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 amitrole (PC Code 004401). The purpose of the database search is to 

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

amitrole 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 

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 separate module called 

Aggregate IDS. 

In Aggregate IDS, from January 1, 2002 to February 1, 2011, there are five cases reported for 

amitrole. 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 

amitrole, there appears to be a low potential for exposure. For the Main IDS, from January 1, 

2002 to November 30, 2010, there are no cases reported that involve the active ingredient 

amitrole. 

Amitrole 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.