### Date: S ubj ect: UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , 

### D
. C
. 20460

2 8-0CT- 20 15 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### S pirotetramat. Occupational and Res idential Expo s ure Assessment for a Propo se d Use on C itru s Tre es Grown in Residential Areas P C Co de: 39220 I Deci sio n No. : 495325 Petition No.: NA OP Barcode: 0429878 Re g istr at ion No.: 432-xxx Re g ulatory Actio n : Sec ti o n 3 Case No.: 7452 R is k Assessment Type: Occupat ional/Resi d ential Exposure Assessme nt T XR No.: NA CAS No.: 2033 13-25

- 1 40 CFR: § 18 0.641 M RID No .: N A 

### F rom:

T hr o u g h:

To:

Introduction K e ll y M. Lowe, Environmental Scientist**~** Risk Assessment Branch l (RAB I ) Health Effec ts Division ( H ED, 7509P) Charles S mith, Branch Chief RAB l/HE D ( 7509P ) and**-.- ~** 

## (_**~**

Shalu S h e la t , ExpoSAC R ev iewe r

## ~ < Barry O'Keefe, Ex poSAC Revi ewe r /]

## ~**I~** Exposure Sc ience Adviso ry Co mmitt ee (ExpoSAC) I

## HE~ Rita Kumar Fungicide Branch Registration Di v i sio n ( 7505P )

T he Registration Divi s io n (RD) requested that th e Health Effects Division ( H E D) conduct an e xposure and risk assessment for the proposed us e of s pirotetramat on citrus trees in residential areas. When re g i s te red, thi s will be the fir s t res id e nti a l u se of s pirotetramat. No ri s k estimates of co n ce rn were identifi e d ; a ll s hort- and intermediate-term occupational handl e r (with baselin e attire) and s hort-te rm re s idential handler MOEs were g reater than th e leve l of co ncern (LOC = 100).

Page I of 1 3It is HED polic y to use the bes t available data to assess exposure. Several sources of generic data were used in this assessment as surrogate data in the absence of c hemi cal-specific data , including the Pestic ide Handlers Exposure Databa se Version 1 .1 ( Pl-IED 1 .1 ); the Agricultural Handler Exposure Task Force (AHETF) database; and the Outdoor Residentia l Exposure Task Force ( ORETF ) database. Some of these data are proprietary , and s ubject to th e data protection provisions of th e Federal In sec ticide , Fu ngicide, and Rodenticide Act (FI FRA). Note: This memorandum wa s r ev iewed by the Exposure Science Advisory Co mmittee (Ex poSAC) on 7 1 9115

.

Pa ge 2of 1 3

### Ta bl e of C onte nts 1.0 Executive Summary
................. . ........ ...... ...................................... . .. . .. . ..................................... 4 2 .0 Risk Assessment Conclus ions and Recommendations
................... . ... . ..................................... 5 2.1 Summary of Risk Es timates
................................................... . .. . .. . ...... . ........................ . ........ 5 2.2 Data Deficiencies and Requirement s ... .. .. .. .. .. .. .. . .. .... . ...... . .. . .. .. .. . .. .. ..... . .. . ............................. 5 3.0 1-Iazard Characterization
...... . ........................................................ . ..... . .................... . . . .. . .. . ......... 5 4.0 Propo sed Use Profile
............... . ... . ...................... . ... . ... . ........ .. ....... . ...... . ..................................... 7 5.0 R esidential Ex posure and Ri s k Estimates
................................................................... . .. . .......... 7 5.1 Residential Handl e r Exposure/Risk Es timates
..................................................... . .. . ............. 7 5.2 Residential Post-application Exposure/Risk Estimates
............. . .................... . .. . .. . . . .. . .......... 8 5
. 3 Reside n tial Risk Estimates for Use in Aggregate Assessment
............................................. 9 6.0 Occupational Exposure and Risk Estimates
...................................................... . . .. . . .. . .... . .. . ...... 9 6.1 Occupational Handler Exposure/Risk Est imates
... . ............................................. . .... . ........... 9 6 .2 Occupational Po s t-application Exposure/ Ri sk Estimate s ......................................... . ......... 11

