### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHIN G TON , D
. C

. 2 0460 OFFICE OF C H E MI CA L SAFETY A N D POLL UTI O N PR EVE N T I O N

ME MORAND U M Date : ovemb e r 2 4 , 20 1 5 S UBJECT : Prop ic o n az o le: T ie r 

### I (Scopi n g) R ev iew of Hum a n In cid e nt s a n d E pide mi o logy

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# ,#tlf T ox ico logy a nd Epi de mi o logy Bra nc h H e a lth E ff e c ts D i v is ion ( 7509 P) Thurs to n M o rt o n , Ris k Assesso r Ri s k A ss e ss m e nt Branch 

### IV H ea lt h E ff ec t s Di v is io n (7509 P ) a nd C hri s tin a Sc he l tema , Chemica l R ev ie v v Manage r Ri s k M a n age me nt 

### & Im p lemen ta tio n Branc h 3 Pes ti c i d e Re- e va lu a tio n Di v is io n (7508 P) S ummary and C o nclu s io n s Based o n th e re la ti ve ly low fre qu e nc y a nd seve rit y o f inc id e nt c as e s r e p o rted for propiconazol e i n bo th IDS and S EN O R

- Pes ticid es there d ocs n o t a pp ea r to be a co n cern a t thi s tim e that wo uld warrnnt furthe r in ves ti g ati o n. T he Age ncy w ill c o ntinue to m o nit o r th e in c id e nt

Page 1 o f 4infonnation and i f a concern is tri gge re d. ad diti o n a l a n a l ys i s \V iii be in c lud ed in the ri sk assessme nt. Detailed R ev iew I. 

### AC TI ON R EQU E STED Thi s r eview is intended to fulfill o ur requ iremen t to docket s umm a ri es of incident data th a t v .iere reported to the Age n cy . as well as to e n su re hum an in c ide nt dat a a nd th e Ag ri c ultural He a lth

tud y (A HS ) are part of th e problem formu la ti on phase of regi s trati o n r ev iew. Re ports of adverse health effect s a ll ege dl y due to a s p ec ific pe s ticide exposu r e 

### (i.e
.. a n " inc ident ' " ) are la rge l y se lf-reported a nd th e refo re , generally s p ea k in g, n e i the r exposure to a pesticide o r r epo rted sy m ptom ( o r th e connectio n be twe e n th e two) i s va li da ted or o th e rw i se co n fir m ed. Typ ica ll y, causation ca nn o t be dete rmined ba sed o n incident data
. How eve r , incid e nt information can be a n imp o r1 ant so urce of feedback to the Age nc y: in c id e nt s of severe outcome. o r a s uggested pattern o r tre nd a m o ng l ess seve r e in c id e nt s, can signal th e Agency to further investigate a particul a r c hemical or product. Ob se r va ti ona l ep id emio logy s tudie s relate the risk of disease
. 

### e.g. . cancer. a nd expos ure to an age nt s u c h as a pesticide product in the general populati on or specific s ub-groups like pe st ic id e applicator s . 

### II . B AC K G RO U ND Propiconazo l e is a sys tem i c broad spectrum fungicide u se d for contro l of di sease in a var iety of field and orchard crops. 1 For this evaluatio n. both th e O PP Incid ent Data ys tem ( ID S) and the Cen ters for Di sease Co ntrol and P reven ti on/National In stitu te for Occupatio n a l Safet y and H ea lth (C DC T OSH ) e ntinel Eve nt o tifi cati o n System for O ccupat io n a l R i sk -P est icid es ( ENSO R) databases were cons ulted for pesticid e incident data on th e ac ti ve in g red ie nt propic o na zo le (pc code: 1 22 101 ). T he purpose of the d a t abase sea rch i s to id e nti fy potent ia l patterns in th e fr e que n cy a n d severity of th e he a lth effects a ttribute d to propiconazo le ex p os ure. Propiconazo l e i s no t incl u ded in the A H S. a nd the r efo re thi s s tudy does not provid e informati on fo r th i s r e p o rt. 

