### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D .C. 20460
OFFICE OF C HEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: October 28, 20 15 

### SUB J EC T: Tebuco n azo le: Tier I (Scop in g) Rev iew of Human In c id e nt s a nd Ep id em iolo gy

P C Co de : 128997 OP B arco d e: 0429846 De cis i o n No

. : 505240 Petition No.: NA Ri s k Assess m en t T y pe : A T XR No. : A MR IO No.: NA R eg i stra tion No .: NA Re g ulat o r y Act i on: NA C a se No.: NA C AS No.: 107534-96-3 -' O C FR : 1A Ver.Apr

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### FRO M : Shanna Recore, Industrial H yg ienist () n A4 /') I ii 

### Toxicology a nd Ep id e mi ology Branch

# ~**~~ ~**  H ea lth Effec t Div is io n (7509 P) and 

## C/J Elizabeth Eva n s, Env i ronmental Protection Specia li st**()!--~~'-"\..** 

### Toxicology and Epidemiology Branch 

## U Health Effects Div isio n (7509 P)

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### THROUGH: Dav id Mi ll er, Acting Branch Chief

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TO: Tox ico logy and Ep id em iology Branch Health Effec ts Divi s io n (7509P) Barry O'Keefe , R isk Assessor Risk Assessment Branch III H ealth Effec t s Division (7509 P ) and Jose Gayoso, Chemical Review Manager Risk Mana ge ment & Im p l ementation Branch 2 Pestic id e Re-eval u at ion Di v is ion ( 7 508 P) Sum mary and Conclusions Although there were a moderate number of tebuconazo le in ci d ents reported to Main and Aggregate IDS and SENSO R-Pe st icides , most of th ese incidents were classified as low seve rity. The effects experienced were generally minima ll y traumatic and resolved rapidly and usually involved skin , eye or respiratory irritation. Based on the low severity of in cidents repo11ed to both ID S and SENSOR-P estic id es , there does not appear to be a concern at this
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### time

. The Agency will con tinue to monit or th e incident data and if a concern is triggered , additional analys is will be conducted. Detailed Review I. 

### ACTION R E QUEST E D This review is intended to fulfill our requirement to docket summaries of incid e nt data that were reported to the Agenc y, as well as to ensure human incident data and the Agricu ltural Health Study (A HS ) are part of th e p roblem formulat ion phase of re gistration review. Reports of adverse health effects allegedly due to a specific pesticide exposure 

### (i.e., an " incident '") are large ly sc i f-reported and therefore, generally s peaking , neither exposu re to a pesticide or report ed sympto m (or the co nn ect ion b etwee n the two) is valid ated o r othe rwise confirmed. Typically , causation cannot be determined based on incid en t data. How ever, incident information can be an important sour ce of feedback to the Agency: incident s of severe outcome, or a suggested pattern or tre nd among less severe i ncidents , can s ignal the Agency to further investigate a particular chem ical or product. Obse rvational epidemiology studies relate the r isk of d isease, 

### e.g., cancer , and exposure to an agen t such as a pesticide product in the general populat ion or spec ific sub-g r oups like pesticide applicators. 

### II. BACKGROUND Tebuconazole is a systemic fungicide regi s tered for use in a wide variety of agricultural, ornamental, and residential settings. For this evaluatio n , both the OPP Incid ent Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (C DC/N IOSH ) Sentinel Eve nt Not ifi catio n Syste m for Occupational Ri sk -P esticides (SENSOR) databases were consulted for pesticide incident data on the ac ti ve ingredient tebuconazole (pc code: 128997 ). The purpose of the database search is to id ent if y potential patterns in the frequency and severity of the hea lth effects attri buted to tebuc o na zole exposure. Tebuconazo le is not includ e d in the AHS , and therefore this study does not provide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP 's IDS includes reports of a lleg ed human health incidents from various sources, including mandatory Federal Insecticid e, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) repor1 s from registrants, other federal and state health and environmenta l agencies, and individual consume rs. Since 1 992, OP P has compiled the se reports in IDS. ID S contain s reports from across the U.S. a nd most incidents ha ve a ll relevant product information recorded. Reports subm itted to th e IDS represent anecdo ta l report s or allegations only, unle ss o th erw ise stated in the r epor t. IDS records inc idents in one of two modul es: Main IDS and Aggregate IDS:

