UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: October 28, 20 15 

SUBJECT: Tebuconazole: Tier I (Scoping) Review of Human Incidents and Epidemiology 

PC Code: 128997 OP Barcode: 0429846 

Decision No.: 505240 

Petition No.: NA 

Risk Assessment Type: A 

TXR No.: A 

MRIO No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 107534-96-3 

-'O CFR: 1A 

Ver.Apr.OS 

FROM: Shanna Recore, Industrial Hygienist () n A4 /') I ii 

Toxicology 

Health Effec

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and C/J 

Elizabeth Evans, Environmental Protection Specialist ()!--~~'-"\.. 

Toxicology and Epidemiology Branch U 

Health Effects Division (7509P) . ~ /) ~/£ "J.-.9.ovf.t,d r.., 

THROUGH: David Miller, Acting Branch Chief ~J " 

TO: 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

Barry O'Keefe, Risk Assessor 

Risk Assessment Branch III 

Health Effects Division (7509P) 

and 

Jose Gayoso, Chemical Review Manager 

Risk Management & Implementation Branch 2 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Although there were a moderate number of tebuconazole incidents 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 low severity of incidents 

repo11ed to both IDS and SENSOR-Pesticides, there does not appear to be a concern at this 

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time. The Agency will continue to monitor the incident data and if a concern is triggered, 

additional analysis will be conducted. 

Detailed Review 

I. ACTION REQUESTED 

This review is intended to fulfill our requirement to docket summaries of incident data that were 

reported to the Agency, as well as to ensure human incident data and the Agricultural Health 

Study (AHS) are part of the problem formulation phase of registration review. Reports of 

adverse health effects allegedly due to a specific pesticide exposure (i.e., an " incident'") are 

largely sci f-reported and therefore, generally speaking, neither exposure to a pesticide or 

reported symptom (or the connection between the two) is validated or otherwise confirmed. 

Typically, causation cannot be determined based on incident data. However, incident 

information can be an important source of feedback to the Agency: incidents of severe outcome, 

or a suggested pattern or trend among less severe incidents, can signal the Agency to further 

investigate a particular chemical or product. Observational epidemiology studies relate the risk 

of disease, e.g., cancer, and exposure to an agent such as a pesticide product in the general 

population or specific sub-groups like pesticide applicators. 

II. BACKGROUND 

Tebuconazole is a systemic fungicide registered for use in a wide variety of agricultural, 

ornamental, and residential settings. 

For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease 

Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) 

Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were 

consulted for pesticide incident data on the active ingredient tebuconazole (pc code: 128997). 

The purpose of the database search is to identify potential patterns in the frequency and severity 

of the health effects attributed to tebuconazole exposure. Tebuconazole is not included 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 alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) repor1s 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents have all relevant product information recorded. Reports 

submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in 

the report. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS: 

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o Main IDS contains incidents resulting in higher severity outcomes and provides 

more detail with regard to case specifics. This system stores incident data for 

death, major and moderate incidents, and it includes information about the 

location, date and nature of the incident. Main IDS incidents involving only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered to provide more certain information about the 

potential e ffects of exposure from the pesticide. 

o Aggregate IDS contains inc idents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as 

counts in what are aggregate summaries. 

For the Main IDS, from January 1, 2010 to May 27, 20 15, there were 8 incidents reported for the 

single chemical tebuconazole only in the database. These incidents were classified as moderate 

severity. More information about these incident can be found in Appendix 1. There were 3 1 

additional incidents reported involving than one chemical. 

In Aggregate IDS, from January 1, 20 10 to May 27, 20 15, there were 444 incidents reported 

involving tebuconazole. These incidents were classified as minor severity. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2 

0 1 I, although reporting varies from state to state . Cases of pesticide-related illnesses are 

ascertained from a vari ety of sources, including: reports from local Poison Control Centers, state 

Department of Labor workers' compensation claims when reported by physicians, reports from 

State Departments of Agriculture, and physician reports to state Departments of Health. 

