### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMI CA L SAFETY AND POLLUTION PREVENT IO N



### MEMORANDUM D ate : September l , 2015 

### SUBJEC T: U ni conazo le: Ti er I (Scoping) R ev iew of Hum a n Incid e nt s and Epidemio l ogy

P C Code : 128976 DP Barcode: 0428899 D e ci s io n No .: 508172 Petition No.: NA Re g istration No.: NA R eg ul atory Ac ti o n: NA C a se No.: NA Ri sk A ssess m e n t T y 1 >e: NA TX R No.: NA CAS No. : 83657-17 -4 40 C FR: A**!RID** N o.: A 

### FROM:

THRO UG H:

TO: Shanna Recore , l ndustrial H yg ienis t Toxicology and Ep id emio logy Branch Health Effec t Division (7509 P) and E li zabeth Evans , Enviro nm en tal P rotec tion Specialist Toxicology and Ep idemi o logy Branch H ea lth Effects Division (7509 P) /)/ David Miller , Ac tin g Branch Chief

# d:J~ Toxicology and Epidem iology Branch Health Effec t s D ivision (7509P) Jaime D"Ago s tino , Risk Assessor Risk Assess m en t Branch II H ea lth Effec t s Division (7509 P) and Matthew Manupella, Chemical Revi ew Man age r Risk Management 

### & Implementation Branch 4 Pesticide R e -e va lu at ion Division (7508 P) Summary and Conclusions Ver.Apr.OS

There were no incident cases reported , involving uniconazole , to e ith e r lD S or SENSO RPcsticide s . There does not appear to be a co ncern at thi s time that would wa n- an t further investigation. The Age ncy will co ntinu e to monitor the in c id e nt information and if a concern is triggered , add iti ona l a nal ys is will be includ ed in th e ri s k assessment.

Page I of 3Detailed Rev iew 

### I. 

### ACT I ON REQUESTED This review is inte nd ed to fulfill our requirement to d ocket summaries of incident data that were reported to th e Agency, as well as to e n s ure hum an incid en t data and the Agricultural Health Study (AHS ) are part of the probl em fo rmul a ti o n phase of r eg is tration rev iew. Repo rt s of adve rse health effects a ll egedl y due to a spec ific pesticide exposure 

### (i.e., an " incident " ) are large l y se lf-repo rted and therefore, genera ll y spea kin g, ne ither ex po su re to a pesticide or reported symp tom (or the connection between the t wo) is val i dated or otherwise confi m 1ed. Typ ica ll y, causation cannot b e determ ined ba se d o n incid e nt d a ta. H oweve r, incid e nt information can be an important source of feedback to the Agency: incidents of seve re outcome, o r a sugges ted patte rn or trend among less seve re incident s, can sig nal th e Agency to further investigate a particular che mi cal o r p roduct. Observationa l epidemiology stud ies relate the risk of di sease, 

### e.g., cancer, and exposure to an age nt suc h as a pesticide product in the ge n eral population or spec i fic sub-groups like pesticide applicators. 

### II

. BA C KGROUND U nic onazo le is a tri azo le fung i c ide and p lant g r owth regulator. 

### It is reg is tered for u se in commerc ial g reenhouses on various orname nt a l plants and fruiting vegetab les. For this evaluation , both the OPP Incident Data System (IDS) and the Centers for Disease Co ntro l and Preventio n /Na tion a l In s titute fo r Occupat ional Safety and Hea lth (CDC/N IOSH) Sent i nel Event Notification System for Occupational Ri sk- Pes ti cides (SENSO R) databases we r e co n s ulted fo r pesticide in cide nt data o n th e ac tiv e in gred ie nt uniconazole (pc code: 128976). The purpose of the database search i s to identify potential patterns in th e fr eq u e n cy and sever ity of the health effec t s attribu ted to uniconazole exposure . Uniconazole is not included in the A H S , an d th e r efore this s tudy does n o t prov ide in fo nnati o n for this re port. 

### II I. RESULTS/D I SCUSS I ON

a. I DS ( In cide nt Data S ys te m ) OP P ' s ID S includ es reports of alleged human health incid en t s from various sources , in cluding mandatory Federa l Insecticide , F un gicide a nd Rod e nticid c Act (F IFRA ) Section 6(a)(2) r epo rt s from registrants, other federal and state health and envi ronme nt a l agencies, and individual co n su mer s. Si nce 1992, O PP h as compiled th ese re port s in ID S. lD S contains rep o rt s fro m across the U.S. and mo st incidents h ave a ll re levant product in fo rm ation recorded. Reports subm itte d to the ID S re prese nt a nec dot a l re p o rts o r a ll egati ons o nl y, unl ess o th e r w i se s tated in the report. IDS records incidents in o ne of two modules: Main ID S and Aggregate ID S:

o Main ID S conta in s incide nt s res ul ting in hi g her severit y outcomes a nd provides m ore de ta il w ith regard to case s p ecifics. This system stores incident data for

Page 2of3death, major and moderate incidents , a nd it includes information about the location , date and nature of the incident. M ai n ID S incidents involving only one active in g redi e nt (as opposed to pesticide products w ith multip le act i ve ingredients) are considered to provide more certain information about the potential effec ts of expos ure from the p est icide.

o Aggregate IDS contains incidents re su lting in less severe human incidents (mino r , unknown , o r no e ffect s o utcom es). These are repo rted by reg istrant s only as counts in what are aggregate summaries. There were no in c id ents in vo lving uniconazole reported to Main or Agg rega te ID S. from January 1 , 2010 to May 27, 2015. b. SENSOR-Pestic id es The SENSOR-Pesticides datab ase covers 12 states from 19 98-201 1 , a lthough reporting varies from s t ate to state. Cases of pesticide-related illn esses are asce rtain ed from a variety of sources, including: reports from local Poison Control Centers , state Department of Labo r wo rkers' compe n sa ti o n claims when reported b y physicians, repo 11s from State Dep artment s of Agriculture , and physician rep ort s to s tate Departments of H ealth. Although both occupational and non-occupational incidents are include d in the d a tabase , SENSO R-Pe st ici de s focuses o n occupat iona l pesticide incidents , a nd is of particular va lue in providing that information. The state coordinator at each of the 1 2 respective state D epartments of Health conducts case followup act iviti es s u ch as obtaining medica l records to verify sy mpto m s and seve rity. Us ing standardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pestic id e coordinator enters th e incident information into th e state-based system which is sent to N IOSH ann u ally to be agg regated

. A review of SENSO R-P est icid es I 998-201 1 ident ifies no in c ide nt s involvin g unic o nazol e .
c . Agric ultura l Health Stu d y (AHS) The AHS is a high quality, prospective epidem io lo gy s tud y eva luatin g the link between pesticide use and various hea lth ou tcomes including cancer. The AHS includes private and co mme rcial pesticide app lic ato rs and their spo use s. 

### ff there a re AHS findings re levant to a particular pestic id e going through registration review, the Agency w ill ensure th ey are considered in th e problem fo rmul ation/scoping phase of the process and , if appropriate, fully rev iewed in the risk assessmen t phase of the process. The AHS in c lud es informati on on u se of 80 different pesticide active ingredients commonly used in agric u lture. Uniconazole is not included in the A H S , a nd therefore this study does not provide information for this r e p or t. IV. C ON CLUS ION There were no incident cases reported, involving uniconazole , to either IDS o r SENSORPe s ticides. There does not a pp ea r to be a concern at thi s time that wou ld warra nt furt her investigation. The Agency will con tinu e to monitor the incident in fo rmati on and if 

### a concern i s triggered, additional analysis will be included in the risk assessment.

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