and dermal exposures were not combined with inh alation exposures.

Summary of Occupational Handler Non

- Cancer Exposure and Risk Estimates There are some occupational handler risk estimates of concern for the registered uses of azoxystrobin at baseline, PPE, and engineering control mitigation. The LOC for occupational inhalation risk estimates is an MOE of 300. At baseline, occupational han dler inhalation MOEs ranged from 1.1 to 50,000.

The following scenarios are of concern with baseline PPE (no respirator):

 Mixing/loading dry flowables for aerial, airblast, groundboom, and chemigation application to all registered crops at maximum regi stered application rates;

 Mixing/loading granules for aerial application to sod;

 Mixing/loading granules for tractor

- drawn spreader applications to sod and golf course fairways, greens, and tees.

 Mixing/loading liquids for aerial application to orchard s/vineyards, sod, typical field crops, and high acreage field crops at maximum registered application rates;

 Mixing/loading liquids for chemigation application to orchards/vineyards, sod, typical field crops, high acreage field crops;

 Mixing/loading liq uids for groundboom application to sod and high acreage field crops;

 Applying sprays with airblast application equipment to nursery ornamentals and orchards/vineyards;

 Applying sprays with groundboom application equipment to sod; golf course fairways,

te es, and greens; typical field crops; and high acreage field crops;

 Applying granules with aerial application equipment to sod;

 Applying granules with a tractor

- drawn spreader to sod, and golf course fairways, greens,
and tees;Page 30 of 64



###  Flagging for aerial applic ation to sod during liquid and granular applications;

 Mixing/loading/applying dry flowable or liquid formulations with a backpack sprayer to orchard/vineyards, Christmas tree farms, and nursery ornamentals;

 Mixing/loading/applying dry flowable or liquid formulations using a manually pressurized handwand to Christmas tree farms, nursery ornamentals, and landscaping;

 Mixing/loading/applying dry flowable or liquid formulations using a mechanically pressurized handwand to orchard/vineyards, Christmas tree fa rms, nursery ornamentals, golf courses, landscaping, and typical field crops;

 Mixing/loading/applying liquids with a manually pressurized handwand to greenhouse
ornamentals;

 Mixing/loading/applying liquids with a mechanically pressurized handwand to

orch ards/vineyards, Christmas tree farms, nursery ornamentals, greenhouse ornamentals, landscaping, and typical field crops;

 Loading/applying granule formulations with a rotary spreader to golf courses;

 Mixing/loading for post

- harvest treatments in a closed system to citrus;

 Mixing/loading dry flowable formulations in an automated system for post

- harvest
treatment of bananas,

 Mixing/loading liquids in an automated system for post

- harvest treatment fo r citrus;

 Applying direct post

- harvest sprays using a mechanically pressurized handgun to citrus
and bananas;

 Loading/applying, sewing, bagging, and multiple activities for numerous liquid seed treatment uses of azoxystrobin;

 Planting treated barley, legume vegeta ble, peanut, potato, triticale, tuberous and corm vegetable, turf, and wheat seeds with liquid formulations of azoxystrobin;

 Loading/applying, sewing, bagging, multiple activities for dust seed treatment applications to peanuts;

 Plant ing peanut seeds tre ated with dust formulations;

 Loading/applying, sewing, bagging, and multiple activities for cotton dry flowable seed treatment uses of azoxystrobin; and

 Sorting and packing following post

- harvest treatment of citrus and bananas.

The following scenarios are of concern with maximum available personal protective equipment

or engineering controls :

 Mixing/loading dry flowable formulations for aerial or chemigation application to sod and high acreage field crops;

 Mixing/loading granul e formulations for aeria l application to sod;

 Mixing/loading/applying dry flowable formulations for backpack sprayer application to landscaping;

 Mixing/loading/applying dry flowable formulations for mechanically pressurized handgun applications to golf courses, landscaping, and typical field crops.

 Mixing/loading/applying liquid s for backpack application to landscaping and turf ;

 Mixing/loading/applying liquids for mechanically pressurized handgun applications toPage 31 of 64



### typical field crops and greenhouse ornamentals;

 Mixing/loading liquids for post

- harvest treatment of citrus in a closed automated system;

 Mixing/loading liquids for post

- harvest treatment of citrus in an open automated system;

 Mixing/loading/applying liquids for post

- harvest treatment of citrus using a mechanically pressurized handgun.

 Loading/applying liquid formulation to sunflower seeds;

 Sewing bags of treated sunflower seeds following liquid seed treatment;

 Multiple activities following/during liquid seed treatment for sunflower seed treatment;

 Planting potato, tuberous and corm vegetable, and turf seeds following liquid seed

treatment;

 Loading/applying, sewing, bagging, and multiple activities following/during dust treatment of peanut seeds;

 Loading/applying, sewing, bagging, and multiple acti vities following dry flowable

formulation treatment of cotton seeds.

The Agency matches quantitative occupational exposure assessment with appropriate characterization of exposure potential. While HED presents quantitative risk estimates for human flagg ers where appropriate, agricultural aviation has changed dramatically over the past two decades. According the 2012 National Agricultural Aviation Association (NAAA) survey of their membership, the use of GPS for swath guidance in agricultural aviation has grown steadily from the mid 1990’s. Over the same time period, the use of human flaggers for aerial pesticide applications has decreased steadily from ~15% in the late 1990’s to only 1% in the most recent (2012) NAAA survey. The Agency will continue to mo nitor all available information sources to best assess and characterize the exposure potential for human flaggers in agricultural aerial applications.

HED has no data to assess exposures to pilots using open cockpits. The only data available is for

expos ure to pilots in enclosed cockpits. Therefore, risks to pilots are assessed using the engineering control (enclosed cockpits) and baseline attire (long

- sleeve shirt, long pants, shoes, and socks); per the Agency’s Worker Protection Standard stipulations f or engineering controls, pilots are not required to wear protective gloves for the duration of the application . With this level of protection, there are currently no risk estimates of concern for applicators , except for aerial application of granules to s od

.Page 32 of 64

Table 8.1.1. Occupational Handler Non

- Cancer Exposure and Risk Estimates for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Maximum
Application Rate 2 Inhalation MOE

(LOC = 300)

Baseline PF5 Respirator PF10 Respirator Engineering Control

Mixer/Loader

Mixing/Loading Dry Flowables for Aerial

Application Nursery Ornamentals 0.25 lb ai/A 35 180 350 2,300

Orchards/Vineyards 0.25 lb ai/A 6.0 30 60 390

Sod 0.95 lb ai/A 1.6 7.9 16 100

Field Crop, Typical 0.33 lb ai/A 4.6 23 46 300

Field Crop, High Acreage 0.4 lb ai/A 1.1 5.5 11 72

Mixing/Loading Dry Flowables for Airblast

Application Nursery Ornamentals 0.25 lb ai/A 110 530 1,100 6,900

Orchards/Vineyards 0.25 lb ai/A 53 260 530 3,400

Mixing/Loading Dry Flowables for Chemigation

Application Orchards/Vineyards 0.25 lb ai/A 6.0 30 60 390

Sod 0.95 lb ai/A 1.6 7.9 16 100

Field Crop, Typical 0.33 lb ai/A 4.6 23 46 300

Field Crop, High Acreage 0.4 lb ai/A 3.8 19 38 250

Nursery Ornamentals 0.25 lb ai/A 35 180 350 2,300

Mixing/Loading Dry Flowables for Groundboom

Application Golf course (tees and greens) 0.95 lb ai/A 110 560 1,100 7,200

Golf course (fairways, tees, and greens) 0.95 lb ai/A 14 69 140 900

Field

- Grown Ornamental Crops 0.25 lb ai/A 53 260 530 3,400

Nursery Ornamentals 0.25 lb ai/A 35 180 350 2,300

Sod 0.95 lb ai/A 6.9 35 69 460

Orchards/Vineyards 0.25 lb ai/A 53 260 530 3,400

Field Crop, Typical 0.33 lb ai/A 20 100 200 1,300

Field Crop, High Acreage 0.4 lb ai/A 6.6 33 66 430

Mixing/Loading Granul es for Aerial Application Sod 0.95 lb ai/A 15 73 150 300

Mixing/Loading Granul e s for Tractor

- Drawn

Spreader Applications Golf Course (Fairways, Tees, Greens) 0.95 lb ai/A 130 640 1,300 2,600

Golf Course (Tees and Greens) 0.95 lb ai/A 1,000 5,100 10,000 21,000

Sod 0.95 lb ai/A 64 230 640 1,300

Mixing/Loading Liquids for Aerial Application Nursery Ornamentals 0.25 lb ai/A 1,400 7,200 14,000 6,600

Orchards/Vineyards 0.25 lb ai/A 250 1,200 2,500 1,100

Sod 0.99 lb ai/A 62 310 620 290

Field Crop, Typical 0.33 lb ai/A 190 930 1,900 860

Field Crop, High Acreage 0.4 lb ai/A 45 220 450 210Page 33 of 64

Table 8.1.1. Occupational Handler Non

- Cancer Exposure and Risk Estimates for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Maximum
Application Rate 2 Inhalation MOE

(LOC = 300)

Baseline PF5 Respirator PF10 Respirator Engineering Control

Mixing/Loading Liquids for Airblast Application Nursery Ornamentals 0.25 lb ai/A 4,300 22,000 43,000 20,000