Page 3 of 131.0 Executi ve S umma ry Spirotetramat is a systemic in sec ticide , active ag ainst sucking in sect s . It can contro l hidden p ests and protec t n ew shoots. S pirotetram at i s currently regi s te re d for use on a va ri ety of agricultural crop s , and i s being propo se d for use on citrus trees in residential areas. Wh e n registered , thi s will be th e first residentia l use for sp irotetramat. The proposed en d-use product is a so lubl e concentrate (SC), 14ACP7 03 SC Insecticid e/M iticide (EPA Reg
. #43 2-xxxx ) , which contain s 2 lb ai/ga ll o n or 22.4% ai. The proposed lab el allows for up to 2 fo liar spray a pplications per year (with a 2 1 day retreatm e nt interva l) usin g handh e ld sprayers at a maximum si n g le application rate of lO 

### fl ozJA ( 0.156 lb ai/A), 4.25 fl o zJ lOO ga l ( 0.066 lb ai/100 gal) o r 0.23 fl ozJlOOO ft 2 ( 0.00 36 lb ai / l 000 

### ft 2 ). It i s anticipated that there w ill be s h ort- and interm e diat e -term occupationa l handl er expos ure , as well as s hort -term residential handler and po s t-application expos ures from the prop ose d ornamental u se. For sp irote tramat , a dermal endpo int was not se lec ted. D e rmal e ndpoint s were c h osen in pre v i o u s ri sk assessments; h oweve r , re evalu a tion of the to x ico lo g ical datab ase y ielded no dermal hazard. S inc e there is no co ncern for enhan ce d se nsitivity / s u sce ptibility to off sp ring from s pirotetr amat ex po sure, the effec ts of conc e rn in adults and off s pring are adequate ly assessed in the dermal toxicity study where no adve r se d e rmal or systemic effects were observed up to th e limit dose. The inhalation point of departure ( POD ) i s b ased o n a 90 -day oral tox ic ity s tud y in do gs with a no o bse rved adverse effect leve l (NOAEL) of 32 mg/kg/day. The LOC fo r inhalation exposure scenarios i s for MO Es < I 00 ( 1 OX for inte rs p ec ies extrapolat ion and 1 OX for intra.sp e ci es v ariation). S ince the NOAE L for inhalation ri s k assessment was c ho se n from an oral study , it was assumed that toxicity via the inhalation rout e i s equiva lent to oral toxicity. The residential hand le r expos ur e and ri s k est imate s indi ca t e that the short-term inha lation MOE s are not of conce rn to HED (i.e., M O Es :::: I 00). While re s id e nti a l post-application expos ure m a y potentiall y occ ur for adu lt s e nt e ring treat ed a re as , there i s n o dermal POD fo r sp irote tramat , therefore, a quantitativ e assessment was not co nducted. The occupational handl e r ex posure and ri s k es timates indic a te that the short- a nd intermedi ateterm inhalation MOEs are n ot of concern to HE D ( i.e. , MOEs :::: 100 ) w ith baseline attire (e.g. , lon g - sleeved s hirt , lon g pants , sho es plus socks , no gloves o r respirator). Si n ce the produ c t i s propo se d fo r use in res id e ntial se tting s on ly , it is not anticipated that comm e rci al applicators would n ot r et

urn to the trea t e d area after a pplication. Therefo re , a quantitati ve occ upational post-application assessment was not conducte d. Human Stud ies Re view This ri s k assess ment re li es in part on data from s tudies in which adu lt hum an su bj ects were inte nti o n a ll y exposed to a p est icide or other chemical. Th ese data, whic h include studie s fro m PH ED 1.1 ; the AH ETF databa se; and the ORETF databas e are (1) subject to ethjc s review pursuant to 40 CFR 26 , (2) have received that review , and (3) are compliant w ith applicable ethics requirements. For ce rtain studies , the et hic s revi ew ma y have includ ed rev iew by the

Pa g e 4of13

### Human Stud i es Review Board . D escri p t io n s of da ta sources, as well as g ui dance on their use , can be found at t he Agency we b s ite 1 • 

