UNITED STATES ENVI R ONMENTAL PROTE C TION AGENC Y WASHINGTON , D.C . 20460 OFF I CE OF C H E MI CAL SAF E TY A N D POLLU TI ON PRE VE NTIO N

M E MORAND UM D a t e: June 16 , 2015 

### SU BJE C T : Bromuconazo le: T ier I (Scop ing) Review of Human I ncidents
P C Code : 120503 D ecision No.: 504955 P eti t io n No. : NA Risk A ss essment T ype: NA TX R No
. : NA M RID No.: NA OP Barcode: 0427797 R egistratio n No.: NA R egu la t ory Ac t io n : NA Case No.: NA CAS No. : 1 16255·48-2 4 0 CF R : NA
F R O M : Shanna Recore, Industrial H yg ienist 

### A 1 . . • . Toxico logy and Ep idemio logy**ranch~** I l ealth Effect Division (7509P) and Ver.Apr.OS

E li zabet h Evans,

### nvironm**ntal** P rotection Specialis u::=;-.L..

### ~ Toxicology and Epidemiology Branch v 

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THRO U GH :

TO : Health Effects D ivision (7509 P ) 

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- 1, J ' () David Miller, Acting Branch

### Ch**ef /**  T ox icology and Epidemiology Branch Hea lt h Effects Div i s io n (7509P) B a rry O ' Keefe , Risk Assessor Ri sk Assessment Branch III H ealth Effects Division (7509P) and James Parker , Chemical Review Manager Ri sk Managemen t & Impl e mentation Branch 1 Pe s ticide Re-evaluation Divi s ion (7508P) Summary and Conclusions There we re no incident cases r epo 11ed for bromuconazole to either I DS or SENSOR-Pesticides , there does not appear to be a co n cern at this time tha t wou ld war r a n t furthe r investiga tion. T h e Agency wil l cont inue to monitor the incident informat ion and if a concern i s tr iggered, add itiona l analysis will be included in the risk assessment.
Page I of 4Detailed R ev iew I. A CT IO N REQ UESTE D This re v iew i s int e nd ed to fulfill our re quirem e nt t o doc ke t su mm ar ies of in c id e nt data th a t were r eported t o th e Age nc y, as we ll as to ensu re human incident data and the A g ricultural H ea lth Study (A HS) are part of the pr oble m formula ti on p h ase of r eg istrati o n review. R e ports of adverse h ea lth effec ts a ll egedly due t o a s pecific pe s tic ide expos ure (i.e., an " incident") a re large l y se l f-repo 1 1ed and therefore , generall y s peakin g, neither exposure to a pesticide o r r eporte d sy mpt o m (o r th e connection be twe e n the t wo) is va lid a ted o r otherwise confi rm e d. T y pically , causation ca nn o t be determined ba se d on incident data. H oweve r, incident information can be an important so urc e o f feedback t o the Age nc y: incid en t s of seve re outco m e . or a s u gges ted pattern or trend a mon g less severe in c ident s, can sig n a l the Age nc y t o further in vest i ga te a particular c hemi cal o r product. Observat ional epidemio l ogy s tudies r e late th e ri sk of disea se, e.g., cancer , and expos ure t o an agent such as a p es ticid e product in th e ge neral population or spec ific sub-groups like pesticide applicators. 11. B AC K G RO UN D Bromuconazole i s a fungicide appl ied to ros es t o con tr o l black spo t. It i s formulated as a n e mu l s ifi ab le concentrate. 1 Fo r thi s eva luati o n , both the OPP I ncid e nt D ata System (IDS) and th e Cente r s for Disea se Co n trol a nd Pr eve ntion/National In s titute for Occupational Safe ty a nd H ea lth (C D C/N IO S H ) Sentine l E vent Notifica ti on Sys tem for Occupational Ri sk -P es ticid es (SENSO R ) databases we r e co n s ulte d for pe s ticide incident data o n the active in g re dient bromuc o nazo le (pc code: 1 20503). The purpo se of the d atabase sea rch i s to identif y pot e ntial pattern s in the frequency and seve rit y of the h ea lth effects attr ibuted to bromucona zo le exposure. Bromuconazole is not includ e d in th e AHS , an d th erefore this study d oes not provide inform a ti on for this report. III. RES UL T S /DI SCUSS IO N
a. ID S (In c id e nt D a t a Sys t e m ) OPP's IDS includ es reports of alleged human health incidents from var ious so ur ces, in clud in g mandat o ry Federa l In sect ic i d e, Fu n gicide and Rod e ntic id e Act (FIFRA) Sect ion 6(a)(2) re ports from re g i s trant s , o ther fe deral and sta te health and env ironm e nt a l agen ci es, and in dividua l co n s um e rs. Since 19 92, OPP h as compiled these repo rt s in ID S
. IDS conta in s rep o rts from across the U
. S. a nd mo s t incid e nt s h ave all r e l

eva nt product inform a tion r ecord e d
. R e po11 s s ubmitt ed to the lD S rep resen t anecdotal r eports o r a ll egations only, unless oth erwise stated in th e report. I DS records in c id e nt s in o n e of two module s: Main ID S and Aggregate ID S:

1 h11p: //www .epa.gov / pes1icides/chem

_ se arch/ r eg_act io n s/re g i s tratio n/fs

_ PC- I 20503
_ 0 l -Nov-02
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P age 2 of 4o Main lD S contain s incid e nts result in g in higher s ev erity outcomes and provid es m o re d e t a il with reg ard to cas e s pec ific s. Thi s sys te m st o res incid e nt data fo r dea th , ma j o r and mo de rat e incid e nt s, and it includ es inform a tion a bo ut th e loc ation , date and nature o f the in c ident. Main IDS incid e nt s involving only one ac ti ve in g re di e nt (as op pose d t o pes ti c id e produ c t s w ith multipl e ac ti ve in g re di e nt s) are co n s id er ed to p rov id e mo r e ce rt a in in fo rm a ti o n ab o ut the potential e ffect s of expo s ure from th e p es ti c ide
. o Agg r ega t e ID S co nt a in s in c ident s r es ultin g in le ss seve re hum an in c id e nts ( minor, unknown , or n o e ffects o utcome s). These are report e d by reg i s trant s only a s co unt s in w h at a re agg reg at e summ ari es . Fo r th e Main ID S, from Januar y I , 2010 t o Febru a ry 5 , 2 015 , th ere were no incid e nt s repor te d i nvo l v in g bro mu co n azo le. In A gg reg at e I D S, from Januar y I , 20 I 0 to Febru a r y 5 , 2 015 , th e r e were no incid e nt s rep o 1te d in vo l v in g b ro m uco nazo lc. b. SENSO R-Pe s ticide s Th e SENS OR-P es ti c id es data base cove rs 1 2 s ta tes from 1 99 8- 20 1I , alth o u g h re p o rtin g v ari es fro m s ta t e to s t a t

e. C ases of p es ti c id e -re late d illn esses a re asce rta in e d fr o m a v ari e ty of so ur ces, includin g: rep o rt s from lo cal P o is on Control C e nt e rs, stat e Departm e nt of Labor worker s' co m pe n sa ti o n c l a im s w he n r e p o rt e d by p hys i c i an s, r e p o rt s fr o m S tate D epa rtm e nt s o f Ag ri c ulture, a nd ph ys ic ia n rep o rt s t o s t a t

e Dep a rtment s of He alth . A lth o ug h b o th oc cupati o na l a nd no n-occup a tional in c id e nt s are includ e d in th e databa se, SEN S OR-P es ticide s fo c use s o n occ upa ti o n a l pes ti c id e in c id e nt s , and i s of pa rti c ul ar va lu e in p rov idin g th a t inform a ti o n . Th e state coo rdin ato r a t eac h of th e 12 r e sp ec ti ve sta t e De p a rtment s of Hea lth co nduct s cas e fol low up ac ti v ities s uc h as obt a inin g me dical rec ords to verif y sy mptom s and se v e rity . U s ing sta nd ard ize d pr o t oco l a nd case d e finjti o n s de ri ved fr o m po iso n ce nt e r re po rtin g, th e s tat e SENSO R

- Pes ti c id e coo rd in a t o r e nte rs th e incid e nt inform ati o n into the s ta t e -ba se d s y s tem w hich is s e nt to NIO S H annu a ll y to b e agg re ga te d
. A review of SENS OR

- Pes ticid es 19 98- 20 11 id e ntifi e s n o c a ses in vo lv in g bromucon az ole.

c. Agr icultural He a lth Study (AHS) T he AHS i s a hi g h qu a lit y , pro s pec tive e pid e mi o log y stud y ev alu atin g th e link be tw ee n p es ti c ide u se a nd va riou s he alth o utc o m es includin g c anc er. Th e A HS includ es pri va te and co mm er c ia l pestic ide a pp lic ato rs an d th e ir spo u ses. If the r e are A H S fin d in gs re lev ant to a p arti c ul ar pes ti c ide go in g thr o ug h r eg is trati o n re vi ew , the Age nc y will en s ure they a re c on s id e re d in th e p robl e m fo rmul ation /s c o pin g ph ase of th e proc ess and , if appropri a te , full y rev iew e d in th e ri s k assessme nt ph ase of th e process. T he A H S i nc lu des in fo rm a ti o n o n u s e o f 80 diff ere nt p es ti c id e ac ti ve in g redi e nt s c omm o nl y u se d in ag ri c ultur e . Bromu co naz ol e is not in c luded in th e AH S, a nd th e r e fore thi s s tudy d oe s n o t provid e infonn at io n fo r thi s rep o rt. IV . CONCLUSION

Page 3o f4There were no incid e nt cases reported fo r bromuconazole to e ith er IDS or SENSOR

- Pesticides, there does not appear to be a concern at this tim e that would war r ant fu1ther investi ga ti o n. The Ag e ncy w ill conti nu e to monitor th e incident in fo rm atio n and if a concern is trigg ered, ad diti ona l an alys is will be inc l uded in the risk assessment.

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