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 hum an incident data, and th e Agricultural Health Study (AHS) are part of the problem formulati on phase of registrati on 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 exposur e to a pesticide or reported symptom (or the connectio n between the two) is validate d. Typically, causation cannot

be determined based on incident data. Howeve r, incident information can be an important feedback loop to the Agency – incidents of se vere outcome, or a suggested pattern or trend among less severe incidents can signal the Agency to further investigate a pa rticular chemical or product. Observational epidemiology studi es relate the risk of disease, e.g. , cancer, and exposure to an agent such as a pesticide product in th e general population or specific sub-groups like pesticide applicators.

III. BACKGROUND

For this evaluation, the OPP Incide nt Data System (IDS) was utili zed 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 se verity of the health effects attributed to amitrole exposure. The IDS includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticid e, Fungicide and Rode nticide Act (FIFRA) Section 6 (a) (2) reports from registrants, ot her federal and state health and environmental agencies and individual consum ers. Since 1992, OPP compiles these reports in IDS. IDS contain reports from across the U.S. and most incidents have all releva nt 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, prospect ive epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators an d 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 a nd, if appropriate, fully reviewed in the risk assessment phase of the pr ocess. The AHS includes information on use of 50 different pesticide active ingredie nts 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 inci dents are listed in the Table 1 at the end of this report. Additionally, since higher severity incidents are generally of greater concern, incidents involvi ng death and major outcomes include a narrative summary in

Table 1. The less severe human incident s (minor, unknown or no effects outcomes) are reportedby registrants as counts called a ggregate summaries and are record ed in separate module called Aggregate IDS.

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

amitrole. Because it falls w ithin 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 indi cates there is a high potential for exposure and vice versa. For amitrole, there appears to be a low potential fo r exposure. For the Main IDS, from January 1, 2002 to November 30, 2010, there are no cases re ported that involve the active ingredient

amitrole.

Amitrole is not included in the AHS, and therefor e does not provide information for this report.

Based on the low frequency and severity of incide nt cases, there does not appear to be a concern

at this time that would warrant further inves tigation. The Agency will co ntinue to monitor the

incident information and if a con cern is triggered, additional analysis will be included in the risk

assessment.