Dat e: Subject: 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D.C. 20460

November I 0, 20 1 5 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

Nica rba z in. Occupational and Re s identi a l Exposure and Ri sk Assessment for Registration Review. PC Code: 085712 Decision Numb er : 505007 Petition N umb er : NA DP Barcode: 0429981 R eg is tra tion Number: 80224- 1 , 80224-2 Regulatory Ac tion : Registration Review Case N umb er: 7628 Ri s k Assessment Type: NA TXR Numb er: NA CAS N umb er: 330-95-0 MRID N umb e r s: NA 40CFR : NA


### From:

T hrou g h:



### To: Matthew Crowley , Biologi st /

# ~ Ri sk Assessment Branch 2 

# CRf B2) H ealth Effects Di visio n (HE D ; 7509 P ) Christina Swartz, Branch Chief

# ~ Ri sk Assessment Branch 2 (RAB2) Health Effects D iv i s i on ( H ED; 7509P) and Seyed Tadayon,

# Reviewer**£~~** Shalu Shelat,

# Revi**ewe ~**  Exposure Science Advisory Committee (ExpoSAC) I HED Bonnie Adler, Chem i ca l Rev iew Manager Risk Management and Implementation Branch 5 (RM 185) P esticid e R e-eva luation Di v is ion (PRO)
As part of Regi strati on Rev iew , th e Pesti c ide R e-eva luation Divi s ion (PRD) of EPA's Office of Pesticide Program s (OPP) h as r eq ue ste d that the Health Effects Division (HED) evaluate the ha z ard and exposure data and conduct occupat ional and resident ial expos ure assessments, as needed , to es tim ate the risk to human health that will res ult from the currently registered use s of pesticides. This memorandum serves as HED's Regis tration Revi ew assessme nt of the occupati onal and reside ntial handler and post-application exposure and ri sk from the currently registered uses of nicarbazin
.

Page I of 14It 

### is HED po li cy to use the best available data to assess exposure. Several sources of generic data were used in this assessment as surrogate data in the absence of chemical-specific data, including the Pesticide Handlers Exposure Database Version 1.1 

### (PHED 1 .1) 

### and the Outdoor Residential Exposure Task Force (ORETF) database. Some of these data are proprietary, and subject to the data protection provisions of the Federal Insecticid e, Fungicide, and Rodenticide Act (FIFRA)
. No te: 

### This m e morandum was reviewed by th e Exposure Science Advisory Committee (ExpoSAC) on 29-0CT-2015.

Page 2 of 14Ta bl e of Contents 1.0 Exec uti ve S um inary
.. . .. . ... . .. .. .. .. . .. .. .. . .. .. .. .. .. . .. .. .. .. .. . .. ......................... . ...... . . ..... .. . .. . .. . .. .. . .. .. . . 4 2.0 Risk Assessment Concl u sio n s and R ecommendations
... . .. . ... . . ...... . .. .. . . ..... . .. .. . .................... 5 2.1 Summary of Risk Estim ates . .. .. . .. .. . ... . .......... ..... .... ........................ . . .. . .. .. . .. . .. . .. .. . .. . .. .. . .. . .. .. 5 2.2 Label Recommendations
........................ .. .. .. .. .. . .. .. .. . .. .. .. . .. .. . .. . .......................................... 5 2.3 D ata Deficiencies and R equi r ements ............................... . .. .. . ........ . ... . .. .. . .. . ...................... 5 3.0 H azard Characterizati on ................................... .. . ... . ...... . .. .. . ... . .. . ........ .. . .. ............................ 5 4.0 Exposure a nd Use Profil e .. .. .. . ...... .. .. . .. .. .. .. .. .. .. . ... . .. ......................................................... . ... 7 5.0 Residential Expos ure an d Risk Est imates ...... . ........................................................ . .. . .. . .. .. .. 8 6
. 0 Non-Occupational Spray Drift Exposure and Ri sk Est im ates .. . .. ........................................ 8 7
. 0 Non-Occupational B ysta nd er P ost-Ap pli cation Inh al at io n Expos ur e and Ri sk Estimates .8 8
. 0 Occupational Exposure / Ri sk C h aracte ri zati on .. .. . .. . ... .. . . ... .. . .. . ... . ........................................ 9 8. 1 Occupational H a ndl er Expos ure and Risk Estimates
..................... . .. .. . ..... . .. . ......... . ..... . .... 9 Appendix A. Summary of Occupational Non