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### o M a in ID S co nt a in s incid e nt s resul ti n g in hi ghe r severity o utcomes and provide s more de t ai l with regard to case s p ec ifics. Thi s syste m sto res incident data for d eath , major and moderate incid e nt s, and it inc ludes info rmati on about the location , date a nd nature of the in c id e nt. Main IDS in cide nt s in vo lv ing on ly o ne ac tive in g r e dient (as o pp osed to pes ti cide product s with multiple active in gred ie nt s) are considered to provide more certain informat io n about the potentia l e ffec t s of exposure from the p es ti cide

.


### o Aggregate ID S contains in c ident s res ulting in less severe human incidents (m in or, unknown , or no effects outco m es). T hese a r e r e p o r ted by r eg i s trant s on l y as co unt s in w h at a re aggrega te su mm ari es. Fo r the Main ID S , fr o m January 1 , 2010 to May 27, 20 15 , there were 8 in c id e nt s reported for th e s in g le chemica l teb uc o n azo le on ly in the dat abase. These incid ents were class ifi ed as moderate seve rity. More information abo ut these incident ca n be fou nd in Appendix 1. There we re 3 1 additiona l incid ents reported involving th an one c hem ic a l. In Aggregate ID S, from J a nuary 1, 20 10 to May 27, 20 15 , there were 444 in c id e nt s reported involving tebuc o na zo le . These incid e n ts were class ifi ed as min or severity. 

### b. SENSOR-P es ti c id es The SENSO R-P esticides database covers 12 s ta tes from 1 998

- 2 0 1 I , al though report in g va rie s from state to state . Cases of pesticide-relate d illn esses are asce rt a ined from a va ri ety of so urces , in c lu ding: repo rt s from loca l Poison Co ntrol Centers, s tate Department of Labor workers' compensation c la im s w hen reported by physic ia n s, reports from S t ate Department s of Agricu lture , and p h ysician repo rts to state D epartme nt s of Health. Although both occ up a ti ona l a nd non-occup at i o n a l in c idents are in cluded in the dat a base , SENSO R-Pesticide s focuses on occ upationa l pest ic ide in c id e nt s, an d is of pa rti cu lar va lu e in providi n g that inform at io n. Th e s tate coo rdin ato r at eac h of th e 1 2 res p ec ti ve s ta te Departmen t s or H ea lth conduct s case fo ll ow -up activities s uch as ob t a ining m ed ica l r ecords to verify sy mptoms and seve rit y. Us in g s tandardized protocol and case definiti o n s derived from poison cen ter reporti n g, the state SENSO R-P esticide coordinato r enters the incident in formatio n int o the s tate-based system w hi ch is sen t to NIOSH annually to be aggregated. A query of SENSO R-P es ticide s 1998- 20 11 identifi es a total of 16 cases involving tebuconazole (pc code 1 28997); two of which in vo l ve a s in g le a i. B o th s ingle ai cases we re low in severi ty. One case was an agricultu r a l worke r who was ex p ose d while conducting r o utin e fieldwork. The case re ported a sk in ras h , co u g h , nau sea, vo mitin g, s tomach pain , a nd h eadache. The seco nd case was a hom eowner w h o app li e d the product in w ind y co ndit io n s and inh a le d th e product. This case report ed dermal and oc ular sy mptom s (sk in pain a nd conjunc tivi tis).



### c. Ag ri c ul t ura l H ea lth Stu dy (AHS) T he AHS is a high qu a lit y, prospec ti ve epidemiology study eva luatin g the link betwee n pe s ti cide use and various hea lth ou tco m es includin g ca n ce r . The A H S in cludes p r ivate and commercial pesticide app li cato rs a nd their s pouses. If there a re A H S findings rel evant to a p a rticular
Page 3of6pesticide going through registration review , the Agency will ensure they are considered in the problem fonnulation/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 ingredi e nt s commonly used in agriculture. Tebuconazole is not includ ed in the AHS, and therefore this study does n ot provide information for this report. 