### III. 

### RES UL T S/ DI SCU S S IO N
a . ID S ( In cid ent Data Sys tem ) OPP" s IDS includ es repo rt s of a lleged hum a n h ea lth incident s from vari o u s so urce s, includin g mandatory Fe d e ra l In sec ti c id e, Fungicide and Rod e nticid e Act (FIFRA) Sec t ion 6(a)(2) report s from r eg i s tra n t s. othe r f e d era l and state h ealth a nd enviro n mental agencies. and indiv id u al co nsumers. Since 19 92. O PP ha s co mpiled th ese re p o rt s in IDS. ID S co ntain s r e port s from across the U .S

. a nd mo s t in c id e nt s hav e all relevant product inform a tion reco rd e d. Re ports s ubmitted to th e 

### ID S r eprese nt anecdo t al report s o r a ll egat i o n s o nl y, unle ss o th e rw ise stated in the report.

1 EPA factsheet. found on lin e at : http: //www.epa.gov/oppOOOO I/chem search/ cleared revicws /csr PC-12210 I IOMar-05 a.pdf
Page 2o f4ID records incidents in o ne of two modules: Main JD S and Aggregate IDS:


### o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system sto res incident data for death. major and moderate in cidents. and it includes information about the location. date and nature of the in c id e nt. Main ID incidents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more cer tai n information about the potential effects of exposure from th e pesticide.

o Aggregate IDS contains incident s re s ultin g in less severe human in cidents (minor, unknown , or no effects outcomes)
. The se arc rep o rted by r egistrants on ly as cou nt s in what are aggregate summaries. For th e Main IDS. from January 1 , 2010 to May 27. 20 15, th ere were 6 incidents reported for the single chemical propiconazole only in the database. These in ciden t s we r e classified as moderate severity. There were 

### 26 additional incidents reported in vo l ving than o ne chemical. In Aggregate ID
. from January 1, 2010 to May 27. 2015. therc were 

### 68 i ncidents reported involving propiconazole. The se incidents were classified as minor severity. 

### b. SENSOR- Pe st i cid es The EN OR-Pesticides database covers 

### 12 states from 1998-201 

### I. a lthou gh reporting varies from state to state. Cases of pesticide-related illn esses arc ascerta in ed from a variety of sources. including: reports from local Po iso n Control Centers, s ta te Department of Labor workers· compensation claims w hen reported by physicians, r epo rt s fr om State Departments of Ag ri culture, and physician reports to state Department s of Hea lth. Although both occupational and non-occupational incidents are included in the database, SENSO R-Pesticides focuses on occupa ti o n a l pesticide incidents , and is of pa rti cu lar value in providing that information. The state coordinator at eac h of the 12 r espective state Departm e nt s or Hea lth conducts case fo ll owup activit ies such as obtaining medical record s to verify sy mpt o m s and severity. Us ing standa rdi zed protocol and case definitions derived from poison center reporting. the state

ENSO R-P esticide coordinator enters th e incident inform a ti on int o the s tate-based system which is sent to 10 H annually to be aggregated. A query of ENSOR-Pesticides 1998-2011 identifies a total of 66 cases involving propiconazole. Of these seven cases involve a s ingle ai. Six cases were low in severity and one case was moderate in severity. The moderate severity case involved a farmworker in a field who was exposed and experienced resp irat ory and gastrointestinal symptoms. The moderate severity case occurred in California in 1999 and no case narrative is provided. Of th e seven single ai cases. 5 cases were occupational agricu ltural (occurred on farms) and two cases were residential use cases. Of the seven cases. four expe rienc ed dermal symptoms. three had ocular symptoms, two had gastrointest in al symptoms and one case reported respiratory symptoms.

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### c. Ag ri cu ltur a l H e alth Study (A H S) The AHS is a high quality, prospective epidemiology stud y evaluating the link between pesticide use and various hea lth o utcomes including cancer. The AHS inc lu des privat e and commerc ia l pesticide applicators a n d their spouses. If there a r e J\FIS findings rel evan t to a pm1icular pestic ide go in g through registration review, the Agency w ill ensure they a re considered in the problem formulation/scoping phase of the process and. if appropriate. fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 80 different pesticide active ingredients commonly used in agriculture. Propiconazolc is not included in th e AHS
. and therefore this study does not provide infonnation for this report. 

### IV. CONCLUS I ON Based on the relatively low frequency and severi ty o f incident cases reported 

### for propiconazolc in both IDS and SENSOR- Pesticides there docs not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered. add iti onal analysis wi ll be included in the risk assessment.

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