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 Case No.: NA Risk Assessment Type: NA TXR No.: NA CAS No.: 173584-44-6 40CFR: NA MRID No.: NA FROM: Ver.Apr.08 Elizabeth Evans, Environmental Protection Specialist
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# r-'; Toxicology and Epidemiology Branch

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# J//1"\**~** Health Effects Division (7509P) '(/

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# d Shanna Recore , Industrial Hygieni s t Toxicology and E pidemiology Branch Heal th Effects Division (7509P)

# ~~ THROUGH: David J. Miller, Acting Branch Chief

# ~:2:1**~~~** Toxicology and Epidemiology Branch Health Effects Divi sion (7509P) TO: Danette Drew, Risk Assessor Risk Assessment Branch V Health Effects Division (7509P) and K. B allard, Chemical Review Manager Risk Management & Implementation Branch I Pesticide Re-evaluation Division (7508P) S ummary 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 of4The 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 in formation 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 pestic ide 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) i s validated or otherwise confirmed. Typicall y, 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 s ignal the Agency to further investigate a particular chemica l 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 i s used for the contro l 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 ofthe 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 qu ality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. Indoxacarb i s not included in the AHS , and therefore this study does not provide information for this report.


### Ill. RESULTS/DISCUSSION a. IDS (Incident Data System)

Page 2 of4OPP's IDS includes reports of alleged human health incidents from var ious 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. S ince 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 incident s in one of two modules: Main IDS and Aggregate IDS:
o Main IDS conta ins 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 ID S incidents involving only one pesticide are considered to provide more certain information about the potential effects ofexposure 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 count s in what are aggregate summaries. For the Main IDS, from January 1, 2007 to December 1 1 , 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 ID S, 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 w ith 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 ofHealth 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 4A 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 lndoxacar b. A summary of symptoms reported is provided. SENSOR-Pesticides 1998-2009 :

Reported Health Effects for Indoxacarb Cases* Dermal 30 Ocular 26 Respiratory 24 Gastrointesti nal 19 Renal 10 Nervous System 31 Cardiovascular 10 Misc
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* 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 proces s and, if appropriate, fully reviewed in the risk assessment phase ofthe 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 informa tion 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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