- cancer A l gorithms
.. . .. .. . .. . ..... . ... . .. . .. . .. . .. .. . .. . .. .. . .. . .. 13

Page 3of141.0 Exec uti ve Summary Nicarbazin is the act ive in gred ient in one registered end-use product , OvoControl P (EPA Reg. No. 80224-1 ) , a 0.5% active in gredient granule/ba it pigeon contracepti ve packaged in a 30 lb bag
. Use sites are limited to paved / concrete areas or rooftops of office parks , malls , hospitals , schoo l s, bridges, airports, other commercial / industrial buildings/ structures. The label specifies use in secured areas with lim ited public access. Based on this use pattern , on l y dermal and inhalation exposures are anticipated for occupational handlers (mixer / loaders and app li cators)
. No occupat ional post-application exposures are expected, nor i s any non-occupational/residential exposures expected via app li cat ion, postapplicati on , spray drift , or volatilization. Hazard Profile and Dose Response Based on the available data submitted to the agency and an avai lable European Food Safety Authority (EFSA) report, the toxicology database for nicarbazin is sufficient for assess in g risk. Nicarbazin has low acute toxicity, is a moderate eye irritant, and is not a dermal irritant or sensitizer. Availab le studies did not indi cate any concerns for neurotoxicity or immunotoxicity. No evidence of mutagenicity was observed. The lowest observed adverse effect level (LOAEL) of 181 mg/kg/day from the 90 -d ay rat oral toxic ity study is considered appropriate for assessing risk for a ll exposure scenarios. A 1 

### OX database uncertainty factor was applied for a LOAEL to no observed adverse effect level (NOAEL) extrapolation , resulting in a 1000-fold UF 

### (!OX for interspecies extrapolation , 

### lOX for intraspecies variation , and 1 

### OX Ufdb) for all exposure scenarios. Nicarbazin is a non-food use chemical with no residential uses and exposure to children i s not expected
. Therefore , additional safety factors accord in g to the Food Quality Protection Act (FQPA) do not apply. Occupational Exposure and Risk The quantitative exposure / risk assessment developed for occupational handlers of nicarbazin is based on app li cat ions of granules by h and or w ith hand-operated equipment such as a belly grinder or rotary spreader. There were no combined (dermal + inhalation) risk estimates of concern w ith label-specified work att ire and personal protecti ve equipment (PPE) (long s leeve shirt , pants , shoes , socks , g loves). The product l abe l specifies wearing a long-sleeved shirt, long pants, shoes, socks, and g loves - it does not specify whether the g loves shou ld be chemical-res i stant. This should be confirmed, both i n terms of risk estimates described below assuming the exposure reduction prov id ed by chemical-resistant gloves , as we ll as any ot h er PPE requirements based on the end-use product acute toxicity profile. Human Studies Review

Pa g e4of14This ri s k assessment relies in part on data from studi es in w hi ch ad ul t hum an su bj ec ts we r e intentionall y exposed to a pesticide or other chemical. These data, which include studies from the Pesticide Handlers Exposure D atabase Vers i on 1 .1 ( PHED 1
. 1) and th e Outdoor Re s i den ti a l Exposure Task Force (ORETF) database ar e ( 1) s ubj ect to ethics review pursuant to 40 CFR 26, (2) hav e received that review , and (3) are compliant w i th app li cab l e ethics requ iremen t s . For certa in studies, the ethics rev i ew may have included review by th e Human St udi es Review Board . D escript ions of data sources, as we ll as gu id a nce on their use , can be found at the Agency website'. 

### 2.0 Risk Assessment Conclusions a n d Recom m endations 2
. 1 Summary of Risk Estimates No occupational dermal o r inhalation h andl er ri sks of co ncern were identified
. 

