UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Date: 

Subject: 

16-0CT-2014 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Spirotetramat. Occupational and Residential Exposure Assessment for a 

Proposed Use on Turfgrass (Sod Farms and Golf Courses only). 

PC Code: 392201 

Decision No.: 478963 

Petition No.: NA 

DP Barcode: D414958 

Registration No.: 432-xxxx 

Regulatory Action: Section 3 

Risk Assessment Type: Occupational/Residential Exposure Assessment Case No.: 7452 

TXRNo.:NA CAS No.: 203313-25-1 

MRIDNo.:NA 40 CFR: § 180.641 

From: 

Through: 

To: 

Introduction 

UmaHabiba 

Kelly M. Lowe, Environmental Scientist fo-1:::..-c:;...c;...,..--v 

Risk Assessment Branch 1 (RAB 1) 

Health Effects Division (HED, 7509P) 

Charles W. Smith III, Branch Chie C:::.G~ RAB 1/HED (7509P) 

and 

Monica Hawkins, ExpoSAC Reviewer j Zaida Figueroa, ExpoSAC Reviewer 

Exposure Science Advisory Committee ( poSAC I HED 

Rita Kumar 

Insecticide/Rodenticide Branch 

Registration Division (7505P) 

The Registration Division (RD) requested that the Health Effects Division (HED) conduct an 

exposure and risk assessment for the proposed use of spirotetramat on sod farm and golf course 

turf. The formulated end-use product evaluated in this assessment is 12ESP703 SC 

INSECTICIDE (EPA Reg. #432-:XXXX) (8.60% ai spirotetramat and 21.4% ai imidacloprid). 

This document only assesses exposure and risk associated with the active ingredient, 

spirotetramat. No risk estimates of concern were identified for all exposure scenarios [risk 

estimates were greater than the level of concern (LOC = 100)]. 

Page 1 of 12 
It is HED policy to use the best available data to assess exposure. Several sources of generic 

data were used in this assessment as surrogate data in the absence of chemical-specific data, 

including the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1 ); the Agricultural 

Handler Exposure Task Force (AHETF) database; the Outdoor Residential Exposure Task Force 

(ORETF) database; the Residential SOPs (Turf SOP). Some ofthese data are proprietary, and 

subject to the data protection provisions of the Federal Insecticide; Fungicide, and Rodenticide 

Act (FIFRA). 

Note: This memorandum was reviewed by the Exposure Science Advisory Committee 

(ExpoSAC) on February 27,2014. 

Page 2 of12 
Table of Contents 

1.0 Executive Summary ............................................................................................................. 4 

2.0 Risk Assessment Conclusions and Recommendations ........................................................ 5 

2.1 Summary of Risk Estimates and Label Recommendations ............................................. 5 

2.2 Data Deficiencies and Requirements ............................................................................... 5 

3.0 Hazard Characterization ....................................................................................................... 5 

4.0 Proposed Use Profile ............................................................................................................ 7 

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

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

5.2 Residential Bystander Post-Application Inhalation Exposure ......................................... 8 

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

6.1 Occupational Handler Exposure/Risk Estimates .............................................................. 8 

6.2 Occupational Post-application Exposure/Risk Estimates .............................................. 11 

6.2.1 Occupational Post-application Inhalation Exposure/Risk Estimates ...................... 11 

6.2.2 Occupational Post-application Dermal Exposure/Risk Estimates .......................... 11 

Page 3 of 12 
1.0 Executive Summary 

Spirotetramat is a systemic insecticide, active against sucking insects. It can control hidden pests 

and protect new shoots. Spirotetramat is currently registered for use on a variety of agricultural 

crops1

, and is being proposed for use on turfgrass (sod farms and golf courses only). The 

proposed end-use product is 12ESP703 SC INSECTICIDE (EPA Reg. #432-XXXX), which 

contains 0.8 lb active ingredient (ai)/gallon or 8.6% ai. This product also contains imidacloprid 

as an active ingredient; this ai already has a turf use and has been assessed separately (D400191). 