### 2
. 0 Ri s k Assessme n t C onclusions a nd Recommendations 2.1 Summary of Ri s k Es timates There are no resident ial or occupational risk est imates of conce rn for the proposed use of s pirotetramat on resident ial c itrus trees. All reside nt ia l MOEs are greate r than 5,500 , 000 and all occupationa l MOEs are g reate r than 690 , 000. 2.2 Data Deficiencies a nd Requirements In accordance w it h the u pdate d Part 1 58 data requ ireme n ts (2007) , a turf tran sferab l e r es i d u e (TTR) study is required fo r all occupati onal or residential turf uses, and one or more dis l odgeable foliar residue (DFR) studies are req u ired when a pest ic ide has resident ial or occupati o n al uses that could resu l t in post-applicati on dermal expos u re. Spirotetramat has no registe red o r proposed turf uses ; therefore , a TTR study is not req ui red at thi s time
. A DFR stu dy has been s ubmitted fo r spirotetramat (M RID 46904605) and has bee n rev iewe d by the Agency (D 407669); however, since the re is no derma l po in t of departu r e , th e stu dy h as no t bee n used in thi s assessme nt. 3
. 0 Hazard Characte rization Acute Toxic ity Spirotetramat is classified as Toxicity Category Ill for acute oral and acute dermal tox i c ity, Toxicity Category IV for acute inhalation toxic i ty , and Toxicity Category II for pri mary eye irritation. Spirotet ramat is not an i rritan t to the skin of rabb it s (T oxicity Category IV), bu t was s hown to be a skin se n s i tizer in mi ce . Table 

### 3. 1 p rese nt s a s ummary o f the ac u te toxicity info rmation for sp irotetram at. Ta b l e 3. 1. A c ut e T ox ic it v Profil e - S oirotetram a t Guideline No. Study Type MRID( s) 870.1100 Acute oral (rat) 46904527 870.1200 Acute dermal (rat) 46904529 870.1300 Acute inhalation (rat) 46904530 870.2400 Primary eye irr itation (rabbit) 46904531 870.2500 Pr im ary de rm a l irrita t i on (rabb it) 46904532 870.2600 Dermal se nsitization ( m ouse) 46904565

1 http: // www.epa.gov/ pes ticid es/ sc ience/handler -expo s ure-data.htm l and hnp : //www.epa.gov/ pesticid es/ sc ience/post
- app - exposure-data.html
Page 5of 1 3 Results Toxicity Category LD so >2000 mg/kg (F) 111 LD so > 2000 mg/kg (M&F) III LCs o >4.183 m g/ L (M&F) I V Corneal opacity and iritis II (grade I ); cleared by day 8 Negat ive IV Pos it ive N I A ( Loca l Lymph Node Assay)Toxicolog ica l PO Os Used for Risk Assessment For spirotetramat, a dennal endpoint was not selected. D enna ! endpoint s were chosen in previous risk assess ments; however , reevaluation of the toxicological database yie lded no dennal hazard. Since there i s no concern for enhanced se nsiti vity /susceptibi lity to offspring from sp irotetramat exposure, the effects of concern in adults and offspring are adequately assessed in the dermal toxicity study w here no adverse dermal or systemic effects were observed up to the limit do se. The inhalation POD is based on a 90

- day oral toxicity study in dogs with a NOAEL of 32 mg/kg/day. The lowest

- observed adverse-effect l eve l (LOAE L) of72 mg/kg/day is based on depressed red blood cell parameters , thymus atrophy, and decreased food consumption. The LOC for inhalation exposure scenarios i s for MO Es <100 ( I 

### OX for interspe cies extrapo lation and l 

### OX for intra spec ies variation). Since the NOA EL for inh al ati on risk assessment was chosen from an ora l st udy, it was assumed that toxicity via the inh a lation route i s equiva le nt to oral toxicity. As part of the revised 40 CFR Toxicology Data Requirements, subchronic inhalation and subchro ni c neurotoxicity (SCN) studies are necessary for registered uses ; however , the H azard and Science Policy Council (HASPOC) concluded, using a weight-of

- evidence approach, that these studies are not required at this time (TXR# 0056480). A lthough t he SCN study is not required accord in g to HA SPOC, a SCN study has been sub mitted , and the res ult s of the stu d y incorporated into the current assessment (neurotoxic effects were not displ aye d up to the highest dose tested). A summary of the toxicolog ical POD s and e ndpoints chosen for the re l evan t exposure scenarios fo r hum an ri sk assessment are found in Table 3.2.