### 2.2 Labe l Recommendations The product l abe l spec i fies wearing a long- s l eeved shirt, long pants , shoes, socks, and gloves

- it does not specify whether th e gloves s h o uld be chem i cal -res istant. This s ho uld be co n firme d , both in terms of ri sk est im ates de sc rib ed below assuming the exposu re reduction provided by chemical-res istant g loves, as we ll as any other PP E r e quirements based on th e e nd-u se product acute tox i city profi l e. 

### 2.3 Data Deficiencies and Requ irem e nts The exposure database i s sufficient to support Registration Review of nicarbazin and any data requirements have been sat is fied. 

### 3 .0 Hazard Characterizati on Nicarbaz in i s a complex of two compounds, 4 ,4'-dinitrocarbanilide (DNC) and 4,6-dimethy l -2- pyrimidino l ( HOP). DNC is cons id ered to be the active component, wh il e HOP aids in absorption. Nicarbazin h as low acute toxicity, is a moderate eye irri tant , and i s not a d e rm al irritant or se nsitizer.
Tab l e 3.1: Acute Toxicity Profile for Nicarbazin

G uideline Study Type MRID #(S) Results Toxicity Category No. 81-1 Acute Oral [rats) 46416413 LD so> 10 ,000 mg/kg I V

870. 1000 81-2 Acute Inh a lation fratsl 464 16415 LCso > 0.147 m gf

L IV

1 http :// www2
. epa.gov/ pes ticide-science

- and

- assessing

- pestic ide-risks/occupational

- pesticide-handler-exposure-data and http ://www 2. e pa .gov/pes t icide-sci e nee - and

- assessing

- pest i cide

- risks/o ccu patio na 1

-p estici de

- posta pp Iica t ion

- exposure

Page 5 of 14870.1200 8 1-4 Primary Eye Irritati o n 46416416 Moderate Irritant III

870.2400 frabbit s l 8 1-5 Primary Dermal Irritation 464 16417 Non

- Irritant IV

870.2500 frabbit s l 8 1 -6 Derma l Sensi ti za tion 46416418 Not a sensi ti ze r

870.2600 

### r guinea pig sl Ba se d on the available data submitted to the agency and an available EF SA report , the toxicology database for nicarbazin is suffic ient fo r a ss essing risk. Although the current 40 CFR Part 158 Toxicology Dat a Requirements include 90-day derma l , subchronic inhalation , immunotoxicity , and neurotox icity (acute and subc hronic) s tudie s, the s e s tud ies were not s ubmitted fo r n icarba z in. H owever, using a weight-of-evidence (WOE) approach, considering all ava il ab le hazard and exposure in formation , the H azard and Science Pol icy Co unc il (HASPOC) d ete nnined that the 2 1 /28- day derma l , subchron ic inhalation , immunotoxicity , and neurotoxicity (acute and subchronic) are not required to s upp o rt the regi stered u ses of ni carba zi n (Bever , R , 10/21 / 2015; TXR #005726 1). Ba sed on the available data , while all effects at 90 day s appear to be of m i nimal seve rity , an in c rease in toxicity ove r time i s s ugge sted when comparing the 90-day a nd developmental s tudi es in rats. In rabbits , lobulation of the liver was observed in the maternal animals. Howeve r, due to low inc idence and absence of corresponding effects, the tox ico logical s ignificance of thi s effect i s unc l ear . ln deve lopmental toxici t y studies , no developmental toxicity was observed in the rabbit. I n rats , d ec r ease d feta l weights were observe d in the pre se nce of maternal toxicity (decreased body weights in dams). Therefore , there i s no concern for pre-natal susceptibili t y. The avai lable stu di es did not indicate any conce rn s for neurotoxicity or i mmunotoxicity. As a non-food u se chemical , carcinogenicity studies are not requi red, though no e v id e nce of mutageni c i ty wa s observed. No effects were observed in studie s using the 3: 1 mixture of DNC to HOP or u s ing DNC alone inc l uding: the chron ic oral toxicity studies w i th a NOA EL of 400 mg/kg in both dogs and rats; the r e productive toxicity study with no parenta l or reproducti ve effect s observed up to the highe s t dose te ste d of 400 mg/k g/day i n rats; and th e 90-day oral gavage st udy with DNC s howing no effect s up to 709 mg/kg/day in rats. Therefore, based on th e available data , nicarbazin appears to b e more tox ic than D NC alone , and the 3: l D NC to HOP mixture. The LOAEL of 181 mg/kg/day from the 90-day toxicity study is considered approp riate for assess ing ri s k for a ll expos ure scenario s. Exposures from different route s s hould therefore be combined for risk asse ss ment when applicable. Since no dermal or inhalation absorption data are available, toxicity by both routes i s considered to be equivalent to the es timated toxicity by th e oral route of exposure. The s tandard bod y weight for the general p op ulati o n (80 kg) was u sed for a ll exposure sce nario s cove red in this ri s k a ssess ment since the endpoint s se lected were n ot developmental and/or fetal e ffects.