Orchards/Vineyards 0.25 lb ai/A 2,200 11,000 22,000 9,900

Mixing/Loading Liquids for Chemigation

Application Orchards/Vineyards 0.25 lb ai/A 250 1,200 2,500 1,100

Sod 0.99 lb ai/A 62 310 620 290

Field Crop, Typical 0.33 lb ai/A 190 930 1,900 860

Field Crop, High Acreage 0.4 lb ai/A 150 770 1,500 710

Greenhouse Ornamentals 0.26 lb ai/A 1,400 6,900 14,000 6,400

Nursery Ornamentals 0.25 lb ai/A 1,400 7,200 14,000 6,600

Mixing/Loading Liquids for Groundboom

Application Golf Course (Tees and Greens) 0.99 lb ai/A 4,400 22,000 44,000 20,000

Golf Course (Fairways, Tees, Greens) 0.99 lb ai/A 550 2,700 5,500 2,500

Field

- Grown Ornamentals 0.25 lb ai/A 2,200 11,000 22,000 9,900

Nursery Ornamentals 0.25 lb ai/A 1,400 7,200 14,000 6,600

Greenhouse Ornamentals 0.26 lb ai/A 1,400 6,900 14,000 6,400

Sod 0.99 lb ai/A 270 1,400 2,700 1,300

Orchards/Vineyards 0.25 lb ai/A 2,200 11,000 22,000 9,900

Field Crop, Typical 0.33 lb ai/A 820 4,100 8,200 3,800

Field Crop, High Acreage 0.4 lb ai/A 270 1,300 2,700 1,200

Applicator

Applying Sprays with Aerial Application Equipment Nursery Ornamentals 0.25 lb ai/A

N/A 32,000

Orchards/Vineyards 0.25 lb ai/A 5,400

Sod 0.99 lb ai/A 1,400

Field Crop, Typical 0.33 lb ai/A 4,100

Field Crop, High Acreage 0.4 lb ai/A 990

Applying Sprays with Airblast Application

Equipment Nursery Ornamentals 0.25 lb ai/A 98 490 980 6,800

Orchards/Vineyards 0.25 lb ai/A 49 250 490 3,400

Applying Sprays with Groundboom Application

Equipment Golf Course (Tees and Greens) 0.99 lb ai/A 1,400 6,900 14,000 39,000

Golf Course (Fairways, Tees, Greens) 0.99 lb ai/A 170 860 1,700 4,800

Field

- Grown Ornamentals 0.25 lb ai/A 680 3,400 6,800 19,000

Nursery Ornamentals 0.25 lb ai/A 450 2,300 4,500 13,000

Greenhouse Ornamentals 0.26 lb ai/A 440 2,200 4,400 12,000

Sod 0.99 lb ai/A 86 430 860 2,400Page 34 of 64

Table 8.1.1. Occupational Handler Non

- Cancer Exposure and Risk Estimates for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Maximum
Application Rate 2 Inhalation MOE

(LOC = 300)

Baseline PF5 Respirator PF10 Respirator Engineering Control

Orchards/Vineyards 0.25 lb ai/A 680 3,400 6,800 19,000

Field Crop, Typical 0.33 lb ai/A 260 1,300 2,600 7,200

Field Crop, High Acreage 0.4 lb ai/A 85 430 850 2,400

Applying Granul e s with Aerial Application

Equipment Sod 0.95 lb ai/A N/A 19

Applying Granul es with a Tractor

- Drawn Spreader Golf Course (Fairways, Tees, Greens) 0.95 lb ai/A 180 900 1,800 980

Golf Course (Tees and Greens) 0.95 lb ai/A 1,400 7,200 14,000 7,900

Sod 0.95 lb ai/A 90 450 900 490

Flagger

Flagging for Aerial Applications (Sprays) Sod 0.95 lb ai/A 71 350 710 N/A Flagging for Aerial Applications (Granul es ) Sod 0.95 lb ai/A 170 820 1,700

Mixer/Loader/Applicator

Mixing/Loading/Applying Dry Flowable or Liquid Formulations with Backpack Sprayer Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals (Ground

Directed) 0.025 lb ai/gal
1,800 9,100 18,000 N/A

Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals (Broadcast) 0.025 lb ai/gal 120 600 1,200

N/A Landscaping (Plants, Flowers, Trees, Turf) (Broadcast Treatment) 0.119 lb ai/gal 25 130 250

Landscaping Turf (Spot Treatment) 0.119 lb ai/gal 380 1,900 3,800

Mixing/Loading/Applying Dry Flowable or Liquid Formulations with a Manually Pressurized

Handwand Christmas Tree Farm, Nursery Ornamentals (Broadcast) 0.025 lb ai/gal 270 1,400 2,700

N/A Landscaping (Plants, Flowers, Trees,

Turf) 0.119 lb ai/gal 58 290 580

Mixing/Loading/Applying Dry Flowable Formulations with a Mechanically Pressurized

Handwand Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals 0.025 lb ai/gal 38 190 380

N/A Golf Course (Tees, Greens, Fairways) 0.95 lb ai/A 24 120 240

Landscaping (Trees, Shrubs, Bushes) 0.119 lb ai/gal 8 40 79

Field Crop, Typical 0.033 lb ai/gal 29 140 290

Mixing/Loading/Applying Liquids with a Manually

Pressurized Handwand Greenhouse Ornamentals 0.026 lb ai/gal 260 1,300 2,600 N/A

Mixing/Loading/Applying Liquids with a Mechanically Pressurized Handwand Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals 0.025 lb ai/gal 38 190 380 N/A

Greenhouse Ornamentals 0.017 lb ai/gal 4 20 40Page 35 of 64

Table 8.1.1. Occupational Handler Non

- Cancer Exposure and Risk Estimates for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Maximum
Application Rate 2 Inhalation MOE

(LOC = 300)

Baseline PF5 Respirator PF10 Respirator Engineering Control

Golf Course (Tees, Greens, Fairways),

Landscaping Turf, 0.01 lb ai/A 50,000 250,000 500,000

Landscaping (Trees, Shrubs Bushes) 0.01 lb ai/gal 8 40 79

Field Crop, Typical 0.033 lb ai/gal 29 140 290

Loading/Applying Granul e Formulations with a

Rotary Spreader Golf Course (Fairways, Tees, Greens) 0.95 lb ai/A 99 500 990 N/A

1 Assessment is based on maximum registered azoxystrobin application rate for each scenario. Crops were grouped according to re gistered application rates and applicable exposure scenarios to cover all registered use sites. Shaded MOEs represent risk estimat es of concern (LOC = 300).

2 Inhalation MOE = Inhalation HED (mg/kg/day) ÷ Inhalation Dose. Inhalation Dose = Inhalation Unit Exposure ( μ g/lb ai) × Conversion Factor (0.001 mg/ μ g) × Application Rate (lb ai/acre or gal) × Area Treated or Amount Handled Da ily (A or gal/day) ÷ BW (kg). Unit Exposures are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference

Table 14 ”, which, along with additional information on HED policy on use of surrogate data, including descriptions of the vari ous sources, can be found at the Agency website 15

. Area or Amount Treated Information is available in ExpoSAC Policy 9.1. Inputs for MOE calculations may be found in Appendix C

.

Table 8.1.2. Occupational Handler Non

- Cancer Exposure and Risk Estimates for the Registered Post

- Harvest Uses of Azoxystrobin.

Exposure Scenario Crop or Target Maximum
Application Rate 1 Inhalation MOE (LOC = 300)

lb ai/gal solution Baseline 5 PF5 PF10

Mixing/Loading For Post

- Harvest Treatment in a Closed Automated System Citrus 0.15 15 N/A N/A

Potatoes 0.0000049 460,000 N/A N/A

Bananas 0.00034 6,600 N/A N/A

Mixing/Loading Dry Flowable Formulations

in an Automated System Bananas 0.00034 62 310 620

Mixing/Loading Liquids in an Automated

System Citrus 0.15 5.7 29 57

Bananas 2 0.00034 2500 13,000 25,000

Applying Direct Post

- Harvest Sprays with a Mechanically Pressurized Handgun Citrus 0.15 0.32 1.6 3.2

Bananas 2 0.00034 140 700 1,400

1 Based on registered labels (Reg. No. 89442

- 21, 100

- 1098, 100

- 1093).

2 Based on ExpoSAC Post

- Harvest Policy.

3 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/ gal) × Are a Treated or Amount Handled Daily (gal/day) ÷ BW (80 kg).

4 Inhalation MOE = Inhalation N OAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Shaded MOEs indicated MOEs of concern (LOC = 300). 5 For closed automated system, baseline exposures represent engineering control protection. “Baseline” for all other scenar ios represents no respirator. I nputs for MOE calculations may be found in Appendix C.

14 Available: http://www.epa.gov/opp00001/science/handler

- exposure

- table.pdf

15 Available: http://www.epa.gov/pesticides/science/handler

- exposure

- data.htmlPage 36 of 64

Table 8.1.3

. Primary Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Liquids

.