The proposed label allows for up to two spray applications using aerial, groundboom, and 

handheld equipment at a maximum single application rate of25.6 fl oz/A (0.16lb ail A) to sod 

farms and golf course turf only. This assessment addresses exposure and risk associated with the 

proposed end-use product for spirotetramat when used as directed by occupational workers. 

There is a potential for short-term (1 to 30 days) occupational exposure associated with handler 

activities (i.e., mixing, loading, and applying) as well as with post-application activities (i.e., reentering treated areas). However, the short- and intermediate-term points of departure (POD) are 

the same for spirotetramat, therefore, the short-term assessment will be protective of any longerterm exposure (greater than 1 month). It is also anticipated that there will be short-term 

residential post-application exposures from the proposed golf course use. 

Quantification of dermal risks is not required, since no POD was selected for short- or 

intermediate-term dermal exposures. The POD for short- and intermediate-term inhalation 

exposures is a no-observable adverse-effect level (NOAEL) of32 mg/kg/day based on effects 

observed in a 90-day oral toxicity study in the dog. Since the NOAEL for inhalation risk 

assessment was chosen from an oral study, it was assumed that toxicity via the inhalation route is 

equivalent to oral toxicity. HED determined that, based on a weight of evidence (WOE) 

approach, a 28-day inhalation study is not required; therefore, an additional database uncertainty 

factor (UF) is not required for spirotetramat (HASPOC, TXR # 0056480). A body weight of 80 

kg was used in the assessment of adult exposures since the effects were not developmental or 

fetal effects. The total uncertainty factor (UF) that was applied to the spirotetramat risk 

assessment is 100 for short- and intermediate-term risk estimates. 

Since the proposed use is only on sod farms and golf courses, residential handler exposure is not 

anticipated. Residential post-application dermal exposure from the use on golf courses is 

expected; however, since there is no dermal POD, quantification of dermal risk is not necessary. 

The occupational handler exposure and risk estimates indicate that the short- and intermediateterm inhalation MOEs are not of concern to HED (i.e., MOE :_:: 130,000; LOC = 1 00). Since 

there is no dermal POD, a quantitative occupational post-application assessment was not 

conducted for spirotetramat. The restricted entry interval (REI) is based on the acute toxicity of 

spirotetramat technical material. Spirotetramat is classified as Toxicity Category III for acute 

oral and acute dermal toxicity, Toxicity Category IV for acute inhalation toxicity, and Toxicity 

Category II for primary eye irritation. Spirotetramat is not an irritant to the skin of rabbits 

(Toxicity Category IV), but was shown to be a skin sensitizer in mice. Therefore, the acute 

1 A use on residential ornamentals had been assessed previously (Memo, K. Lowe, 12-SEP-2013, D406654), but the 

use was withdrawn subsequent to the finalized risk assessment. 

Page 4 of 12 
toxicity categories for this chemical require a 24 hour REI under 40 CFR 156.208 (c) (2) (iii). 

The proposed label recommends a 24-hour REI. 

Based on the Agency's current practices, a quantitative non-cancer occupational post-application 

inhalation exposure assessment was not performed for spirotetramat 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 spirotetramat. 

Human Studies Review 

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pest~cide or other chemical. These data, which include studies from 

PHED 1.1; the AHETF database; the ORETF database; and the Residential SOPs (Turf SOP) are 

(1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are 

compliant with applicable ethics requirements. For certain studies, the ethics review may have 

included review by the Human Studies Review Board. Descriptions of data sources, as well as 

guidance on their use, can be found at the Agency website2. 

2.0 Risk Assessment Conclusions and Recommendations 

2.1 Summary of Risk Estimates and Label Recommendations 

There are no residential or occupational risk estimates of concern for the proposed use of 

spirotetramat on sod farms and golf courses. Quantification of dermal risk is not necessary since 

no dermal POD has been selected. All occupational handler inhalation MOEs are greater than 

130,000 (LOC = 1 00). 

2.2 Data Deficiencies and· Requirements 

TurfTransferable Residue (ITR): 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. For the proposed spirotetramat turf uses, 

dermal post-application exposure is anticipated; however, since no dermal POD was selected, 

quantification of dermal risk is not necessary, and therefore, submission of TTR data are not 

required at this time. 

