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 GolfCourses only).
PC Code: 392201 Decision No.: 478963 Petition No.: NA DP Barcode: D414958 Registration No.: 432-xxxx Regulatory Action: Section 3 Case No.: 7452 RiskAssessment Type: Occupational/Residential Exposure Assessment TXRNo.:NA CAS No.: 203313-25-1 40 CFR: §180.641 MRIDNo.:NA From:

Through:

To:

Introduction UmaHabiba Kelly M. Lowe, Environmental Scientist fo-1:::..-c:;...c;...,..--v Risk Assessment Branch 1 (RAB1) 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 ofspirotetramat on sod farm and golfcourse 

### 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 ofconcern were identified for all exposure scenarios [risk estimates were greater than the level ofconcern (LOC = 100)].

Page 1of 12Itis HED policy to use the best available datato assess exposure. Several sources ofgeneric data were used in this assessment as surrogate data in the absence ofchemical-specific data, including the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database; the OutdoorResidential Exposure Task Force (ORETF) database; the Residential SOPs (TurfSOP). Some ofthese data are proprietary, and subject to the dataprotectionprovisions ofthe Federal Insecticide; Fungicide, and Rodenticide Act (FIFRA). Note: This memorandum was reviewed bythe Exposure Science Advisory Committee (ExpoSAC) onFebruary 27,2014.

Page 2 of12Table ofContents 

### 1.0 Executive Summary

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

........................................................ 5 2.1 Summary ofRisk 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. Itcan control hidden pests and protectnew shoots. Spirotetramat is currently registered for use on a variety ofagricultural crops 1
, and is being proposed for use onturfgrass (sod farms and golfcourses 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 turfuse 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 golfcourse turfonly. 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 ofdeparture (POD) are the same for spirotetramat, therefore, the short-term assessment will beprotective ofany longerterm exposure (greater than 1month). Itis also anticipated that there will be short-term residential post-application exposures from the proposed golfcourse use. Quantification ofdermal 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 inthe dog. Since the NOAEL for inhalationrisk assessment was chosen from an oral study, it was assumed that toxicity viathe inhalationroute is equivalent to oral toxicity. HED determined that, based on a weight ofevidence (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 of80 kg was used inthe assessment ofadult exposures since the effectswere not developmental or fetal effects. The total uncertainty factor (UF) that was applied to the spirotetramatrisk assessment is 100 for short- and intermediate-term risk estimates. Since the proposed use is only on sod farms and golfcourses, residential handler exposure is not anticipated. Residential post-application dermal exposure from the use on golfcourses is expected; however, since there is no dermal POD, quantification ofdermal risk is notnecessary. The occupational handler exposure and risk estimates indicate thatthe short- and intermediateterm inhalation MOEs are not ofconcernto 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 onthe 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 ofrabbits (Toxicity Category IV), but was shownto be a skin sensitizerinmice. Therefore, the acute

1A use on residential ornamentals had been assessed previously (Memo, K. Lowe, 12-SEP-2013, D406654), butthe use was withdrawn subsequent to the finalized risk assessment. Page 4 of 12toxicity 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 onthe Agency's currentpractices, a quantitative non-cancer occupational post-application inhalation exposure assessment was notperformed for spirotetramat at this time. Ifnewpolicies orprocedures 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 inpart 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 (TurfSOP) are (1) subject to ethics reviewpursuantto 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 reviewby the Human Studies Review Board. Descriptions ofdata sources, as well as guidance on their use, canbe found atthe Agency website 2

. 

### 2.0 Risk Assessment Conclusions and Recommendations 2.1 Summary ofRisk Estimates and Label Recommendations There are no residential or occupational risk estimates ofconcern for the proposed use of spirotetramat on sod farms and golfcourses. Quantification ofdermal risk is not necessary since no dermal POD has been selected. All occupational handler inhalation MOEs are greater than 130,000 (LOC 

### = 100). 

### 2.2 Data Deficiencies and·Requirements 

### TurfTransferable Residue (ITR): In accordance with 40CFR158, TTR data are required for all occupational (e.g., sod farms, golfcourses, parks, and recreational areas) or residential turfuses that could result inpost-application exposure to turf. Forthe proposed spirotetramat turfuses, dermal post-application exposure is anticipated; however, since no dermal POD was selected, quantification ofdermal risk is not necessary, and therefore, submission ofTTR data are not required atthis time. 

