### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D .C. 20460 OFFICE OF CHEMICAL SAFETY AND PO LL U T ION PREVENTION



### MEMORANDUM Date: May 26. 2015 

### SUB JECT : Nicarbazin: Tier 

### J Review of Human In cide nt s

P C Co d e : 0857 12 DP Barcode: D-t27460 Deci s ion No.: 50500-t P etition No.: NA Ri sk Assessment T y pe: A TXR No.: NA MRIO No.: NA R eg i stra tion No
. : NA Regulat or y Action: NA Case No.: 1 A CAS No.: I 07-02-8 40 CFR: I A Vcr.Apr.08 

### F ROM: Elizabeth Evans, Environmental P rotection Specialist 

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# -----J Toxicology and Ep idemiology Branch

# ~~<.,**ft\ "v4~**  Health Effects Di v ision (7509P) and Shanna Recore, Industrial Hygienist 

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...... _ Toxicology and Epidemio lo gy Branch**~ ~**  Health Effect Division (7509 P) 

### TH RO UG H: David Miller , Acting Branch Chief 

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# (ov Toxicology and Epidemio logy Branch

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TO: Health Effects Division (7509P) Jaime o·Agostino, Ri sk Assessor Ri sk Assessment Branch 

### II Health Effects Divi s ion (7509P) and Bonnie Adler, Chemical Review Manager Risk Management 

### & Implementation Branch 5 Pesticide Re-evaluation Division (7508 P ) Summary and Conclusio n s Based on the low frequency and severit y of incid e nt cases repo11ed for nicarbaz in in both IDS and SE r soR- Pesticides there does not appear to be a concern at this time that wou ld warrant further investigation. The Age ncy will co ntinue to monitor the incident information and if a concern is triggered , additional analysis will be includ ed in the risk assessment.
Pagelof4Detailed Re v iew 

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### A CTION REQ UES TED Thi s re v iew is inte nd ed to fulfill our requirement to docket s ummarie s of incident data that were reported to the Agency , as well as to ensure human incident dat a and the Ag ri c ultural Health Stud y (A HS ) are part of the problem fonnulation phase of registration r ev iew. Rep o rt s of adverse health effects alle ge dl y due to a s pecific pesticide exposure 

### (i.e
.. an ' ·incident'" ) are large ly se lf-re ported a nd th e refo re , ge nera ll y s p eakin g. neither exposu re to a pesticide o r repo rted sy mptom (o r the co nn ec ti o n b etween th e tw o) i s va lidated o r otherwise confirmed. T ypically. causatio n cannot be detennin e d b ased o n in c ident d a ta . How ever. incid e nt info rmation can be an important source of feedback to the Age nc y : incident s of seve r e outcome. or a s u ggested pattern or tre nd among less severe inc ident s, can signal the Age nc y to furth e r inv es ti gate a particular chemical or product. Observational e pid em i o logy s tudies relate the ri s k of disease , 

### e.g., cancer. and exposure to an agent s uch as a pesticide product in the ge n e ral populat ion o r specific sub-g r oups li ke p est ic ide applicators. 

### II. BAC KGRO UN D N icarbaz in is was re gis tere d in 2005
. it is a granulated bate for "Egg Hatc h R e ducti o n in Canad a Geese". Use is omitted to urban areas such as office parks , recre ational park s, golf cour ses, schools , ho sp ital s, re s taurant s, and co mmercial and industrial sites. Bait may be applied with bait pan s . broa dc as t directl y o n the g r o und by hand o r with m ec hanica l feed e rs (up to a 20 

### ft rad i us). Th e appl icati o n rate is 50 g ram s per goose per day. B eginnin g three weeks pri o r to fir st anticip ated egg lay ing , a s mall amount of bait is offe r e d (7 grams pe r goose). a nd the amount is increa se d eac h day. as geese bec o me accl imated to the ba i t. Ba it in g cont inu es throughout the ne s tin g per io d , which last s 8 to I 0 weeks. For this eva luati on, both the OPP Incident D ata System (fDS ) and the Centers for Disease Control and Pre ve nti on/Nation a l In s titute for Oc c upati o nal Safety and Health (C DC/N I OSH) Sentinel E ve nt No tification System for Occupational R isk-Pest ic ide s (SENSOR) database s were consulte d for pe s ticid e incide nt data on the active ingredie nt ni c arbaz in (pc code: 08 5712 )
. The purpo se of the database sea rch is to identify potential patterns in the frequenc y and severity of th e health effects attributed to nicarbazin exposure . N icarbazin i s not includ ed in the AHS , and therefore thi s s tud y d oes n o t provide inform a tion for thi s r eport . 

