### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D . C . 20460 O F F I C E O F C HEMI C AL SA FE TY AND P O LLUTI ON P RE VE NTI O N



### MEMORAN D UM Date: A u g u st 25, 20 1 5 

### SUB JECT : Triticonazole: Ti er I (Sco p in g) R ev iew of Human In c idents and Ep id e mi o logy

PC Co d e : 125620 DP Barcode: 0428796 D ecis io n No
. : 499940 P etit io n No.: NA Ri sk Assessment T y p e: NA TX R No
. : NA M RID No
. : NA Reg i s tra ti o n No.: NA Re g u l atory Act io n : NA Case No. : NA CAS No.: 1 3 1983-72

- 7 40 CFR: NA


### F R OM : E li zabeth Evan s, E nv ironm e ntal Protec tion Spec ia li st T ox ic ology a nd Epidem i o lo gy Branch Health Effects Div is io n (7509 P) a nd Shanna Recore , Indu stria l H ygien ist Ver.Apr.OS



### THROUGH: Toxicology and Epidem iol ogy Branch

### _JJ~**~** Health Effect Divi s ion (7509P) David Miller , Acting Branch C hi e f

# ~:;J.,/J"A,**..¥ ·**  ...,,.,.- Tox ico logy and Ep id e mio logy Branch


### TO: Health Effects Di vision (7509P) Nancy Keller , Risk Assessor Ri sk Assess m e nt Branch I H ea lth Effects Div is io n (7509 P) a nd M ig uel Zava la , Che mical R eview Manager Risk Management & Implementation Branch 3 Pesticide R e-eva luation Di v i s ion (7508 P) S umm ary and Concl u s ions B ased on the low freq u ency a nd severity of incident cases reported 

### for tritic onazole in both IDS and SENSO R-Pe s ticid es there d oes n ot appea r to b e a co n cern at thi s time that would warran t further investigation. The Age ncy wi ll con tinu e to mon ito r th e in c id ent informati o n a nd if a co nc e rn i s triggered , add i t io n a l ana lys i s wi ll be included in the risk assess m ent.
Page 1 of 4Detailed Review 

### I. 

### ACT I ON REQUESTED This review is intended to fu lfill our requireme nt to docket summaries of incident data that were repo1ted to the Agency , as well as to ensure hum an incident data and the Agr icultura l Health S tud y (AHS) are part or the problem formulation phase of re gistration review. Reports of adverse health effects a ll egedly due to a specific pesticide exposure 

### (i.e ., an " incidenf') are largely se lf-reported and th erefore, generally speaking , neither exposure to a pesticide o r reported symptom (or the connection between the two) is va lidated or otherwise confirmed. Typically, causation cannot be determined based on incident data. H owever, incident in formation can be an important source of feedback to the Agency: incidents of seve re outcome, o r a s uggested pattern o r trend among le ss severe in cidents, can signa l th e Agency to further investigate a particu la r chemica l or product. Observationa l epidemio logy s tudi es re late the risk of disease, 

### e.g., cancer , and exposure to an agent suc h as a pesticide product in the general population or specific sub-groups like pesticide applicators. 

### II. B AC K G RO UN D Triticonazole is a seed treatment fungicide fo r grain and cereal. For this eva lu ation, both the OP P In cident D ata System (IDS) and the Ce nters for Di sease Con trol and Prevent ion/Nat ional Institute for Occupational Safety and Health (CDC/NIOSH) Sentine l Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient triticonazole (pc code:). The purpose of the database search is to id ent i fy potential patterns in the frequency and severity of the health effects attributed to tritic onazo le exposure. Triticonazole is not included in the AHS. and therefore this s tud y does not provide information for this report. 