### 3.0 Hazard Characterization Acute Toxicity Spirotetramatis 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 ofrabbits (Toxicity Category IV), but was shownto be a skin sensitizer in mice. Table 3.1 presents a summary ofthe 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 12Table 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 ); clearedby 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 ofthe toxicological database yielded no dermal hazard. Since there is no concern for enhanced sensitivity/susceptibility to offspring from spirotetramat exposure, the effects ofconcern in adults and offspring are adequately assessed inthe dermal toxicity study where no adverse dermal or systemic effects were observed up to the limit dose. A NOAEL of32 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 viathe inhalation route is equivalent to oral toxicity. HED determined that, based on a weight ofevidence (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 ofthe toxicological PODs and endpoints chosen for the relevant exposure scenarios for human risk assessment are found in Table 3.2.

Table3.2. Summary ofToxicology Endpoint Selection for Spirotetramat Exposure Uncertainty Level ofConcern POD for Risk Study and ToxicologicalEffects 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 ofincreased 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 12Table 3.2. Summary ofToxicology Endpoint Selection for Spirotetramat. Exposure Uncertainty Level ofConcern POD for Risk Study andToxicological Effects Scenario Factors Assessment Cancer (oral, Classification: Not likely to be carcinogenic to humans based on lack ofevidence of dermal, carcinogenicity in two oralrodent carcinogenicity studies. inhalation) PomtofDeparture (POD)

- A datapomt or an estimated pomt that IS denved from observed dose-response data and used to mark the begmrung ofextrapolation to determine risk associated with lower environmentally relevant human exposures. UF = uncertainty factor

. UFA= extrapolation from animal to human (interspecies). UFH =potential variation in sensitivity among members ofthe human population (intraspecies). NOAEL =no observed adverse effect level. LOAEL =lowestobserved adverse effect level

.MOE= margin ofexposure.LOC = level ofconcern. The Agency's LOC for risks is defined by UFs. The Agency applies a factor oflOX 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 canbereduced 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 inhalationroute is considered to be equivalent to the estimated toxicity by the oral route ofexposure. 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 ofspirotetramat on turfgrass, for use on golfcourses and sod farms only. Applications canbe made viaaerial, groundboom, and handheld equipment. The product can be applied up to 2 times per year. The summary ofuse directions for the proposed use, including the end use product, formulation, and proposed application rate are described in Table 4.1.
Table4.1. Summary ofDirections for Use ofSpirotetramat. 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 ailA) Turfgrass including golfcourses and sod farms Apply priorto egg Liquid hatch oftarget pest. [432-XXXX] Ifrainfall 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 RiskEstimates

Page 7 of 12There is the potential for short-term post-application dermal exposure from the proposed use on golfcourses. However, no dermal POD has been selected for spirotetramat; therefore, quantification ofresidential 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 ofexposure 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 ofexposure 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 ofvarious registrants which was developed as a result ofa Data Call-In issued by EPA), EPA Regional Offices and State Lead Agencies for pesticide regulation and otherparties to develop the best spray drift managementpractices (see the agency's Spray Drift website for more information). 3 The agency has also developed a policy on howto appropriately consider spray drift as a potential source ofexposure 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 thatpesticide will be considered concurrently. The approach is outlined inthe revised (2012) Standard OperatingProcedures For ResidentialRiskAssessment (SOPs) -ResidentialExposureAssessmentStandard Operating ProceduresAddenda 1: Consideration of Spray Drift. This document outlines the quantification ofindirect non-occupational exposure to drift. 

### 5.2 Residential Bystander Post-Application Inhalation Exposure Volatilization ofpesticides may be a source ofpost-application inhalation exposure to individuals nearby pesticide applications. The agency sought expert advice and input on issues related to volatilization ofpesticides 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 ifdata (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/oppOOOOl/ factsheets/spraydrift.htm Page 8 of 12HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinctjob functions ortasks related to applications and exposures can vary depending onthe specifics ofeach task. Job requirements (amount ofchemical used in each application), the kinds ofequipmentused, the target being treated, and the level ofprotection 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 ofequipment 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 onthe following scenarios: (1) Mixing/loading liquids for aerial and groundboom applications; (2) Applying sprays via aerial and groundboom equipment; (3) Flagging for aerial applications; and, (4) Mixing/loading/applying liquids for application viamechanically-pressurized handguns. Occupational HandlerExposure Data and Assumptions A series ofassumptions 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. ApplicationRate: Maximum application rates, as outlined in Table 4.1, were used to assess occupational handler exposure. Unit Exposures: Itis the policy ofHED to use the best available data to assess handler exposure. Sources ofgeneric handler data, used as surrogate data in the absence ofchemical-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 protectionprovisions ofFIFRA. 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 onuse ofsurrogate data, including descriptions ofthe various sources, canbefound atthe Agency website5• Area TreatedorAmountHandled: Estimates ofarea treated/amount handled are based on guidance in ExpoSAC Policy 9.1: • 350 acres for aerial applications to sod farms; • 5 acres for groundboon;t applications to golfcourses (tees and greens only); • 40 acres for groundboom applications to golfcourses (fairways, tees, greens); • 80 acres for groundboom applications to sod farms; and, • 5 acres for applications viamechanically-pressurized handguns. Exposure Duration: HED classifies exposures from 1to 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 of12including the exposed population, the use site, the pestpressure triggering the use ofthe pesticide, andthe cultural practices surrounding that use site. Formost agricultural uses, itis reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one-month time frame; however, there maybe a large