Page 6of 14A l 

### OX databas e u ncertainty fac tor wa s app li ed fo r a LOAEL to N O AEL e xtrapo lati o n . A s a n o n-food u s e c h e m ical with no res id e nti al u s e s and ex p os ure to chil dren not e xpecte d , FQ P A co n s id e ration s do not app l y . Thu s, fo r a ll expo s ure sce nari os, a 1 000-fo ld 

### UF ( 1

### OX fo r inter s p e cies extrap o lation , 

### lOX for i ntra s p ec ies va ri ati o n , a nd 

### l OX UF ctb) wa s app l ie d
. T a bl e 3
. 1 Nicarba zin : S umma ry of T oxicologi c al Do ses and E ndpoint s for Non-O c cupational Human H ea l t h Ri s k As s ess m e nt s . Lev el of Ex po s ur e P oint of U n certain ty C onc ern (LO C) S tud y a nd To xi c ological E ff ects S c e nario D ep a rtur e F a ct or s for Ri s k Asses sm e nt s De rm a l S ho rt- LO AE L = 1 8 1 U FA = 10 LO C fo r MO E = 90

- Day Ora l Toxi c it y Tenn( ! to30 mg/kg/d ay UF H= 1 0 10 00 (EFSA 20 10) d ays), UFdb = I O LOA EL= 18 1 m g/kg/day based on In te rm e di a t e T e m1 ( 1 t o 6 mo nth s ) dec r eases in bo dy weights, erythrocytes, he m og lobin , an d h

c m atocrit. In c r eases in bl ood u rea nitroge n and p l as m a c r ea tinin e. In c r eases in severa l re lat ive or ga n we i ghts . Tubul ar dege n er

ati o n i n th e kidn ey and degeneration in the se mini fe r o us tu bul e. No NOAE L was id en ti fie d
. Inh a la ti o n S ho rt
- LO AE L = 1 8 1 UFA = 1 0 LOC fo r MO E= 90- D ay Ora l To xi c i !Y T enn ( I to 30 mg/kg/d ay UFH = 1 0 10 00 (E F SA 20 10) d ays), UFdb= 1 0 ln te m 1e di ate Tem 1 LOA EL= 1 8 1 m g/kg/day base d on (I to 6 m o nth s) dec r eases in body weig ht s, eryth r ocytes, h emog lobin, an d he m atoc ri t. In c r eases in bl ood urea nitr oge n and pl as m a c r ea tinine. In

c r

eases in seve r al r el

at ive or ga n we i ghts. Tubul ar d egenerati on in the ki d ney and d egenerati o n i n th e se min ifc r ous tu bul e. No N OA EL was id e n tifi ed. Po111t of Departure = A data p o int o r an es ti ma t e d p o in t t h a t is d e rived fr o m o b se rv e d d ose-r es pon se dat a and use d to ma rk th e b eg innin g o f ex trap o lati o n t o d e t e rmin e r is k a ssoc ia t e d w ith lowe r e n viro nm e n ta ll y re leva nt hum an expos ures. NOA E L = no ob se rv e d ad ve rse e ff ec t leve l. LO AE L = lowes t o b se rv e d ad ver se e ff ec t leve l. UF = unce rt a int y facto r. UF A= ex tr ap o la ti o n fr o m a nim a l to hum an ( i nte rs pec ies )
. UFH = p o te ntial variati o n i n se n s itivit y a mo ng me mb ers of th e human p o pul a ti o n ( intras pec ies). UF db = un ce rtai nty du e t o ex trap o la tio n fro m a LOA EL to NOAE L. 

