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II. 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. Typically, causation cannot 

be determined based on incident data. However, incident information can be an important 

feedback loop 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. 

III. BACKGROUND

For this evaluation, the OPP Incident Data System (IDS) was utilized for pesticide incident data 

on the active ingredient flumioxazin (PC Code 129034). The purpose of the database search is to 

identify potential patterns on the frequency and severity of the health effects attributed to 

flumioxazin exposure. The 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 compiles these reports in IDS. IDS contain 

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. 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.

IV. RESULTS/DISCUSSION

IDS records incidents resulting in higher severity outcomes in more detail, in a module called the 

Main IDS module. This system stores incident data for death, major and moderate incidents, and 

it includes more details 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, and therefore these incidents are listed in the 
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Table 1 at the end of this report. Additionally, since higher severity incidents are generally of 

greater concern, incidents involving death and major outcomes include a narrative summary in 

Table 1. The less severe human incidents (minor, unknown, or no effects outcomes) are reported 

by registrants as counts called aggregate summaries and are recorded in a separate module called 

Aggregate IDS. In Aggregate IDS, from January 1, 2002 to May 27, 2010, there are nine cases

reported for flumioxazin. Because it falls within the categories reported as counts (which 

includes minor, unknown or no effects), there is no unique report that provides details about the 

incident and single chemical incidents are not distinguished from multiple chemical incidents; 

however, a high frequency of incidents indicates there is a high potential for exposure and vice 

versa. For flumioxazin, there appears to be a low potential for exposure. For the Main IDS, from 

January 1, 2002 to November 30, 2010, there are four cases reported that involve the active in 

flumioxazin. Of these four cases, there are three cases reported for single chemical flumioxazin

only in the database. They are all ranked moderate severity. Overall, there are few incidents 

involving flumioxazin reported to IDS and most of lower severity.

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

report.

Based on the low frequency and severity of incident cases, 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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IDS Report Human 

Incidents

Chemical: Flumioxazin PC code:129034

Incident 

Number

Incident 

Date

Product 

Name Registration Number City State

Exposure 

Type*

014129 001 12-May-03 VALOR WP 05963900098 AUGUSTA GA HC

019900 001 02-Jun-08

CHATEAU 

HERBICIDE 

SW 05963900099 ALAMOSA CO HC

020257 001 18-Aug-08

BROADSTAR 

HERBICIDE 05963900128 SNELLVILLE GA HC

* Severity Categories

H Human

H-A Human Fatality

H-B Human Major

H-C Human Moderate

H-D Human Minor

H-E Human Unspecified