### Page 3 of 18 Table of Contents

1.0 Executive Summary

................................ ................................ ................................ ............. 4

2.0 Summary of Conclusions/Data Deficiencies

................................ ................................ ....... 5

3.0 Hazard Characterization

................................ ................................ ................................ ....... 5

4.0 Use Profile

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

................................ ................................ ............ 9
5.1 Spray Drift

................................ ................................ ................................ ........................ 9
5.2 Residential By stander Post

- Application Inhalation Exposure

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

6.0 Occupational Exposure and Risk Estimates

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

6.1 Occupational Handler Exposure/Risk Estimates

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

6.2 Occupational Post

- application Exposure/Risk Estimates

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

6.2.1 Occupational Post

- application Inhalation Exposure/Risk Estimates

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

6.2.2 Occupational Post

- application Dermal Exposure/Risk Estimates

.......................... 18

### Page 4 of 18

1.0 Executive Summary

Fenpyrazamine is a new active ingredient fungicide that is proposed for reg istratio n in the United

States. Fenpyrazamine is a fungicide to be used for control of gray mold (Botrytis) in berries and small fruits, almonds, lettuce and ornamentals. It is not systemic but there is some translocation in plants. Fenpyrazamine shows its fungi cidal activity through inhibition of germ tube elongation and mycelium elongation. However, the exact biochemical mechanism of fungicidal activity is not currently known.

Valent U.S.A. Corporation is proposing the US registration of fenpyrazamine for uses in almond, small fruit climbing subgroup 13

- 07F, head and leaf lettuce, low growing berry subgroup 13

- 07G, and ornamentals. In addition, IR

- 4 is proposing the use of fenpyrazamine on bushberry subgroup 13

- 07B, caneberry subgroup 13

- 07A, ginseng, and pistachio. The product, V

- 10135 4 SC Fungicide, is a suspension concentrate formulation containing 43.6% active ingredient fenpyrazamine (4 lbs a.i. per gallon)

. Th ere are no proposed residential uses; therefore, only occupational exposure is assess ed in this memorandum.

Fenpyrazamine has a low order of acute toxicity and is classified as Toxicity Category III for the oral, dermal and inhalation routes of exposure. It produces minimal eye irritation (Toxicity Category IV) and is not a dermal irrita nt (Toxicity Category IV). It is a dermal sensitizer.

In the dermal toxicity study there is no evidence of enhance d susceptibility of the young and all critical effects of concern were evaluated; a dermal hazard was not identified and therefore no

quan tification of risk is required. The short

- and intermediate

- term inhalation endpoints were
derived from the developmental rabbit study in which the maternal LOAEL was 50 mg/kg/day
based on decreased body weight and food consumption (NOAEL = 30 mg/kg/day). The developmental rabbit NOAEL of 30 mg/kg/day is supported by NOAELs identified in the 2

- generation reproduction study and the 90

- day dog study

.

Occupational handler inhalation MOEs are greater than the level of concern of 100 for all
scenarios assessed associated with the proposed uses and are therefore not of concern. No quantification of dermal post

- application risk is required as no dermal hazard was identified.

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

- cancer post

- application inhalation
exposure assessment is not needed for fenpyrazamine at this time. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative post

- application inhalation exposure assessment for fenpyrazamine

.

The proposed restricted

- entry interval (REI) for fenpyrazamine is 12 hou rs; based on the acute toxicity of the chemical, this REI meets the Worker Protection Standard (WPS) requirement.

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 includ e studies from

PHE D 1.1 ; the AHETF database; and the ORETF database , are (1) subject to ethics review

### Page 5 of 18

pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable

ethics r equirements. For certain studies , the ethics review may have included review by the Human Studies Review Board. Descriptions of data sources

, as well as guidance on their use

, can be found at http://www.epa.gov/pesticides/science/handler

- exposure

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

- app

- exposure

- data.html

.

2.0 Summary of Conclusions/Data Deficiencies

There are no occupational/residential risk estimates of concern associated with the proposed new
uses of fenpyrazamine

. There are no data gaps in the exposure database . A s quantification of
dermal risk is n ot required for fenpyrazamine, a dislodgeable foliar residue ( DFR ) study is not required for fenpyrazamine at this time. Additionally, a s there are no proposed uses on turf, a turf transferable residue ( TTR ) study is no t required for fenpyrazamine at this time.

