### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C . 20460 O FFI C E O F C HEMIC A L SA F E TY A N D PO LLU T I O N P R EV ENTI ON



### MEMORANDUM Date: September 15 , 2015 

### SUBJECT: Cyproconazo le: Tier I (Scop in g) Review of Human Incid ents and Ep idemiology

P C Co d e: 128993 DP Barcode: 0429119 D ec i s io n No .: 508975 P et ition No.: NA Registrat ion No.: NJ\ Regu l atory Action: NA Case No.: NJ\ Ri s k As sess ment T y pe: NA TXR No.: NJ\ CAS No. : 94361-06-5 40 CF R: NA MRID No.: NJ\


### FROM : Shanna Recore , Industrial H yg i enist Toxicology and Epidem io logy Branch Health Effect Division (7509 P) a nd El izabet h Eva n s, Env ironme nt a l Protection Specialist Tox ico lo gy and Ep idemio logy Branch Yer.Ap r.08



### Health Effec t s Di v i sion (7509P) 

### T H ROUGH: David Miller, Acting Branch

# hi**ef~ i!L** **dv(); J1-** **1tt-r!tn** Toxicology and Epidemiology Branch

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TO: Health Effects Division (7509 P ) George Kramer, Risk Assessor Risk Assessment Branch I Health Effects Division (7509P) and Kelly Ballard , Chem ical Review Manager Risk Management & 

### Impl eme nt at ion Branch l Pesticide Re-evaluation Division (7508 P) Summary a nd Conc lu sio n s Based on the low frequency a nd severity of incident cases reporte d for cyproco nazole in both l DS and SENSOR-Pesticides there does not appear to be a co nc ern at this t ime that would warrant furthe r in vest igat io n . The Age ncy w ill co ntinu e to monitor the incident information and if a concern is triggered , add itio nal ana lys i s wil l be includ ed in the ri s k assessment
.

P age 1 of 4Detailed Re v iew 

### I. 

### ACTION REQUESTED Thi s review is inte nded to fulfi ll our requirem e nt to docket summar ies of incident data that were reported to th e Agency, as well as to ensure human incident data and th e Agricultura l Health S tud y (A HS ) are part of th e problem formulation phase of registration r ev iew. Re ports of adverse health effec t s a ll egedly due to a specific pesticide exposure 

### (i .e., an "inc id e nt " ) are largely self -reported and therefore , generally s peaking , neither exposure to a pesticide or reported sy mpt o m (or the connec tion between th e tw o) is validated or otherwise confirmed. T ypica lly , causation cannot be determined based o n incident data. H owever , incident information can be an impo11ant source of feedback to the Agency: in cide nt s of severe outcome , or a suggested pattern o r trend among less seve r e incidents , can signal the Agency to fu11her investigate a particular chemical or product. Observational epidemiology s tudi es relate the ri s k of di sease, 

### e.g., cancer , and exposure to an agent s uch as a pesticide product in the general population or s p ec ific sub

- g roups like pesticide applicators. 

### II
. BACKGROUND Cyproco nazol e is a broad-spectrum tri azo le (G roup 3) fungicide that is a mixture of two distereoisomers (2RS , 3 RS: 2 RS ,3 SR; - 1: I )

. Cy proconazole is current ly re g is tered for u se o n greenhouse

- and field-grown roses , as a wood pre servative, and on sod farms, go l f cours es , as we ll as a number of crops. There are no propo se d or registered use s for cyproconaoz le in th e r esi dential setting. For this evaluation , bo th the OPP Incid en t Data System (IDS) and the Centers for Dise ase Control and Preve nti on/Nat io nal In stitute fo r Occupational Safety and Health (CDC IOSH ) Se ntinel Eve nt No tifi cat io n System for Occupational Ri sk-P esticides (SENSO R) databases were consulted for pe s ti c id e incident data on th e active in g redient cyproconazole (pc code: 128993). The purpose of th e database se arch is to id entify pote ntial patterns in the frequency and severity of the health effects attr ibuted to cyproconazo le exposure. Cyproconazole is not in cluded in the AHS, and therefo re thi s s tudy does not provid e information for thi s repo rt. 

