UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: September 23, 2014 

SUBJECT: Tebufenozide: Tier I Review of Human Incidents for Preliminary Risk 

Assessment 

PC Code: 129026 DP Barcode: D422657 

Decision No.: 482454 

Petition No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXRNo.:NA 

MRIDNo.:NA 

CAS No.: 112410-23-8 

40CFR:NA 

FROM: 

THROUGH: 

Sharma Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effect Division (7509P) 

and 

Elizabeth Evans, Environmental Protection Specialist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) ./<) ·',./ I) , /:' 

David Miller, Acting Branch Chie6'l_/!U-'~~/{z Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Mohsen Sahafeyan, Risk Assessor 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

and 

Christina Scheltema, Chemical Review Manager 

Risk Management & Implementation Branch I 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Ver.Apr.08 

Based on the low frequency and severity of incident cases reported for tebufenozide in both IDS 

and NIOSH SENSOR-Pesticides, there does not appear to be a concern at this time that would 

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warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be conducted. 

The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Tebufenozide is not included in the 

AHS, and therefore this study does not provide information for this report. 

Detailed Review 

I. ACTION REQUESTED 

Tebufenozide is a pesticide being considered under the FQPA-mandated Registration Review 

program established to review, on a 15 year cycle, pesticides for which a Re-registration 

Eligibility Decision has been made. One component of the Agency's Registration Review 

Program is consideration of human incident data. In conjunction with a human health risk 

assessment based on other data sources, such human incident data can assist the Agency in better 

defining and characterizing the risk of pesticides/pesticide products. 

III. BACKGROUND 

Tebufenozide is an insecticide and miticide registered for use on a wide range of food and feed 

commodities as well as ornamentals and trees (primarily forestry). There are no tebufenozide 

products intended for sale to homeowners or for use in 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) database were 

consulted for pesticide incident data on the active ingredient tebufenozide (PC Code 129026). 

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

of the health effects attributed to tebufenozide exposure. 

In addition, we sought information from the Agricultural Health Study (AHS). The AHS is a 

high quality prospective epidemiology study evaluating the link between pesticide use and 

various health outcomes, including cancer. Tebufenozide is not included in the AHS, and 

therefore this study does not provide information for this report. 

II. 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) reports 

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 

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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: 

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 

pesticide are considered to provide more certain information about the potential 

effects of expos.ure from the pesticide. 

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

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

counts in what are aggregate summaries. 

From January I, 2009 to September 9, 2014, there were no incidents reported for tebufenozide in 

either Main or Aggregate IDS. 

b. NIOSH SENSOR-Pesticides 

The SENSOR-Pesticides database covers II states from 1998-2010, although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a variety 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 focuses on occupational 

pesticide incidents, and is of particular value in providing that information. A state SENSOR 

contact specialist attempts to follow-up with cases and obtains medical records to verify 

symptoms, circumstances surrounding the exposure, severity, and outcome. Using standardized 

protocol and case definitions, derived from poison center reporting, SENSOR coordinators at 

State Departments of Health enter the incident interview description provided by the case, 

medical report, physician and patient into the SENSOR data system. The SENSOR data system 

is accessible to participating states and EPA. 

A query of SENSOR-Pesticides 1998-2010 identifies a total of nine cases involving tebufenozide 

(pc code 129026) stemming from five events. Three cases involved a single active ingredient 

and were all minor severity. The remaining six cases involved multiple active ingredients. All 

nine cases resulted from drift1

• Only one case was work-related; therefore 8 cases involved 

bystander drift. One multiple exposure drift event that occurred in Texas in 1998 resulted in four 

cases reported to SENSOR, 3 minor severity and one moderate severity. The description of this 

event states, "Family lives across the road from a pecan orchard. Complainant claims that pecan 

1 SENSOR-Pesticides does not currently distinguish drift from volatilization. The definition of drift is "Indicates 

whether the individual was exposed via the movement of pesticides away from the treatment site. The pesticide 

spray, mist, fumes, or odor are carried from the target site by air." 

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fanner sprays pesticides daily with a tractor." This event involves several active ingredients. 

The remaining five cases were exposed from drift due to aerial applications. All nine cases 

experienced gastrointestinal symptoms, commonly nausea; and five cases experienced 

neurological symptoms such as a headache . 

-· .. ,Y '', . ;n .. ·' 

Table 1. SENSOR-Pesticides 1998-2009: Reported 

Health Effects for Tebufenozide Cases (N=9) 

,'' ',.J;,. 'f• ·: 

Health Effect> '" Frequency~ r,~ '.1L ' '>_ 

Gastrointestinal 9 

Neurological 5 

Dermal 3 

Ocular 2 

Respiratory 2 

•·cases may report multiple health effects 

c. AHS 

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

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

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

pesticide going through registration review, the Agency will ensure they are fully reviewed in the 

risk assessment phase of the process. The AHS includes information on use of 50 different 

pesticide active ingredients commonly used in agriculture. 

Tebufenozide is not included in the AHS, and therefore this study does not provide information 

for this report. 

III. CONCLUSION 

Based on the low frequency and severity of incident cases reported for tebufenozide in both IDS 

and NIOSH SENSOR-Pesticides, there does 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, additional analysis will be conducted. 

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