3 .0 Hazard Characterization

Acute Toxicity

Fenpyrazamine has a low order of acute toxicity and is classified as Toxicity Category III for the oral, dermal and inhalation routes of exposure. It produces minimal eye irritation (Toxicity Category IV) and is not a dermal irritant (Toxicity Category IV ). It is a dermal sensitizer.

Table 3.1.1. Acute Toxicity Profile

– Fenpyrazamine Technical

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

870.1100 Acute oral [rat] 48400106 LD 50 > 2000 mg/kg (♀) III

870.1200 Acute dermal [rat] 48400109 LD 50 > 2000 mg/kg (♂,♀) III

870.1300 Acute inhalation [rat] 48400111 LC 50 > 0.61 mg/L (♂, ♀) III

870.2400 Acute eye irritation [rabbit] 48400112 Minimally irritating IV

870.2500 Acute dermal irritation [rabbit] 48400115 Not irritating IV

870.2600 Skin sensitization [Guinea pig] 48400117 Dermal

sensitizer N/A



### Toxicological PODs Used for Risk Assessment
ToxSAC memo; FENPYRAZAMINE

- Summary of Toxicology Science Advisory Council (ToxSAC) Meeting of August 2, 2012; Jessica Kidwell; September 26, 2012.



### Short

- and Intermediate

- Term Incidental Ora l Endpoint : This endpoint was not established since there are no residential uses being proposed which would raise the concern for incidental
oral exposure of children.

### Page 6 of 18

Short

- (1

- 30 days), Intermediate

- (1

- 6 months) and Long

- Term Dermal Endpoints: An acceptable/guideline dermal toxicity study is available. No effects were observed at the limit dose (1000 mg/kg/day). Since there is no evidence of enhance susceptibility of the young and all critical effects of concern were evaluated in the dermal study, a dermal hazard was not identified and therefore no quantification of risk is required.

Short

- (1

- 30 days) and Intermediate

- (1

- 6 months) Term Inhalation Endpoints: The s hort

- and
intermediate

- term inhalation endpoints were derived from the developmental rabbit study in
which the maternal LOAEL was 50 mg/kg/day based on decreased body weight and food consumption (NOAEL = 30 mg/kg/day). The developmental rabbit NOAEL of 30 mg/kg/day is supported by NOAELs identified in the 2

- generation reproduction study and the 90

- day dog study

.

Table 3.1.2. Summary of Toxicological Doses and Endpoints for Fenpyrazamine for Use in Occupational Human
Health Risk Assessments

Exposure/ Scenario Point of Departure Uncertainty

Factors Level of

Concern for
Risk Assessment Study and Toxicological
Effects

Dermal Short

- , Intermediate

- , and Long

- Term (1

- 30 days

and 1

- 6 months) No hazard identified. No quantification required

.

Inhalation Short

- and

Intermediate

- Term (1

- 30 days,

and 1

- 6 months) NOAEL =
30 mg/kg/day UF A = 10 x

UF H = 10x Occupational

LOC for MOE =

100 Developmental Toxicity

Study

- Rabbit LOAEL = 50 mg/kg/day based on decreased body weight and food consumption

Cancer (oral, dermal, inhalation) Based on the lack evidence of carcinogenicity in mice and rats, in accordance with the Agency's 2005 Guidelines for Cancer Risk Assessment, fenpyrazamine is classified a "Not Likely to be Carcinogenic to Humans". 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 ob served 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 (intraspecies). UF L = use of a LOAEL to extrapolate a

NOAEL. UF S = use of a short

- term study for long

- term risk assessment. UF DB = to account for the absence of key data (i.e., lack of a critical study). MOE = margin of exposure. LOC = level of concern. N/A = not ap plicable.



### Inhalation absorption Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure.

Body Weight The standard body weight for the general population (80 kg) was used for all exposure scenarios covered in this risk assessment since the endpoints selected were not developmental and/or fetal
effects.