### Ill. RESULTS/D ISCUSSION


### a. IDS (In ci d ent Data Syste m ) OPP's IDS includes reports of a ll eged human health incidents from various sources , including mandatory Federal In sectic ide , Fungicide and Rodenticide Act (FIFRA) Sectio n 6(a)(2) reports from registrants , other federal and state health and environmental agencies , and individual consumers. S in ce 1992 , OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents have a ll relevant product information recorded. Reports subm itted to the IDS represent anecdotal repor t s or allegations only, unless otherwise stated in th e report. IDS records in c id e nt s in one of two modul es: Main IDS and Aggregate IDS:



### o Ma in IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for death , maj or and moderate incidents, and it includes information about the location , date and nature of the incident. Main ID S in cidents involving only one
Page 2 of 4active in g red ie nt (as oppo se d to pesticide produ c ts with multiple act ive ingred ie nt s) arc co n s id ered to provid e more certain in format ion ab o ut the potential effec t s of ex p osure from the pe st icide.


### o Agg regate IDS co ntain s in ciden ts r es ultin g in less severe hum a n incidents ( min or, unknown , o r n o effects outcomes). These are re ported by re g is tr a nts only as cou nt s in what are aggregate s ummaries. For the Main JDS , from Jan u a r y 1 , 20 I 0 to Februa ry 4 , 20 1 5, th e re we re n o in c id e nt s repo rted involving triticonazole. In Aggrega te IDS , from Janu a ry 

### I , 20 

### I 0 to February 

### 4 , 20 1 5, there were 

### 3 in c id e nts reporte d involvin g tritic o na zo le. Th ese in cidents we re classified as minor se verity. Overall , th e re are f ew incidents reported to ID S in vo lvi n g triti cona zo le . 

### b . SENSOR-Pest ic ide s The SENSOR-Pest ic id es database covers 1 2 states from 1998-201 1 , a lthou g h reporting varies from state to s t a te. Cases o f pesticide -r elated illn esses are ascertained from a va ri ety of sourc es , inc l udin g: re ports from loca l Poi so n Control Centers, sta te D e p artment of L abor workers' compensa ti on claims when reported b y physicians , report s from Stale Departm e nt s of Agricu lture, a nd physician reports to s t ate Departments of H ea lth . A lthou g h both occupational and n on -occupational incident s are included in the d atabase, SENSO R-P est ic id es foc u ses on occupational pesticide in c iden ts, and is of particular value in providing that information
. The state coordinator a t each of th e 1 2 respectiv e s tale Departme nt s o f Health conducts case followup activit ies s uch as obtainin g medical rec o rd s to verify symptoms and seve rity. Us in g standard ized protocol and case definitions der ive d from poi so n ce nter reportin g, th e s tate SE SOR-Pest ic id e coord in ator enters the incident information into the s t ate-based sys tem wh ich is sent to N IOSH a nnu ally to be aggregated. A rev iew of SENS OR-P es ti c ide s 1998-2011 id e ntifies no cases involving triti co nazo le.



### c. Ag ricultura l Health Stud y (A H S) The A H S is a hi gh quality , prospective ep id emio logy stud y eva luatin g th e l i nk between pest ic id e use and various h ea lth outcomes includin g can cer. The AHS in cludes pri vate and co mme rc ial pesticide app li cato r s a nd th e ir s pouse s . If there a r e AHS findin gs relevant to a p a rti cu lar pesticide go in g through re g is tration rev iew, th e Agency will e n s ure they are co n s id e red in the pro blem fo rmulation/scop in g pha se of th e proc ess and , if appropria te, fully revi ewe d in the ri s k assessment phase of the process. The A H S in cl ud es inform a ti on o n u se of 80 different pe s ti c id e active ingredients commonl y used in ag ri culture. Tritic o n azo le is n ot included in th e AHS , and therefore thi s s tud y does not provide information for this report. 

### IV. CONCLUS ION Based on the low frequency a nd seve rity of the in c ident cases reported for triti co n azo le in both ID S and SENSO R-P est icides th e re does not appear to b e a co n cern a t thi s time th a t wo uld

P age 3 of 4warran t f urther investigation. The Age n cy will cont inue to m o nitor th e incident infomiation a nd if a concern is tri gge r e d , additional anal ys is wi ll be include d in the ri sk assessment.

P age 

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