### UN IT E D S T A T ES EN VIRO NM ENTAL PROT E CTIO N AG ENCY WA S ID NGTON , D.C. 2 04 6 0 

### O FF I C E O F C H E MI C AL SAFETY AN D POLL U TIO N PRE VEN TIO N

D a t e: 03 / 20/ 2016 

### S ubject: Coumaphos : Regis tration R ev iew Occupati onal Expos u re Assessment for Use on Cattle , Cattle Ear Tags, Horses , Swine, Swine Bedding, and B eehives. P C Co d e: 03650 I De ci s io n No. : 475453 P et i t i o n No.: DP B a r co d e : 0410244 R eg is tra tion N o .: See Use Profile R eg u lato r y Actio n : Reg Review Case No.: Ri s k Assess m e n t Type: Occupational / Resid ential Exposure Assessment TX R No.: NA C A S No.: 95266-40-3 40 CF R : §180.189 MRID No.: NA
From :


### Through :

T o : /]"7**~~** B ridg e tt Bobowiec, Biolog ist -)j-t.e

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### VI Health Effects Division (7509P) D onna Davis, Branc h Chief ((/\

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## ~**._.,.. ~**  Health Eff ects Di v ision (750 9P) And

.**~** ,7 Barr y O ' Keefe , Senior Biologist 

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# tl..i.<J<., // 

# 'J:;;?{ Jame s S. Mille r, Env i ronmental

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- - -- .- Exposure Science Advisory Committee (fuq{oSAC) 

### I HED Shelia Piper, Ri sk Assessor Branc h VI H ealth Effects Division (7509P) And Brian Kettl, Chemical Review Manager Tom Myers, Team Leader Kevi n Cos tello, B ranch Chief Ri sk Management and Implementation Branch IV Pesticide Re-e valuation Division (7508 P)

Page I of29

### Introduction The Pesticide Reevaluation Division (PRD) requested that the Health Effects Division (RED) conduct an expo sure and ri sk assessment for the curren t ly r eg istered u ses of coumaphos as part of the regi stration review process. Coumaphos is registered for use on livestock including cattle , cattle ear tags , horses , swine as well as swine bedding, and bee hive s . There are curre ntl y no registered non- occupational (residential uses) for coumaphos. 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: P esticide Handlers Exposure Database Version 1.1 (PHED 1.1 ); and the Agricultural Handl er Exposure Task Force (AHETF) database
. Some of these data are proprietary, and subject to the data protection provisions of the Federal Insecticide , Fungicide , and Rodenticide Act (FIFRA)
. 

### No te: This memorandum was reviewed by the Exposure Sc ienc e Advisory Committee (ExpoSAC) on 10/ 3 1/2013
.

Pag e 2 of29

### Tab le of Co ntents 1
. 0 Executive Summary
............... ... ... . ................... ... .. ... .......................................... . .. .... .. . ........ 4 2.0 Risk Assessmen t Conclusio ns and Recommendations
......... . .. ....... .. . .................................. 7 2. 1 Su mmary of Risk Estimates
. .................. ........ .................. .. .. .. .. .. .. . ................................... 7 2.2 Label Recomm endat ions from Occupational Assessme nt.. . .. .. ... .. . .. ... ............................. 7 2
. 3 Data D eficiencies a nd Re quire m ents ........ ........ . ... .. ... ................ . .......... . .. . ..... ............ . .. . .. 8 3.0 H azard Charac terizati on ...................................................................................... . ..... .. ......... 8 4.0 Use Profile
..................... .. ... .. .................................................................................. . .......... 

### 11 5.0 R eside ntial Expo sure and Risk Est imates ........... . ....................... . ...................................... 14 5.1 Re sidential Risk Es timates for Use in Aggregate Assessment
...................................... 14 6.0 Non Occupational Spray Drift Expo su re s and Ri sk Es timates
. ........ ............ .. . ........... ..... .. 14 6 .1 Non-Occ up ati ona l B ysta nder Post-Application Inh a lation Expos ur e a nd Ri sk Estim ates 

### 14 7 .0 Occupationa l Expos ure and Risk Estimates
. ..... . .. .............. . ... .. .. . .................. . .. . .. .. . ..... ...... 14 7 .1 Occupational Handler Exposure/Risk Est imates
............................................................ 14 7.2 Occupational P os t-application Exposure/Risk Estimates ... .. .. ... ................... . .. ..... . .. ...... 28 7.2. I Occupationa l P ost-application Inhalation Exposure
.. .. .. .. ... ...................... .. . .. .. . ...... 28 7
. 2
. 2 Occupational Post-app li cat ion Dermal Ex p os ure ............. ... . ...... .. . ......................... 28 Appendix A. Summary of Occupatio n al Non-cancer A lgorithms
. .. .. .. ..................... . .. . .. .. ........... 29

Page 3 of29

### 1.0 Exec uti ve S ummary This document presents an occupational and residential exposure and risk assessment for the currently registered u ses of coumaphos or (0 , 0-diethyl 0-(3-ch loro-4-methy l- 2-oxo-2 H-1

- benzopyran- 7-yl) phosphorothioate)
. It 

### is a member of an organop hosp hate (OP) in sect icide class that primarily affects th e ne rvou s system thr oug h acety lc holinesterase (AChE) inhibition. Coumaphos is applied directly to animals , including dairy cattle, beef cattle, swine , horses , and swin e bedding. The chemical is also embedded into cattle ear tags and bee hive strips. Co umapho s is registered for the contro l of arthrop od pests such as : ticks , mites, li ce, flie s (incl udin g face flies and horn flies), fleece wom1s , and screw worms. There are no reg is te r ed non-occupational (residential) uses for coumaphos. Use Profil e Coumaphos is formulated as a technical 96% active ingredient (a.i
. ), as well as a dust formulation intermediate (25%a .i.), a dust ( I %a. i. ) , an emulsifiable concentrate (6.15 and 11.6 % a.i.), and a flowable conce ntrate (42%a. i .). Coumaphos is a lso embedded into cattle ear tags , (20% a.i) and bee hive pest control strips (10%a.i). The app li cation of coumaphos to live s tock can include use of the following equipment: sw im and hydraulic dip vats , shaker cans , dust bags , back oilers/rubbe rs , pressurized handguns , backpack, handheld hand-wands , and ear tags. Applicat ion rates range from 0.005 to 0.025 lbs a.i. per gallon for sprays or dips, 0.076 lbs a.i. per gallo n of oil for back-rubbers. 0.000625 to 0.013 lbs a.i. per an imal for dust application, and 0.000042 lbs a. i. per 1 ,000 square feet of swine bedding treatment. There are various leve l s of p erso nal protective eq uipment , or PPE , mandated on coumaphos label s depending on the formulation and application rate. Some of the hi g her rates for spray application require handlers to wear a single layer dennal protection with gloves and a PF I 0 respirator, while some of th e lower application rates do not require any respirators. Co um aphos dust formulations r equire handler s to wear a sing l e l ayer dermal protect ion along with gloves and at least a Pf5 respirator. This assessment addresses expos ure and ri sk associated with the end u se products for coumaphos when used as directed by occupational workers. The re is a potential for occupational exposure associated with handler activities (i.e
.. mixing, loading , and applying). Based on the Agency's current practices, a quantitative post-application inh alation and dermal exposure assessment and a spray dr i ft assessment was not performed for coumaphos at this time due to the label direct ions and use pattern . 

### Exposu re Duration: For OPs such as coumaphos. matching the toxicological endpoint and the exp osure duration is different than HED ' s approach fo r conventional chem ical s . OPs exhib it a phenomenon known as s tead y state acetylcholinesterase (AChE) inhibiti on. R epeate d exposures to OPs gene rall y result in more AChE inhibition at a given administered dose compared to acute stud ies.
Page 4 of29Moreover, AChE inhibition in repeated dosing guideline toxicology studies with OPs show a consistent pattern of inhibition reaching steady state at or around 2-3 weeks of exposure in adult laboratory anima ls (U.S. E PA, 2002). After repeated exposure at th e same dose , the degree of inhibi t ion comes into eq uilibrium with the production of new, uninhibited enzyme . As such, AChE studies of 2-3 weeks gene rally show the same degree of inhibition w ith those of longer duration 

### (i.e. , up to 2 years of exposure). The steady state approach is appropriate for coumaphos given the toxicolog ical and exposure profile. The · 'steady s tate,. endpoint selection for coumaphos ove rl aps with HED ' s traditional s ho11-tenn exposure duration endpoint selection and is considered health protective for occupational handlers that apply commercially over l onger periods of time (i.e. , intermediateterm exposures). C hroni c expos ure is not expected for the r egistered use pattern so that duration was not considered. H azard Profile The toxicology databa s e for couma phos is complete for risk assessment. There are acceptable data available for toxicity endpoin t selection from s tudies across multipl e lifestages , durations , and routes for both red blood cell ( RBC ) brain AChE inhibition. The acute toxicity of coumaphos is high via the oral route of exposure (Catego ry 

### I), moderate v ia the inhalation route (Category II ), and s li g ht via th e dermal route (Category III ). Coumaphos is not a dermal sens itize r or a dermal ir r i ta nt and it does not cause delayed neuropathy. Cou maphos is negativ e for mutagenicity and in accordance with the Agency's Draft Cancer Risk Assessme nt Guidelines (July 2 , 1999) is classified as "no evidence " of carc inogenic ity for humans based on adequate s tudies in two animal s p e cies. E ndpoints and point s of de partures ( PoD s) using a s teady state duration were selected for dermal , and inhalation routes of exposure. A steady state dennal PoD was selected from a 21-day dermal tox icity study (MRTD 4266640 1) in rats based on red blood cell, RBC ChE inhibition bench mark dose limit , BMDL1 0 = 0.5 mg/kg/day; and bench mark dose , BMD1 0 = 0.72 mg/kg/ day) in the fema l e rat. In the absence of a repeat dose inh alat ion study, a 2 ge ne rat io n oral reproducti on study was used to select the steady-state inhalat ion PoD ; a BMD1 0 of 0.05 mg/kg/ day associated wi th RBC ChE inhibition in both male and female adult rats of the FO and F 1 generation s. The coJTespond in g BMDL 1 0 was 0.04 (0.036 rounded) mg/kg/ day. An e stimated 100 % default absorption facto r ( of o ral absorption) was assumed. A total uncertainty factor of 1 OOOX i s appropriate for oral and dennal routes of exposures for occupational handlers and post-appl ication exposure [1 OX for interspecies extrapolation , I OX for intraspecies varia tion , and FQPA SF for 1 OX safety factor is retained. A tota l uncertainty factor of 3000X [I OX for inte rspec ies ex trap o lat ion , 1 OX for intraspecies variation , and 3 0X for database unc ertainty facto r] incorporating uncertainty in the human dose-response relationship for neurodevelopmental effects 1 and the uncertainty due to lack of subchron ic inhalation toxicity s tudy). The Hazard and Science Policy Council ( HASPOC) (April 29 , 2013. TXR 0056625 ) recommends , based on a we ight of evidence (WOE) approach , that a subchronic inhalation study

1 For more details , s ee Section 4.4 in the human health ri s k a ss e s sment: Memo , S. Piper e t a l, -2015 , 0409347. Pag e 5 of29