.agricultural business and/or commercial applicators who may apply a product over a period ofweeks (e.g., completing multiple applications for multiple clients within a region). For spirotetramat, based onthe proposed use, itis anticipated that there will likely only be shortterm occupational handler exposure since the labels only allow for up to two applications per year. However, boththe short- and intermediate-term PODs are the same; therefore, estimates of short-term exposure and risk are protective ofanyrepeated exposure for longer than 30 days. Mitigation/Personal Protective Equipment: Estimates ofdermal and inhalation exposure were calculated for various levels ofpersonal protective equipment (PPE). Results are presented for "baseline," defmed as a single layer ofclothing consisting ofa long sleeved shirt, longpants, shoes plus socks, no protective gloves, and no respirator, as well as baseline with various levels ofPPE as necessary (e

.g., gloves, respirator, etc)

. The spirotetramatproductlabels directmixers, loaders, applicators and otherhandlers to wear long-sleeved shirt and long pants, shoes plus socks, and chemical-resistant gloves. Summary ofOccupational HandlerNon-Cancer Exposure and Risk Estimates The occupational handler exposure and risk estimates indicate that the short- and intermediateterm inhalation MOEs are not ofconcernto HED (i.e., MOE 2:_ 130,000; LOC = 1 00).
Table 6.1.1. Occupational Handler Non-Cancer Exposure and RiskEstimates 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 Golfcourse (tees, greens) 0.219 Baseline 0.161b ai/acre 5 acres 0.0000175 1,800,000 Groundboom Golfcourse (fairways, 40 acres 0.000035 910,000 tees, greens) Applicator Aerial 0.0049 350 acres 0.00000343 9,300,000 Sod EC Groundboom 80 acres 0

.0000034 9,400,000 Golfcourse (tees and 0

. 16 lb ai/acre greens only) 0.34 Baseline 5 acres 0.0000273 1,200,000 Groundboom Golfcourse (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 Golfcourse (tees, greens,

pressurized and fairways) 1.9 Baseline 0

. 16 lb ai/acre 5 acres 0

.000019 1,700,000

handgun Page 10 of 12I Based onthe "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (May 2013); Level ofmitigation: Baseline, Engineering Controls

. 2 Based onproposed 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 enterpreviously treated areas to performjobfunctions, including activities related to crop production, such as scouting for pests orharvesting. Post-application exposure levels vary overtime and depend on such things as the type ofactivity, the nature ofthe crop ortarget that was treated, the type ofpesticide application, and the chemical's degradation properties

. In addition, the timing ofpesticide applications, relative to harvest activities, can greatly reduce the potential for post-application exposure. 

### 6.2.1 Occupational Post-application Inhalation Exposure/RiskEstimates There are multiple potential sources ofpost-application inhalation exposure to individuals performing post-application activities inpreviously treated fields. These potential sources include volatilization ofpesticides and resuspension ofdusts 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) inDecember 2009, and received the SAP's final report onMarch 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-HQOPP-2014-0219). During Registration Review, the agency will utilize this analysis to determine ifdata (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-applicationinhalation exposure data generated bythe 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 ofpesticides outdoors is likely to result in higher exposure thanpost-application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective ofmost occupationalpost-application inhalation exposure scenarios. 

### 6.2.2 Occupational Post-application Dermal Exposure/Risk Estimates

Page 11 of 12A quantitative dermal post-application assessment was not conducted since no dermal POD was selected for spirotetramat. Restricted Entry Interval

. The REI specified onthe proposed label is based onthe acute toxicity ofspirotetramat. 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 ofrabbits (Toxicity Category IV), but was shown to be a skin sensitizer inmice. Short- and intermediate-termpost-applicationrisk 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 orprimary skin irrigation are assigned a 24-hour REI. Therefore, the [156 subpart K] Worker Protection Statement interim REI of24 hours is adequate to protect agricultural workers from post-application exposures to spirotetramat. The proposed label recommends an REI of24 hours.

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