### Page 7 of 18

4 .0 Use Profile

Table 4 .1. 1. Summary of Directions for Use of Fenpyrazamine

.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per
Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and Limitations

Almond

Aerial, Chemigation

, Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 8

- 12 fl

oz ( 0.25

- 0.375 lb ai/A) 2 Sequential Applications,

3 Applications per Season 36 fl oz

(1.125 lb ai/A) 21 For Aer ial Application : use a

minimum of 20 gal of water / acre.

For G round A pplication: us e a minimum of 100 gal of water/ acre.

Immediate Rotational Interval

For Brown Rot and Blossom Blight: Begin applications at pink bud (approx. 5% of bloom). If
conditions are favorable for disease development, make additional applications at full

bloom and at petal fall. For Green
Fruit Rot/Jacket Rot: Begin applications prior to disease development . Generally, a single application at full bloom is most

effective.

Grape (Small Fruit Vine Climbing Subgroup, Except Fuzzy Kiwifruit , 13

- 07F )

Aerial, Chemigation

, Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz ( 0.375

- 0.5 lb ai/A) 2 Sequential Applications,

3 Applications per Season 48 fl oz (1.5

lb ai/A) 3 For Aerial Application: use a

minimum of 20 gal of water / acre. For Ground Application: us e a minimum of 100 gal of water/ acre.

Immediate Rotational Interval
For Botrytis Bunch Rot : First application at early bloom. Second application at pre

- bunch closure. Third application at
veraison. Up to 3 days prior to

harvest

. Lettuce (Head and Leaf)

Aerial, Chemigation

, Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz ( 0.375

- 0.5 lb ai/A) 2 Sequential Applications,

3 Applications per Season 48 fl oz (1.5

lb ai/A) 14 For Aerial Application: use a

minimum of 5 gal of water / acre. For Ground Application: use a minimum of 20 gal of water / acre.

Immediate Rotational Interval
For Lettuce Drop and Gray Mold : Apply from planting to just after thinning and again 10 days later.
If conditions still favor disease development, a third application

should be made 7

- 10 days after the

second spray.

### Page 8 of 18

Table 4 .1. 1. Summary of Directions for Use of Fenpyrazamine

.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per
Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and Limitations

Strawberry (Low Growing Berry Subgroup 13

- 07G )

Aerial, Chemigation

, Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz ( 0.375

- 0.5 lb ai/A) 2 Sequential Applications,

4 Applications per Season 64 fl oz (2 lb

ai/A) 0 For Aerial Application: use a

minimum of 5 gal of water / acre. For Ground Application: use a minimum of 20 gal of water / a cre.

Immediate Rotational Interval
For Gray Mold : First application at early bloom and continue on a 7 to 14 day interval until last harvest.

Ornamentals (Greenhouse and Nursery)

Aerial, Ground, Chemigation

, Handheld V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz/100 gal ( 0.375

- 0.5 lb
ai/100 gal) 2 Sequential Applications,

3 Applications per Growing Cycle 48 oz/A per

growing cycle N/A For chemigation to ornamental sites apply this product only through microirrigation, overhead

ir rigation or motorized calibrated irrigation equipment.
For Botrytis Blight and Gray

Mold : Apply before disease development. Reapply after 7 to

14 days.
100 gal of spray solution will treat approximately 20,000 sq ft of area. Apply the spray solution to all plant surfaces and to the point of

run

- off.

Bushberry (Subgroup 13

- 07B)

Aerial, Chemigation,
Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz ( 0.375

- 0.5 lb ai/A) 2 Sequential Applications,

3 Applications

per Season 48 fl oz (1.5

lb ai/A) 0 For Aerial Application: use a

minimum of 5 gal of water / acre.
For Ground Application: use a minimum of 20 gal of water / acre.

Immediate Rotational Interval
For Gray Mold and Mummy Berry : Apply when conditions
favor diseas e development and prior to infection. Continue applications on a 7 to 14

- day

interval.

Caneberry (Subgroup 13

- 07A)

Aerial, Chemigation,
Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz ( 0.375

- 0.5 lb ai/A) 2 Sequential Applications,

3 Applications per Season 48 fl oz (1.5

lb ai/A) 0 For Aerial Application: use a

minimum of 5 gal of water / acre.
For Ground Application: use a minimum of 20 gal of water / acre.

Immediate Rotational Interval
For Gray Mold : First application at early bloom and continue on a 7 to 14 day interval until last harvest.