Tab le 3.2. S umma ry of Toxicological Do ses a nd E n d p o in ts for S pir otetr amat for Use in Human H ea lt h Ri sk Assessments. Exposu re Sce nari o POD Uncenainty LOC for Ri s k Study and Toxicological Effects Factors Assessment Dermal Shon- and In a dermal toxicity study in rat s. no adverse effects were observ ed up to th e limit do se . Since there i sIntermediateTerm ( 1-30 day s no evidence of increased susceptibility. a dermal assessment i s not needed. and 1-6 months) OAEL = 32 90-Day om ! toxicity (dog) Inhalati on mg/kg/day UF A= I OX LOAEL -= 72 mg/k g/day [F] Shon-and UFtt = !OX Occupational I based on depressed RB C I ntermediate- Inhalation toxicity is FQPA SF = IX Residential LOC for parameter s (red b lood cell count. Term ( 1-30 days con s idered equivalent MOE = 100 hemoglobin level and and 1-6 m o nth s ) to oral toxicity. hematocrit). thymus atrophy and decreased food consumption. Cancer (oral. Classification : .. not likel y to be carcinogenic 10 human s.. based o n lack of evidence of carcinogenicity dem1al. inhalation) in rats and mice. Abbrevinuon s: UF = uncenamt )' factor . UF,. = extrapolation fromammal to human ( mtcrspec1e s)
. U F " =potential vanauon in sensi ti vity am on g members of ihc human population ( intraspcc ic s), FQPA**SF ~**  FQPA Safe!)' Factor
. NOA E L • no-ob se rved advcrsc-cITect level. LOAEL = lowes t-ob serve d adverse·eITect level
. MO E = margin of exposure. LOC 

### =l eve l cf concern . 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.
Page 6of13

### 4.0 Propo se d Us e Pro fil e Bayer CropScience has submitted a draft label for 14ACP703 SC Insecticide/Miticide (E P A Reg. #432-xxxx). Information pertaining to the proposed end

- use product is li sted in Table 3.3. There are no requ i red label changes at this time.
Tab l e 3.3. Summary of Dir ect ion s for U se of S piro t e tra m at. Appli c. Timin g, Formulati o n Applic
. Rate ( lb M ax . No. M ax. Year l y Type. a n d [EPA Reg. o .] ai/ A ) Appli c . per Y e ar A ppli c. R a te ( lb Us e Directi o n s and Limit a ti o n s Equip. a i / A ) R esi d ent ia l C i trus Trees 10 

### n o v A = 0. 1 56 Apply to ful l- lb ai/ A

s i ze mature Solub l e trees C oncentra te 4. 2 5 fl o z/ 100 ga l Do not a pply within I 0 days [432- xxxx] prior to bl oo m. durin g blo o m. = 0.06 6 lb a i/ 100 2 20 

### n ov A = or until p etal fall i s complete
. Fo li a r gal 0.3 2 lb ai/ A a ppli ca ti o n 2 lb a i/ga l Rctre auncnl interval = 21 days u s in g ha ndh e ld 22.4 % ai 0
. 23 

### n oz/ 1 000 f l2 s pra ye r s = 0.0036 lb ai/I 000 ft 2 

### 5
. 0 Re s identi a l E xposure and Risk Estimates There is the potential for r es id e ntial short-term handler and po st-ap plication d ermal and inhalation expos ure from the proposed u se on r es i de n tial ornamenta ls; how eve r , s in ce a derm a l POD has not been selected for sp irote t ram at , a quantitative assessment of dermal risk was not conducted. 

### 5
. 1 Re s id e ntial Handler Ex po s ure/Ri s k Es timates HED uses the term " handl e rs" to describ e those individual s who are involved in the pesticide appl ic ation process. HED believes that there are distinct tasks related to app li cat io n s and that exposure s can vary depending on the specifics of each task. R es id ential handlers are addressed somewhat differently by HED as homeowners are assumed to complete all eleme nt s of an application witho ut u se of any protective eq uipm ent. The quant i tative exposure/ ri sk assessment deve loped for resident ial h and le rs i s base d on the follow in g sce narios: ( 1) mixing/loading/app l y in g a liquid form ulation using a m anuall ypressurized handwand , (2) mixing/ l oading/applying a liquid formulat ion using a hose

- end spray er, an d (3) mixing/load i ng/applying a l iquid formulation using a backpack sp rayer. Residentia l Handler Exposu re Data and Assumptions A se ri es of ass umption s and expos ure factors se rv ed as the bas i s for comp leting the residentia l handler risk assess men ts. Each assumption and factor i s detailed below.