Although both occupational and non-occupational incidents are included in the database, 

SENSOR-Pesticides focuses on occupational pesticide incidents, and is of particular value in 

providing that information. The state coordinator at each of the 12 respecti ve state Departments 

or Health conducts case follow-up activities such as obtaining medical records to verify 

symptoms and severity. Using standardized protocol and case definitions derived from poison 

center reporting, the state SENSOR-Pesticide coordinator enters the incident information into the 

state-based system which is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides 1998-20 11 identifies a total of 16 cases involving tebuconazole 

(pc code 128997); two of which involve a single a i. Both single ai cases were low in severity. 

One case was an agricultura l worker who was exposed while conducting routine fieldwork. The 

case reported a skin rash, cough, nausea, vomiting, stomach pain, and headache. The second 

case was a homeowner who appli ed the product in windy conditions and inhaled the product. 

This case reported dermal and ocular symptoms (skin pain and conjunctivitis). 

c. Agricultural Health Study (AHS) 

The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide 

use and various hea lth outcomes including cancer. The AHS includes private and commercial 

pesticide applicators and their spouses. If there are AHS findings relevant to a particular 

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pesticide 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 ingredients commonly used in agriculture. Tebuconazole is not included in the AHS, and 

therefore this study does not provide information for this report. 

IV. CONCLUSION 

Although there were a moderate number of tebuconazole incidents 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 generally low severity of 

incidents reported to both IDS and SENSOR-Pesticides, there does not appear to be a concern at 

this time. The Agency will continue to monitor the incident data and if a concern is triggered, 

additional analysis will be conducted. 

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Appendix 1 

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

2010 to May 27, 2015 

Human Incidents Chemical: Tebuconazole I PC Code: 128997 

Incident 

Package Incident 

Report Date Location Reg Number Product Name Incident Description 

A 64 year male used the 

product I to 2 times per 

week for 3 months to treat 

DISEASE CONTROL nowers. Sometimes he 

FOR ROSES, inhaled the mist. He 

023213 - FLOWERS & experienced loss of voice 

00009 3/ 1/2011 LA 072155-00014 SHRUBS cough and dizziness. 

An adult female used the 

product with gloves on for 

about 10 minutes. The 

product went through her 

gloves. She washed her 

DISEASE CONTROL hands for 15 minutes with 

FOR ROSES, soap and water. She 

02375 1 - FLOWERS & developed redness on her 

00004 12/17/20 11 ELKIN, NC 072155-00014 SHRUBS hands. 

DISEASE CONTROL An 83 year old male used 

FOR ROSES, the product and developed 

024295 - GRANADA FLOWERS & a rash on his hands and 

00002 61312012 HILLS, CA 072155-00014 SHRUBS arms. 

DISEASE CONTROL A 73 year old male used the 

FOR ROSES, product without gloves or a 

024496 - BRENTWOOD, FLOWERS & mask. He experienced 

00006 8/ 10/20 12 TN 072155-00014 SHRUBS dizziness and nausea. 

A 57 year old male sprayed 

the product on fruit trees 

and roses. 2 days later he 

ate fruit that had been 

treated. Within 30 minutes 

DISEASE CONTROL he experienced sweating, 

FOR ROSES, vomiting and dizziness. 

026592 - EHRHARDT, FLOWERS & The product is not labeled 

00002 5/ 13/20 14 SC 072 155-000 14 SHRUBS for use on fruits. 

A 52 year old female 

applied the product to her 

rose bushes. Two weeks 

later, she was nicked by the 

thorns on her arms, hands 

and ankles when she 

trimmed the roses. A few 

DISEASE CONTROL days later, she experienced 

FOR ROSES, blisters, dermal irritation, 

026723 - FOX ISLAND, FLOWERS & swelling, pruritus, and 

00003 5/ 16/20 14 WA 072155-000 14 SHRUBS muscle pain. Also a water 

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droplet from lea f splashed 

her eye. She experienced 

blurred vision, ocular 

irritation, and 

conjunctivitis. 

A 73 year old female 

experienced blotchy. red. 

itchy skin on her face and 

DISEASE CONTROL neck three days after 

FOR ROSES, trimming roses 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 some of it 

DISEASE CONTROL misted on her thighs and 

FOR ROSES, stomach. Two days later, 

026871 - SOUTHGATE, FLOWERS & she developed an itchy, red, 

00003 7/ I3/20I4 Ml 072155-000I4 SHRUBS hard bump. 

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