3.0 Hazard Characterization 

Acute Toxicity 

Spirotetramat is classified as Toxicity Category III for acute oral and acute dermal toxicity, 

Toxicity Category IV for acute inhalation toxicity, and Toxicity Category II for primary eye 

irritation. Spirotetramat is not an irritant to the skin of rabbits (Toxicity Category IV), but was 

shown to be a skin sensitizer in mice. Table 3.1 presents a summary of the acute toxicity 

information for spirotetramat. 

2 http://www .epa.gov/pesticides/sciencelhandler-exposure-data.html and 

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

Page 5 of 12 
Table 3.1. Acute Toxicity Profile- Spirotetramat. 

Guideline No. Study Type MRID(s) Results Toxicity 

Category 

870.1100 Acute oral (rat) 46904527 LDso >2000 mg/kg (F) ill 

870.1200 Acute dermal (rat) 46904529 LDso >2000 mg/kg (M&F) III 

870.1300 Acute inhalation (rat) 46904530 LCso >4.183 mg!L (M&F) IV 

870.2400 Primary eye irritation (rabbit) 46904531 Corneal opacity and iritis n (grade 1 ); cleared by day 8 

870.2500 Primary dermal irritation (rabbit) 46904532 Negative IV 

870.2600 Dermal sensitization (mouse) 46904565 Positive N/A (Local Lymph Node Assay) 

Toxicological PODs Used for Risk Assessment 

Dermal endpoints were chosen in previous risk assessments; however, reevaluation of the 

toxicological database yielded no dermal hazard. Since there is no concern for enhanced 

sensitivity/susceptibility to offspring from spirotetramat exposure, the effects of concern in 

adults and offspring are adequately assessed in the dermal toxicity study where no adverse 

dermal or systemic effects were observed up to the limit dose. 

A NOAEL of 32 mglkg/day based on decreased body-weight gain and food consumption, 

depressed RBC parameters (red blood cell count, hemoglobin level and hematocrit), and thymus 

atrophy from the 90-day oral toxicity study in dogs was selected as the POD for short- and 

intermediate-term inhalation exposure. Since the NOAEL for inhalation risk assessment was 

chosen from an oral study, it was assumed that toxicity via the inhalation route is equivalent to 

oral toxicity. HED determined that, based on a weight of evidence (WOE) approach, a 28-day 

inhalation study is not required; therefore, an additional database uncertainty factor (UF) is not 

required for spirotetramat (HASPOC, TXR # 0056480). A summary of the toxicological PODs 

and endpoints chosen for the relevant exposure scenarios for human risk assessment are found in 

Table 3.2. 

Table 3.2. Summary of Toxicology Endpoint Selection for Spirotetramat 

Exposure Uncertainty Level of Concern 

POD for Risk Study and Toxicological Effects Scenario Factors Assessment 

Dermal In a dermal toxicity study in rats, no adverse effects were observed up to the limit dose. Since there 

Short- and is no evidence of increased susceptibility, a dermal assessment is not needed. 

IntermediateTerm (1-30 days 

and 1-6 months) 

Inhalation NOAEL=32 UFA =lOX Occupational and 90-Day oral toxicity (dog) 

Short- and mg!kg/day UFH= lOX Residential LOC LOAEL = 72 mglkglday [F] 

Intermediate- forMOE= 100 based on decreased body-weight 

Term (1-30 days Inhalation toxicity gain and food consumption, 

and 1-6 months) is considered depressed RBC parameters (red 

equivalent to oral blood cell count, hemoglobin 

toxicity. level and hematocrit), and thymus 

atrophy. 

Page 6 of 12 
Table 3.2. Summary of Toxicology Endpoint Selection for Spirotetramat. 