### is ne e ded t o characterize th e pote ntial for a dve rse effects associat ed with th e inhalation rout e of ex po sure. R esident ia l Ex posure/Ri sk: There ar e no re g iste red n o n- occ upati o n al (resi d e ntial ) u ses for co umaph os , a nd ther efo re a quantitative res idential h a ndl er and post-application assessment was not co nducte d
. No n-O ccupational Spray Drift Exposure and Ri sk A quantitative non - occupational spray drift assessme nt was not conducted for th e reg iste red u s e s of coumaphos due to th e lim ited u se pattern on livestock , ho rses, and in bee hi ves. Occupational Handl er Expos ure and Ri sk In 

### o r de r to detern1 ine what leve l o f persona l protection i s requi red to a ll eviate ri s k concerns and t o ascertai n if l abe l modi ft 

### cations are needed , s teady state expos ure a nd ri s k est im ates were calcul ated for occupat ional h a ndl e rs of co um ap hos for a va ri e t y of sce n a ri os at differing leve ls of pe rso n a l pro t ec ti o n inc ludin g e ng ineerin g co ntrol s. It 

### is a nti c ip ated that th e r e w ill be occupationa l handler s h or t- a nd intermed iate-te rm e xp osu re to cou mapho s; however, the steadystate tox endpoint overlaps th e expected exposure duration s a nd is health protective. Chronic exposure i s not expected for the registered u ses. Eight m ajo r handler exposu re sce nari os we re assesse d as fo llow s : mixin g/ load ing liquids for hyd rau li c type dip vats; mi x ing/loading liquid s for sw im type dip vats; mi x in g/ loadin g liquid s for back rubb e r / o il e rs; lo ad in g dust into bag s; app l y in g du sts with a s haker can to li vestock o r swine bedding ; mi x i ng/loa din g/applyi ng liquid s for backpack , mechanically p ressurized hand guns , and manu ally pre ss urized handh e ld hand

- wands. Expos ure to coumaphos from handling and appl yi ng li vestock ear tags a nd bee hive pe st contro l strip s i s conside red to b e negligible becau se lab e l s req uire g lo ves . A f e m al e - s p ec ifi c body we i g ht of 69 kg was u se d to protect pregnant workers b ased on the un ce rtainty in the hum a n do se- r es p o n se re l ationship for neurod eve lop mental effects 2

. 

### D efaul t assump ti ons established b y the H ED Sc ie nce Advisory Coun cil for Exposure (ExpoSAC) were u sed for othe r parame ters s uch as amou n t handled. H E D co nt inues to request more quantit ati ve dat a. s uch as the number of cattl e dipped per day, nu mber of day s dipping takes place pe r year, etc. , to refine exposu re to dip vat workers in quarantin e areas und e r th e anima l a nd plant hea l th in s pection serv ic e , (AP HI S) U S DA program . A total agg regated risk index (A RI ) app r oach was used as a risk metric to accou nt for the d iff erent l eve ls of concern (LOCs) between de r mal (L OC 

### = 1 ,000) and inh alati on (LOC 

### = 3 , 000) exposure. The target A Rl is l ; th e refore. A RJ s of less than I are risk estimates of conce rn . A lm ost a ll of the occupational exposure sce n ari os show ri s ks of concern fo r both dermal and inhalati o n r outes at varyi ng le ve l s o f PPE
. Ca lc ulation s of ri sks indicate that the AR Tval ues a re below 1 

### fo r all ex po s ure sce nari os except fo r mixing and load in g back o il rubb e rs w i th the e mul s ifi ab l e conce ntrate formulatio n.

2 For more details , se e Section 4.4 in the human hea lt h ri sk assessment: Memo , S. Pi per e t a l, I 5-SE P-2015 , 0409 347. Pag e 6 of29

### Occ u pationa l Post

- Appl ication Exposure Dermal post-app l ication exposure is not anticipated due to the limited coumaphos use pattern and the refore was not included in this asse ss ment. Coumaphos product label s include the language, "Do not contact treated animals unti l sprays have dried and dusts have settled on the coat." Based on the Agency's current p rac t ices , a quantitat ive non-cancer occupationa l post
- app li cation inhalation ex posure assessment was not performed for coumap hos a t this time. 

### If new policies or procedure s are put into plac e, the Agency may revisit the need for a quantitati ve occupational post-application inhalation exposure assessment for coumaphos. H uman Stud ies Review This risk assessment relie s in part on data from studies in which adult human s ubjects were intentionally exposed to a pesticide or other chemical. The se data, which include studies from P H ED 1.1 ; the A H ETF database; and pub li shed literature studies, and are 

### (1) subject to ethics review p ur suant to 40 CFR 26, (2) have received tha t rev iew, a nd (3) are compliant w i th app li cab le et hi cs r eq ui rements. F or certain s tudies, t h e ethi cs review may have inc lu de d review by the Human Studies R eview Board. Descriptions of data so urces , as well a s guidance on the i r use . can b e found at the Agency website 3

. 

### 2.0 Ri s k Ass e ss ment C onclu s ion s and Recommendation s 2.1 S ummary of Ri s k E s timate s There are occupational handler inhalation and dermal risk estimates of concern for the c u rrentl y registered uses for coumaphos
. Occupational exposure scenarios us i ng coumaphos flowab l e concentrates, emulsifiab l e concentrates and dust formu lations were of concern (ARis < 

### I) with the excep ti o n of m ix i ng an d load in g l iq uid prod ucts E P A regis tratio n nu mbe rs 11 556 -11 5 an d 11556-23 fo r livestock back o il rubbe rs (ARI 

## = I 

### with doub l e layer derma l protection and PF5 respirato r). See Tab les 7.1.1 through Table 7.1.9 for risk estimates. A spray drift assessment was not completed for the currently reg iste red uses of coumaphos because of the use pattern is limited to li ves tock applicat ions and beehive s. 

### 2.2 Label Recommendations from Occupationa l As s ess ment A summary of the risk estimates have been provided , and shows that there are ri sk estimates of concern for registe red use s of coumaphos based on the labe l-required personal protective equipment for occupational worke rs. Mechanical dusting is prohibited yet appears on some of the dust formu l ated label s (Co-Ral B ulk Dust (1%) [ 34704-267 , and Co-Rat ( 1 %) [960 -1 84].

3 hrrp: //www2.epa.gov/ pesticide-science-and-assessing-pesticide-risk s/ occupational-pesticide-handler-exposure-data and hrrp: //www2.epa.gov/ pesticide-science

- and-assessing-pesticide-risks/ occupation al-p esticide-post -applicationexposure Page 7 of29Label corrections/ re v ision s s h ou ld be made to remove all mechanical dusting and inconsistent respirator requirements including the TC 2 I C respirator nomenclature. 

### 2 .3 Dat a D e fici e n c i es and Re qui re m e nts HED continues to recommend that registrants submit more information on quarantine dipping practices to comply with 40 CFR 158.1070 post-application gu id elines includin g use pattern information (e.g., cattle dipped per day, number of days dipping takes place per year , and etc.) in order to clarify and refine exposure scenarios. 

### 3 . 0 Haza rd C h a racteriza ti o n Co umaphos i s an OP with a neurotox ic adverse outcome pathway (AO P) , a lso often called the mode of action ( MO A). Inhibiti on of the enzyme acetylcholinesterase (AChE) v ia phosphorylation of the seri ne residue at the active site of the enzyme leads to accumulation of acety lc holin e and ultimately to neurotoxic ity in the centra l and/or peripheral ne r vous system. Consequently, AChE i nhibition, as an indicator of neurotoxicity, is being used to der ive the PoD s. HED 's toxico logists hav e determined that the red blood cell (RBC) AChE in hibition i s substa ntiall y more sens iti ve than brain AChE inhibition for all li festages evaluated (adults , juveni les, pregnant dams, and fetuses) in oral and dermal studies. Afte r repeated dosing at the same dose, the degree of inhibition comes into equi l ibrium with the production of new , uninhibited enzyme. At this point , the amount of AChE innibition at a given dose remains consistent across duration. After repeated exposure at the same dose , the degree of inhibiti on comes into equilibrium with the production of new, uninhibited enzyme. In general , OPs reach steady state within 2-3 weeks but this can vary among OPs. In th e case of coumaphos, pattern of s teady state i s reached at or near 11 day s of expos ure. Coumaphos has high quality dose response data across mult iple lifestages , durations, and routes for both RBC and brain AChE inhibition. Many of these studies have been evaluated using benchmark dose modeling tec hn iques. I n addit ion to th e consistency across durations, the data across multiple s tudies (repeat CCA study , gestational data from th e ONT , subcnronic neurotoxicity study , and subchro nic rat toxicity study) are similar. For the purpo ses of the occupational and residential risk assessment , only the steady -state duration is relevant to th e occupational exposure scenarios. Coumaphos is negative for muta ge nicity and in accordance with the Agency's Draft Cancer Risk Assessment Guidelines (Ju ly 2, 1999) i s classified as " n o ev id ence" of ca r cinogenicity for human s based on adequate studies in two animal s pecies. Acute Toxicity Th e acute toxicity of coumaphos is nigh via the ora l route of exposure (Category I) , moderate via the inhalation route (Category II ) , and s li ght via the dermal route (Category TIT ). Coumaphos is not a dermal sensitizer or a dermal irritant. See Table 3. l. I for info rmation on acute toxicity profile.

Page 8 of29Tab l e 3.1.1. Ac u te Tox i ci ty Profile for Co um ap h os Guideline No. Study Type MRID(s) Results Toxicity Category 870. 11 00 Acute oral [rat] 00 11059 7 LD so (M) >240 mg/kg I L

D

so (F) = 17 m g/

kg 870.1200 Acute dermal [rabbi t] 00 11 0598 LD so : > 2400 mg/kg lil 870.1300 Ac ute inhalation [rat] 00110601 LC so (M) = 1.081 mg/L 11 LC so (F) = 0.34 1 m g/L 870
. 2400 Acute eye irri tation [rabbit] 00 11 0599 Mild Irritant. reso lved by IV day 7 870
. 2500 Acute dermal irrit ati on [rabbit] 001 1 0600 No Irrit ation IV 870.2600 Skin sensitizat i on [guinea pig] 00 11 0602 Non sens iti ze r N I A 

### Toxicological PODs Used fo r Ri sk Assessment 

### Dermal. Steady State A s teady-state dermal PoD was se lected from a 21-day dermal toxicity study (MRID 4266640 l) in rats based on RBC ChE inhibition ( BMDL 1 0 

### = 0.5 mg/ kg/day; BMD1 0 

### = 0.72 mg/ kg/ day) in the female rat. It is not e d that the fema le and male data for the second dermal s tudy (that tested higher dose s of 2, 4, 20 and 100 mg/kg/ day ) did not provide statistically acceptable results with a P-value of 0.05 using a l og- li kelihood ratio test for RBC AC hE inhibi tion ; however , visual observation of the data s how a good fit and s imilar findings to th e females in the s tud y (BMDL10 of 0.71 mg/ kg/day). RBC AChE inhibition was s ign ifi cant ly more sensitive than brain AChE inhibition (between 6 and 8.3 fold) in the dermal toxicity study. A total uncertainty factor of I OOOX is appropriate for dermal exposures (I OX for interspecies extrapolation, l OX for intraspecies variation, and a I OX FQPA safety factor due to uncertainty in the human dose-r esp on s e relationship for neurode ve lopmenta l effects 4 )

. 