### 4
. 0 Ex po s ur e a nd Us e Profile Tabl e 4
. 1 b e l o w o u tl in es th e u se pro fil e for O v oCo ntro l P ( E P A Reg. No. 80224- 1 ) , th e on l y product reg i s tere d conta i ning n i c a rb az in a s the ac ti v e ingredi e nt.

P

age 7of 1 4Table 4.1 Nicarbazin Use Profile (EPA Reg. No. 80224-1) Application Work Use Direc tion s and Use S iteffarg et Formulation Equipment Attire/ Rat e PPE Limitat ions Commercial and 0.5% ai


### - H and 1 ounce of Long


### - Use on l y in sec ur ed indu strial granu le/ba it dispersal product per 5 s leeved areas with limited buildings (e.g. , 

## - R otary pigeons shi rt , long public access. office parks , sp r eade r pants,



### - Condition pigeons over malls, hospita ls, B e ll y 1 ozl5 pigeons s hoes, a period of 5 to 14 days, sc hools, bridges , 

### - socks, grinder * llb/16oz* starti ng with small airports): 0
. 5% = g loves. amounts of bait and rooftops or 0
. 0000625 lb v isually observing paved/concrete a i/ pigeon whether the pigeons are areas of limited feeding. pub l ic access



## - Remove excess bait Produ ct is a 30 after each feeding. lb bag, eno ugh to treat 2400 

### - Di sco ntinue u se after 14 pigeons days if cond iti o nin g fail s . 

### 5.0 Residentia l Exposure and Risk Es timates Because the product is not specified for u se in or around hom es, cons umer / residentia l applicator exposure is not expected
. Add iti o na ll y, because the l abe l spec ifi es u se in secured areas of limited pub li c access and directs app li cators to observe the pigeon feed ing a nd remove excess bait after each feeding, exposures to adults or ch il dren fo ll ow in g app li cat ions are li kew i se not expected. 

### 6
. 0 Non

- Occupational Spray Drift Exposure and Risk Estimate s Off-target movement of pes ti cides can occur via many type s of pathways and it is governed by a va ri ety of factors. Sprays that are released and do not deposit in the app li cati on area end up offtarget and can lead to exposu r es to those it may directly contact. They can a lso depos i t on surfaces where contact with residues can eventually lead to indirect ex posures (e.g
. , ch ildren playing on law n s w h ere resid ues have deposited next to treated fields). The potential ri sk estimates from these residues can be calcul ated u s in g drift modeling coup l ed with methods emp l oyed for r esidenti al risk assessments for turf products. B ecause nicarbazin i s both a granule and app li e d by hand or hand-operated equipment, exposure via drift is unli kely to occur. 

### 7.0 Non-Occupationa l Bystander Post-Application Inhalation Exposure and Risk Estimates Volatil izat io n of pestic id es may be a source of post
- application inhalation exposure to ind i vidua l s nearby p es ticide applications. The agency sought expert advice and input on i ssues related to vo latilizati on of pes t icides from it s Federal In sec ticide , F un g i c id e, and Rodenticide Act Scient i fic Advisory Panel (SA P) i n D ecember 2009, and rece ived the SAP's final report on Page 8 of 1 4March 2, 2010 (http: //www.epa.gov/ scipoly / SAP/ meetings/ 2009/I 20 109meeting.html). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http: //www.regu l ations
. gov/#!docketDetail;D=EPA-HQ -OPP- 20 14-02 1 9). During Reg i strati on Review, the Agency will utilize this ana l ysis to determine if data (i.e., flux stud i es) or further analysis are required for nicarbazin. 