### Page 9 of 18

Table 4 .1. 1. Summary of Directions for Use of Fenpyrazamine

.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per
Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and Limitations

Ginseng

Ground

, Chemigation

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12

- 16 fl

oz ( 0.375

- 0.5 lb ai/A) 2 Sequential Applications,

4 Applications per Season 64 fl oz (2 lb

ai/A) 2 For Ground Application: use a

minimum of 50 gal of water / acre.

Immediate Rotational Interval
For Gray Mold Blight : Begin applications when conditions favor disease development (cool, wet weather and high hum idity). Repeat at 7

- to 14

- day intervals if favorable conditions persist.

Pistachio

Aerial, Chemigation,
Ground

Foliar Spray V

- 10135 4

SC Fungicide
Suspension

Concentrate
4 lb ai/gal 12 fl oz

(0.375 lb ai/A) 2 Sequential Applications,

3 Applications per Season 36 fl oz

(1.125 lb ai/A) 21 For Aerial Application: use a

minimum of 20 gal of water / acre.
For Ground Application: use a minimum of 100 gal of water/acre.

Immediate Rotational Interval

For Blossom, Shoot and Fruit Blight : Begin applications at 5 to
10% bloom. If conditions are favorable for disease development, make additional applications at full bloom then every 7 to 10 days or
when conditions favor disease development.



### 5 .0 Residential Exposure and Risk Estimates

There are no proposed residential uses of fenpyrazamine at this time

.

5

. 1 Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from the ground application metho d employed for fenpyrazamine

. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Agency’s Spray Drift website for more information at http://www.epa.gov/opp00001/factsheets/spraydrift.htm ). On a chemical by chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling. The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appr opriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods.

### Page 10 of 18

After the policy is in place, the Agency may impose further refinements in spray drift
management practices to reduce off

- target drift with specific products with significant risk
estimates associated with drift.

Although a quantitative residential post

- application inhalation exposure assessment was not performed as a result of pesticide drift from n eighboring treated agricultural fields, an inhalation exposure assessment was performed for flaggers. This exposure scenario is representative of a worse case inhalation (drift) exposure and may be considered protective of most outdoor agricultural and co mmercial post

- application inhalation exposure scenarios

.

5

. 2 Residential Bystander Post

- Application Inhalation Exposure

Based on the Agency's current practices, a quantitative post

- application inhalation exposure assessment was not performed for fenpyrazamine at this time primarily because of the low acute inhalation toxicity ( Toxicity Category III ) and low vapor pressure ( 2.17x10 - 10 

### mmHg at 25 oC )

. However, volatilization of pesticides may be a source of post

- application inhalation exposure to

i ndividuals nearby pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and receiv ed the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate post

application inhalation exposure into the Agency's risk assessments. If new policies or procedures are developed, the Agency may revisit the need for a quantitative post

- application inhalation exposure assessment for fenpyrazamine

.

6 .0 Occupational Exposure and Risk Estimates

6 .1 Occupational Handler Exposure/Risk Estimates

HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each t ask. 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 occupat ional handlers is based on the following scenarios:

Mixing/Loading suspension concentrate for ground, air, and chemigation application; Applying spray by aerial and ground equipment; Flagging in support of aerial application; and

### Page 11 of 18

Mixing/Loading/Applying s uspension concentrate for handheld equipment application.

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 : Application rates on the labels are as follows: The maximum single application rate for almonds and pistachio is 0.375 lb ai/acre. The maximum single application rate for grapes, lettuce, low growing berry subgroup, bushberry subgroup, caneberry subgroup, and ginseng is 0.5 lb ai/acre. The application rate for ornamentals grown in greenhouse and nursery is 0.5 lb ai/100 gallons. Di rections on the label indicate that for ornamental applications, 100 gallons of spray solution will treat approximately 20,000 ft 2 

### of area. At a rate of 0.5 lb/100 gallons, this equates to an approximate application rate of 1.09 lb ai/acre for ornamentals grown in greenhouses and nursery.

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

- specific data,
include PHED 1.1 , the AHETF database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant

- submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting handler exposure that are used in this assessment, known as “unit exposures”, are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( http://www.epa.gov/opp00001/science/handler

- exposure

table.pdf ), which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found a t http://www.epa.gov/pesticides/science/handler

- exposure

- data.html

.