### Inhalation
. Steady State In the absence of a repeat do se inhalation study, an ora l study was us e d to assess a s teady-state inhalation occupat ional exposure and ri s k. HED assumed that the time to reach steady

- s tate is comparab l e for oral and inhalation exposure . A PoD for the s tead y - s tate inha lat ion exposure scenario was d e rived from the re s ults of a 2-generation reproduction study (MRID 4306 1701 )
. A BMD10 of 0.05 m g/ k g/day associated with RBC ChE inhibition in both male and fe mal e ad ul t rat s of the FO and Fl generations from th e 2-generation re productiv e study was se l ected as a suitable PoD for the steady-state inhalation (all populations) exposure sce nario. Th e correspond in g BMDL1 0 was 0.04 (0.036 rounded) mg/kg/da y . An 

### estimated 100 % d efault absorption factor (of oral absorption) was assumed
.

4 For m o re detail s , see Section 4.4 in th e human heal th ri sk assessment: Memo, S
. Pip er et al , I 5

- SEP

- 2015, 0409347. Page 9 of29

### In some cases toxicity v ia the inhalati on route i s higher than toxicity via th e oral route , which can res ult in an und e res tim ati o n of risks from inhal ati o n ex po s ure if an oral PoD is used to estimate inhalation exposure. In a ddition , there m ay be a potential for portal of entry effec t s v ia the inhalation route, which would not be accounted for in the oral studies. As a res ult , the HASPO C (A pril 29, 2013, TXR 0056625) concluded th a t a subc hronic i nhalation study is needed for a m o r e accurate assessme nt of inhalation risks. EPA app li ed an additional da tabase uncerta inty factor t o account for the missing st ud y. For steady-s ta t e inhalation exposures, a total un certa int y facto r of 

### 3000X was appl ied [1 

### OX for interspecies extrapo lat ion, l 

### OX for intraspec ies variat ion, and a 30X FQPA safety factor due to un certainty in the hum an dose-response re la ti o n s hip fo r ne urode ve lopm e nt al effec t s 5
, 

### and a database uncertainty due a lack of a r epeat inh a lati on toxicity st ud y ]. Based o n the oral studies , l ife s tages sensitivity is not expected for th e inhalation route of expo s ure . A s umm ary of the toxicological doses and endpo ints fo r u se in the occ up at ional exposure and risk assess ment are provided in Table 3 .1 .2.

Tab l e 3.1.2. S u m m ary o f Tox i co logi cal D oses a nd E n dpoi n t s fo r Co um a ph os for Us e in Occ up at i o n a l Hu ma n H ea l t h R isk Assess me n ts Level of Expo s ure/ Point of Uncertainty Concern for Study and T ox icolog ical Eff ec ts Scenario D e parture Factors Ri sk As sess ment Dermal 21-day dermal t ox i city study ( MRID Steady State BMDL1 0 = 0.5 UFA= IOx Occupa ti onal 42 66640 1 ) in female rats UFtt=IOx LOC for MOE = (2 1 days and mg/kg/ day U F

os =I Ox IOOO BMD 10 = 0. 72 mg/kg/day for inhibition of longer) RBC ChE in adult female rats. BMDL 10 = 0.04 2 generation reproductive study (M RID mg/kg/day In ha l ation UFA= I Ox Occupat ional 4306 170 1) Steady Stat e Inh alat i o n UF11 = I Ox LO C for MOE = (2 1 days and absorption UFos= 30x 3000 BMD 1 0 = 0.05 m g/kg/day for Inhi bition of longer) 100 % of oral RBC ChE in f- o and F 1 young adults at 90 days ab sorption in both males and females
'- I Cancer (oral. dermal. Classification: no evidence of carcinogenicit y to humans. inhalation) Point ofDepanure (POD) = A data point or an esumated point that is derived from observed dose-re sponse data and used to mark the beginning of extrapolation to determine risk associa ted with lower environmentally re l evant human exposu res. BMDL 1 0 = lower confidence interval on th e benchmark dose for 10 % respon se. LOC = l evel of concern. For occupationa l derma l and inh alation sce nario s, UFos =da tab ase uncertainty facto r fo r uncertainty in th e human dose-re spon se relationship for ncurodevclopmental efTeets (see Section 4.4 of the hum an health risk assessmen t, 0409347). 

### Absorp tion Prev iously, the HED HI ARC determined that in th e absence of demial absorpt io n data and conside rin g the observat ion that e rythrocyte C h E inhibition is observed in both oral g a vage and

5 For more detail s, see Section 4.4 in the human health risk assessme nt: Memo , S. P ip e r et al, I 5-SEP

- 2015, 0409347. Page 1 0of29dennal rat studies at similar dose levels , the default of l 00% absorption should be used. However, the steady-state dermal point of departure PoD was based on a route-specific toxicity study, and therefore no absorption factor was necessary to estimate exposure. Body We i ght The body weights assumed for this assessment differ from those used in 2000 occ upational and residential exposure assessment and are based on the recommendations of the 20 12 R es idential SOPs. For adults , when an endpoi nt is not sex-specific ( i.e. , the endpoints are not based on developmental or fetal effects) a body weight of 80 kg i s typically used in risk assessment; however , in this case , a female-specific body weight of 69 kg was used. While the endpoint of concern, brain AChE inhibiti o n , is not sex - specific , the female-specific body we ight was used to protect for pregnant women due to uncertaint y in the human dose-response re lation s hip for ne urodevelopmental effects 6

. 

### 4.0 Use 

### Profile Coumaphos is formulated as a technical 96% active ingredient , (a .i. ) as we ll as a dust formulat ion intermediate (25%a. i. ), a dust (1 %a .i.) , an emulsifiab le concentrate ( 6.15 and I l .6%a.i.) , and a flowable concentrate (42%a.i.). Coumaphos is also imbedded into cattle ear tags, (20%a.i
. ) and bee hive pest control strips, (10%a.i.)
. Multiple applications to liv estock and/ or livestock areas are permitted during a one year period. There are howev e r , l abel restrictions on the amount of l ivestock and livestock area treated pe r day. Applicators are restric t ed to spray in g no more than 100 animals in one day and dusting no more than 25 animals in one day. In addition. app li cato r s can dust no more than I 000 square foot of bedding in one da y . Applicat ion of coumaphos to livestock can include the use of the following equip ment: swim and hydraulic dip vats, shake r cans, dust bags , back oile rs/ rubbers, pressurized h a nd guns, backpack, handheld hand-wand s , and ear tags. Application rates range from 0.005 to 0.025 lbs a.i. per ga llon for sprays or dips , 0.076 lbs a.i. per gall on of oil for back-rubb e r s , 0.000625 to 0.013 lb s a. i. per animal for dust app lication , and 0.000042 lbs a.i. per 1000 sq uare fee t of swine bedding treatment. There are va ri ous levels of PPE mandated on the different labels depending on the formulation. Co-Ral Flowable , EPA registration numb er 11556-98. has the highest spray application rates and requires single layer attire with the addition of gloves and a PF I 0 respirator. EPA registration numbers 11556-115 and 11556-23 have lower spray applicatio n rates and do not require any respirators for handlers. The dust coumaphos formulations require baseline attire a lon g with g lo ves and at least a Pf 5 respirator. Table 4.1.1 provide s a s ummary of the regist e re d u ses of coumaphos for eac h of the formulations. Based o n the registered u se pattern for coumaphos , dermal and inhalation exposu res are anticipated for occupational handlers. The r eg istered u se s are sorted in the table by the type of livestock, and in addition, includes th e swine bedding , cattle ear t ags , and bee hive s ites.

6 For more detail s, see Sec ti on 4.4 in the human h e alth ri sk ass essment: Memo , S. Pip er e t al , I5-SEP-2015 , 0409347. Page 11 of29T nbl e 4. J. Summ nry of Dir ecti o ns fo r Use of Co um npho s. Max
. Ap pli cat ion Fo rm u la ti o n M n ximum M nx. No. Appli cn ti on Timin g, T y p e, (% ai .) Appli cati o n Appli cat io n R ate o r Use Dir ec ti o n s a nd Limit at io n s a nd Equip
. I E PA R eg. No.I Rate per Se a s on Treatm e nt Int e r va l Catt le / H o r ses Swi m Dip Vat R UP ' and use is restricted to employees of the USDA A PHI S 2 who Ca ttle onl y 0.025 lb s arc enrolled in the USDA-AP I ll S ch o line s terase monitoring ll ydrau lic Dip Co -Ral Flowab l c Co ncentrat e ai /g allon of 2 time s/ye ar Do not make prog ram. Chnrgc dip vats with concentration of product and vo lume Vats (42%) spray app lication s 11.:ss of water. Do not tip excessively thirsty animal s. Applicators usi ng Ca ttle only than I 0 day s handheld sprayers are limited to 10 0 animal s arc day at maximum Manual and 

### r11556-981 0.021 lbs apart. application rate and 200 animals a day at Yi the maximum Mechanical Spray a i/

gallon of 6**time s/** **~car** application rate. Apply as hi g h pre ssure spray to wet the skin to runCa ttle and Horse s sorav ofT. Rep ea t applications as necessary. Re spirator requirement. Do not make 1 1 .6 % is a R UP. Lactating and yo un g cattle arc s ubject to l ower app lication s l ess applica t ion rate s . Do no t apply rate above 0.0025 lb ai/ gallon within Co -Ral Fly and Tick Spray (6. 1 S°/o) 14 days of freshening. Do not appl y on animals less than 3 month s Manual and [I 1556-115J. 0.0 1 lb s than 10 days old. Do not spray animal s for 1 0 da y before shipping or weaning. Mechanical Spray And ai/ ga ll o n of 6 times/year apart. Label limit s ha ndler to I 00 applications to cattle a day and 200 a day Re-treatment Ca ttle and Horses Co -Ral Em ul s ifiable Live sto ck spra y on l y nece ssary if treated at Yi the maximum applicat ion rate. Apply for complete In sec ticid e ( 11.6%) LI 1556-23 1 wett i ng to run-off. Do not contact treated animal unti l coats arc dry
. when in sec t s Do not s pray in con lined area. Do not use in co njunction with other reappear. OPs. Co -Ral Fl y a nd Tick Spray (6. 15% Re-treatment for dairy cattle su spend at hei g ht that will prev en t s traddlin g . No ai) (11556-115]. 0.076 lb s ai/ only nece ssar y interval needed between treatment and s lau g hter or u se of milk
. !lack Rubbers Oil when insect s Back rubber application for hom files and face flie s. Mi x specified Ca ttle And gallon of unknown reappear and dosage in I gallon of No. 2 fuel oil. Hang so no dairy cattle can Co -R al Emul s ifiab le Li ve s to ck fue l In sec ticide ( 11 .6%) [I 1556-23 