### 8.0 Occupational Ex posure/Risk Characterization As a granule/bait pigeon contraceptive used on paved/concrete areas or rooftops of office parks, malls , hospitals, schools, bridges, airports, other commerc i al / industrial buildings/ structures, dennal and inhalation exposures to nicarbazin are ant ic ip ated for occupational handlers (loaders and applicators
. Post-application exposure is not expected because residues on concrete / paved areas are expected to be limited , nor are any worker activities in areas previously treated with nicarbazin expected that would involve significant hand or body contact with any residues. Therefore, any applicable restricted-entry intervals (REis) for ni carbaz in wou ld default to technical grade active ingredient acute toxicity-based requirements
. As the most severe acute tox icity category for nicarbazin is Category III , the REI , when applicable according to E P A's Worker Protection Standard , would be 12 hours. 

### 8.1 Occupational Handler Ex posure and Risk Estimates HED uses the tenn handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each task. Job requirements (amount of chem i cal used in each application) , the kinds of equipment used, the target being treated , and the level of protection used by a handler can cause exposure levels to differ in a manner spec ifi c to each app li cation event. The quantitative exposure/ risk assessment developed for occupational handlers of nicarbazin is based on applicat ions of granu l es by hand or with hand-operated equipment such as a belly grinder or rotary spreader. Occupational H andler Exposure Data and Assumptions A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. 

### Application Rate and Amount of Product Handled: As outlined in Table 4.1 , the application rate used in this assessment is based on the product label specifying a maximum rate of l ounce of product per 5 pigeons. Applying 0.5% nicarbazin will result in an application rate of approximate ly 0
. 0000625 lb ai per pigeon. For the purposes of risk assessment it is assumed that an entire sing le product (i.e. , a 30 lb bag) i s used per day, or approximately 0.15 lb nicarbazin. This would treat approximately 2 ,400 pigeons.

Pa g e 9of14

### Unit Exposures: It is the policy of HED to use the best availab le data to assess handler exposure. Sources of generic handler data , used as surrogate data in the absence of chemical-specific data, include PHED 1.1 and the ORETF database. Some of the se data are proprietary (e.g. , ORETF data) and subject to the data protection provisions of FIFRA. The standard values recommended for u se in predicting handler exposure that are used in thi s assessment, known as " unit exposures'', are outlined in the "Occ upational Pe sticide Handler Unit Exposure Surrogate Reference Table2 '', which, along with additiona l in formation on HED policy on use of surrogate data , including descriptions of the vari ous sources, can be found at the Agency website 3

. 

### Exposure Duration: H E D typ ically classifies exposures from I to 30 days as short-term and exposures 30 days to s i x months as in termediate-term. Exposure duration i s detennined by many thing s, includ ing the exposed population, the use s ite, the pest pressure triggering the use of the pesticide , and the cultural practices surrounding that us e s ite. For most agricultural use s, it is reasonable to b e li eve that occupational handlers wi ll n o t apply the same chem i cal every day for more than a onemonth time frame; however , there may be a l arge agribusiness and/ or commerc ia l applicators who may apply a product over a period of weeks (e.g
. , complet in g multiple app li cat ions for multip le clients within a region). Thus , both short- and intermediate

- tenn exposures are anticipated for nicarbazin; long-term exposures not expected. 

### Mitigation /

Personal Protective Equipment: The nicarbaz in l abel requires a long-sleeved sh irt , l o ng pants, shoes, socks and gloves
. For the purposes of ri sk assessment, the gloves are assumed to be chem i cal -resistant, though , per s tandard H ED practice, ri s k est im ates are also provided at baseline work attire (i.e., no chemical

resistant gloves or other PP E). Inhalation exposure is assessed assum in g no r esp iratory protection. Occupational Hand l er Non-Cancer Exposure and Risk Estimate Equations The algorithms u se d to estimate non-canc er exposure and dose for occupational handlers can be found in Appendix A. Combining Expos ure s/ Risk Est im ates Dermal and i nha l ation ri sk estimates were combined in this assessment, s in ce the tox i cological effects for these exposure routes were s imilar. Dermal and inhalation ri sk estimates were combined usin g the fo ll owing formula: Total MOE = Point of Departur e (mg / kg

/ day) -;- Combined D e rmal + Inhalation dos e (mg / kg

/

clay)