Exposure Uncertainty Level of Concern 

POD for Risk Study and Toxicological Effects Scenario Factors Assessment 

Cancer (oral, Classification: Not likely to be carcinogenic to humans based on lack of evidence of 

dermal, carcinogenicity in two oral rodent carcinogenicity studies. 

inhalation) 

Pomt of Departure (POD) - A data pomt or an estimated pomt that IS denved from observed dose-response data and used to mark the begmrung 

of extrapolation to determine risk associated with lower environmentally relevant human exposures. UF = uncertainty factor. UF A= 

extrapolation from animal to human (interspecies). UFH =potential variation in sensitivity among members of the human population 

(intraspecies). NOAEL =no observed adverse effect level. LOAEL =lowest observed adverse effect level. MOE= margin of exposure. LOC = 

level of concern. 

The Agency's LOC for risks is defined by UFs. The Agency applies a factor of lOX to account 

for interspecies extrapolation to humans from the animal test species and another factor of 1 OX 

to account for intra-species sensitivity. HED has concluded that the FQPA safety factor for 

spirotetramat can be reduced to 1 X. The total UF that has been applied to the spirotetramat risk 

assessment is 100 for short- and intermediate-term inhalation exposures. 

Absorption 

Toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the 

oral route of exposure. 

Body Weight 

Since the inhalation POD is not based on developmental and/or fetal effects, the body weight 

appropriate for inhalation assessments is 80 kg. 

4.0 Proposed Use Profile 

The registrant has proposed new uses of spirotetramat on turfgrass, for use on golf courses and 

sod farms only. Applications can be made via aerial, groundboom, and handheld equipment. 

The product can be applied up to 2 times per year. The summary of use directions for the 

proposed use, including the end use product, formulation, and proposed application rate are 

described in Table 4.1. 

Table 4.1. Summary of Directions for Use of Spirotetramat. 

Applic. Timing, Formulation Applie. Rate Max. No. Max. Yearly 

Type, and Equip. [EPA Reg. No.] (lb ail A) Applic. per Applie. Rate Use Directions and Limitations 

Year (lb ail A) 

Turfgrass including golf courses and sod farms 

Apply prior to egg Liquid 

hatch of target pest. [432-XXXX] If rainfall does not occur within 

25.6 fl oz/A= 2 25.6 fl oz/A = 24 hours after application, irrigate 

0.16lb ai/A 0.16lb ai/A to move ai through the thatch. 

Aerial, Groundboom, 0.8 lb ai/gal REI = 24 hours. 

Handheld equipment. 8.6%ai 

5.0 Residential Exposure and Risk Estimates 

Page 7 of 12 
There is the potential for short-term post-application dermal exposure from the proposed use on 

golf courses. However, no dermal POD has been selected for spirotetramat; therefore, 

quantification of residential dermal post-application risk is not necessary. 

Previously, a use for spirotetramat on ornamentals in residential settings had been assessed 

(Memo, K. Lowe, D406654, 12-SEP-2013); however, since this memo was finalized, the request 

for the ornamental use was withdrawn by the Registrant. Therefore, there are no currently 

registered residential uses for spirotetramat. 

5.1 Spray Drift 

Spray drift is a potential source of exposure to those nearby pesticide applications. This is 

particularly the case with aerial application, but, to a lesser extent, spray drift can also be a 

potential source of exposure from the ground application methods (e.g., groundboom and 

airblast) employed for spirotetramat. The agency has been working with the Spray Drift Task 

Force (a task force composed of various registrants which was developed as a result of a Data 

Call-In issued by EPA), EPA Regional Offices and State Lead Agencies for pesticide regulation 

and other parties to develop the best spray drift management practices (see the agency's Spray 

Drift website for more information). 3 The agency has also developed a policy on how to 

appropriately consider spray drift as a potential source of exposure in risk assessments for 

pesticides. The potential for spray drift will be quantitatively evaluated for each pesticide during 

the Registration Review process which ensures that all uses for that pesticide will be considered 

concurrently. The approach is outlined in the revised (2012) Standard Operating Procedures 

For Residential Risk Assessment (SOPs) -Residential Exposure Assessment Standard Operating 

Procedures Addenda 1: Consideration of Spray Drift. This document outlines the quantification 

of indirect non-occupational exposure to drift. 