Pag e 7of 1 3Application Rate: Maximum app licati on rates, as outlined in Table 3.3, we re used to assessed re siden tial handl e r exposure. Unit Exposures andArea Treated or Amount Handled: Un it exposure values and es timate s for area treated or amount handled were taken from HED 's 2012 Residential SOPs 2 • Exposu re Dural ion: Although the product can be app l ied every 21 days, a maximum of only 2 applications can be mad e per year; therefore , only short-term resid e ntial handler expos ure was assessed. Residential Handler Non-Cancer Exposure and Ri sk Est imate Equat ion s The algorithms u sed to estimate exposure and dose for reside nti a l handlers can be found in Appendix A and/or the 2012 Residential S0P s 3

. Summary of Residential Handler Non-Cancer Exposure and Risk Es timates The residential handler exposure and ri sk estimate indicates that the short

- term inhalation MOEs are not of concern to HED (i.e., MOE::::_ 100). Tab l e 5.1. Residentia l Handler Non-ca n ce r Expos ure and Ri s k Estimates for S 1 >irotetramat. Inh alation Unit Maximum Amount Inhalation Level of (LOC 

### = 100) Exposure Scenario Concern Exposure Appl ication Handl ed Dose (mg/lb ai) Rate 1 Oaily2 (mg/kg/day) 3 MOE 4 Mixer /Loader / AoolicatorManuallypressurized 0.018 0.00066 5 0.00000074 43,000,000 hand wand 100 Ho se-e nd sprayer 0.0014 0.00066 II 0.00000013 250 ,000,000 Backpack sprayer 0.14 0.00066 5 0.0000058 5,500.000 1 Based on proposed loocl (E PA Reg
. #432-xxxx)
. 2 Base d o n HED" s 2012 Residential SOPs (http :// www e11a , gov/ pcsticide s/scicncc/ residential-exnQsurc -sop.html)
. l Inhalation Dose = lnhalatim Uni I Exp os ure (mg/ lb ai ) x Applicati o n Rate ( lb ai/gal) x Amoun t I land l ed (gallons/ da y) + Body Weight (ID k g). • Inhalation MOE = Inhalation NOAEL (32 mg/kg/day) + Inhalation Dose ( m g/kg/d ay)
. 

### 5.2 Residential Post-application Exposure/Risk Est imate s T he re is the potential for post-application expos ure fo r individuals expose d as a r es ult of being in an env ironment that has been previously treated with sp i rotetramat. For the spirotetramat proposed use on residential c itrus trees, there would be the potential for derma l exposure for adults and children (6 to < 11 years old) ; howe ver, since there is no dermal POD , a quantitative assessment of dermal risk is not necessary and has not been conducted. Post-application inhalation exposure while pe rforming activities in previously treated gardens or trees has not been quantitatively assessed due to the combination of low vapo r pressure for spirotetramat ( 1 .5 x 1 

# o· 8 Pa at 25 °C) and the expected dilution 

### in outdoor air.

2 Available: htlp: // www.epa.gov/ pe s ticides/ science /residential-cxposure-sop.html 3 Available: htto: // www .epa.gov / pesticide s/ science /resident ial-expo s ure-sop.htm I

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### 5.3 Res id e nti a l Ri s k Es timates for Use in Agg r ega t e Assess m ent Table 5.3.1 reflects the re s i dential risk esti mates tha t are r ecommended for use i n the aggregate assessment for spirotetramat.

• The recomm e nd ed re s idential exposure for u se in the adult aggregate assessme nt reflect s handler inhalation ex po s ure when using a backpack sprayer. Table 5.3.1. R ecommen d ations for the Res i de n t ia l Ex p osures for t h e Spirotet r amat Aggregate A ssess ment. Lifestage Dose ( m g/kg/day) 1 MOE 2 (Scena rio) Dermal Inhal ation Oral To tal Dermal Inh ala ti o n Ora l Total Ad ult (Backpac k Sprayer) NA S h o r t-te rm R es ide n t ia l H a ndl er 0.0000058 NA 0.0000058 NA
1 Dose= the hi ghes t dose for eac h ap pli cab le lifc stage of all sce narios assessed from Table 6 1
. I
. 2 MOE= the MOEs associated with th e hi ghes t doses identified in Table 6
. 1
. 