### I V. CONCLUS I ON Although there were a moderate number of tebuconazole incident s reported to Main and Aggregate IDS and SENSOR-Pesticides , most of these incidents were classified as low severity. The effects experienced were generally minimally traumatic and resolved rapidly and usually involved skin, eye or respiratory irritation. Based on the generall y low severity of incid ents reported to both IDS and SENSOR-Pesticides , th ere does not appear to be a concern at this time. The Agency will continue to monitor th e incid ent data and if a concern is triggered , additional analysis w ill be conducted.

Page 4of6Append i x 1 

### Tebuconazole Single Chemical Moderate Severity Incidents Reported to IDS from January I , 

### 20 10 to May 27, 2015

Human Incidents Che mi cal: Tebuconazo le 

## I PC Code: 128997 Incident Packa ge I ncide n t Report Date Locat io n Reg Nu mber Product Name I nc ident Desc ri pt io n A 64 yea r mal e use d th e product I to 2 time s p er week for 3 month s to treat DIS E ASE CONTROL n owe rs. Sometimes he FOR ROS ES, inh aled the mist. He 023213

- FLOWERS & expe ri enced lo ss of voice 00009 3/ 1 /2011 LA 072155-00014 SHRUBS cough and di zz ine ss. An a dult female used th e product with g loves on for about 10 minut es. Th e product went through he r gloves. She washed her DISEAS E CONTROL hands for 15 minutes with FOR ROSES , soap and water. She 02375 1

- FLOWERS & developed redn ess o n he r 00004 12/17 /20 11 ELKIN , NC 072155-00014 SHRUBS hand s. DISEASE CONTROL An 83 year old mal e use d FOR ROSES , th e product a nd dev e loped 024295

- GRANADA FLOWERS & a ra s h on his hands and 00002 6 1 31

2012 HILLS , CA 072155-00014 SHRUBS arms. DI SEASE CONTROL A 73 year old mal e used th e FOR RO SES, product without g loves or a 024496

- BRENTWOOD , FLOWERS & ma s k. He experienced 00006 8 / 10 / 20 12 T N 072155-00014 SHRUBS dizziness and nau sea . A 57 year old mal e sprayed th e product on fruit trees and ro ses. 2 days late r he ate fruit that had b ee n treated. Within 30 minutes DISEAS E CONTROL he experienced sweating, FOR ROS ES, vom itin g and dizz ines s. 026592

- EHRHARDT , FLOW ER S & Th e product i s not lab e l ed 00002 5/ 1 3/ 20 1 4 SC 072 155

-000 1 4 SHRUBS for use on fruits. A 52 ye ar old female appl ied the product to her ro se bushes. Two weeks later, s he was nicked by the thorn s on her arms, hand s and ank les when s he trimm ed the roses. A few DISEASE CONTROL days late r, s he ex pe ri e nc ed FOR ROSES , bli s ters , de rm a l irritation , 026723

- FOX ISLAND, FLOWERS & swelling, pruritus, a nd 00003 5/ 16/20 1 4 WA 072155-000 1 4 SHRUBS mu sc le pain

. A lso a water


### Page 5of6droplet from lea f sp la shed her eye. She experienced blurred vision , ocular irritation , and conjunctivit is. A 73 year old f e male expe ri enced blotchy. red. itchy sk in on her face and D ISEASE CONTROL nec k three da ys after FOR ROSES , trimmin g r oses that had 026871

- FLOWERS & been treated with the 00001 7 / 3/20I4 CRANSTON, RI 072 I 55-000 I 4 SHRUBS product. An 82 year old female used the product and s ome of it DISEASE CONTROL misted on her thi ghs and FOR ROSES, s tomach. Two days later, 026871

- SOUT HGATE , FLOWERS & she developed an itchy, red, 00003 7 / I3 / 20I4 Ml 072155-000I4 SHRUBS hard bump.



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