### J constitu t e a s traddle. No i nterva l required between treatment and s laug hter or problem
. milk use. Co

- Ra l Animal In se cticide (1%) I 0 days apart. Bulk Du s t (11556-141. Shaker can: No interval Dust Bags and Co -R a l Shaker C an ( I %) (11556-41. 0. 125 lb s 12 r eq uired Mechanical du s t ers arc prohibited
. For la ctatin g dairy cow s s u spend S haker Can Co-Ra l Bu l k Dust (1%) (34704- 267 ). ai /bag time s/year between bags in exit of mi l king barn. Li mit number of animals can tre at/day Cattle
. Horses. S haker Du s ter ( I%) [69208-11 cow s treatment and to no more than 25 animal s and 1 .000 fee t of sw in e bedding. One Sw ine. Swine Y-Tex Co-Ral ( 1 %) [390 39- 15 1. 0.0013 lb s 6 time s/year s laughter or 12 .5 lb du ster per 25 animal s . For direct application by shaker ca n D- Lou se ( I%) (34704

- 3061. animal s dusted using no more 2 oz. of du s t pe r a nimal. PPE base lin e Beddin g Diolicc ( 1 %) l2393-378]. of ai/ cattle horses between plus glo ves. unknown treatment and Co-Ral ( I %) [960-184] , use of milk. Z ioc i de Du s t Bag (I%) [960- 169 i

P age 12 of29Tab le 4
. 1. S u mmar v o f Di rect io n s for Use o f Co u ma o h o s . M ax. A pp li ca t io n Fo rmulati o n M ax imum M ax. N o. Appli cati on T imin g, T y p e, (% ai. ) Appli catio n Ap p lica ti o n Ra te o r Use Directio ns a nd Limit at ions

a nd Eq u ip . !E PA R eg. No.I R ate pe r Seaso n T r ea tm e n t I nt erva l E

ar Ta gs Co raihon ( 15 %) [11556-1481. 0.5 oz ( 1 4 g rams ) per ta g. Wear chemical resistant g love when Beef and Non And 20%a.i., Replace as necessar y applying tags. All mature anima l s should be tagged. Attach one tag Lactating Dairy Co- Ral Plu s Insectic i de Ca ttle Ear 15% to each car. Do not use on cattle less than 3 mo nth s o ld. Ca H l e Tag (20%) [1 1 556-1231 R e mo ve ta gs at end of ny sea so n prior to slaughter. Sw in e Co -Ral Emulsifiable Li vestock In sec ti ci de ( 11 .6%) f 1 15 56- 14 ) , Co-Ral S haker Can ( 1 %) [11556-4). Do not make Co-Ra I 13ulk Du st (I%) 1 34 704-267). 0.000625 6 time s a applications less Mechanical dusters arc prohibited
. Limit numb er of pi g can treat S haker Can Shaker Du s ter ( 1 %) [69208-1 ], lb s ai/ p i g year than 10 days per day to 25. Do not e nte r allow contact with animals until dust has Y-Tcx Co- Ral ( ! %) [39039-15 ] , se ttled
.

D- L ouse ( I %) [34 704-306 ]. apart. Diolicc (1%) [2393-3781. Co -Ra I ( I%) !960-1841 Co-Ra l Fly and Tick Spray (6. 15% Do not make Lab e l limit s handler to 1 00 applicati ons to swine a day at maximum 0.005 lb s ai / app lic a ti on rate. Do not contact treated animal until coa ts are dry. Mcchnnical and ai) 1 11556-115 ]
. and Co -Ra! ga llon of 6 timc s a app li ca tion s le ss Do not s pray an imal s for 10 day s before s hippin g or weaning. Do Manual S pray Emu l s iliablc Livestock Insecticide yea r t ha n 10 days not spray in confined area. Do not u se in conjunct i on w ith other (11.6%) [ 11 556-23 1 s pra y apart. OPs. Sw in e B edd in g Co -Ral Emulsiliable Live s tock In sec ticide ( 11.6%) ( 11556-14)
. Do not make Co-RaI Bulk Dust ( I%) [34 704

- 267. 4.5xJO ·S 6 time s a applications less Apply 2 oz. uniformly over 30 square feet of fresh dry bedding. S haker Can Shaker Duster ( 1 %) 169208 -1 ). lb s ai/rt 2 year than 10 days Limit area of swine beddin g treated pe r day to I000 ft 2 D- Louse (1%) [34704- 306 1 , Dio lice (I%) [2393-378 1
. apart. Co -Ra I (I%) f960- I 84 I Be e Hi ves C hcckmitc .,. Bee Hi ve Pe st Con trol 1 0'%ai by Twice a year for Varroa mites Bee Hiv e Strips S trip ( I0%ai) [ 1155 6-138 ) weight and no more than four tim es Leave strip s in hive for at lea s t .J2 days but not over 45 days. for small hive beetle. I Rcstncttd u.., P ts ti cidc ( RUP ) 2 U
. S Dcpanmcnt ofAgri cultur e An1 111 n l a nd Plant Health I n s pecti o n Service (USDA·APH IS)

Page 13 of29

### 5.0 Residential Exposure and Risk Es timate s T here are cmTently no r eg istered non-occupational ( r esidentia l) uses for coumaphos at thi s time
. 

### 5.1 Re s idential Ri s k Estimates for Use in Aggregate Assessment There are no registered non-occupational (resident ial) uses of coumaphos. Based on the labeled use pattern and the exposW'e profile of coumaphos , there is no recommended residential contribution to the aggregate risk assessment. 

### 6.0 Non Occupational Spray Drift Ex posure s and Ri s k Estimates Spray drift i s a potentia l so urce 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 soW'ce of exposure from the ground appl ication methods (e.g. , groundboom and airblast). The approach is outlined in the revised (2012) 

### Standard Operating Procedures For Residential Risk Assessment (SOPs)

- Residential Exposure Assessment Standard Operating Procedures Addenda I: Consideration of Spray Drift. Thi s document outlines the quantification of indirect non-occupational ex po sure to drift. Co umapho s is not applied nor reg iste red on u se sites that are li kely to r es ult in sp ray drift. Therefore , a s pray drift analysis is not included in thi s assessment. 

### 6.1 Non-Occupational Bystander Po s t -A pplication Inhalation Ex po s ure and Risk Es timates Vo lat ili zation 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 In sectici de , Fungicide , and Rodenticide Act Sc ientifi c Adv iso ry Panel (SAP) in Decemb e r 2009, and received th e SA P 's fina l report on March 2, 2010 (http: //www.regulations.gov/#!documentDetail:D=EPA-HO-OPP-2009-0687- 0037). The agency has eva luated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http: //www.regulations.gov/# !docketDetail:D = E P A-HQ-OPP-20 14-0 219). During Registration Review , the agency w ill utilize this analysis to determine if data (i
. e., flux studies , route-specific inhalation toxicological studies) or further analysis is required for coumap ho s. 

### 7.0 Occupational Exposure and Ri s k Estimates 7.1 Occupational Handler Exposure/Risk Es timate s HED uses the term handlers to describe those individuals who are involved in the pesticide application process. H ED 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
Page 14 of29

### treated, and the level of protection u sed by a handler can cause exposure leve ls to differ in a manner specific to each application eve nt. B ased on the anticipated use patterns and current labeling, types of equipment and techniques that can potentially be used , occupation al handler dermal and inhalation exposure i s expected from the proposed uses. App lying ear tags to cattle and in sert in g pest control strips into bee hives was not quan titatively assessed. The exposure to these tasks was considered neg li g ibl e based on the product formulation a nd g lo ve requirement. Therefore, the quantitative expos ure/risk assessment developed for occupational hand lers i s based on the following scenarios:

• mixing/ l oad in g flowable concentrate for hydraulic type dip vats, • mixing/ loading flowable concentrate fo r swim type d i p vats , • mixing/ loading flowable and emulsifiable concentrate for back rubber / oilers , • loading dust into bags , • app l ying dust with a shake r can to livestock, • applying dust to sw ine bedding v ia shaker can , • mixing/ loading/applying li quid sprays for backpack , • mixing/loading/applying liquid sprays for mechanically pressurized handguns, and • mixing/loading/ applying liqu id sprays for manuall y pressurized hand-wands. Occupational Handler Exposure Data and Assumption s A series of assumptions and expos ure factors served as the basis for comp l etin g the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. 

### Application Rat e : App li cation rates range from 0.005 to 0.025 lbs a . i. per gal lon fo r sprays o r dips , 0
. 076 lbs a.i
. per gallo n of oil for back

- rubbers, 0
. 000625 to 0.013 lbs a .i
. per animal for dust application, and 0.000042 lbs a . i. per 1000 square feet of sw in e bedding treatment. Cattle ear tags are 20% coumaphos by weight and the bee hi ve strips are 10% coumap ho s by weight. See Table 4
. 1
. 1 for a summary of the registered uses of coumaphos for each of the coumaphos formulations. 

### Un it Exposures: It 

### is the policy of HED to u se the best available data to assess handl er exposure. Sources of generic handler data , used as surrogate data in the absence of chem ic al- specific data , includ e PHED 1
. 1, the AHETF database or other r egistrant-submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FlFRA. The standard values recommended for use in predicting handl er exposure that are used in this assessment , known as "uni t exposures ", are outlined in the " Occupational Pesticide Handler Unit Exposure S urro gate Reference Table 7 ", 

### which, along with additional

7 A vai lable: http: //www2.epa.gov/ s ite s/ production / files /2015-09/ docum e nts/h andler- ex posure-table-2015 .pdf

Page 15 of29information on HED po li cy on u se of s urrogate data. including description s of the vario u s so urces, can be fo und at the Agency website 8

. 

### Area Treated or A mount Handl ed: The an1ount treated o r amount handled was based on guidanc e in H E D Ex poSAC Polic y 

### 9.1, language o n the labels, and HE D 's best profe ss ional ju d geme nt of t a nk and cat t le herd sizes. The previous assessment memo ( 0267778 , R
. Sandvig, August 3, 

### 1 999) ci ted the che mi cal spec ifi c study, 

### Reassessment of Operator Exposu re and Risk for th e Animal Sp ray and Dip Uses ofCoumaphos dated Jun e 

### 10 , 19 97. For thi s cur r e nt assess ment , the same quanti ty est imates for h andler expos ur e to dip vats we re u sed. H ydrau li c-ty p e dip vats are est im ated to ho ld 1 ,8 00 gall ons and swim dip vat s can hold 4 , 000 ga llon s. Hand le rs are estimated to mi x and l oad 14 ga ll o n s of mixture for b ack oi l rubb e rs . Cow he rd s izes were row1d e d to represe nt s mall and large 

### farm operations fo r app licators loadin g a nd h a ng in g du s t ba gs . H e rd s izes w ere e s tim a t e d as 100 cows , 350 cows , a nd 500 cows. 

### It is not expected that du s t bags o r o il back rubbers wou ld be u sed on ve r y large farms as it wou ld require a lot of material and time to hang in order to be efficacious. Du s t app li cati on v ia shaker can i s restricted on the label to 25 animals a d ay and 1000 ft 2 o f beddin g a da y . T herefore, it assumed an applicator wou ld handle the correspo ndin g a m ou nt of m ate ri al. App li cators are restricted to spray in g no more than l 00 an imal s in one da y a t th e maximum appl ication rate with handheld e quipm e nt and 

### 200 anim a l s a d ay at one half the m ax imum application rate. Mechanically pre ss uri zed h a nd g un s are est im ated to hold 

### 1 , 000 gall o n s of spray; howev e r , u s in g th e lan g uage from the labels this a mount was lowe re d to 

### 400 ga ll ons of s pray a da y w hil e manually pressurized hand wand a nd b ac kpack ap pli catio n were assumed 40 ga ll ons of spray a day based on policy gu id a nce. 