Estimates of inhalation exposure were calculated. Results are presented for “baseline,” defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no
prote ctive gloves, and no respirator . The product label direct s mixers, loaders, applicators and
other handlers to wear long

- sleeved shirt and long pants, chemical

- resistant gloves, socks and
shoes

.

Area Treated or Amount Handled :

Area treated or amount handled includes:

Aerial equipment: 350 acres for field and orchard crops, 60 acres for nursery crops Airblast: 40 acres for orchard crops, 20 acres fo r nursery crops Chemigation: 350 acres for orchard and field crops, 60 acres for nursery and greenhouse

crops Groundboom equipment: 80 acres for field crops, 60 acres for nursery and greenhouse crops, and 40 acres for field

- grown ornamentals

### Page 12 of 18

Flagger: 350 a cres for orchard and field crops, 60 acres for nursery crops

Body Weight: The standard body weight for the general population (80 kg) was used for all exposure scenarios covered in this risk assessment since the endpoints selected were not developmental and/or fetal
effects.

Absorption factors: Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure.

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

- term and exposures 30 days to six months

as intermediate

- term. Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggering the use of the pesticide, and the cultural practices surrounding that use site. For most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one

- month time frame; however, there may be a large agribusines s 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 fenpyrazamine , based on the proposed use, short

- and intermediate

- term exposures are anticip ated for the following reasons: (1 ) 3 to 4 applications of the fungicide can be made to

crops per season, and (2) commercial applicators could apply and re

- apply the fungicide to multiple crops over a period of weeks (e.g., completing multiple application s for multiple clients for multiple crops within a region).

Mitigation/Personal Protective Equipment: Occupational handler exposure assessments are completed by HED using different levels of risk mitigation. Typically, HED uses a tiered approach. The lowest tier is designed as the baseline exposure scenario (i.e.

, long

- sleeve shirt, long pants, shoes, socks, no respirator). If risk estimates are of concern at baseline attire, then increasing levels of PPE (i.e.

, gloves, respirators) are evaluated. I f risk estimates remain a concern with maximum PPE, then engineering controls (i.e.

, enclosed cabs or cockpits, water

soluble packaging, and closed mixing/loading systems) are evaluated. This approach is used to ensure that the lowest level of risk mitiga tion that provides adequate protection is selected, since the addition of PPE and engineering controls involves an additional expense to the user and (in the case of PPE) also involves an additional burden to the user due to decreased comfort and dexterity and increased heat stress and respiratory stress.

Occupational Handler Non

- Cancer Exposure and Risk Estimate Equations

Potential daily exposures for occupational handlers were calculated using the following
formula s :

Daily Exposure (mg ai /day) = UE ( μ g ai / lb ai) * AR (lb ai /A) * AT (A /day) * 1E

- 3 mg/μg

w here:

### Page 13 of 18

Daily Exposure = Amount (mg ai/day) that is available for dermal or inhalation absorption,

UE = Unit Exposure ( μ g ai / lb ai)

, AR = maximum application rate according to proposed label (lb ai /A) , and

AT = daily acres treated (A /day)

.



### The daily doses were calculated using the following formula:

Average Daily Dose (mg ai/kg/day) = [Daily Exposure (mg ai/day) * Absorption ( %)] Body Weight (kg)

w here: Average Daily Dose = Absorbed dose received from exposure to a pesticide in a given scenario (mg pesticide active ingredient/kg body weight/day), Daily Exposure = Amount (mg ai/day) that is available for dermal or inhalation absorption, Absorption Factor = A measure of the amount of chemical that crosses a biological boundary such as the skin and lungs (%) , and Body Weight = Body weight determined to represent the population of interest in a risk

assessment (kg)

.



### Margin of Exposure: Non

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

MOE = PO D (t

ypically a NOAEL in mg/kg/day) ADD (mg/kg/day)



### w here:

MOE = Margin of Exposure: value used by HED to represent risk or risk estimates (unitless)

, PO D = Point of Departure

, NOAEL = No Observed Adverse Effect Level (mg/kg/day) : Dose level in a toxicity study

, where no observed adverse effects occurred in the study, and

ADD = Average Daily Dose (mg/kg/day) : the absorbed dose received from exposure to a pesticide in a given scenario

.