### 6
. 0 Occ up a tio na l Ex po s ure a nd Ri s k Estim a t es 6.1 O cc up a ti o n a l H a ndl e r E xpo s ure /Ri s k Es t ima t es 5,5 00 , 000 N A 5 , 500 , 000



### H ED uses the term handler s to desc ribe those in d i viduals w ho are i nvolved in t he pes t icide app lication proces s. H E D be lieves that there are di st inct job functions or tas k s related to applications and exposures can vary dependin g on the s pecifics of eac h task. Job requirements (amount of chemical u sed in eac h application) , the kind s of equipment u sed , the target bei n g trea ted , and th e le ve l of protection used b y a handler can cause exposure leve l s to differ in a manner sp ecifi c to each ap plication event. Based on the anticipated use patterns and current l abeling , types of equipme n t and techni qu es that can potentially b e u se d , occupational handl e r exposure is expected from the proposed u ses. The quanti tative exposure/ risk assessment developed for occ u pational h andlers is based on the fo ll owing scenarios: ( 1) mixing/ loadi ng/app l y ing a liquid formulation usin g a man ually

pressurized handwand , (2 ) m ixing/loading/ app ly ing a liquid formulation u s in g a mec hanicall y pressurized hand g un , and (3) mixing/loadin g/ applying a liquid formulation u s ing a backpack sp ra yer. Occupational Handler Expos ur e Data and Assumptions A se rie s of assumption s and exposure factors served as the basis for comp le ting th e occ upatio na l ha ndler risk assessmen t s . Eac h ass um ption and factor is deta i le d be low o n an in d ividual basis. 

### A

pplication Rat e : Maximum application rates , as o utlin e d in Tab l e 3.3 , w ere u se d to assessed occ upational handl er exposu re. 

### U

nit Exposures: It 

### is the pol icy of HED to u se th e bes t available data to assess handler exposure. So urces of generic h andl e r data , u sed as s urro gat e data in the absence of c he mical-specific
. data, Page 9 of 1 3include PHED 1.1, the AHETF 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 FTFRA. 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 s urrogate data , including descriptions of the various sources , can be found at the Age ncy website 5

. 

### Area Treated or Amount Handled: An estimate of 40 and 1000 gallons handled/day was used in the occupational handler exposure calculations for backpack/manually-pressurized handwands and mechanically

- pressurized handguns, respectively, based on guidance in ExpoSAC Policy 9.1. 

### 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 u se s ite. For most agricultural uses , it is reasonable to believe that occupatio nal handlers w ill not apply the same chem ical every day for more than a one - month time frame; however, there may be a large agribusiness and/or commercial applicators who may apply a product over a period of weeks (e.g ., completing multiple applications for multiple clients within a region). For spirotetramat, based o n the proposed use , short

- and intermediate

- term exposures are expected s in ce there is the potential for mu l tipl e applications at the maximum applicat ion rate. The proposed label is for use on residential citrus trees, and the product co uld be used by professional applicators for multiple clients. The label does state that the product can be applied up to 2 times per year with a 2 1 day interval. It should also be noted that for spirotetramat , both the short- and intermediate-term PO Os are the same; therefore, estimates of short

- term exposure/ risk are protective of any repeated exposure for lon ger than 30 days. 

### Mitigation /

Personal Protective Equipment: The proposed product label for this use recommends that applicators and other hand ler must wear protective eyewear , long

- sleeved shirts and long pants , chemical -resistant gloves , and shoe s plus socks. Occupational Handler No n- Cancer Exposure and Risk Est im ate Equation s The algorithms used to estimate non - cancer exposure and dose for occupationa l handlers can be found in Appendix A. Summary of Occupat ional Handler Non-Cancer Exposure and Risk Estimates The occupat ional handler exposure and risk estimates indicate that the short- and intermediateterm inhalation MO Es a re not of concern t o HED (i.e.,**MOE ~**  l 00).

4 Availabl e : http: //www.epa.g o v /oppOOOO I/ s cience /handler-exposure-table
. pdf 5 A vai I abl e : http: //www.epa . gov/ pe sticides / scienc e /handler-expo s ure-data
. htm I

Pa ge 10of13T ab le 6. 1. 1. Occupational H a n d ler N on -Ca nc er Ex p os ur e a nd Ri sk Est im ates fo r S piro tet r a m at. Inhal ation Unit Inh alation Exposure Maximum Amount Handled (LOC 

### = 100 ) Exposure ccnario Crop or Target (ul!/lb ai) 1 Application Rat c2 Oaily3 Dose Mitigat ion Leve l (mj!,/kg/day) 4 MOE 5 Mi x er/loader/ Aool i cato r Manua ll y-p rcss uri zed 140 handwand fo r fo liar (baseline) 40 0.0000463 690,000 applications Backpack s praye r for Residential 30 0.00066 40 0.0000099 3,200.000

foliar annlications Citrus trees (baseline)