### Body Weight For ad ult s, w hen an endpo int i s not sex - specific (i .e., the endpoint s are not ba se d on developmental o r fetal effects) a b o d y we ig ht of 80 kg i s typicall y u sed in ri sk assessment; h oweve r , in thi s case, a fema l e-spe cific body weight of 69 kg was u se d. Whil e the e ndpoint of concern, RBC AC h E inhibition , is not sex - s pecific , th e female-spec ific bod y weight was u se d to protect for preg nant women due to unc erta int y in the human do se -r espo n se re lation shi p for neurodevelopmental effects 9

. 

### Abs01ptionfactors: A d ermal to x i c ity sn 1dy is the b asis of dermal points of departure , a dermal absorpt io n factor is n o t re quired. 

### Expos ur e Duration :

8 AvaiI ab le: http ://www2
. epa . gov / pesticide-science-and-a ssessi ng-pest ic ide

-risks/occu pat i ona I-pesticide

- handlerex posure-data 9 For more detai l s, see Section 4.4 in the human health ri sk assessment: Memo , S. Piper e l al , 15-SEP-2015, 0409347. Pa ge 1 6of29

### HED typically classifies exposures from l to 30 days as short-term and ex po s ure s 30 days to s ix months as interm e diat e- term. Exposure duration is determined by man y things, incl uding the ex posed population , th e u se site, the pest press ure triggering the use of th e p est i cide, and the cultu r a l p ractices surro undi ng that use s i te. For OP s, the matc h betwee n the toxico logical e ndpoi nt selectio n and the exposure d uration is diffe r e nt than HE D 's approach for co nve ntiona l chemicals. The endpoint se lect ion fo r organo pho s phate pest ic ide s invo l ves a "s teady state" approach based on an indi v idual chemical's cho l in es te rase inhibition. Th e "s tead y s tate " e ndpoint selection for cou mapho s overlaps H E O' s traditional steady s tate -te rm e ndpoint select ion as we ll a s being appro priatel y health prote c ti ve for occupational ha ndl e rs that appl y co mm e rciall y over lon ge r p eriods of time (i.e. , inte nnediate-term exposures). For most agricultura l u ses, it is reasonab le to believe that occupational hand le rs wi ll not apply th e sam e chemical eve ry day for mo re than a one-mo nth time frame; howe ve r, th ere may be a la rge agrib usiness and/ or comme rc i a l app l icators w ho m ay apply a product over a period of wee ks (e
. g. comp l eting multip le app li cation s for multiple clients within a reg ion). Co umaphos can be t ox ic to live s tock if over applied so it i s assumed mo s t farmers will only app l y when pe s t s a r e an issue. H owever, there is no quantitati ve data s uc h as number of cattle dipped per day, numb e r of days dipping take s place per year, etc. HED co ntinu es to request more quantitative data , s uc h as the number of cattle dipped per day , numb e r of days dipping ta ke s place per year, etc., to refine expos ur e to d ip vat worke rs in quarantin e areas under the a n ima l and p l ant hea l th inspec ti o n serv ice , (AP HI S) USDA p rog r a m. 

### Mi ti ga tio n/ Pe r so nal Protective Equipment: Estimates of dermal and inhalation exposure we re ca lcu lated for vario u s le ve l s of P P E. Re s ult s are pre se nted for ' ·ba se li ne," defined as a s in g le laye r of clothing consisting of a long s lee ved s hirt , lo ng pants , shoes plu s socks, no protective g lo ves, and no respirator , as we ll a s baselin e with va rious leve ls of PPE as n ecess ary (e.g. , gloves, res pirator , etc). The coumaphos product labe l s direct m ixers, loaders, applicators and o t he r hand lers to wear ba se l in e attire with chemical res istant g l oves. Co-Ral F lowab le , EPA Reg. No
. 11 556-98 has th e h i ghest s pray app l ication rates and req ui re s hand l e rs to wear a P FlO respi r ator. EPA Reg. No s. 11556-115 and 11 556

-23 have lower spray application rates and do not requi re any respirators for hand le rs. The various dust formulations r equ ire baseline attire along with g love s . Protectiv e eyewear , s hield , and apron are also li s te d o n so me of the label s. Th ese types of P PE address the ac u t e toxicity catego ries of the chemica l. See pre v iou s Table 3. 1.1 for acute toxicity co umapho s s ummary. HED does not consider a face s hield equi va lent t o a re s pirator nor an apron over long sleeve shirt e quivalent to doub l e laye r protection
. Occupati o n a l H andl e r No n -Cancer Exposure and Ri s k Es t imate Equations The a l gorithms u se d to es timate non-cancer exposure and dose for occupational hand l ers can be found in Appendix A. The toxico l ogical Po D s for input s can be found in th e prev ious Table 3 .1. 2
.

Page 1 7 of29

### Combining Expos ure s/Risk Estimates: A total aggregated risk index (ARI) was used si nce the toxicological effects for the dermal and inhalation exposure routes were similar (RBC cholinesterase inhibition) , because the LOC values for dermal exposure (I 000) and inhalation ex posure (3000) are different. The target ARI i s I ; therefore , A Ri s of less than I are risk estimates of concern. The al gorithm used to estimate combined no n cancer exposure for occupational handler can be found in Append i x A as well. Summary of Occupational Handler Non-Cancer Exposure and Ri sk Estimates Based on the labeled PP E for occupationa l handlers for the various formu l ations , there are ri sk estimates of concern identified ( i.e. , dermal MOEs 

### < 1000 and inhalation MO Es 

### < 3000) for th e steady-state expos ure assessment. Combined occupational handler risk estimates are presented using the ARI approach with a target of 1. There are dermal and inhalation risk estimates of concern for all formulation types and exposure scenarios excep t for back oil rubber app li cations. The product s are sorted by formulation typ e (e.g
. , tlowabl e, emu l sifiable concentrate , and du st) with correspond in g regi s tration number s. Risk estimates are presented in the following tables Tabl e 7.1.1.

- Table 7. 1. 9 with the unit exposures for each formulation presented in a separate table. The unit formulation tables are th en followed by scenario spec ific inhalation and dermal exposure risk estimates and then lastly followed by the AR I estimate tables. Th e followi ng li st provides a summary of the scenarios that resulted in ri sk estimates of concern:
• The US DA cholinesterase monitorin g program scenarios include gloves and PFl 0 respirator and result in A Ris 

### < 1. At labe l level PPE ARls range from 0.003 to 0.06. ARis range from 0.006 to 0.08 wi th PPE increased to double layer de rmal protection and a PF 10 respirator. • The liquid coumapho s product s that require gloves but no respirator also result in ri s k est imates of concern. At label level of PPE ARis range from 0.002 to 0.7. ARls ran ge from 0.03 to 1.1 with PPE increased to double laye r dermal protection and a PF 10 respi rator. • The dust formulations require gloves and at least a PF5 respirator and result in result in ARls 

### < 1. At label leve l PPE ARls ran ge from 0.003 to 0.28. ARls range from 0.006 to 0.46 with PPE increased to double layer dermal protection and a PF I 0 respirator.

Pa ge 18 of29Tab le 7. 1.1. De rm a l a nd I nh a la ti o n U ni t Ex p o s ures fo r Co- R a l Flowa bl e In sect ic ide , RE G # 11 556-98
EC Denna! Unit Exposure s (ug/lb ai) 1 Application Equipment 

# I Application R ate2 

# I Amount Handled I Arca Treatcd l ' SL/G 

# I DL/G EC No -R PF5 R 

# I PF IO R 

# I SL/No G Inh ala ti on U nit Exposures (ug/lb ai) 1
Mixe r/ Lo ade r


### - 

### -- 00219 

# j 0 Sw im Dip Vat 0.025 4000 220 37.6 29. 1 8.6 0.2 1 9 0.0438 lb ai /g allon of dip gallons/day I ly clraulic Dip Vat 0.025 1800 220 37.6 29. 1 8.6 0 .2 19 0.043 8 0.02 19 0 lb a i /g allon of dit) gallon s /day 0.083 .083 Mi xe r/ Loa d er /A pp li ca t o r



## -- _, Backpack 0.02 1 40 25 1 0 2500 1 600 N D 

## I 30 

## I 6 

# I 3 

# r-=- lb ai/ ga llon gallons



## - -i - Manually-pressuri:1cd I landwancl 0.02 1 40 100000 430 365 N D 30 6 

# I 3 lb ai/gallon
_ 

### - - ga llon s**~** 

## - - 

## - ND ND

## _J ND
_ 

# J Mechanically-pres s urized Hand gu n 0.021 1 00 18 00**6~0** 365 ND 79 15.8 7.9 lb ai / g allon gallons



## - Mec hani cally

-pressurized Handgun 0.02 1 400 18 00 640 

## I 365 N D 79 15 .8 7.9 lb ai/gallo n ga llon s I. B ased on th e "Occ up a ti o nal Pe sticide Handler Unit Ex p os ure S urroga t e Referen ce Tab l e (Sep temb e r 2015)
. PPE r ep r ese nt ed in c lude s SL= ba se line derm al ( l o ng s leeve d s hirt, l ong pant s. s hoes and socks). SL/G ba se lin e derma l plus g loves , D L/G = covera ll over baselin e de rmal plu s g l oves. EC= c l osed sys tem . NR = no re spirator: PF5 = ""Protection Factor 5", i ndicatin g a r eduction in ex po sure of 80 %: PF IO = ··Pr o tec tion Fac tor I O" indi ca tin g a r ed uction in exposure o f 90%. 2. B ased on regi stered l abel Co -R a l Flowable In secticide R eg ff 11556-98
. L abe l is re s tricted use to employees e nro ll ed in the USDl\

- 1\ PHI S choline s terase m o nitorin g program 3. Exposure Science Advisory Cou nc il Po li cy #9. 1. and assump ti o ns from Memo 0262059
. Reassessmen t of Operator Exposure and Ri sk fo r th e Animal Sp ray and Dip Uses ofCoumapho s June 1 0. 1999 and EXPOSAC discussion 03114 /2013.