Scenario Application Rate (lb ai/lb seed) 1 Amount of

Seed Treated (lb/day) 3 SOP

15.1 Inhalation Dose (mg/kg/day) Inhalation MOE LOC = 300)

Baseline PF5 PF10 EC Baseline PF5 PF 10 EC

Loader/Applicator

Corn ( field, pop, sweet), Peanuts, Bulb Vegetables , Cotton, Cucurbits, Okra, Ornamental

Bulbs 0.000244 339,500 0.000352 0.000070 0.000035 0.000045 170 840 1700 1300

Rice 0.000070 302,500 0.000104 0.000018 0.000009 0.000011 570 3300 6600 5200

Barley, Triticale, Wheat, Sorghum, 0.000244 360,000 0.000433 0.000075 0.000037 0.000047 140 790 1600 1200

Brassica, Eggplant, Leafy Vegetables, Bell Pepper, Non

- Bell Pepper, Tomato, Wa tercress, Ornamental Seed, Turf 0.000244 3,000 0.000004 0.000001 0.000000 0.00000039 16,000 95000 190000 150000

Leaves of Root and Tuber Vegetables, Root Vegetables, Tuberous and Corm Vegetables 0.000244 800,000 0.000962 0.000166 0.000083 0.000105 61 360 710 560

Potato 0.000244 800,000 0.018106 0.003123 0.001562 0.000105 3 19 38 560

Legume Vegetables 0.000244 281,250 0.000338 0.000058 0.000029 0.000037 170 1000 2000 1600

Soybean 0.00003 281,250 0.000042 0.0000072 0.000004 0.000005 1,400 8200 16000 13000

Sunflower 0.00244 339,500 0.004082 0.000704 0.000352 0.000445 14 84 170 130

Cotton 0.00018 339,500 0.000301 0.000052 0.000026 0.000033 200 1100 2300 1800

Sewer

Corn (field, pop, sweet), Peanuts, Bulb Vegetables, Cotton, Cucurbits, Okra, Ornamental

Bulbs 0.000244 339,500 0.000276 0.000048 0.000024 N/A 210 1200 2500 N/A

Rice 0.00007 302,500 0.000071 0.000012 0.0000061 N/A 840 4800 9700 N/A

Barley, Triticale, Wheat, Sorghum, 0.000244 360,000 0.000293 0.000051 0.000025 N/A 200 1200 2300 N/A

Brassica, Eggplant, Leafy Vegetables, Bell Pepper, Non

- Bell 0.000244 3,000 0.0000024 0.00000042 0.00000021 N/A 24,000 140000 280000 N/APage 37 of 64

Table 8.1.3

. Primary Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Liquids

.

Scenario Application Rate (lb ai/lb seed) 1 Amount of

Seed Treated (lb/day) 3 SOP

15.1 Inhalation Dose (mg/kg/day) Inhalation MOE LOC = 300)

Baseline PF5 PF10 EC Baseline PF5 PF 10 EC

Pepper, Tomato, Watercress, Ornamental Seed, Turf,

Leaves of Root and Tuber Vegetables, Potato, Root Vegetables, Tuberous and Corm

Vegetables 0.000244 800,000 0.000651 0.000112 0.000056 N/A 91 530 1100 N/A

Legume Vegetables 0.000244 281,250 0.000229 0.000039 0.000020 N/A 260 1500 3000 N/A

Soybean 0.00003 281,250 0.000028 0.0000049 0.000002 N/A 2,100 12000 24000 N/A

Sunflower 0.00244 339,500 0.002761 0.00048 0.000238 N/A 21 120 250 N/A

Cotton 0.00018 339,500 0.000204 0.000035 0.000018 N/A 290 1700 3400 N/A

Bagger

Corn (field, pop, sweet), Peanuts,

Bulb Vegetables, Cotton, Cucurbits, Okra, Ornamental

Bulbs 0.000244 339,500 0.00019 0.000033 0.000017 N/A 310 1800 3600 N/A

Rice 0.00007 302,500 0.000049 0.0000085 0.0000042 N/A 1,200 7000 14000 N/A

Barley, Triticale, Wheat, Sorghum, 0.000244 360,000 0.000204 0.000035 0.000018 N/A 290 1700 3400 N/A

Brassica, Eggplant, Leafy Vegetables, Bell Pepper, Non

- Bell Pepper, Tomato, Watercress, Ornamental Seed, Turf, 0.000244 3,000 0.0000017 0.00000029 0.00000015 N/A 35,000 200000 400000 N/A

Leaves of Root and Tuber Vegetables, Potato, Root Vegetables, Tuberous and Corm

Vegetables 0.000244 800,000 0.00045 0.000078 0.000039 N/A 130 760 1500 N/A

Legume Vegetables 0.000244 281,250 0.00016 0.000027 0.000014 N/A 370 2100 4300 N/A

Soybean 0.00003 281,250 0.000020 0.0000034 0.0000017 N/A 3,000 17000 35000 N/A

Sunflower 0.00244 339,500 0.0019 0.000331 0.000166 N/A 31 180 360 N/A

Cotton 0.00018 339,500 0.000142 0.000024 0.000012 N/A 420 2400 4800 N/A

Multiple Activities

Corn (field, pop, sweet), Peanuts,

Bulb Vegetables, Cotton, Cucurbits, Okra, Ornamental

Bulbs 0.000244 339,500 0.00192 0.000331 0.00017 0.000045 31 180 360 1300Page 38 of 64

Table 8.1.3

. Primary Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Liquids

.

Scenario Application Rate (lb ai/lb seed) 1 Amount of

Seed Treated (lb/day) 3 SOP

15.1 Inhalation Dose (mg/kg/day) Inhalation MOE LOC = 300)

Baseline PF5 PF10 EC Baseline PF5 PF 10 EC

Rice 0.00007 302,500 0.00049 0.000085 0.000042 0.000011 120 700 1400 5200

Barley, Triticale, Wheat, Sorghum, 0.000244 360,000 0.00204 0.000351 0.00018 0.000047 29 170 340 1200

Brassica, Eggplant, Leafy Vegetables, Bell Pepper, Non

- Bell Pepper, Tomato, Watercress, Ornamental Seed, Turf, 0.000244 3,000 0.000017 0.0000029 0.0000015 0.00000039 3,500 20000 40000 150000

Leaves of Root and Tuber Vegetables, Potato, Root Vegetables, Tuberous and Corm

Vegetables 0.000244 800,000 0.0045 0.00078 0.00039 0.000105 13 76 150 560

Legume Vegetables 0.000244 281,250 0.0016 0.00027 0.00014 0.000037 37 210 430 1600

Soybean 0.00003 281,250 0.00020 0.000034 0.000017 0.0000045 300 1700 3500 13000

Sunflower 0.00244 339,500 0.019 0.0033 0.0017 0.00045 3 18 36 130

Cotton 0.00018 339,500 0.0014 0.00024 0.00012 0.000033 42 240 480 1800

1 Seed Treatment Application rates based on the registered liquid azoxystrobin labels (100

- 1159, 100

- 1177, 100

- 1208, 100

- 1286, 100

- 1352, 100

- 1369, 100

- 1384, 100

- 1399, 100

- 1405, 100

- 1449, 100

- 1450).

2 Unit Exposures from HED Exposure Science Advisory Council Policy 14 : Standard Operating Procedures for Seed Treatment (baseline inhalation = no respirator). Unit Exposures for PF5 and PF10 respirators were adjusted in the inhalation dose calculation accordingly (baseline inhalation UE ÷ 5 = PF5 UE, etc)

. 3 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).

4 Daily Inhalation Dos e (mg/kg/day) = daily inhalation unit exposure (mg/ lb ai) × application rate (lb ai/lb seed) × amount planted (lb seed/day) ÷ body weight (80 kg adult).

5 Inhalation MOE = Inhalation POD (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Short

- term level of concer n = 300. Shaded MOEs indicated MOEs of concern (LOC = 300).

Table 8.1.4. Secondary Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Liquids.

Scenario Application

Rate (lb ai/lb seed) 1 Inhalation

UE

Baseline (mg/lb ai) Amount of

Seed Planted ( lb /A ) Acres

Planted (A/day)

SOP 15 Inhalation Dose (mg/kg/day) Inhalation MOE (LOC = 300)

Baseline PF5 PF10 Baseline PF5 PF 10

Planters

Barley 0.000244

0.0034 138 200 0.00033 0.000057 0.000029 180 1,000 2,100

Bell pepper 0.000244 1.39 80 0.0000013 0.00000023 0.00000012 44,000 260,000 510,000

Brassica 0.000244 2.64 80 0.0000025 0.00000044 0.00000022 23,000 130,000 270,000Page 39 of 64

Table 8.1.4. Secondary Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Liquids.

Scenario Application

Rate (lb ai/lb seed) 1 Inhalation

UE

Baseline (mg/lb ai) Amount of

Seed Planted ( lb /A ) Acres

Planted (A/day)

SOP 15 Inhalation Dose (mg/kg/day) Inhalation MOE (LOC = 300)

Baseline PF5 PF10 Baseline PF5 PF 10

Bulb vegetables 0.000244

0.0034 31 80 0.0000302 0.0000052 0.0000026 2,000 11,000 23,000

Corn (field) 0.000244 30 200 0.000071 0.0000123 0.0000061 830 4,800 9,600

Corn (pop) 0.000244 22 200 0.000053 0.0000091 0.0000046 1,100 6,500 13,000

Corn (Sweet) 0.000244 33 200 0.000080 0.0000138 0.0000069 740 4,300 8,600

Cotton 0.000244 19 200 0.000045 0.0000078 0.0000039 1,300 7,500 15,000

Cucurbits 0.000244 12 80 0.000011 0.0000019 0.00000096 5,300 31,000 61,000

Eggplant 0.000244 7.56 80 0.0000073 0.0000013 0.0000006 8,100 47,000 94,000

Leafy Vegetables 0.000244 0.78 80 0.00000075 0.0000001 0.0000001 78,000 450,000 910,000

Leaves of

root and

tuber vegetables 0.000244 14 80 0.000013 0.0000023 0.0000012 4,400 26,000 51,000

Legume Vegetables 0.000244 327 80 0.00031 0.0000542 0.000027 190 1,100 2,200

Okra 0.000244 23 80 0.000022 0.0000038 0.0000019 2,700 16,000 31,000

Ornamental

bulbs 0.000244 4.48 80 0.0000043 0.00000074 0.00000037 14,000 79,000 160,000

Ornamental

seed 0.000244 4.48 80 0.0000043 0.00000074 0.00000037 14,000 79,000 160,000

Peanut 0.000244 228 80 0.00022 0.0000379 0.0000189 270 1,600 3,100

Pepper

- non bell 0.000244 4.18 80 0.00000402 0.0000007 0.00000035 15,000 85,000 170,000

Potato 0.000244 6,970 300 0.025 0.0043 0.0022 2.3 14 27Page 40 of 64

Table 8.1.4. Secondary Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Liquids.