### Ill. RES U LT S/DI SCUSS IO N

a . 

### ID S (Incid e nt Data System) OP P 's I DS includes r epor t s of a lle ge d human health incid e nts from variou s sources, including ma ndatory Federal In se cticide , Fungicide and Rodenticide Act (FIF RA ) Sec ti o n 6(a)(2) rep o rt s from re g i s trant s, o ther federal and s tate health and e n v ironment a l agencies, and individual consumers. S inc e 199 2, O PP has comp il ed these r epo 1 1 s i n ID S. ID S contain s r e port s from across the U.S
. and most incid e nt s hav e all re lev a nt product in fo rmation recorded. Reports s ubmitte d to the IDS r e prese nt a necdota l r eports o r allegations o n l y. unl ess otherwise s tated in the r epo r t.
Page 2of4IDS records in c id e nt s in o n e of two modul es : Main IDS and Aggregate ID S:

o Main ID S contains in c ident s re su ltin g in high e r seve rit y o ut co m es and provides more detail w ith regard to case s p ec ifics. This syste m s tore s incident data for death, m ajor a nd moderate incidents , and it in cl ud es in fo rm a tion a bout th e location , date and nature of th e in cident
. Main ID S incident s in vo lving onl y one ac ti ve in g redi e nt (as opposed to pesticide product s with multipl e acti ve ingredi en t s) are considered to pro vi d e m o re certain info rmation a bout the p otential effec ts of exposure from th e pe s ticid e.
o Aggregate ID S contain s incident s res ultin g in l ess seve r e human incident s ( min or, unknown. or no effects outco m es)
. These are r e ported b y re g istrant s o nly as co unt s in w hat are agg regate summaries. For the Ma in IDS , from January I , 2010 to February 4, 2015, there we r e no incident s re porte d involving nicarb azin
. In Agg regate IDS , fro m J anuary I , 20 10 to February 4, 20 1 5. there we r e 3 incid e nt s rep o 11ed involving nicarb az in. These incid e nt s were cl assifie d as min o r severi t y. Overall , th e re are few incidents reported to ID S in vo lving ni carb azi n. b. SENSOR-Pesticide s T he SENSO R-P es ti cide s database covers I 2 s tates from I 998-20 I I, alt hough r e porting varies from stat e to s ta te . Case s of pesticide-related illn esses are ascerta in ed from a variety of sou r ces, including: reports from local Poi so n Co ntro l Ce nters , s tate D e partment of Labor wo rk ers ' compensation c l aims when reported by physicians , reports from Sta t e Departments of Ag ri c ulture, and ph ys ician re port s to s tate Dep a 11m e nts of H ea lth
. Although both occupational and non - occupational incidents are included in the database , S E NS OR-P es ticid es focuses on occ up at ion al pesticide in cide nt s . and is of parti cu lar valu e in prov idin g that infonnation. Th e state coordinato r at eac h of the 1 2 re s p ect iv e s tate D e partment s of H ea lth conducts case fo ll owup activ iti es such a s obtain in g m edical records to verify sympto m s and seve ri ty. Us ing standa rdi zed protoc o l and case d e finiti o n s deri ve d from po i son center reporting. the state SENSO R-P est i c id e coord in ato r en ter s the incident information into th e s tate -ba se d sys te m which i s sent to NIOSH annua ll y to be aggregated. A rev iew of SENSO R-P est icides 1998-20 I I identifies no cases involving nicarbazin.

c . Agr icultur al Health Stud y (AHS) The AHS is a high quality, pros p ecti ve epidem iology study eva lu atin g the link between pesticide u se and va riou s he a lth o utc o me s includin g can cer. Th e A HS includes private and commercial pesticide app li ca tors and their s p ouses . 

### If there a re A HS findings r e le va nt to a part ic ular pestic id e go in g through registration re view. the Agency w ill ensure the y are cons idered in the problem fo rmul ati on/sco pin g pha se of th e process and , if a ppropri a te , fu ll y r eviewe d in th e ri sk a s sessment phase of the process. T he AHS includes information on use of 80 differe nt pesticide

Page 3of4active ingredients commonly used in agriculture. Nica rbazin is not inc l uded in the AHS, and therefore this study does not p r ovide information for this report. 

### I V
. C O NC L US IO N Based on the l ow frequency and sever ity of incident cases reported for n icarbazin in both IDS and SENSO R -Pesticides there does not appear to be a concern at this time that would warrant fm1her investigation. The Agency w i ll continue to monitor the incident infonnation and i f a concern is triggered. additional analysis wi ll be included in the risk assessment.

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