Page 19 of 29T a b le 7. 1. 2. S t ead y S tate-Te rm Du ra t io n O cc up at ional Der m a l a n d In h a la tion Handl e r No n -C an ce r Ex p os ur e a nd Ri s k Es tim a t es fo r Co- R a l Flowab lc In sec ti cid e, R EG# 11 556-98 

## I Amount ,___Q e rmal Do se (mg/kg/day)J De rma l MOE7 EC 

# I No

- R Inh alation Do se (mg/kg-dav) 5 I nha l ation MOE6 App lication Ap p lica ti o n Handled SL/ SL / G DL/ EC SL/ DL/ 

## I

# No**~0** Equipment Rate 1 I Area SL/G PF5 R PFIO R EC EC Treated 2 NoG G NoG G R R R M ixer / Loader 0.025 4000 Swim Dip Vat lb ai/g a ll on ga llon s 0.3 19 0.0545 0.042 0.0 13 1.6 9.2 12 40 0.0003 6.35E-05 3. 17E-05 0.00012 11 0 570 11 00 300 of dip



### - 1 lydraulic Dip 0.025 18 00 lb ai/ gallon 0.143 0.025 

## o.o 19 

# I 0.006 3.5 20 26 89 0.0001 2.86E

- 05 I .43E-05 5.42E

- 05 250 1300 2500 660 Vat ofd iQ gallons 

### I 

# .**~** Mi xe r/ Lon d e r/ A nn lica t or Backpac k 0
. 021 40 0.03 1 0.030 0.019 ND 16 16 26 ND 0.0004 7.3E-05 3.65E-05 NO 

# =1 99 490 990 ND lb a i / ga ll on gallo ns Manually- 0.02 1 40 pressurized lb ai/ gallon ga llon s 1.22 0.005 0.004 ND 0.41 96 11 0 N O 0.0004 7.3E-05 3.65E-05 ND 99 490 990 ND Handwand Mechanically- 0.021 100

pre ss uri zed l b ai /ga ll on ga llon s 0.055 0.0 19 0.0 11 ND 9. 1 26 45 ND 0.002 4 .&E -04 2E-04 ND 15 75 150 ND Hand g un

- Mechanically- 0.02 1 400 0.078 

## I 0.045

pre ssu ri zed lb ai/gallon ga llon s 0.2 19 ND 2.3 6.4 11 N D 0.0 1 0.002 0.00 1 ND 3.7 19 37 ND Hands?.Un I 

### I I B ased on r egiste r ed labe l Co -Ral Flowabl c Ins ecticide Reg# 1 1556 -98
. Label i s restricted u se to e mp l oyees e nrolled in the US DA-A Pl-I IS cho li ne sterase monit o rin g program 2 Exposure Sc i e nce Advisory Co uncil Poli cy /19 .1.and assump t i o ns from Memo D 26205 9. Reassess m e nt of Op era tor Exposure and Ri s k for the Animal S pra y and Dip Uses of Co umap hos J une I 0. 1999 and EX P O SAC discus s ion 03/ 14/ 2013 3 Dermal Dose= Dem1al Unit Expos ure (μg/lbs a.i.) x Applica ti on Rate (l bs a.i ./ acre or gal) x Arca Treated or Amount Handled Dail y (A o r gal/day) ..;. BW (kg). 4 Dermal MO E = Dermal NOAE L (mg/kg/day) ..;. Demial Dose (mg/kg/day) 5 Inhalati on Dose = Inh alation Unit Exposure ( pg/lb s a.i.) x Conve rs ion Fac tor (0.00 I m g/

μg) x Applicat io n R ate ( l bs a.i ./ acre or gal) x Area Treated or Amount Han dled Daily(/\ or ga l /day)..;. BW (k

g)
. 6 In halation MOE = Inhalation NOAE L (mg/k g/da y)+ Inha l atio n Dose (mg/kg/day).

Page 20 of29Ta bl e 7
. 1. 3. S tea d y s t ate-Te rm Dur a ti o n O cc up at io n a l A RI H a ndl er No n -C an ce r Exp os ur e a nd Ri s k Es timat es for Co- Ra I Flowa bl e I n sec ti cid e, R EG# 11 556-98 1 Application Equipmen t 

# I 1 \pplication 

# I /\mount Handled I Area AR l 4

Rate2 Trcatcd J SL/No G + 

# I SL/G + 

# I DIJG + 

# I SL / G + 

# I DIJG + SL/G +**-- -~-----** **-'** ___ No-R
. No -R
_ No-R
_ PF5 R
_ PF5 R PF I0 R

Sw im Dip Vnt 0.025 lb ai/g allon of dip 4000 ga llon s Mi xe r/ Loader 0.00 15 0.0074 0.009 0.0088 0.0 11 0.009 I**LIG +~** **PFI ~** **"' --** 


### o.o 12 I 0.029 Hydraulic Dip Vat 0.025 lb a i / gallon of

di 0.016 0.02 0.0 1 9 O.Q25 0.02 0.0034 1 

### soo I L-- --i ga ll ons O.D25 I 0.063**--- --** **~- xe** **oa pplic** **r** 

# I 0.021 1- ·- 40 

# I I I Backpack lb
. 1 II II 0.0 11 0.011 1-----

------ ai ga on ga ons _ .**~** Manually-pre ssuri zed 0.02 1 40

_ _ 1landwand lb ai/ a ll on _ gallons _,_ 0.015 0.025 O.Q25 0.000 4 

# I 0.015 

# I 0.022 0.015 

## ---+----- ----- 0.06 0.066 

## --- 0.024 NO 0.074 0.083 NO Mechanically-pre ssurized 0.02 1 1 00 Hand g un lb ai /g allon ga ll o n s 0.0 16 0.0045 0.0032 0.0 13 0.0042 0.0 17 0.024 ND Mechanica ll y-pre ss uri zed 

# I 0.02 1 

# I 400 I l andgun lb ai/g allon ga ll ons 0.0008 0.00 1 0.00 1 1 0.0032 0.004 0.0042 0.0058 ND I B ased on th e "Occupati o n a l Pestici de H andler Uni t J:::xpos urc Surroga te Refere n ce Table (Septembe r 2015). L evel of miti gat ion represented in tab l e in clude: SL = baseline derma l ( l ong s l eeved sh irt, long pants. s hoe s and soc ks). SL/G baseline dermal plus gloves. DL/G = coverall over base lin e dermal plu s gloves. EC= closed system. N R = no respirator: PF5 = ··Protection r:actor 5". indicating a reduction in exposure of 80%: PF I0 = "Protection Factor I O" indicatin g a reducti o n in exposure of 90%. 2 Based on regi s tered label Co -R al Fl owable In sec ticide Reg# 11556-98. L abel is restricted use to employees enrolled in the US DA-/\ PHIS cholinesterase monitoring program 3 Exposure Science Advisory Council Policy #9. 1.and assumptions from Memo 0262059. Reassessmen t of Operator Exposure and Ri s k for the Animal Spray and D ip Uses of Coumaphos June I 0. 1 999 and EXPOSAC discussion 03114/ 20 1 3 4 A RI = Aggregate Ri sk In dex= I + [(Oennal LO C + Dermal MOE) + ( Inh alation LOC + Inh alation MOE)].

P age 21 of29Tabl e 7. 1.4 S t ea d y s tat e-T e rm Durati on Unit E x po s ur es fo r Liquid F ormul a ti o ns R eg #s. 1 15 56- 11 5, and 11 5 56-2 3 App lication Equipment Target Application Rate2 Amount Hand l ed I Arca Dermal Unit Exposures (ug/lb ai) 1 Inha l ation Unit Expos ure s (ug/lb ai) 1 '- Category Treated 3 SL/No G SL/G DL/G EC No-R Pf-5 R P F I O R EC M ixe r/ Loader 13ack Oil Rubbers 

# I Cattle 

# I 0.07617 

# I 14 

# l 220 37.6 29.1 8.6 

## I 0.219 0.0438 0.0219 0.083 lb ai/ ga llon gallons/day Mi xer /Loader /A p p li c at o r Backpack Cattle 0.0 1

'- lb ai/ 1!.a llon 40 25 1 0 2500 1 600 ND 30 6 3 ND Backpack Swi ne 0.005 gallo ns lb ai /gallon



## -

- Manua ll y-pressurized 1-fandwand Ca ttle 0.01 I lb ai / gallon 40 0.005 ga llon s 100000 430 365 ND 30 6 3 ND Manually-pressurized Handwand Swi ne lb ai/gallon



### - 

### - Mechanicall y-pre ss urized Hand gun Callie 0.0 1 100 1800 640 365 ND 79 15
. 8 7.9 ND lb ai / ga ll on gallons Mecha n ica ll y-pressurized Hand g un Sw ine 0.005 100 1 800 640 365 ND 79 15.8 7.9 N D

- lb ai/ga ll on ga ll ons



## - -

Mechanically-pressurized Hand gun Cattle 0.0 1 400 1800 640 79 15 .8 7.9 ND lb ai / ga llon ga llons

# ~ I 

# I

-

0.005 400 

# I I I 1 Mechanically-pressurized Hand gun 

# I Swine 18 00 640 D 79 15 .8 7.9 ND lb aill!.a llon gallo n s I Based on the
.. Occupational Pe s ticide Handler Unit Exposure S urrogate Reference Table (S eptember 2015). PPE repre se nted includes SL= baseline dennal (long sleeved s hirt. long pants. shoes and socks). SL/G basel ine derma l plus g loves
. DL/G = coverall over baseline dermal plus gloves, EC= c l osed sys tem. NR = no re spirator: P F5 = .. Protect i on Factor 5'' , indicatin g a reduction in expos ure of80 %; Pf- 1 0 = ··Pro tec t ion Fac tor 1 0" in dica t ing a red ucti o n in expos u re of90%. 2 Based on regi s tered l abe l Co- Ral Flowab l e I

nsect i c ide Reg II 11 556

- 98. Labe l is re s t ricted use to employees enrolled in the USDA-A PHI S cholines terase monitor ing program 

### -

3 Exposure Science Advisory Council Policy 11 9. 1 .and assumpt i ons from Memo D262059. Reasses s ment of Operato r Exposure :md Ri sk for the Anima l S pray and Dip Uses of Co umaphos June I 0. 1999 and EX PO SAC discussion 03 / 14 120 13.

Page 22 of 29Tabl e 7. 1.5. S tead 'rm Duralio n Occupational ll andler N on- C ancer Ex pos ure and Ri s k E s timat es for Liquid Formu hlli o n s R eg #s
. 11 556- 11 5, a nd 1 1 556-23 1 

# =] Applica1ion 

# I Amount I Demlal**MOE ~**  I Inhalation MO E' Denna! Dose ( mg/k g/ day )' lnhala1i on Dose (mg/k g-dayt Application Target 

# I**~~** 1

# s~ I

# 0~**1** 

# I . E

quipment C atego r y Rate 1 llandlcd ' SI.I S LIG DL/G 

## I EC EC No-R PF5 R I PFIO R 

## I EC No-R 1 1'1"5 R PFIO R EC NoG 

## I 1\1 i xe r / Loader Dack O il 0
. 076 17 1 4 

# I 3
.391::- 6
. 77E- 3.39E· 

## J 1
.2812 Rubber s Call ie lb ail ga ll o n ga ll o ns/ 0
.003 0
.0006 0 0005 0
.000 1 1 50 860 1100 3800 06 07 07 -06 11 000 53000 1 !0000 28000 day 1\ l i xc r /Loa der/Ap pli cato r



### - 0 .0 1 54 

## I 1.7E- 3.48E- 

# I - Backpack Ca lli e 0.0 15 0
.0 15 0
.009 34 34 1.14 F.- 

## I 2 1 0 IOOO 2 1 00 lb ai/g all o n 40 04 05 05

0.00 5 I gallo ns ND ND 1.7..JE- 8
. 7F.- ND I ND Backpack $ \1in e 0007 0.007 0
.005 69 69 110 9F. -05 ..JI O 2100 41 00 I--

- lb ai/gallon



### . 05 06


## - . --- Manuall y- 0.0 1 1.74E- 3 ...J8E- l.74E

- pr

ess uri zed Ca llie lb ai/gallon 0
. 58 0.003 0
.002 0.86 200 240 0 4 05 05 2 1 0 1 000 2 1 00 llandw and 40