### Combining Exposures/ Risk Estimates : Dermal and inhalation risk estimates were not combined in this assessment, since no dermal hazard was identified; the refore no derm al quantitative risk assessment is required

.

Summary of Occupational Handler Non

- Cancer Exposure and Risk Estimates Occupational handler i nhalation risk estimates are not of concern (MOEs > LOC) for all proposed uses assessed. The label

- r equired PPE on the proposed label is that all handlers must wear long

- sleeved shirt and long pants, chemical

- resistant gloves, and socks and shoes. Inhalation MOEs range from 4,000 (mixing/loading/applying soluble concentrate formulation by mechanically

- p ressurized handwand) to 550,000 (mixing/loading soluble concentrate in support of airblast application). A summary of inhalation risk estimates for occupational handlers can be
found in Table 6.1.1

.

### Page 14 of 18

The Agency has evaluated scenarios that may be limited in nature such as flagging during aerial applications because engineering controls (i.e., Global Positioning Satellite technology) are now predominantly used as indicated by the 1998 National Agricultural Aviation Association (NAAA) survey of their members hip. It appears, however, flaggers are still used in approximately 10 to 15 percent of aerial application operations. In cases like these, the Agency strongly encourages the use of the engineering control system but will continue to evaluate risks
for fl aggers and any other population where a clear exposure pathway exists until the potential for exposure is eliminated. The Agency is aware that NAAA is conducting another survey on exposure issues and will consider those results as are timely and appropria te.

HED has no data to assess exposures to pilots using open cockpits. The only data available is for exposure 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); pilots are not required to wear protective gloves. With this level of protection, there

are no risk estimates of concern for applicators.

### Page 15 of 18

Table 6 .1. 1. Short

- /Intermediate

- Term Occupational Exposure and Risk Estimates for Fenpyrazamine

.

Exposure Scenario Crop or Target Inhalation Unit Exposure (ug/lb ai) 1 Maximum

Application Rate 2 Area

Treated or

Amount
Handled Daily 3 Inhalation

Baseline Dose (mg/kg/day) 4 MOE 5

Mixer/Loader

M/L, L/SC/EC, Aerial, Broadcast Nursery

0.219 1.09 lb ai/acre 60 acres 0.000179 170,000

Orchard, Field Crop 0.5 lb ai/acre 350 acres 0.000479 63,000

M/L, L/SC/EC, Airblast,

Broadcast Nursery 1.09 lb ai/acre 20 acres 0.0000596 500,000

Orchard 0.5 lb ai/acre 40 acres 0.0000548 550,000

M/L, L/SC/EC, Chemigation,
Broadcast Orchard, Field Crop 0.5 lb ai/acre 350 acres 0.00479 63,000

Greenhouse, Nursery 1.09 lb ai/acre 60 acres 0.000179 170,000

M/L, L/SC/EC, Groundboom,

Broadcast Field

- grown ornamentals 1.09 lb ai/acre 40 acres 0.000119 250,000

Nursery, Greenhouse 1.09 lb ai/acre 60 acres 0.000179 170,000

Field Crop 0.5 lb ai/acre 80 acres 0.00011 270,000

Applicator

Applicator, Spray, Aerial,
Broadcast Nursery Engineering Control:

0.068 1.09 lb ai/acre 60 acres 0.0000556 540,000

Orchard, Field Crop 0.5 lb ai/acre 350 acres 0.000149 200,000

Applicator, Spray, Airblast,
Broadcast Nursery 4.71 1.09 lb ai/acre 2 0 acres 0.00129 23,000

Orchard 0.5 lb ai/acre 40 acres 0.00118 25,000

Applicator, Spray, Groundboom,

Broadcast Field

- grown ornamentals

0.34 1.09 lb ai/acre 40 acres 0.000185 160,000

Nursery, Greenhouse 1.09 lb ai/acre 60 acres 0.000278 110,000

Field Crop 0.5 lb ai/acre 80 acres 0.00017 180,000

Flagger

Flagger, Spray, Aerial, Broadcast Nursery 0.35 1.09 lb ai/acre 60 acres 0.000286 100,000