Scenario Application

Rate (lb ai/lb seed) 1 Inhalation

UE

Baseline (mg/lb ai) Amount of

Seed Planted ( lb /A ) Acres

Planted (A/day)

SOP 15 Inhalation Dose (mg/kg/day) Inhalation MOE (LOC = 300)

Baseline PF5 PF10 Baseline PF5 PF 10

Rice 0.00007 156 200 0.00011 0.000019 0.0000093 550 3,200 6,300

Root Vegetables 0.000244 0.12 80 0.00000011 0.000000020 0.0000000098 520,000 3,000,000 6,000,000

Sorghum 0.0002

0.0034 59 80 0.000046 0.0000080 0.0000040 1,300 7,400 15,000

Soybean 0.00003 167 200 0.000049 0.0000085 0.0000043 1,200 6,900 14,000

Sunflower 0.00244 4.00 80 0.000039 0.0000066 0.0000033 1,500 8,900 18,000

Tomato 0.000244 1.09 80 0.0000011 0.00000018 0.0000000903 56,000 330,000 650,000

Triticale 0.000244 116 200 0.00028 0.0000482 0.0000241 210 1,200 2,400

Tuberous

and Corm Vegetables 0.000244 6,970 300 0.025 0.00434 0.0022 2.3 14 27

Turf 0.000244 5,238 80 0.00504 0.00087 0.00043 12 68 140

Watercress 0.000244 17 80 0.000017 0.0000028 0.0000014 3,600 21,000 42,000

Wheat 0.000244 188 200 0.00045 0.000078 0.000039 130 760 1,500

1 Seed Treatment Application rates based on the registered liquid azoxystrobin labels (100

- 1159, 100

- 1177, 100

- 1208, 100

- 1286, 100

- 1352, 100

- 1369, 100

- 1384, 100

- 1399, 100

- 1405, 100

- 1449, 100

- 1450).

2 Unit Exposures from HED Exposure Science Advisory Council Policy 14 : Standard Operating Procedures for Seed Treatment (baseline inhalation = no respirator). Unit Exposures for PF5 and PF10 respirators were adjusted in the inhalation dose calculation accordingly (baseline inhalation UE ÷ 5 = PF5 UE, etc)

. 3 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).

4 Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/ lb ai) × application rate (lb ai/lb seed) × amount planted (lb seed/day) ÷ body weight (80 kg adult).

5 Inhalation MOE = Inhalation POD (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Short

- term level of concern = 300. Shaded MOEs indicated MOEs of concern (LOC = 300).Page 41 of 64 1 Seed Treatment Application rates based on the registered dust azoxystrobin labels ( 100

- 1190, 100

- 1438 ).

2 Unit Exposures from HED Exposure Science Advisory Council Policy 14 : Standard Operating Procedures for Seed Treatment (baseline inhalation = no respirator). Unit Exposures for PF5 and PF10 respirators were adjusted in the inhalation dose calculation accordingly (baseline inhalation UE ÷ 5 = PF5 UE, etc). The wettable powder mixing/loading UE (PHED Scenario

4/PHED Scena rio 5) was used a surrogate for loader/applicator, sewer, bagger, and multiple activity scenarios for baseline and engineering control dust exposures.

3 HED default for lb seed treated/planted per day from HED Exposure Science Advisory Council Interim Poli cy 15.1 and the BEAD memo “Acres Planted Per Day and Seeding Rates of Crops

Grown in the United States ” (J. Becker, March 2011).

4 Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/ lb ai) × application rate (lb ai/lb seed) × amount plan ted (lb seed/day) ÷ body weight (80 kg adult).

5 Inhalation MOE = Inhalation POD (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Short

- term level of concern = 300. Shaded MOEs indicated MOEs of concern (LOC = 300).

1 Seed Treatment Application rates based on the registered dust azoxystrobin labels (100

- 1190, 100

- 1438).

2 Unit Exposures from HED Exposure Science Advisory Council Policy 14 : Standard Operating Procedures for Seed Treatment (baseline inhalation = no respirator). Unit Exposures for PF5 and PF10 respirators were adjusted in the inhalation dose calculation accordingly (baseline inhala tion UE ÷ 5 = PF5 UE, etc). The wettable powder mixing/loading UE (PHED Scenario Table 8.1.5 . Seed Treatment Exposure and Risk Estimates for the Registered Uses of Azoxystrobin

– Dust Formulations.

Scenario Application

Rate (lb ai/lb seed) 1 Inhalation

UE Baseline (mg/lb ai) 2 Inhalation

UE Engineering

Control (mg/lb ai) 2 Amount of

Seed Treated

or Planted (lb/day) 3 Inhalation Dose (mg/kg/day) Inhalation MOE (LOC = 300)

Baseline 4 PF5 4 PF10 4 EC 4 Baseline 5 PF5 5 PF10 5 Engineering

Control 5

Loader/Applicator, Sewer, Bagger, Multiple A ctivities

Peanuts 0.00008 0.043 0.00024 339,500 0.01 5 0.0029 0.0015 0.0015 4 20 40 40

Planters

Peanuts 0.00008 1.69 N/A 228 0.0006 2 0 .00012 0.000062 N/A 95 480 950 N/A

Table 8.1.6 . Seed Treatment Exposure and R isk Estimates for the Registered Uses of Azoxystrobin

– Dry Flowable Formulations.

Scenario Application

Rate (lb ai/lb seed) 1 Inhalation UE

(mg/lb ai) 2 Inhalation UE

Engineering Control (mg/lb ai) 2 Amount of

Seed Treated

or Planted (lb/day) 3 Inhalation Dose (mg/kg/day) Inhalation MOE (LOC = 300)

Baseline 4 PF 10 4 Engineering

Control 4 Baseline 5 PF 10 5 Engineering

Control 5

Loader/Applicator, Sewer, Bagger, Multiple A ctivities

Cotton 0.0002 0.00896 0.0024 339,500 0.0089 0.00088 0.00024 6.7 67 250

Planters

Cotton 0.0002 0.00896 N/A 19 (lb planted/day) 200 (Acres Planted per day (SOP 15)) 0.000098 N/A N/A 600 N/A N/APage 42 of 64 4/PHED Scenario 5) was used a surrogate for loader/applicator, sewer, bagger, and multiple activity scenarios for dust exposu res. 3 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).

4 Daily Inhalation Dose (mg/kg/day) = daily inhalation unit expos ure (mg/ lb ai) × application rate (lb ai/lb seed) × amount planted (lb seed/day) ÷ body weight (80 kg adult).

5 Inhalation MOE = Inhalation POD (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Short

- term level of concern = 300. Shaded MOEs indicated MOEs of concern (LOC = 300).Page 43 of 64



### 8.2 Occupational Handler Exposure/Risk Estimates

– Antimicrobial Uses

There is the potential for occupational handler inhalation exposure during the use of azoxystrobin as a material preservative in interior and exterior paints, paper, wallboard, ceiling tiles, caulks, sealants, adhesives, binders, non

- apparel textiles and p lastics . The exposure duration is assumed to be primarily intermediate to long term because these uses occur in manufacturing plants that operate on a year round basis.

There is also a potential for occupational handler exposure during the application of azoxystrobin preserved paints using airless sprayers, brushes and rollers. These exposures are anticipated to occur on a short to intermediate term basis because several other preservatives besides azoxystrobin are used in paints.

Occupational Handle r Exposure Assumptions

The following assumptions were used:

 Paint is a representative material and is protective of the other materials on the label.

 The paint contains 0.31 percent azoxystrobin by weight

.

 One handler treats 2000 gallons of paint per day. This is an AD standard value that is based on information provided by the paint industry.

 The paint has a density of 10 lb/gal.

 One handler applies 5 gallons per day for brush/roller applications and 50 gallons per day for airless sprayer applications. These are standard AD and HED assumptions

.

 The body weight of an adult handler is 80 kg.

Occupational Handler Risk Summary

The occupational handler risk estimate (i.e. MOE) for the material preservation uses of azoxystrobin is summarized in Table 8 . The MOE is less than the LOC of 3 00 (i.e. the target MOE) for paint manufacturing w ithout respirators w hich means that the risk is of concern. If a

PF

- 10 elastomeric half face respirator is worn, the MOE is increase d to 300 and is no longer of

concern.

The MOEs are also of concern for both airless spray and brush/roller paint application. These risks cannot be mitigated with respiratory protection because preserved paints are not EPA registered pesticide products and thus do not have labels that could i nclude PPE requirements.

Table 8.2. Azoxystrobin Occupational Handler Inhalation MOEs for Preserved Paint

. Scenario Application

Rate 1 Amount Paint

Manufactured or Applied (lb/day) 2 Amount Ai

Handled (lb/day) Unit Exposure

(mg/lb ai) 3,4,5 Daily Dose 6

(mg/kg/day) Inhalation

MOE 7
(LOC =300) Adding Azoxystrobin to Paint During Paint Manufacture

Open pour liquid (No Respirator) 0.31% ai by wt 20,000 lb (2,000 ga l x 10 lb/ga l ) 62 0.0017 0.0013 30

Open pour liquid (PF10 Respirator) 0.017 0.00013 300Page 44 of 64



### 8

. 3 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 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 the chemical’s degradation properties. In addition, the timing of pesticide applica tions, relative to harvest activities, can greatly reduce the potential for post

- application exposure.

8

. 3 .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/2 009/120109meeting.html ). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( ht tp://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 , additional route specific inhalation toxicity studies ) or further analysis is required for azoxystrobin

.

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

.