5.2 Residential Bystander Post-Application Inhalation Exposure 

Volatilization of pesticides may be a source of post-application inhalation exposure to 

individuals nearby pesticide applications. The agency sought expert advice and input on issues 

related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act 

Scientific Advisory Panel (SAP) in December 2009, and received the SAP's final report on 

March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html). The 

agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a 

subsequent Volatilization Screening Analysis 

(http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2014-0219). 

During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux 

studies, route-specific inhalation toxicological studies) or further analysis is required for 

spirotetramat. 

6.0 Occupational Exposure and Risk Estimates 

6.1 Occupational Handler Exposure/Risk Estimates 

3 Available: http://www .epa. gov/oppOOOO l/factsheets/spraydrift.htm 

Page 8 of 12 
HED uses the term handlers to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct job functions or tasks related to 

applications and exposures can vary depending on the specifics of each task. Job requirements 

(amount of chemical used in each application), the kinds of equipment used, the target being 

treated, and the level of protection used by a handler can cause exposure levels to differ in a 

manner specific to each application event. 

Based on the anticipated use patterns and 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 occupational handlers is based on the 

following scenarios: 

(1) Mixing/loading liquids for aerial and ground boom applications; 

(2) Applying sprays via aerial and groundboom equipment; 

(3) Flagging for aerial applications; and, 

(4) Mixing/loading/applying liquids for application via mechanically-pressurized handguns. 

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: Maximum application rates, as outlined in Table 4.1, were used to assess 

occupational handler exposure. 

Unit Exposures: It is the policy of HED to use the best available data to assess handler exposure. 

Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, 

include PHED 1.1, the AHETF database, or other registrant-submitted occupational exposure 

studies. Some ofthese 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 Table4", which, along with 

additional information on HED policy on use of surrogate data, including descriptions of the 

various sources, can be found at the Agency website5• 

Area Treated or Amount Handled: Estimates of area treated/amount handled are based on 

guidance in Expo SAC Policy 9.1: 

• 350 acres for aerial applications to sod farms; 

• 5 acres for groundboon;t applications to golf courses (tees and greens only); 

• 40 acres for groundboom applications to golf courses (fairways, tees, greens); 

• 80 acres for groundboom applications to sod farms; and, 

• 5 acres for applications via mechanically-pressurized handguns. 

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, 

4 Available: http://www .epa.gov/opp'OOOO 1 /sciencelhandler-exposure-table.pdf 5 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.html 

Page 9 of12 
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. agricultural business 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 spirotetramat, based on the proposed use, it is anticipated that there will likely only be shortterm occupational handler exposure since the labels only allow for up to two applications per 

year. However, both the short- and intermediate-term PODs are the same; therefore, estimates of 

short-term exposure and risk are protective of any repeated exposure for longer than 30 days. 

Mitigation/Personal Protective Equipment: Estimates of dermal and inhalation exposure were 

calculated for various levels of personal protective equipment (PPE). Results are presented for 

"baseline," defmed 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 spirotetramat product labels direct mixers, 

loaders, applicators and other handlers to wear long-sleeved shirt and long pants, shoes plus 

socks, and chemical-resistant gloves. 

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates 

The occupational handler exposure and risk estimates indicate that the short- and intermediateterm inhalation MOEs are not of concern to HED (i.e., MOE 2:_ 130,000; LOC = 1 00). 

Table 6.1.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Spirotetramat. 

Exposure 

Inhalation Unit 

Maximum Area Treated or Inhalation 

Scenario Crop or Target Exposure Application Ratel Amount 

Dose (mglkg/day)4 MOE5 

(Jlg/lb ai)1 Handled Dailyl 

Mixernoader 

Aerial 350 acres 0.000154 210,000 Sod 

80 acres 0.00000219 15,000,000 

Golf course (tees, greens) 0.219 Baseline 0.161b ai/acre 5 acres 0.0000175 1,800,000 Ground boom 

Golf course (fairways, 40 acres 0.000035 910,000 tees, greens) 