Orchard, Field Crop 0.5 lb ai/acre 350 acres 0.000766 39,000

Mixer/Loader/Applicator

M/L/A, L/SC/EC, Backpack,
Broadcast Greenhouse, Nursery 140

0.005 lb ai/gallon 40 gallons 0.00035 86

, 000

M/L/A, L/SC/EC, Manually

pressurized handwand, Broadcast Greenhouse, Nursery 30 40 gallons 0.000075 400

, 000

M/L/A, L/SC/EC, Mechanically

pressurized handwand, Broadcast Nursery 3.9 1000 gallons 0.000244 120

, 000

Greenhouse 120 0.0075 4

, 000

### Page 16 of 18

M/L = Mixer/Loader. M/L/A = Mixer/Loader/Applicator. L/SC/ EC = Liquid/Suspension Concentrate/Emulsifiable Concentrate

1 Based on “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( March 2012 ); includes data from PHED/ORETF/AHETF (level of mitigation: Baseline, no respirator )

. 2 Based on proposed label

. The maximum single a pplication rate for almonds and pistachios is 0.375 lb ai/A ; however this use is covered by the assessed maximum application rate of 0.5 lb ai/A for other orchard crops.

3 Exposure Science Advisory Council Policy #9.1

. 4 Inhalation Dose = Inhalation Unit Exposure (ug/lb ai) x Conversion Factor (0.001 mg/ug) x Application Rate (lb ai/acre or gal) x Area Treated or Amount Handled Daily (A or gal /day) /BW ( 80 kg)

. 5 Inhalation MOE = Inhalation NOAEL ( 30 mg/kg/day)/ Inhalation Dose (mg/kg/day)

.

### Page 17 of 18

6

. 2 Occupational Post

- application Exposure/ Risk Estimates

HED uses the term post

- application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re

entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting. Post

- application exposure levels vary over time and depen d 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 applications, relative to harvest activities, c an greatly reduce the potential for post

- application exposure. As no dermal hazard has been identified for fenpyrazamine, quantification of dermal post

a pplication risk is not required. Further, a post

- application inhalation exposure assessment was

not p erformed at this time.

6

. 2 .1 Occupational Post

- application Inhalation Exposure/Risk Estimates

Based on the Agency's current practices, a quantitative post

- application inhalation exposure assessment was not performed for fenpyrazamine at this time primarily because of the low acute
inhalation toxicity (Toxicity Category III) and the low vapor pressure ( 2.17x10 - 10 

### mmHg at 25

oC ). However , there are multiple potential sources of post

- application inhalation exposure to individuals perfor ming post

- application activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report as well as available post

- application inhalation exposure data generated by the ARTF and may, as appropriate, d evelop policies and procedures, to identify the need for and, subsequently, the way to incorporate occupational post

- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revis it the need for a quantitative occupational post

- application inhalation exposure assessment for f enpyrazamine

.

Although a quantitative occupational post

- application inhalation exposure assessment was not performed, an inhalation exposure assessment was pe rformed for occupational/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post

- application exposure. Therefore, it is expected that these handler inhalation exposure estim ates would be protective of most occupational post

- application inhalation exposure scenarios.

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)].

### Page 18 of 18

6

. 2 .2 Occupational Post

- application Dermal Exposure/Risk Estimates

As no dermal hazard has been identified for fenpyraz amine, quantification of dermal post

application risk is not required. In accordance with the updated 40 CFR Part 158 data requirements (2007), one or more dislodgeable foliar residue (DFR) studies are required when a pesticide has residential or occupati onal uses that could result in postapplication dermal exposure. However, as quantification of dermal risk is not required for fenpyrazamine, a DFR study is not required for fenpyrazamine at this time. Additionally, a turf transferable residue (TTR) study is required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses. As there are no proposed uses on turf, a TTR study is not required for fenpyrazamine at this time.

Restricted Entry Interval

The REI specified on the proposed label is based on the acute toxicity of fenpyrazamine

. Fenpyrazamine is classified as Toxicity Category III via the dermal route, Toxicity Category IV for acute eye irritation, and Toxicity Category IV for acute dermal ir ritation. It is a skin
sensitizer. Under WPS for agricultural pesticides, ai’s classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12

- hour REI. Therefore, the WPS interim REI of 12 hours is adequate to protect agricultural workers from post

- application
exposures to fenpyrazamine

.