UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: March 13,2013 

SUBJECT: lndoxacarb: Review of Human Incidents 

PC Code: 067710 DP Barcode: 0409841 

Decision No.: 475 167 

Petition No.: NA 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 173584-44-6 

MRID No.: NA 40CFR: NA 

FROM: 

Ver.Apr.08 

Elizabeth Evans, Environmental Protection Specialist .... r-'; 

Toxicology 

Health Effects 

and 

Division 

Epidemiology 

(7509P) 

Branch (~ '(/ { 

~ 

~ J//1"\ ~ 

and d 

Shanna Recore, Industrial Hygienist 

Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

~~ 

THROUGH: David J. Miller, Acting Branch Chief ~:2:1 ~~~ Toxicology and Epidemiology Branch 

Health Effects Division (7509P) 

TO: Danette Drew, Risk Assessor 

Risk Assessment Branch V 

Health Effects Division (7509P) 

and 

K. Ballard, Chemical Review Manager 

Risk Management & Implementation Branch I 

Pesticide Re-evaluation Division (7508P) 

Summary and Conclusions 

Based on the low frequency and severity of incident cases reported for indoxacarb 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 included in the risk assessment. 

Page 1 of 4 
The Agricultural Health Study (AHS) is also a potential source of information associated with 

human health effects associated with certain pesticides. Indoxacarb is not included in the AHS, 

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

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 self-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 

lndoxacarb is an is an oxidiazine insecticide registered for use on apples, pears, Brassica, sweet 

corn, lettuce, fruiting vegetables as a water dispersible granule and as a suspension concentrate 

for cotton only. Indoxacarb is used for the control of certain lepidopteran pests including the 

beet armyworm. 

For this evaluation, both 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 indoxacarb (PC Code: 06771 0). 

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

of the health effects attributed to indoxacarb exposure. 

In addition, findings from the Agricultural Health Study (AHS) were reviewed. The AHS is a 

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

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

this study does not provide information for this report. 

Ill. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

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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 

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 specific. 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 exposure from the pesticide. 

o Aggregate IDS contains incidents 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, 2007 to December 11, 2012, there were 11 incidents reported 

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

There were 2 additional incident reported involving more than one chemical. Overall, there are 

few incidents involving indoxacarb reported to IDS. 

In Aggregate IDS, from January I, 2007 to December 11,2012, there were 130 reported 

incidents involving indoxacarb. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 11 states from 1998-2009, 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. 

Page 3 of 4 
A query of SENSOR-Pesticides from 1998-2009 identifies 47 cases) stemming from 3 events, 

involving indoxacarb. One of these cases was high in severity, 24 were moderate in severity, 

and 22 were low in severity. One event that occurred in Texas in 1999 involved 45 individuals 

(including one high severity) residing in a Colonia who were made ill following an adjacent 

application for experimental pesticide development. The product implicated in this event is 

Steward Insecticide which has two active ingredients) Spinosad and lndoxacarb. A summary of 

symptoms reported is provided. 

SENSOR-Pesticides 1998-2009: 

Reported Health Effects for 

Indoxacarb Cases* 

Dermal 30 

Ocular 26 

Respiratory 24 

Gastrointestinal 19 

Renal 10 

Nervous System 31 

Cardiovascular 10 

Misc. 5 

* Cases may report multiple health 

effects 

c. 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. 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 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 50 different pesticide 

active ingredients commonly used in agriculture. 

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

this report. 

IV. CONCLUSION 

Based on the low frequency and severity of incident cases reported for indoxacarb 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 included in the risk assessment. 

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