The Worker Protection Standard for Agricultural Pesticides contains requirements for protecting

workers from inhalation exposures during and after greenhouse applications through the use of ventilation requirements.[40 CFR 170.110, (3) (Restrictions associated with pesticide applications)] Application of Paint Containing Azoxystrobin

Airless sprayer 0.31% ai by wt 500 (50 ga l x 10 lb/ga l ) 1.6 0.560 0.010 6

Brush/Roller 50 (5 ga l x 10 lb/ga l ) 0.16 0.20 0.0004 150

1 Based upon maximum rate listed on label #39967

- 86.

2 AD Standard Operating Procedures (SOPs) for Occupational Exposure Assessment (March 31, 2011).

3 Unit Exposure value is from AEATF Liquid Pour Study.

4 Unit Exposure value divided by 10 to account for the use of a PF10 Elastomeric Half Face Respirator

. 5 HED Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (March, 2013)

. 6 Daily Dose = [Amount ai Handled (lb) * Unit Exposure (mg/lb)] ÷ Body Weight (80 kg)

. 7 MOE = HED (0.059 mg/kg/day for 8 hour 5 day per week exposure at 16.7 liter s/minute) ÷ Daily Dose (mg/kg/day)

.Page 45 of 64



### Occupational Post

- Application Inhalation Exposure Data and Assumptions

Although th e post

- application exposures due to agricultural applications has not been quantitatively evaluated, there is the potential for occupational post

- application inhalation exposures in post

- harvest treatment facilities. During automated treatments, dermal an d inhalation exposure is anticipated for workers performing sorting and packing tasks. Since the workers experience exposure following the treatment, this is technically “post

- application” exposure; however, unlike other post

- application activities (e.g., harvesting, scouting, etc.), this treatment is not governed by the Worker Protection Standard (WPS) and potential re

- entry intervals (REIs). Additionally, for workers in the warehouse or packaging facility not directly

involved in the automated treatment process, there is potential for indirect inhalation exposure. Exposures for these various scenari os are assessed using HED ExpoSAC Policy/Guidance

“ Assessment of Occupational Exposure for Post

- Harvest Commodity Pesticide Treatments ” (M. Crowley, 23

- MAR

- 2 012). A series of assumptions and exposure factors served as the basis for completing the occupational post

- application risk assessment. Each assumption and factor is

detailed below on an individual basis.

Exposure Duration: HED classifies exposures fr om 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 post

- application workers will not apply the same chemical every day for more than a one

- month time frame; however, there may be a large agribus iness 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 azoxystrobin, based on the existing uses, both short

- and intermediate

- term exposures a re expected for occupational handlers in post

- harvest facilities because it could be applied year

round to the registered cr ops. Additionally, the occupational inhalation POD is applicable to both durations; therefore the assessment is protective of both short

- and intermediate

- term

exposures. Long

- term exposures are not expected because exposures resulting from post

- harvest uses are likely a series of short

- or intermediate

- term exposures, rather than continuous long

- term exposure duration just to azoxys trobin.

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

Occupational Post

- application Non

- Cancer Inhalation Risk Estimates There are some occupational post

- application inhalation risk estimates of concern for the registered post

- harvest uses of azoxystrobin at baseline and maximum PPE mitigation. The LOC for occupational inhalation risk estimates is an MOE of 300. At baselin e, occupational post

application inhalation MOEs for the post

- harvest uses of azoxystrobin ranged from 1.5 to 5,200,000 for sorters/packers and from 32 to 1,200,000 for indirect inhalation exposures.Page 46 of 64 Table 8.3.1. 1. Occupational Post

- application Non

- Can cer Exposure and Risk Estimates for Azoxystrobin

Crop/Site Activities Max App.

Rate (% ai in solution) 1 Inhalation Unit Exposure

(μg/% ai) 2 Inhalation Dose (mg/kg/day) 3 Inhalation MOE 4 (LOC = 300)

Baseline PF5 PF10 Baseline PF5 PF10 Baseline PF5 PF10

Citrus

– Concentrated

Solution Sorter
0. 48 6720 1340 672 0.041 0.0081 0.0041 1. 5 7. 3 15

Packer 6760 1350 675 0.041 0.0081 0.0041 1. 5 7. 3 15

Citrus

– Diluted

Solution Sorter
0.12 6720 1340 672 0.0101 0.0020 0.0010 5.8 29 58

Packer 6760 1350 675 0.0101 0.0020 0.0010 5.8 29 58

Bananas Sorter
0.01 6720 1340 672 0.0008 0.0002 0.0001 70 350 700

Packer 6760 1350 675 0.0008 0.0002 0.0001 70 350 700

Potato Sorter 0.000013 6720 1340 672 0.000000011 0.0000000022 0.0000000011 5

, 200

, 000 26

, 000

, 000 52

, 000

, 000

Packer 0.000013 6760 1350 675 0.000000011 0.0000000022 0.0000000011 5

, 200

, 000 26

, 000

, 000 52

, 000

, 000

1. Used the highest ppm rate found on the registered labels (EPA Reg. No. 100

- 1093, 89442

- 21, 100

- 1098 ).

2 . Based on Table 2 in ExpoSAC Policy/Guidance “Assessment of Occupational Exposure for Post

- Harvest Commodity Pesticide Treatments” (M. Crowley, 23

- MAR

- 2012); Level of mitigation: T

- shirt/NG = t

- shirt and no gloves; NR = no respirator.

3 . Inhalation Dose = [U nit E xposure (μg/% ai) * A pplication R ate (% ai in solution) * A djustment F actor (0.001 μg/mg)] ÷ B ody W eight (80 kg).

4 . Inhalation MOE = Inhalation POD ( 0.059 mg/kg/day) ÷ Inhalation Dose.

Table 8.3.1.2 . Occupational Post

- application Non

- Cancer Indirect Inhalation Exposure and Risk Estimates for Azoxystrobin

.

Crop/Site Max App. Rate

(% ai in solution) Inhalation Unit Exposure (μg/% ai) 1 Inhalation Dose (mg/kg/day) 2 MOE 3

Baseline PF5 PF10 Baseline PF5 PF10 Baseline PF5 PF10

Citrus

– Concentrated

Solution 0.49

307 61.4 30.7 0.0019 0.00037 0.00019 32 160 320

Citrus

– Diluted

Solution 0.12 0.00046 0.000093 0.000046 130 640 1

, 300

Bananas 0.04 0.000039 0.0000077 0.0000039 1,500 7

, 600 15

, 000

Potato 0.000013 0.000000050 0.000000010 0.0000000050 1,200,000 5

, 900

, 000 12

, 000

, 000

1. Based on Table 4 in ExpoSAC Policy/Guidance “Assessment of Occupational Exposure for Post

- Harvest Commodity Pesticide Treatments” (M. Crowley, 23

- MAR

- 2012); Level of mitigation: NR = no respirator. 2. Inhalation Dose = [Unit Exposure (μg/% ai) * Application Rate (% ai in solution) * Adjustment Factor (0.001 μg/mg)] ÷ Bod y Weight (80 kg)]. 3. Inhalation MOE = Inhalation POD ( 0.059 mg/kg/day)/Inhalation Dose.



### 8

. 3 .2 Occupational Post

- application Dermal Exposure/Risk Estimates

An occupational post

- application dermal assessment was not completed for azoxystrobin on sod farms because no dermal hazard was identified in the toxicity database.

Because no dermal hazard was identified for azoxystrobin, an occupational post

- application assessment on agricultural crops were not conducted; therefore a DFR study is not required for azoxystrobin at this time.

Restricted Entry IntervalPage 47 of 64



### For Azoxystrobin Products with a >12 H our REI Azoxystrobin is classified as Toxicity Category III via the dermal route and Toxicity Category

IV for skin irritation potential. It is not a skin sensitizer. There was no short

- or intermediate

term dermal hazard identified for azoxystrobin. Under 40 CFR 156.208 (c) (2), ai’s classified as

Acute III or IV for acute dermal, eye irritation and primary skin irri t ation are assigned a 12

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

- application exposures to azoxystrobin

.

For A zoxystrobin P roducts with a 4

- hour REI Based on the acute toxicity categories, the Worker Protection Standard (WPS) REIs for azoxystrobin , is 12

- hours. REIs may be reduced from 12 hours if the registrant submitted 95

- 3 package has been approved and certain criteria are met for both the technical material and the

different end

- use products in accordance with the Pesticide Registration (PR) Notice 95

- 3 [Reduction of WPS Interi m REIs for Certain Low Risk Pesticides] 16



### . Based only on the acute toxicity categories for azoxystrobin , HED recommends a 12

- hour REI.

16 Available: http://w ww2.epa.gov/pesticide

- registration/prn

- 95

- 3

- reduction

- worker

- protection

- standard

- wps

interim

- restricted

- entryPage 48 of 64



### Appendix A. Summary of Occupational and Residential Non

- cancer Algorithms

Residential Non

- cancer Handler Algorithm s

Turf, Gardens, Trees, Indoor Environments Inhalation Handler Exposure Algorithm Daily inhalation exposure (mg/day) for residential pesticide handlers, for a given formulation

application method combination, is estimated by multiplying the formulation

- application

method

- specific unit exposure by an estimate of the amount of active ingredient handled in a day, using the equation below:

E = UE * AR * A

where:

E = exposure (mg/day); UE = unit exposure (mg/lb ai); AR = application rate (e.g., lb ai/ft 2 

### , lb ai/gal); and A = area treated or amount handled (e.g., ft 2 

### /day, gal/day).

Treated Paints and Preservatives

Dermal and Inhalation Handler Exposure Algorithm Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers, f or a given

formulation

- application method combination, is estimated by multiplying the formulation

application method

- specific unit exposure by an estimate of the amount of active ingredient handled in a day, using the equation below:

E = UE * AR * N

whe re:

E = exposure (mg/day); UE = unit exposure (mg/lb ai); AR = application rate ( lb ai/gallon ); and

A = amount of paint used per day ( gallons /day).