### III. R ES UL TS / DISCUSSION

a. ID S (Inc id ent Data System) OPP's ID S in cludes report s of alleged human hea lth incidents from various so urce s , including mandatory Federal In sec ticide , Fungicide and Rodenticide Act (FlFRA) Section 6(a)(2) report s from registrants , other federa l and state h ea lth and env ironmental agenc ies , and individual consumers. Since 199 2 , OPP has compiled th ese re ports in IDS. JDS contains repo rts from across the U.S. and mo st incidents have all r eleva nt product inform at io n r eco rd ed. Report s sub mitte d to the ID S represent anecdotal reports or allegations only , unl ess otherwise stated in the report. IDS rec ords incidents in one of two modules: Main IDS and Aggregate IDS:

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### 2 of 4

### o Main ID S contai n s incident s resulting in higher severit y ou tc omes and provides m o re detail w ith regard to case specifics. This system sto r es in cide nt data for death , major and moderate in cidents , and it includ es information about the location , date a nd nature of the incid ent. Main ID S incidents in volv in g on ly o ne ac ti ve ingre di e nt (as o p posed to pesticide products with mult i ple ac ti ve in g r e dient s) are considered to provide more certain information abo u t the potential effect s of ex po s ure from th e pe s ti c id e . 

### o Agg regate ID S conta in s incide nts resultin g in less seve re human incidents (m in o r , unknown , or n o effects outcomes). Th ese are reported by registrants only as cou nt s in wha t a re agg regate s ummari es. For the Main JDS, from J an u a ry 

### I , 20 I 0 to May 

### 27, 20 15, there we re no incid e nt s reported involving cyproconazole. In Aggrega te ID S, from Janua ry 

### 1 , 20 10 to May 

### 27 , 20 15 , there were 

### 2 incident s re porte d inv o lvin g cyproco n azo le. One in ciden t was c lass ifi ed as minor seve ri ty a nd the ot h er was classified as havin g n o or unknown effects. Overall , the re are few incidents reported to IDS involving cyp r oco n azo le. b. SENSOR -P est icid es The SENS OR-P es ticides database covers 

### 12 s t a tes from 

### 1998

- 20 11 , a lthough rep o rt in g vari es from s t a te to state. Cases of pest ici de -re la ted illnesse s are ascertained from a vari e ty of sources , including: rep o rt s from l ocal Po i so n Con trol Ce nters, s tate D epartmen t of Labor worke r s' compe n sation c lai m s w h en reported b y phy s icians , repo rt s from Sta te D e partme nt s of Agric ulture, a nd p h ys ic i an repo rt s to state Department s of Health

. A lth oug h both occ upation al and non-occupati o nal incident s are included in the databa se, SE SOR-Pesticides focuses on occupatio nal pesticide incident s, and is of particular va lu e in providin g that in format ion . The sta te coo rdinator at each of th e 

### 12 respectiv e state D epa r 1ment s of H ea lth conduct s case fo ll owup act i vit ies s u c h as obta ining med ical r eco rd s to verif y sy mptom s a nd s ever ity. Us ing sta nd ard ize d pro toco l and case defin iti o n s derive d from po iso n ce nte r report in g , the s tate SENSOR -P est ic ide coord i nato r e nters the in c id ent inform a tion into th e s tate-ba se d sys tem which is sen t to NIOS H annua ll y to be agg r egated. A query of SENSO R-P estic id es 

### 1998-2011 id e ntifi es three cases in vo lv in g cyproconazo le (pc code 

### 128993). A ll three cases in vo l ve d multiple active i n g redient s. A ll three cases were low in severity.

c. Agr i cu ltural Health Stud y (AHS) The A HS is a hi g h qua lity , pro spec tive epidemio logy st ud y evalu ating the li nk be tween pesti cide use and va riou s health outcomes including ca ncer. The AHS includ es private and com m e rcial pesticide app li cators a nd their spo uses. Ifth e r e are A H S findings relevant to a p a rti c ul ar pe s ti cide go in g throu g h reg is tr a ti o n revi ew, th e Age n cy will e n s ure th ey a re cons idered in the problem formu la tion/scopin g ph ase of th e process and , if approp ri ate, fully rev iewed in th e ri s k assessment pha se of the proc ess. The AHS include s in fo rmation on u se of 80 diff e re nt pesti c id e

P age 

### 3 of 4active ingredients commonly u se d in agriculture. Cyproconazole is not included in the AHS. and therefore th is study do es not provide information for thi s report. 

### IV
. C O NC L US ION Based o n th e low frequency and severity of incident cases reported for cyprocona zo le in bo th IDS and SENSOR-Pesticides there does not appear to be a concern a t this time that would warrant further investigation. The Age n cy w ill continu e to monitor th e incident inform at ion a nd 

### if a concern is tri ggered , ad diti onal ana lysi s w ill be included in th e ri sk assessment.

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