# - ND ND ND ND Manuall y- 0.005 ga ll o ns 8
. 7E- l.74 E

- 8 .7Epr

essurized S win e lb ai/ga ll o n 0
. 1 46 ND 0.00 1 1. 7 400 470 05 OS 06 410 2 1 00 4 1 00 Hand wand Mechanica l 0.0 1 1 00 I. I4E- 2.29Epr

ess uri zed CaIll e lb ai/gallon ga ll o ns 0
.026 0
.009 0
.005 ND 19 54 95 ND 03 04 I E-04 ND 32 16 0 320 ND Hande.un Mechanica l 0
.005 J OO I 1 0 

# I 5
. 72E

- 1.14 E

- 5
. 72E- 

# I pre ss uri zed S wine lb ai/gallon ga ll o n s 0.0 13 0
.005 0.003 ND 3 8 190 ND 04 04 05 ND 63 320 630 ND Handg un Mechanical**~** - pressurized Ca ul c 0.0 1 400 0. 10..J 0 .037 0
.02 1 ND ..J
.8 13 2-1 ND ..J
. 58E- 9
. 16E- 4
. 58E- ND 7
. 9 39 79 N D llandg un lb ai/gallon gallons 03 0..J 04 Mecha n ical 0
. 005 400 2
. 291::- ..J
. 58E- 2
.29 E· press urized Swi n e l b ailg allon ga ll o ns 0
.052 0 .0 19 0
.0 11 ND 9
.6 27 47 N D 03 04 04 ND 16 79 

## I 16 0 ND Handgun

-- - - - - -· - Oascd on lhc " Occ 11 pn1i o n al Pes ti c ide Handler U ni1 Ex po s ure Surrogmc R e ferenc e Table (S:: pt c mb er 20 15)
. PP E r cprese nlcd include s SL= base l ine dcmial ( l o n

g s lecvcd s hir1
. l ong pru11 s. sh oes and soc ks ), SL/G bas e lin e d e mial p l us g l oves. Dl. ..IG= covera ll ov er baseline dcrmul p lu s g l oves. EC= clo sed sys 1 e m. NR = n o rc s pira 1 o r : PF 5 = .. Pro 1e c ti o n Facto r 5". indi cai in g a reducti o n i n expos ure of 80% : Pf I0 = " Pro tc c 1i o 11 Faaor I O" indicatin g a r cduc 1i on i n exposu r e of90%
. 2 13ascd on re g istered co umap h os label s Reg # 11556-11 5 and 11 556

- 23. 3 Exposure Science Advi so ry Co unc il Policy #9
. 1.and ass umpti o ns fr o m Me m o 026 2059
. Reas s e ss m ent of Operat o r Exposure and Ri sk fo r 1hc A nima l Spray and Dip Uses o f Coumapho s June I 0 , 19 97. EXPOSAC discussion 03/1 4 /20 1 3
. ..J Dcm1al Dose= Dcnnal U ni1 Ex pos ure ( 11 g/ lb s ai
. )" Ap pli cmion Raic (lbs ai ./ acrc o r ga l ) x Arca T n.:mcd o r Amou nt I landled Dail y (A o r g al/day )+ BW ( k g)
. 5 Dcm1al MOF.

- Dcnna l NOA EL ( m g/kg/day) + Dennal D ose (mg/kg/d a y)
. 6 lnhala1i on D ose = lnh a la1im U nit Expos ure (μg/l b s a . i. ) x Conversion Factor (0.00 1 111 g/ 11 g) x App lica1i on Rate ( lb s a i/acrc or ga l ) x Arca T r ea t

ed or A mo unt Handled Dail y {J\ or gal/ day)+ BW ( kg)
. 7 Inhalati on MOE = Inhalation NOA EL ( m g/kg/day) + l11h ala 1im Dose (m g/kg/day).

P age 23 of29Tabl e 7. 1. 6. S t ea d y S t ate- T erm Du ratio n ARJ O cc u pationa l H a ndl er No n-Canc e r Ex po s ure a nd Ri s k Es timat es for Li q uid Formulation s Reg #s
. 11 556- 1 1 5 , a nd 11 556-23 1 Application Crop I Appl i cation Amo unl 1 l a ndl cd**ARI~** App li cation Eq uipm ent Type Targcl Rai c 2 I Area T r cated 3 S L !No G + SL/G+ OLIG + SL/G + DL/G + SL/G+ 

# T D L/G + EC Ca tegory No -R No -R No-R PF5 R PF 5 R PFIO R P F I O R



## - Mi xe r / L oa d e r 

### I 

### I 

## I 0.076 172 14 

# I Back Oil Rubbers 

## I Broadc ast Catt le lb ai / ga ll on gallons 0 .14 0.7 0.85 0.82 I 0.84 I. I 2.7 mixture



### - Mi x er / Load er / App l i ca t o r 0.0 1 40

# 003 - B ac kp ack Broadcast Ca ttl e lb a i /g a ll o n !!ali o n s 0.023 0.031 0.046 0 .0 32 0
. 05 ND Backpack Broadcas t Sw in e 0.005 40 0.046 0.046 0.06 1 0.063 0.095 0.066 0. 1 ND lb ai l!?a ll on ga llon s Manual l y-p rc ss urized Broadca s t Callie 0.01 40 0.00085 0.052 0.054 0.13 

## I 0.14 0. 16 0. 18 ND H an d wand lb ai / gallo n gallon s

. - Manually-pre ss uri zed Broad cas t Swine 0.005 40 0.0017 0. 1 0. 11 0.25 0.28 0.31 0.35 NO H andwand lb ai / 11.allon gallons Mec h ani ca ll y- Broad c as t Ca ll i e 0.0 1 1 00 0.0068 0.0089 0.0096 0.027 0.03 4 0.036 0.05 ND pressurized I land gun lb ai/ga ll o n 1!.a ll o n s

- M ec h anica lly- Broadcas l Swine 0.005 1 00 0.0 14 0.0 1 8 0.0 19 0.054 0.068 0.072 0.1 ND 

# j 2 re ss urized 1 l andgun lb ai /ga ll o n gallon s 

### I Mechanically- 0.0 1 400**~ressurized** 1l andgun Broadcas t Cattle lb ai/ gallon • gallons 0.0017 0.0022 0 .0024 0.0065 I 0.0084 0.0087 0.0 13 ND Mechanically- Broadcas t Swine 0.005 400 0.0034 0
. 0045 0.0048 0.013 

# J_ 0.0 17 

# I 0.0 1 8 O.Q25 ND 1 orcssurizcd I l andgun l b ai / aallon ga ll on s Ba:;ed o n th e "Occ up a ti o n a l Pes ti c id e Han dle r U nit Expo s ure S urrogate Refere nce Tab l e (Sep lcmb e r 20 1 5). PPE rep re sen ted in cl ud es SL= base lin e derma l ( l o ng s l eeved s hirt
. l ong pants. s hoes and sock s). SL/G base lin e derma l p lu s g loves, D L/G = covern ll over baseline dermal plu s g love s . E C= c l osed sys t e m. NR = no re s pirator: P FS =" Protection Factor 5", indi ca tin g a reduct ion in exposure of80%: PF I O = "Protection Factor 1 0" indicatin g a reduclion in exposure of90%. 2 Based on reg i s tered coumaphos label s Reg# I 1556-1 I 5 and I I 556

- 23. 3 Exposure Science Advisory Cou ncil l )o licy #9. 1 .and assumptions from Memo 0262059. Reasse ss me nt of Opera to r Exposu re and Ri s k for the Animal Spray and D ip Uses of Co umaphos June I0. 1997. EXPOSAC d i s cus s ion 03/14 / 2013. 4 ARI= Aggrcga1e Risk In dex = J.;. f (Dcmial LOC .;. Dermal MOE )+ ( Inh alation LOC .;. Inh alation MO E) !
.

Page 24 of29Table 7. 1. 7. Occupational Handl er D e rm a l a nd I nh a l at ion Un it Ex po s ur es for Du s t Ba s ed Formulation s and Impr eg n a t e d Material Crop I Targe t Ca te gory Amount I l and led I Dermal U nit Expos ure s ( u g/lb a i ) 1 Inh alation Uni t Expos ure s (ug/ l b ai} 1 Arca Trcatcdl

- } Applio" i oo R me' 

# I 

# l -- - Appl i cation Equipme nt Value Value SL/No G SL/ G DUG EC No -R PF5 R PFI O R EC Units Units 

# I

---- - -- - Mixe r / L oa d er Dust bag Small Cattle Farm 0.0096 1 5 

# I 100 227 51.6 41.2 

# I ND 8.96 1 .79 ;--r 0.896 ND lb ai /catt le cattle 0.0096 15 

## i >- 

### --- D ust bag Medium Ca ttle 350 227 5 1. 6 4 1. 2 N D 8.96

# ~ 0.896 ND Farm lb ai/ cattle I cattle Dust bag Large Cattle Fann 0.009615 500 227 51.6 41.2 ND 8.96 0.896 ND lb ai /cattle catt le

# ~- .. Ap p 't ator 

### - Shaker can Cattle or Horse 0.00 125 25 4042000 11 0000 72600 ND 17500 3500 1750 ND lb ai/cow or horse Co ws or horses Shaker ca n Sw in e 0.000625 25 4042000 11 0000 72600 ND 17500 3500 1750 ND lb a i / o!!. pig s


### - - 

## - - Shaker can Sw in e Bedding 4. I 7E -05 IOOO 404 2000 1 1 0000 72600 ND 175 00 3500 1750 ND lb ai/ft2 fi2


### ·- I mpr eg n ated Mat er ia l Non Du s t formu l ations EarTag 9 Ca ttle 20% a. i ./ ta g Neg li g ibl e exposure Bee Mite Strip9 B ee hi ves I 0% a.i./s trip Negligible ex po s ure 

# J

- - I B ased on the ""Occupationa l P es ti cide 1l a ndl er Un it Expos ur e S urroga te Refe re nc e Table (Sep te mb e r 20 1 5). PPE represented in c lu des SL = basel in e dermal ( l o n

g s l eeved s hirt. l o ng pants. s hoes and soc ks). SL/G baseline d ermal plus g l oves. DL/G = covera ll ove r baseline dennal plus g l oves. E C= c l osed sys tem. N R = no res pirat o r: PF5 =·· Protec tion Factor 5". indi ca tin g a reduction in ex p os ure of 80 % : PF I0 = ' ' Protection Factor I O" indicating a r ed ucti o n in exposure of 90%. 2 B ased on registered coumaphos dust and so li d fonnu l ated labe l s . 3 Expos ure Science Advisory Co unci l Polic y #9. 1. and assump ti ons from Memo 0262059. R eassessmen t of O perator Exposu re and Ri sk fo r the Anima l Spray and Dip Uses of Co umapho s June I 0. 1 997. EXPOS/\C discussion 03114 / 20 1 3.