Residential Handler Dose Calculations

Dermal and/or inhalation absorbed doses normalized to body weight are calculated as:

D = E *AF / BW

where:Page 49 of 64



### D = dose (mg/kg

- day); E = exposure (mg/day); AF = absorption factor (dermal and/or inhalation); and BW = body weight (kg).

Residential Non

- cancer Post

- application Algorithms

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 * ( F

M 

### * SA H 

### ) * (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 

### );

Fai hands 

### = fraction ai on hands compared to total surface residue from dermal transfer coefficient study (unitless); DE = dermal exposure (mg); and

SA H 

### = 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); andPage 50 of 64



### BW = body weight (kg).

Table A

- 1 : Turf (Physical Activities)

– Inputs for Residential Post

- application Hand

- to

- Mouth Exposure Algorithm

Notation Exposure Factor (units) Point Estimate(s)

Fai hands Fraction of ai on hands

from dermal transfer coefficient study (unitless) Liquid formulations 0.06

Granul e formulations 0.027

DE Dermal exposure (mg) Calculated

SA H Typical surface area of one hand (cm 2 ), children 1 <

2 years old 150

AR Application rate

(mass active ingredient per unit area) 0.99 lb ai/A (liquids) 0.95 lb ai/A (granules)

HR Residue available on the hands (mg/cm 2 ) Calculated via (DE * Fai hands )/SA H

F M 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 * SAM O 

### * (ET * N_Replen) * (1

- (1

- SE O 

### ) ( 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/μg);

SAM O 

### = 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);

SE O 

### = saliva extraction factor (i.e., mouthing removal efficiency); and Freq_OtM = number of object

- to

- mouth contact events per hour (events/hour).

andPage 51 of 64 

### OR = AR * F O 

### * CF2 * CF3

where:

OR = chemical residue loading on the object (μg/cm 2 

### ); AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F O 

### = fraction of residue available on the object (unitless); 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 

### ).

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 Object

- to

- Mouth Exposure
Algorithm

Notation Exposure Factor (units) Point Estimate(s)

AR Application rate (to turf)

(mass active ingredient per unit area) 0.99 lb ai/A (liquids)

0.95 lb ai/A (granules)

F O Fraction of AR as OR following application 1 0.01

SAM O Surface area of object mouthed (cm 2 /event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SE O 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" (μg/g); SIgR = ingestion rate of soil (mg/day); andPage 52 of 64



### CF1 = weight unit conversion factor (1 x 10

- 6 

### g/μg).

and

SRt = AR * FS * (1

- F D 

### ) t 

### * CF2 * CF3 * CF4

where:

SR t 

### = soil residue on day "t" (μg/g); AR = application rate (lbs ai/ft 2 

### or lb a i/acre); FS = fraction of ai available in uppermost cm of soil (fraction/cm);

F D 

### = 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);

C F3 = area unit conversion factor (1.08 x 10

- 3 

### ft 2 

### /cm 2 

### 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

- 3 : 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) 0.99 lb ai/A (liquids) 0.95 lb ai/A (granules)

FS Fraction of AR available in uppermost 1 cm of soil (unitless) 1

F D 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 Episodic Granul e Ingestion Exposure Algorithm

– Physical Activities on Turf Exposure from incidental ingestion of pesticide pellets or granules is calculated as follows:

E = GIgR* FD * CF1

where: E = exposure (mg/day);Page 53 of 64



### GIgR = ingestion rate of dry pesticide formulation (g/day); FD = fraction of ai in dry formulation (unitless); and CF1 = weight unit conversion factor (1,000 mg/g).

Dose, norma lized to body weight, are calculated as:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- X : Turf (Physical Activities)

– Inputs for Residential Post

- application Episodic Granul e Ingestion Exposure
Algorithm

Notation Exposure Factor (units) Point Estimate(s)

F D Fraction of active ingredient in dry formulation 0.3% ai

AR Application rate (lbs/A or lbs/1,000 ft 2 ) 0.95 lb ai/A (granules)

GIgR Granule ingestion rate per day (g/day) 1 0.3

BW Body Weight (kg) Children 1 < 2 years old 11

1 See discussion below on how this value may be adjusted if product specific information is available.



### Incidental Oral Exposure from Treated Vinyl Flooring

Residential Post

- application Non

- Cancer Exposure and Risk Equations

T he following equation s are used to calculate the surface residue (SR), hand residue (HR), exposure (E) and potential daily dose (PDD):

SR = D * VT * WF * AF

Where:

SR = Surface Residue (mg/cm 2 )

D = Density of vinyl flooring (gm/cm 3 )

VT = Vinyl flooring thickness (mm)

WF = Weight Fraction of a.i. in vinyl

AF = Availability Factor

HR = SR * F H

Where:

HR = Hand Residue (mg/cm 2 )Page 54 of 64

SR = Surface Residue (mg/cm 2 )

F H = Fraction ai transferred to hands

Exp = HR * F M * SA H * ET * NR * [1

– (1

- SE) FHtM / NR ]

Where: Exp = Exposure (mg/day)

HR = Hand Residue (mg/cm 2 )

F M = Fraction hand surface area mouthed per event

SA = Surface area of one hand (cm 2 )

ET = Ex posure time (hours/day)

NR = Number of replenishment intervals per hour

SE = Saliva extraction efficiency (%/100)

FHtM = Number of hand

- to

- mouth contacts per hour

BW = Body weight (kg)

PDD = Exp / BW

Where:

PDD = Potential daily dose (mg/kg/day) Exp = Exposure (mg/day)

BW = Body weight (kg)



### Assumptions used to Calculate SR and HR :

The following assumptions are for the calculation of the surface residue (SR) and hand residue (HR) values.

 D: The vinyl density is 1.3 g/cm 3 based on the density of polyvinyl chloride.

 VT: The vinyl flooring is assumed to be 3 mm thick.

 WF1: The fraction of ai in the vinyl flooring is 0.225% based on the labels.

 AF: It is assumed that 0.5% of the azoxystrobin ai impregnated within the vinyl matrix is available at the surface of the flooring which is subsequently available for human exposure (standard AD assumption)

 F H : Since azoxystrobin data are not available from which a chemical specific transfer factor could be estimated, exposures are calculated using a transfer factor of 1.0, which assumes that all of the available

residues are transferable.



### Assumptions used to Calculate Exposure

The following assumptions are for the use of the SHEDs model to calculate the exposure using the HR value calculated above. The SHEDs model assumptions are the same as those used by

HED and are the recommended values f rom Table 9

- 7 of the HED Residential SOPs.

 F M : The fraction hand surface area mouthed per event is 0.13.

 SA: The surface area of one toddler hand is 150 cm 2

.

 NR: The number of replenishment intervals per hour is 4.

 ET: The exposure time is 2 hours/day for hard surface flooring.

 SE: The saliva extraction fraction is 0.48.

 FHtM = The Number of hand

- to

- mouth contacts per hour is 20.

 BW: The body weight is 11.4 for children 1 <2 years old.Page 55 of 64



### Incidental Oral Exposure from Plastic Toys

T he following equation s are used to calculate the surface residue (SR), object residue (OR), exposure (E) and potential daily dose (PDD):

SR = WF x W x CF x F

SA1

Where:

SR = Surface residue (mg ai/cm 2 )

WF = Weight fraction of ai in toy (% ai/100)

W = Weight of toy (g)

CF = Conversion factor (1,000 mg/g)

AF = Fraction additive available at the surface of the toy (%/100)

SA1 = Surface area of toy (cm 2 )

OR = SR * F H

Where:

OR = Object Residue Loading (mg/cm 2 )

SR = Surface Residue (mg/cm 2 )

F O = Fraction available for transfer

Exp = OR * SAM * ET * NR * [1

– (1

- SE) FOtM / NR ]

Where: Exp = Exposure (mg/day)

OR = Object Residue (mg/cm 2 )

SAM = Surface area mouthed (cm 2 )

ET = Exposure time (hours/day)

NR = Number of replenishment intervals per hour

SE = Saliva extraction efficiency (%/100)

FHtM = Number of hand

- to

- mouth contacts per hour

BW = Body weight (kg)

PDD = Exp / BW

Where:

PDD = Potential daily dose (mg/kg/day) Exp = Exposure (mg/day)

BW = Body weight (kg)



### Assumptions used to Calculate SR and OR :

The following assumptions are for the calculation of the surface residue (SR) and object residue (OR) values.

 WF: The weight fraction is 0.00225 is based on the application rate of 0.225% a.i..

 W: The weight of a 500 cm 2 toy is 50 grams, which is based on data showing that a polyethylene highchair

sample has a density of 0.10 grams/cm 2 (AD standard assumption).

 AF: It was assumed that 0.5% of the azoxystrobin impregnated within the plastic matrix is available at the

surface of the toy which is subseque ntly available for human exposure (AD standard assumption).Page 56 of 64

 SA1: It is assumed that 500 cm 2 is a representative surface area of a plastic toy.



### Assumptions used to Calculate Exposure

The following assumptions are for the use of the SHEDs model to calc ulate the exposure using the HR value calculated above. The SHEDs model assumptions are the same as those used by

HED and are the recommended values f rom Table 9

- 7 of the HED Residential SOPs.

 SAM: The surface area mouthed per event is 10 cm 2

.

 NR: The number of replenishment intervals per hour is 4.

 ET: The exposure time is 4 hours/day for mouthing objects indoors.

 SE: The saliva extraction fraction is 0.48.