Mechanically- 3.9 pressurized handgun for (baseline) IOOO 0.000032 1 1 ,000 , 000 fol iar app li catio n s

. . .. 1 Based on lh e '"Occupa ti o nal P es u c 1d c Handler U 111t Ex pos ure S urroga t e Reference Tab l e" (May20 13); Leve l of 1111t1 gat1on : Baseline ( l o n

gs leeved s hirt
. l o n

g pants , s hoes plus socks). Based on proposed l ooel (EPA Reg .# 432-xxxx). 1 Exposure Science Advisory Council Policy 119. l. ' Inhalation Dose = lnhalatiCll Unit Exposure (μg/lb ai ) x Conversion Factor (0.001 m g/

11g ) x Application Rate ( lb ai/g al) x Amount Handled (g al/ day) + BW (80 kg).**~** Inhalation MOE = Inhalation NOAF.L (32 mg/kg/day)+ Inhalati on Dose (mg/k g/day). 

### 6 .2 Occupati ona l Po s t-app li cation Ex po s ure/Ri s k Estimates HED u ses the term po s t- a ppli cat ion to describe ex posure s that occ ur when ind i v iduals are present in an e n v ironment th at has been prev iously treated with a pesticide (al so referred to as r e entry ex po s ure). For th e proposed use of sp irotetrarnat , occ up a tional post-application exposure i s not antic ipated since the u se i s on residential citrus trees. Professio na l applicators would not be expected to return to a res id e ntial area to perform function s associated with prev i ous l y treat e d residentia l c itru s trees. Therefore , a quantitative occupational p os t-application assessment was not conducted.

Page 11 of 13Appendix A. Su mm ary o f Occupational and Re s id e ntia l N on-c ancer Algorithms
R ES IDENTIAL NON- C ANCER H ANDLE R ALGORITHMS Gardens and Trees

-- Inhalation Handle r Exp o s ur e Algorithm D a il y inhalation exposure (mg/ day) for residential pe s ticide handl e r s, for a given formulationappl ication method combination , is estimated by mu lt iplying the formulation-application me thod-specific unit exposure by an estim ate of the amount of active ingred i e nt handled in a da y, using th e equation below: E 

### = UE *AR* A where: E = exposure ( m g/ day ); UE = unit expo s ure (mg/ lb a i); AR = app lic atio n rate (e.g. , lb 

### ai/ ft2, lb a i/g al ); and A = area treated or amount ha ndled (e.g., 

### ft2/ da y, ga l / da y)
.

O CCU PATIO NAL NON

- CANCER H ANDLER ALGORITHMS P o t e nti al dail y exposures for occupational handlers are c alculated u s ing t h e following formul as:

w he r e: E UE AR A = =

= E = UE *AR* A 

## * 0.001 mg! ug

ex po s ure (mg ai / day) , unit exposure (μg ai/lb ai) , maximum application rate accord in g to proposed lab e l (lb ai A or lb ai/ga l), a nd area treated or amount ha ndl e d ( e.g. , Ald ay, gal/day). The dai ly do ses are calculat e d u sing t he fo ll owing formu la :

w here: 

### A DD = E 

### AF = 

### BW ADD= E*AF 

### BW

average dai l y dose absorbed in a given sce nario ( mg ai/kg/day) , ex posure (mg a i/day) , abso rption factor (dermal a nd/ or inh ala ti o n) , and body weig ht (k g).
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### Margin of Exposu re: Non -c ance r risk estimates for eac h application handler sce nario are calcu l ate d using a Margin of Expos ure ( MO E), whjch is a ratio of th e toxicological endpoint to the d a i ly dose of concern. The dai ly derma l and inhalation dose received by occupa ti ona l handl ers are compared to th e appropriate POD (i
. e. , NOAEL) to assess the risk to occupational handlers for each expos ure route. All MOE val ue s are calc ulated u s ing the fo ll owing formul a :

w he r e: MOE POD 

### = ADD = 

### POD MOE = - 

### ADD

margin of exposure: value u se d by HED to represent ri s k estimates (urutless) , point of departure ( m g/kg/da y), and average dail y d ose absorbed in a given s cenario (mg a i /kg/ day).

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