Pa ge 25 of29Table 7. I .8. S t eady S tat (}-T erm Occupat i o na l Han dler No n -Cance r Exposu r e an d R i s k Esti mate s for Du s t B ased Formu l ation s a nd Impre g nat e d Mat eri a l ' Crop / Amount Dermal Dose (mg/kg/day) 4 Dermal MOE 5 Inhalation Dose (mg/kg-da y) 6 Inhalation MOE7 Application App lication Handled I Eq uipment Target Rme 2 Arca S l
. /No G SL/G DL/G SL/No SL/G DL/G No- R PF5 R PF I O R No- PF5 PFIO Ca t egory Treatcd 3 G R R R Mixer / L oa d e r Dust bag Small 0.009615 JOO 0.00316 0.00072 0.0006 160 700 870 

# I J.25E-04 2.49E-05 I .25E

- 05 290 

# I 1400 

## I 2900 C attle Fann lb ai/ cattle cattle Du st bag Medium 0
. 009615 350 0.0 1 11 0.00252 0.0020 45 200 250 4.3E-04 8.74E-05 4.38E-05 82 410 820 Cattle Fam1 lb a i / cattle cattle

- 0.0096 1 5 500 Dust bag Large 0.0158 0.00359 0.0029 32 140 170 6.25E-04 l. 25E-04 6.25E-05 58 290 580 Cattle Farm lb a i / ca ttl e cattle Aoo licator Cattle and 0
. 00125 25 

# I Shaker can lb ai /cow or Cow s or 1.83 0.0-199 0.0329 0
. 27 10 15 7.93E

- 03 I .58E-03 7.93E

- 04 4
. 5 23 45 I lorse s hors e hors e s

- Shaker can Swine 0.000625 25 0.9 16 0.0249 0.0 164 0.55 20 30 3.96E -03 7.93E-04 3.96E

- 0-1 9.1 45 9 1 lb ai/011 p

_ igs Shakcrean Swine 4. 17E-05 1 000 2.43 0.0664 0.0439 0.2 1 7.5 II l .06E

- 03 2. 1 2E-03 l. 06E-03 3.4 17 34 Bedding lb ai/112 n2 

# -
>------ 

## - Impr eg n a t e d Material No n Du s t fo rmulati o n s EarTag 9 Callie 1 20% a. i./ tag Negligible expo s ure Bee Mite Strip9 Bee hives ' I 0 % a.i ./strip Negligible exp os ure


### - Based on the
.. Occupational Pesticide I landler Unit Exposure Surrogate Reference Table (September 20 1 5): Level of mitigation repre s ented in table include s baseline inhnlmion and additional PP E required g l oves (G) a nd a PFS r es pirat o r . It is noted that th e labds s u gges ts that handlers could utilized more protective equipment however it doc s no t appear to be a requirement on various dust label s. 2 Based on reg is t ered coumaphos dust :ind so lid formu la t ed labels 3 Exposure Science Advisory Counc il Policy # 9. 1.and a s sumption s from Memo D262059. June 10, 199 7
. Du s t bag estimate s arc be s t judgments utilizin g fann surveys from memo. EXPOSAC

discussion 03 / 14 / 2013 4 Dermal Do s e = Denna! Unit Exposure (p g/ lb s a.i.) x Application Rate ( lbs a.i ./ acrc or gal) x Area Treated or Amount Handled Dail y (A or gal /day) .;. BW (69kg). 5 Dermal MO E = Dem1al NOAEL (mg/k g/ day) .;. Dem1al Do s e (mg/k g/ day). 6 Inhalati on Do s e = Inhalation Unit Exposure (μg/lbs a.i.) x C onvers ion Factor (0.00 I mg/11g) x Application Rate (lbs a.i./ gal.) x Arca Treated or Amount I land led Daily (A or g a l/ day) .;. BW (69kg). 7 Inhalation MOE = Inh alatio n NOAI]
. ( m g/

k g/day) .;. Inh alation Dose (mg/kg/day).

Page 26 of29T ab l e 7. 1. 9. S t eady Sta t e-T er m A RI Occu p ati o n a l H and ler Non-Ca n ce r Expos u re and R i s k E s t im a t e s for Du st Ba sed For mu lati on s• Target Application /\mount Handl ed I Art:a /\R l 4 Application Equipmen t Category Ra te 2 Treated 3 SL!No G + SL/G + DLIG + SL/G + D L/G + SL/G + DL/G + PFIO R No- R No- R No- R PF5 R Pf-5 R PF I O R Mi xe r / L oa d er Dust bag Small Cattle 0.0096 1 5 1 00 0.06 0.085 0.087 0.28 0.3 0.4 1 0.46 Farm lb ai / catt l e cattle Du s t bag Medium 0.0096 1 5 350 0.0 17 0.024 0.025 0.081 0.088 0. 12 0. 1 3 Cattle Fam1 lb ai/cattlc cattle Dust bag Large Cattle 0.0096 1 5 500 0.0 12 0.0 1 7 0.0 17 0.057 0.062 0.08 1 0.09 Farm lb ai / eattlc cattle A ppli ca t or Shaker can Ca ttle 0.00 1 25 25 0.00023 0.0013 0.00 1 4 0.0043 0.005 1 0.006 0.0075 lb ai /cow cows Shaker ca n Sw in e 0.000625 25 0.00047 0.0026 0.0028 0.0086 0.0 1 0
. 0 1 2 0.0 1 5 lb ai/pJ:! pigs Shaker can Swi ne 4. 17E-05 1000 0.000 1 8 0.00098 0.001 0.0032 0.0037 0.0045 0.0056 Bedding lb ai/ft2 ft2 Based on th e .. Occupa tional Pesticide 1l andlcr Unit Exposu r e Surrogate Rdcrenee Table (Sep tembe r 2015): Leve l of mitigation represented in table includes baseline inhalation and additional P PE r eq ui red g l oves ( G) an d a P FS re s p i rator. It is noted that the labels suggests that handler s could utilized more protective equipmen t however it docs not appear to be a requirement on various dust label s. 2 Based on registered coumaphos dust and solid formulated labels. 3 Exposure Sc i ence Advisory Council P olicy #9. 1.and ass umpti ons from Memo 0262059. June 1 0, 1997
. Du s t bag es timates are best judgment s utilizing fann su rveys from memo. EXPOS/\C discussion 03114 / 2013 4 /\R I = Aggregate Ri s k Ind ex = I + [ (Dt:rmal LOC + Dermal MOE) + ( Inh alation LOC + Inh alation MO E) J

Pa g e 27 of29

### 7.2 Occupational Po s t
- application Expo s ur e/Risk Estimates HE D uses the term post-app li cat ion to describe expos ure s that occu r when individuals are present in an env ironment that has been prev ious ly treated w ith a pesticide (al so referred to as re e ntry exposure). Suc h expos ure s may occur when workers e nte r previou s ly treated areas to perform job functions , including activities related to crop production , suc h as sco uting for pests or harvesting. P ost-app li cat io n exposure levels vary ove r time and depend on suc h things as the type of activity, the n ature of the c rop or target that was treated , the type of pesticide app l ication. and the chemical ' s degradation properties. In addition, the timing o f pesticide applications , re lative to harv est ac ti v iti es, can greatly redu ce the potential for post-application expos ure . 

### 7
. 2.1 Occupational Po s t-application Inh a l ation Expos ure There are multipl e potential sources of post-app li cat i on inhalation exposure to indi v idu als performing post-app li cat i on acti v itie s in previously treated fields. These potential so urce s include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides
. Th e agency soug ht expert advice and input on i ssues related to vo latilization of p est icid es from its Federal Insecticide , Fungicide. and Rodenticid e Act Scie ntifi c Advisory P anel (SAP) in Decemb er 2009, and received the SAP's final report on March 2, 20 10 (http ://www.regulat io n s .g ov/# !documentDetail ;O = EPA-HQ-OP P-2009-0687-003 7). The age n cy ha s evaluated th e SA P report and has dev e lop ed a Volati li zation Screeni ng Tool and a s ub sequent Volatili zati o n Sc r ee ning Analys is ( http ://www.regulation s. gov/# !docketDetai l ;D = E PA-H Q-OPP-2014-0 219). Durin g Regi stration Review, the agency will utilize this analysis to determine if data (i.e
. , flux s tudie s, route
- s pe cific inhal at ion toxicological stud ie s) or further analysis is r eq uired for coumaphos. In addition , the Agency is continuing to evaluate the available post-application inhalation exposure data ge n erated by the Ag ri cul tural Reentry Task Force. Given these two efforts. the Age nc y w i ll cont inue to identify the need for and , subseque ntl y, the way to inc orpo rate occupational postapp li cation inhalati on expos ure into th e agency' s ri sk assess ment s. 

### 7.2.2 Occupational Po s t-application Dermal Expos ure Dermal post-application expos ure i s no t anticipated due to the limited coumaphos use pattern on li vestock and embedded ear and beehive str ip s , and therefore was not included in this assessment. Restticted Entry Interval Co um ap ho s i s c lass ifi ed as To xic ity Ca tegory Ill via t h e dermal route and Toxicity Ca tegory IV for s kin irri tat io n potential. J t is not a skin se n s iti ze r. U nder 40 CF R 156.208 (c) (2) (i ii ), a. i. 's classified as Acute ITI or IV for acute dem1a l, eye irritation and primar y sk in irrigation are ass igned a 12-hour REI. However, 

### in the wo rk er protection s tandard (WPS) (40 CFR 1 70.103: Exceptions), there is a n exception for pesticide s appl ied "on livestock or other animals, o r in or about animal premi ses .,. Therefore , coumaphos labels do not fall under WPS. L ang uage on coumap ho s end use produc t labe ls s hould retain s tatements s uch as, "Do not contact treated an imal s until sprays h ave dried and dusts have sett led on the coat."

Pa ge 28 of29Appendix A. Summary of Occupation a l Non-cancer Algorithms Potential daily exposu res for occupational handlers are calculated using the following formulas:

where: E UE 

### AR A E = UE *AR* A 

### * 0.001 mg /ug

exposure (mg ai/day), unit exposure (μg ai/lbs a i ), maximum application rate acco rdin g to proposed label (lbs ai A or lbs ai/ga l) , and area treated or amo unt handled (e
. g., A/day, gal/day). The daily doses are calculated using the following fom1ula:

where: ADD E 

### AF BW £*AF ADD = -- BW

average da il y dose absorbed in a g iven scena ri o (mg ai/kg/day) , exposu re (mg ai / day) , absorption factor (dennal and /or inhalation), and body weight (kg). Margin of Exposure: Non

-cancer r isk estimates for each application handler sce nario are calcu lated using a Margin of Exposure (MOE) , which is a ratio of the toxicological endpoint to the daily dose of concern. The daily dennal and inhalation dose received by occupational handlers are compared to the appropriate POD (i .e. , BMDL1 0 ) to assess the risk to occupationa l handlers for eac h exposure route. All MOE va lu es are calculated using the following formula:

where: MOE POD ADD BMDL 10= POD MOE=- ADD

margin of exposure : val ue used by HED to represent ri sk estimates (unit less), point of departure (mg/kg/day) , and ave rage daily dose absorbed in a given sce nario (mg ai/kg/day). bench mark dose limit. The aggregate ri sk index (ARl) was calculated as follows: Aggregate Ri sk Index (ARl) = I + (I + Rl dm 11 a1

) + (I + Rl111 1ia1a11mJ Where: Risk Index {RI) = MOE + LOC

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