 FHtM: The number of object

- to

- mouth contacts per hour is 14.

 BW: The body weight is 11.4 for children 1 <2 years old.



### Occupational Non

- cancer Handler Algorithms

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

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

where:

E = e xposure (mg ai/day),

UE = u nit e xposure (μ g ai/ lb ai),

AR = m aximum application rate according to proposed label (lb ai A or lb ai/gal ), and

A = a rea treated or amount handled (e.g., A/day, gal/day)

.

The daily doses are calculated using the following formula:

ADD= E * AF

BW

where:

ADD = ave rage daily dose a bsorbed in a given scenario (mg ai/ kg / day),

E = e xposure (mg ai/day),

AF = absorption fa ctor (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 n 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 a re compared to the appropriate POD ( i.e.

, NOAEL) to assess the risk to occupational handlers for each

exposure route. All MOE values a re calculated using the following formula:Page 57 of 64 

### MOE= POD

ADD

where:

MOE = m argin of e xposure: value used by HED to represent risk estimates (unitless),

POD = p oint of d eparture (mg/kg/day)

, and

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day)

.Page 58 of 64



### Appendix B. TTR and DFR Data Requirements

Turf Transferable Residue (TTR): In accordance with 40CFR158, 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 2 012 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 r ate available for transfer after a turf application (F AR 

### ). 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 F AR 

### 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 F AR 

### 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 azoxystrobin

, EPA is using the default value s for liquid and granular products

. Although there may be a small degree of uncertainty in the use of the default TTR value for azoxystrobin (i.e., there is a small

chance that the F AR 

### value may exceed the applicable default value ), it is likely that the heal th

protective aspects of EPA’s residential 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 F AR 

### 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 ) r esidues 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 coeffic ient 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 spe cifically 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 for residential turf using default

TTR values fo r azoxystrobin is minimal in comparison to the level of concern (i.e., the calculated MOE is greater than 10 times higher than the level of concern, MOE = 2,300 compared to the

LOC of 100 ); EPA is waiving the 40CFR TTR data requirement. In this instance, it is unlikely

that chemical

- specific TTR data would be needed to further refine exposure assessments orPage 59 of 64



### would add appreciably to our general understanding of the availability of turf trans ferable pesticide residues.

An occupational post

- application dermal assessment was not completed for azoxystrobin on sod farms because no dermal hazard was identified in the toxicity database. Therefore, a TTR study on turf is not required at this time

.

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

- specific DFR data, EPA uses default

values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure

Assessment includes an analysis of a number of DF R 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 Agricul tural 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 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 ing redient; 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 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, high

- end default value. Because no dermal hazard was identified for azoxystrobin, a residential post

- application assessment on ornamentals and an

oc cupational post

- application assessment on agricultural crops were not conducted; therefore a DFR study is not required for azoxystrobin at this time.Page 60 of 64



### Appendix C

. Exposure Inputs and Inhalation Doses for Registered Conventional Uses of Azoxystrobin.

Table C .1 . Occupational Handler Non

- Cancer Exposure Inputs and Inhalation Doses for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Area

Treated/Amount

Handed Inhalation Unit Exposure (ug/lb ai) Inhalation Dose (mg/kg/day)

Baseline PF5 PF10 EC Baseline PF5 PF10 EC

Mixer/Loader

Mixing/Loading Dry

Flowables for Aerial Application Nursery Ornamentals 60 Acres 8.96 1.795 0.896 0.24 0.00168 0.000336 0.000168 0.000045

Orchards/Vineyards 350 Acres 8.96 1.795 0.896 0.24 0.0098 0.00196 0.00098 0.000263

Sod 350 Acres 8.96 1.795 0.896 0.24 0.0373 0.00745 0.00373 0.000998

Field Crop, Typical 350 Acres 8.96 1.795 0.896 0.24 0.0129 0.00259 0.00129 0.000346

Field Crop, High Acreage 1200 Acres 8.96 1.795 0.896 0.24 0.0538 0.0108 0.00538 0.00144

Mixing/Loading Dry

Flowables for Airblast Application Nursery Ornamentals 20 Acres 8.96 1.795 0.896 0.24 0.00056 0.000112 0.000056 0.000015

Orchards/Vineyards 40 Acres 8.96 1.795 0.896 0.24 0.00112 0.000224 0.000112 0.000030

Mixing/Loading Dry Flowables for Chemigation Application Orchards/Vineyards 350 Acres 8.96 1.795 0.896 0.24 0.0098 0.00196 0.00098 0.000263

Sod 350 Acres 8.96 1.795 0.896 0.24 0.0373 0.00745 0.00373 0.000998

Field Crop, Typical 350 Acres 8.96 1.795 0.896 0.24 0.0129 0.00259 0.00129 0.000346

Field Crop, High Acreage 350 Acres 8.96 1.795 0.896 0.24 0.0156 0.00314 0.00156 0.00042

Nursery Ornamentals 60 Acres 8.96 1.795 0.896 0.24 0.00168 0.000336 0.000168 0.000045

Mixing/Loading Dry

Flowables for Groundboom Application Golf course (tees and greens) 5 Acres 8.96 1.795 0.896 0.24 0.000533 0.000106 0.0000533 0.0000143

Golf course (fairways, tees, and

greens) 40 Acres 8.96 1.795 0.896 0.24 0.00425 0.000851 0.000425 0.000114

Field

- Grown Ornamental Crops 40 Acres 8.96 1.795 0.896 0.24 0.00112 0.000224 0.000112 0.000030

Nursery Ornamentals 60 Acres 8.96 1.795 0.896 0.24 0.00168 0.000336 0.000168 0.000045

Sod 80 Acres 8.96 1.795 0.896 0.24 0.00851 0.0017 0.000851 0.000228

Orchards/Vineyards 40 Acres 8.96 1.795 0.896 0.24 0.00112 0.000224 0.000112 0.00003

Field Crop, Typical 80 Acres 8.96 1.795 0.896 0.24 0.00296 0.000591 0.000296 0.0000793

Field Crop, High Acreage 200 Acres 8.96 1.795 0.896 0.24 0.00896 0.00179 0.000896 0.00024

Mixing/Loading Granul e s for Aerial Application Sod 350 Acres 1.7 0.34 0.17 0.083 0.00706 0.00141 0.000706 0.000345

Mixing/Loading Granul e s for

Tractor

- Drawn Spreader Applications Golf Course (Fairways, Tees, Greens) 40 Acres 1.7 0.34 0.17 0.083 0.000808 0.000161 0.00008088 0.0000394

Golf Course (Tees and Greens) 5 Acres 1.7 0.34 0.17 0.083 0.000101 0.0000203 0.0000101 0.00000493

Sod 80 Acres 1.7 0.34 0.17 0.083 0.00161 0.000323 0.000161 0.00007895

Mixing/Loading Liquids for Aerial Application Nursery Ornamentals 60 Acres 0.219 0.0438 0.0219 0.083 0.0000411 0.00000821 0.00000411 0.0000156

Orchards/Vineyards 350 Acres 0.219 0.0438 0.0219 0.083 0.00024 0.0000479 0.000024 0.0000908Page 61 of 64

Table C .1 . Occupational Handler Non

- Cancer Exposure Inputs and Inhalation Doses for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Area

Treated/Amount

Handed Inhalation Unit Exposure (ug/lb ai) Inhalation Dose (mg/kg/day)

Baseline PF5 PF10 EC Baseline PF5 PF10 EC

Sod 350 Acres 0.219 0.0438 0.0219 0.083 0.000949 0.00019 0.0000949 0.00036

Field Crop, Typical 350 Acres 0.219 0.0438 0.0219 0.083 0.000316 0.0000633 0.0000316 0.00012

Field Crop, High Acreage 1200 Acres 0.219 0.0438 0.0219 0.083 0.00131 0.000263 0.000131 0.000498

Mixing/Loading Liquids for Airblast Application Nursery Ornamentals 20 Acres 0.219 0.0438 0.0219 0.083 0.0000138 0.00000274 0.00000138 0.00000519

Orchards/Vineyards 40 Acres 0.219 0.0438 0.0219 0.083 0.0000274 0.00000548 0.00000274 0.0000104

Mixing/Loading Liquids for Chemigation Application Orchards/Vineyards 350 Acres 0.219 0.0438 0.0219 0.083 0.00024 0.0000479 0.000024 0.0000908

Sod 350 Acres 0.219 0.0438 0.0219 0.083 0.000949 0.00019 0.0000949 0.00036

Field Crop, Typical 350 Acres 0.219 0.0438 0.0219 0.083 0.000316 0.0000633 0.0000316 0.00012

Field Crop, High Acreage 350 Acres 0.219 0.0438 0.0219 0.083 0.000384 0.0000766 0.0000384 0.000145

Greenhouse Ornamentals 60 Acres 0.219 0.0438 0.0219 0.083 0.0000428 0.00000854 0.00000428 0.0000161

Nursery Ornamentals 60 Acres 0.219 0.0438 0.0219 0.083 0.0000411 0.00000821 0.00000411 0.0000156

Mixing/Loading Liquids for Groundboom Application Golf Course (Tees and Greens) 5 Acres 0.219 0.0438 0.0219 0.083 0.0000135 0.00000271 0.00000135 0.00000514

Golf Course (Fairways, Tees,

Greens) 40 Acres 0.219 0.0438 0.0219 0.083 0.000108 0.0000216 0.0000108 0.0000411

Field

- Grown Ornamentals 40 Acres 0.219 0.0438 0.0219 0.083 0.0000274 0.00000548 0.00000274 0.0000104

Nursery Ornamentals 60 Acres 0.219 0.0438 0.0219 0.083 0.0000411 0.00000821 0.00000411 0.0000156

