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

MEMORANDUM Date: September 23, 2014 SUBJECT: Tebufenozide: Tier I Review ofHuman Incidents for PreliminaryRisk Assessment

PC Code: 129026 DP Barcode: D422657 Decision No.: 482454 Petition No.: NA Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.:NA MRIDNo.:NA CAS No.: 112410-23-8 40CFR:NA FROM:

THROUGH: Sharma Recore, Industrial Hygienist Toxicology and Epidemiology Branch HealthEffectDivision (7509P) and ElizabethEvans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

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### David Miller, Acting Branch

# Chie6**'l_/!U-'~~ /{z**  Toxicology and Epidemiology Branch HealthEffects Division (7509P) TO: Mohsen Sahafeyan, Risk Assessor Risk Assessment Branch VI HealthEffects Division (7509P) and Christina Scheltema, Chemical ReviewManager Risk Management & Implementation Branch I Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr.08

Based onthe low frequency and severity ofincident cases reported for tebufenozide in both IDS and NIOSH SENSOR-Pesticides, there does not appearto be a concern at this time that would
Page 1of4warrant further investigation. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be conducted. The Agricultural Health Study (AHS) is also a potential source ofinformation associated with human health effects associated with certainpesticides. Tebufenozide is not included inthe 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 ofthe Agency's Registration Review Program is consideration ofhuman incident data. In conjunction with a human healthrisk assessment based onotherdata sources, suchhuman incident data can assist the Agency in better defining and characterizing the risk ofpesticides/pesticideproducts. 

### III. BACKGROUND Tebufenozide is an insecticide and miticide registered for use on a wide range offood and feed commodities as well as ornamentals and trees (primarily forestry). There are no tebufenozide products intended for sale to homeowners orfor use inresidential settings. Forthis 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 onthe active ingredient tebufenozide (PC Code 129026). The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to tebufenozide exposure. In addition, we sought informationfrom the Agricultural Health Study (AHS). The AHS is a high quality prospective epidemiology study evaluating the link betweenpesticideuse 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 (IncidentData System) OPP's IDS includes reports ofalleged humanhealth 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 relevantproduct informationrecorded. Reports
Page 2 of4submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:
o Main IDS contains incidents resulting inhigher severity outcomes and provides more detail withregard to case specifics. This system stores incident data for death, majorand moderate incidents, and it includes information aboutthe location, date and nature ofthe incident. Main IDS incidents involving only one pesticide are consideredto provide more certain information aboutthe potential effects ofexpos. ure from the pesticide.
o Aggregate IDS contains incidents resulting in less severe human effects (minor, unknown, orno effects outcomes). These are reported by registrants only as counts in what are aggregate summaries. FromJanuary I, 2009 to September9, 2014, there were no incidents reported for tebufenozide in either Main orAggregate IDS. 

### b. NIOSH SENSOR-Pesticides The SENSOR-Pesticides database covers II states from 1998-2010, although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety ofsources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims whenreported by physicians, reports from State Departments of Agriculture, and physicianreports to state Departments ofHealth. Although both occupational and non-occupational incidents are included in the database, SENSOR focuses on occupational pesticide incidents, and is ofparticular value inproviding 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 centerreporting, SENSORcoordinators at State Departments ofHealth enterthe incident interview description providedbythe case, medical report, physician and patientinto the SENSORdata system. The SENSORdata system is accessible to participating states and EPA. A query ofSENSOR-Pesticides 1998-2010 identifies a total ofnine 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 eventthat occurred inTexas in 1998 resulted in four cases reported to SENSOR, 3 minor severity and one moderate severity. The description ofthis event states, "Familylives across the road from a pecan orchard. Complainantclaims thatpecan

1 SENSOR-Pesticides does not currently distinguish drift from volatilization
. The definition ofdrift is "Indicates whetherthe individual was exposed via the movement ofpesticides away from the treatment site. The pesticide spray, mist, fumes, or odor are carried from the target site by air."
Page 3 of4fanner 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
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### .. ·' Table 1. SENSOR-Pesticides 1998-2009: Reported HealthEffects for Tebufenozide Cases (N=9) ,'' ',.J;,. 'f• ·: HealthEffect> '"**Fre quency** **~ 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 betweenpesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. Ifthere are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are fully reviewed in the risk assessmentphase ofthe process. The AHS includes information onuse of50 different pesticide active ingredients commonlyused in agriculture. Tebufenozide is notincluded inthe AHS, and therefore this study does notprovide information for this report. 

### III. CONCLUSION Based onthe lowfrequency and severity ofincident 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 ifa concern is triggered, additional analysis will be conducted.

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