Applicator 

Aerial 0.0049 

350 acres 0.00000343 9,300,000 Sod EC 

Ground boom 80 acres 0.0000034 9,400,000 

Golf course (tees and 0.16 lb ai/acre 

greens only) 0.34 Baseline 5 acres 0.0000273 1,200,000 

Groundboom 

Golf course (fairways, 40 acres 0.0000544 590,000 tees, greens) 

Flagger 

Aerial Sod 0.35 Baseline 0.161b ai!acre 350 acres 0.000245 130,000 

Mixer/Loader/ Applicator 

Mechanically Golf course (tees, greens, pressurized and fairways) 1.9 Baseline 0.16 lb ai/acre 5 acres 0.000019 1,700,000 

handgun 

Page 10 of 12 
I Based on the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (May 2013); Level of mitigation: Baseline, 

Engineering Controls. 2 Based on proposed label. 

3 Exposure Science Advisory Council Policy #9 .I. 

4 Inhalation Dose= Inhalation Unit Exposure (J.tg/lb ai) x Conversion Factor (0.001 mg/J.lg) x Application Rate (lb ail A} x Area Treated (A/day) 

-;. BW (80kg). 

5 Inhalation MOE= Inhalation NOAEL (32 mglkg!day)-;. Inhalation Dose (mg!kglday). 

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 reentry exposure). Such exposures may occur when workers enter previously treated areas to 

perform job functions, including activities related to crop production, such as scouting for pests 

or harvesting. Post-application exposure levels vary over time and depend on such things as the 

type of activity, the nature of the crop or target that was treated, the type of pesticide application, 

and the chemical's degradation properties. In addition, the timing of pesticide applications, 

relative to harvest activities, can greatly reduce the potential for post-application exposure. 

6.2.1 Occupational Post-application Inhalation Exposure/Risk Estimates 

There are multiple potential sources of post-application inhalation exposure to individuals 

performing post-application activities in previously treated fields. These potential sources 

include volatilization of pesticides and resuspension of dusts and/or particulates that contain 

pesticides. The agency sought expert advice and input on issues related to volatilization of 

pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel 

(SAP) in December 2009, and received the SAP's final report on March 2, 2010 

(http://www.epa.gov/scipoly/SAP/meetings/2009/1201 09meeting.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=EP A-HQOPP-2014-0219). During Registration Review, the agency will utilize this analysis to determine 

if data (i.e., flux studies, route-specific inhalation toxicological studies) or further analysis is 

required for spirotetramat. 

In addition, the Agency is continuing to evaluate the available post-application inhalation 

exposure data generated by the Agricultural Reentry Task Force. Given these two efforts, the 

Agency will continue to identify the need for and, subsequently, the way to incorporate 

occupational post-application inhalation exposure into the agency's risk assessments. 

Although a quantitative occupational post-application inhalation exposure assessment was not 

performed, an inhalation exposure assessment was performed for occupational/commercial 

handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in 

higher exposure than post-application exposure. Therefore, it is expected that these handler 

inhalation exposure estimates would be protective of most occupational post-application 

inhalation exposure scenarios. 

6.2.2 Occupational Post-application Dermal Exposure/Risk Estimates 

Page 11 of 12 
A quantitative dermal post-application assessment was not conducted since no dermal POD was 

selected for spirotetramat. 

Restricted Entry Interval . 

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

Spirotetramat is classified as Toxicity Category III for acute oral and acute dermal toxicity, 

Toxicity Category IV for acute inhalation toxicity, and Toxicity Category II for primary eye 

irritation. Spirotetramat is not an irritant to the skin of rabbits (Toxicity Category IV), but was 

shown to be a skin sensitizer in mice. Short- and intermediate-term post-application risk 

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

activities. Under 40 CFR 156.208 (c) (2) (iii), ai's classified as Acute II for acute dermal, eye 

irritation or primary skin irrigation are assigned a 24-hour REI. Therefore, the [156 subpart K] 

Worker Protection Statement interim REI of 24 hours is adequate to protect agricultural workers 

from post-application exposures to spirotetramat. The proposed label recommends an REI of 24 

hours. 

Page 12 of 12