Greenhouse Ornamentals 60 Acres 0.219 0.0438 0.0219 0.083 0.0000428 0.00000854 0.00000428 0.0000161

Sod 80 Acres 0.219 0.0438 0.0219 0.083 0.000216 0.0000434 0.0000216 0.0000821

Orchards/Vineyards 40 Acres 0.219 0.0438 0.0219 0.083 0.0000274 0.00000548 0.00000274 0.0000104

Field Crop, Typical 80 Acres 0.219 0.0438 0.0219 0.083 0.0000723 0.0000145 0.00000723 0.0000274

Field Crop, High Acreage 200 Acres 0.219 0.0438 0.0219 0.083 0.000219 0.0000438 0.0000219 0.000083

Applicator

Applying Sprays with Aerial Application Equipment Nursery Ornamentals 60 Acres

N/A 0.0049

N/A 0.000000919

Orchards/Vineyards 350 Acres 0.0049 0.00000536

Sod 350 Acres 0.0049 0.0000213

Field Crop, Typical 350 Acres 0.0049 0.00000708

Field Crop, High Acreage 1200 Acres 0.0049 0.0000294

Applying Sprays with Airblast Application Equipment Nursery Ornamentals 20 Acres 4.71 0.942 0.471 0.068 0.000295 0.0000589 0.0000295 0.00000425

Orchards/Vineyards 40 Acres 4.71 0.942 0.471 0.068 0.000589 0.000118 0.0000589 0.0000085

Applying Sprays with Golf Course (Tees and Greens) 5 Acres 0.34 0.068 0.034 0.043 0.000021 0.00000421 0.0000021 0.00000266Page 62 of 64

Table C .1 . Occupational Handler Non

- Cancer Exposure Inputs and Inhalation Doses for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Area

Treated/Amount

Handed Inhalation Unit Exposure (ug/lb ai) Inhalation Dose (mg/kg/day)

Baseline PF5 PF10 EC Baseline PF5 PF10 EC
Groundboom Application Equipment Golf Course (Fairways, Tees, Greens) 40 Acres 0.34 0.068 0.034 0.043 0.000169 0.0000336 0.0000169 0.0000213

Field

- Grown Ornamentals 40 Acres 0.34 0.068 0.034 0.043 0.0000425 0.0000085 0.00000425 0.00000538

Nursery Ornamentals 60 Acres 0.34 0.068 0.034 0.043 0.0000638 0.0000128 0.00000638 0.00000806

Greenhouse Ornamentals 60 Acres 0.34 0.068 0.034 0.043 0.0000663 0.0000133 0.00000663 0.00000839

Sod 80 Acres 0.34 0.068 0.034 0.043 0.000336 0.0000674 0.0000336 0.0000426

Orchards/Vineyards 40 Acres 0.34 0.068 0.034 0.043 0.0000425 0.0000085 0.00000425 0.00000538

Field Crop, Typical 80 Acres 0.34 0.068 0.034 0.043 0.000112 0.0000225 0.0000112 0.0000143

Field Crop, High Acreage 200 Acres 0.34 0.068 0.034 0.043 0.00034 0.000068 0.000034 0.000043

Applying Granul e s with Aerial Application Equipment Sod 350 Acres N/A 1.3 N/A 0.0054

Applying Granul e s with a

Tractor

- Drawn Spreader Golf Course (Fairways, Tees, Greens) 40 Acres 1.2 0.24 0.12 0.22 0.00057 0.000114 0.000057 0.000105

Golf Course (Tees and Greens) 5 Acres 1.2 0.24 0.12 0.22 0.0000713 0.0000143 0.00000713 0.0000131

Sod 80 Acres 1.2 0.24 0.12 0.22 0.00114 0.000228 0.000114 0.000209

Flagger

Flagging for Aerial Applications (Sprays) Sod 350 Acres 0.35 0.07 0.035 N/A 0.00145 0.000291 0.000145 N/A

Flagging for Aerial Applications (Granul e s) Sod 350 Acres 0.15 0.03 0.015 N/A 0.000624 0.000125 0.0000624 N/A

Mixer/Loader/Applicator

Mixing/Loading/Applying Dry Flowable or Liquid Formulations with Backpack

Sprayer Orchard/Vineyard, Christmas Tree

Farm, Nursery Ornamentals (Ground Directed) 40 gal 2.58 0.516 0.258 N/A 0.0000323 0.00000645 0.00000323 N/A

Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals (Broadcast) 40 gal 69.1 13.8 6.9

N/A 0.000864 0.000173 0.0000863

N/A Landscaping (Plants, Flowers, Trees, Turf) (Broadcast Treatment) 40 gal 69.1 13.8 6.9 0.00411 0.000821 0.00041

Landscaping Turf (Spot Treatment) 40 gal 2.58 0.516 0.258 0.000154 0.0000308 0.0000154

Mixing/Loading/Applying Dry Flowable or Liquid Formulations with a Manually

Pressurized Handwand Christmas Tree Farm, Nursery Ornamentals (Broadcast) 40 gal 30 6 3

N/A 0.000375 0.000075 0.0000375

N/A Landscaping (Plants, Flowers, Trees, Turf) 40 gal 30 6 3 0.00179 0.000358 0.000179Page 63 of 64

Table C .1 . Occupational Handler Non

- Cancer Exposure Inputs and Inhalation Doses for the Registered Conventional Uses of Azoxystrobin 1

.

Exposure Scenario Crop or Target 1 Area

Treated/Amount

Handed Inhalation Unit Exposure (ug/lb ai) Inhalation Dose (mg/kg/day)

Baseline PF5 PF10 EC Baseline PF5 PF10 EC

Mixing/Loading/Applying Dry Flowable Formulations with a Mechanically

Pressurized Handwand Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals 1000 gal 8.68 1.74 0.87

N/A 0.00271 0.000544 0.000273 N/A

Golf Course (Tees, Greens, Fairways) 5 Acres 42 8.4 4.2 0.0025 0.000499 0.00025 N/A

Landscaping (Trees, Shrubs,

Bushes) 1000 gal 8.68 1.74 0.87 0.0129 0.00259 0.0013 N/A

Field Crop, Typical 1000 gal 8.68 1.74 0.87 0.00358 0.000718 0.000359 N/A

Mixing/Loading/Applying Liquids with a Manually

Pressurized Handwand Greenhouse Ornamentals 40 gal 30 6 3 N/A 0.00039 0.000078 0.000039 N/A

Mixing/Loading/Applying Liquids with a Mechanically

Pressurized Handwand Orchard/Vineyard, Christmas Tree Farm, Nursery Ornamentals 1000 gal 8.68 1.74 0.87

N/A 0.00271 0.000544 0.000273 N/A

Greenhouse Ornamentals 1000 gal 120 24 12 0.0255 0.0051 0.00255 N/A

Golf Course (Tees, Greens, Fairways), Landscaping Turf, 5 Acres 1.9 0.38 0.19 0.00000119 0.00000023

8 0.000000119 N/A

Landscaping (Trees, Shrubs Bushes) 1000 gal 8.68 1.74 0.87 0.0013 0.0013 0.0013 N/A

Field Crop, Typical 1000 gal 8.68 1.74 0.87 0.00358 0.000718 0.000359 N/A

Loading/Applying Granul e Formulations with a Rotary Spreader Golf Course (Fairways, Tees, Greens) 5 Acres 10 2 1 N/A 0.000594 0.000119 0.0000594 N/A

Table C .2. Occupational Handler Inputs and Inhalation Doses for the Registered Post

- Harvest Uses of Azoxystrobin.

Exposure Scenario Crop or Target Amount ai

Handled Inhalation Unit Exposure (μg/lb ai) Inhalation Dose (mg/kg/day) 3

gal solution Baseline 5 PF5 PF10 Baseline 5 PF5 PF10

Mixing/Loading For Post

- Harvest Treatment in a Closed Automated System Citrus 25,000 0.083 N/A N/A 0.0039 N/A N/A

Potatoes 25,000 0.083 N/A N/A 0.00000013 N/A N/A

Bananas 25,000 0.083 N/A N/A 0.0000089 N/A N/A

Mixing/Loading Dry Flowable Formulations in an Automated System Bananas 25,000 8.96 1.792 0.896 0.0009 6 0.00019 0.0009 6

Mixing/Loading Liquids in an Automated

System Citrus 25,000 0.219 0.0438 0.0219 0.0103 0.002 1 0.00103Page 64 of 64

Table C .2. Occupational Handler Inputs and Inhalation Doses for the Registered Post

- Harvest Uses of Azoxystrobin.

Exposure Scenario Crop or Target Amount ai

Handled Inhalation Unit Exposure (μg/lb ai) Inhalation Dose (mg/kg/day) 3

gal solution Baseline 5 PF5 PF10 Baseline 5 PF5 PF10

Bananas 2 25,000 0.219 0.0438 0.0219 0.00002 4 0.0000047 0.0000024

Applying Direct Post

- Harvest Sprays with a Mechanically Pressurized Handgun Citrus 25,000 3.9 0.78 0.39 0.18 0.03 7 0.018

Bananas 2 25,000 3.9 0.78 0.39 0.0004 2 0.00008 4 0.00004 2

1 Based on registered labels (Reg. No. 89442

- 21, 100

- 1098, 100

- 1093).

2 Based on ExpoSAC Post

- Harvest Policy.

3 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/ gal) × Are a Treated or Amount Handled Daily (gal/day) ÷ BW (80 kg).

4 Inhalation MOE = Inhalation NOAEL (mg/kg/day) ÷ Inhalation Dose (mg/kg/day). Shaded MOEs indicated MOEs of concern (LOC = 300). 5 For closed automated system, baseline exposures represent engineering control protection. “ Baseline” for all other scenarios represents no respirator.