2 Available: http: // www2.epa.gov / s ite s/production/file s/20 1 5-09 /docum en t s/hand ler- exposure-tab le - 20 1 5.pdf 3 Availab le: http: // www2.epa.gov/pesticide-science-and-assessing-pesticide-risk s/occ upational-pesticide-handlerexposure-data Page 10of14Summary of O ccupational H a ndler Non-Cancer Ex po su r e and Ri sk Es tim ates Assuming labe l-req uir ed wo r k att ire a nd PPE , no risks of co ncern from combined d e rm al and inhal at ion exposu re we re identified (MO Es 

### 2: 1000). Table 8. 1
. 1 pre se nts d etailed exposure an d risk cal cu lati o n s .

Page 11 of 1 4T a bl e 8. 1 . 1 . S umm ary o f Occ up a t i o n a l H a n d l er Ri s k E stim ates for Nica r baz in Denna! Inhalation Comb in ed Exposure Amount U nit Exposure Dose (mg/kg/day) 4 Unit MOE5 Equipment App Rate 1 H andled/ Area (ug/Jb ai) 3 Dose (LOC = 1000) Scenario Treated2 Exposure ( mg/k g/day) 4 SUNG/ 

### SUGIN SUNG SUG SUNG 

### SUG (ug/lb ai) 3 NR R Hand 1 04000 71000 0.195 0.134 470 0.00088 930 1.4 00 L oading I d ispersal applying Belly granules to 0.0000625 2400 pigeons 10000 9300 0.0 1 88 0.0 1 75 62 0.000 1 2 9,500 9,900

paved gri nd er lb ai/pigeon (enti re 30 lb bag) / concrete Rotary

areas s preade r 440 240 0.00083 0.00045 10 0.000019 220,000 380 ,0 00 Bast'Cl on r'-gi stercd lnbc l o n reg is tered label s ou 1 l incd in Tnble 4.0
. 2 Expos ure Science Advi so ry Counc il P o licy ff9. I and infom1 at ion provided on labels 3 Bas ed on th e ··occ upa1ional P<. -s ticidc Handler Unit Exposure Surrogate Reference Tab l e" (Scptcrnhcr 20 15). SL = s ingle layer (long-s l eeve s hirt
. pantS. s h oes/socks. NG = no g loves. G = g loves. NR = no respira t or

. 4 D cnnal/ lnhal ation Dose = Unit Exposure ( Jtg/ lb ai) x Conversion Factor(0.00 1 m g/

Ji g) x App l ication Rme " Arca Trcat<.'Cl" 100 % absorption + BW ( kg ). 5 Combined MOE = POD**g/kg/day) ~**  [ D1o:nnal Dose ( mg/kg/day+ Inhalation Dose ( m g/kg/day)]

Page 12of14

### Appendix A
. Summary of Occupational Non-cancer A l gori thms

OCCUPATIONAL NON-CANCER HANDLER ALGO R I THMS 

### Potential daily exposures for occupational handlers are calculated using the following formulas: E = UE *AR *A 

## * 0.001 mg l ug 

### where : 

## E = exposu re (mg ai/ day), 

## UE = unit exposure (μg a i / l

b ai) , 

### AR 

## = maximum application rate according to registered labels (lb ai A , lb a i / ga l , etc.) , and A 

## = area treated or amount handled (e.g. , A/day , gal/day). The daily doses are calculated using the followi ng formu la:

where: ADD 

## = E AF 

### BW 

## = ADD = E*AF 

### BW

average daily dose absorbed in a given scenar io (mg ai /kglday) , exposure (mg a i / day), absorption factor (denna l and/ or inh al ation), and body weight (kg). Margin of Exposure : 

### Non-cancer risk estimates for each application handler scenario are calculated using a Margin of Expos ure (MOE) , whic h is a ratio of the toxicological endpo i nt to the daily dose of concern. The da i ly dermal and inhalation dose received by occupational handlers are compa red to the appropriate POD to a s sess the risk to occupational handlers for each exposure route. All MOE values are calculated using the fo ll owi ng formula:

where: MOE 

## = POD MOE = -- 

## ADD

margin of expos ure: va lu e u sed by HED to represent risk estimates (unitless),

Pa g e 13 of14

### POD ADD 

## = point of de parture (mg/kg/day) , and averag e dai l y dose ab so rb ed in a g iv e n sce nario (mg ai /kg/day).

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