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 inc ident data and the Agricultural Health Study (AHS ) are part of the problem formulation phase ofregistrat ion 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 Fenamidone is a broad-spectrum foliar fungicide for control of certain plant diseases ofpotatoes and other tuberous and corm vegetable, tomatoes, onions and other bulb vegetables, lettuces, squash, melons, cucumbers and other cucurbit crops. For this evaluation, both the 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 fenamidone (pc code: 046679). The purpose ofthe database search is to identify potential patterns in the f requency and severity of the health effects attributed to fenamidone exposure. Fenamidone is not included in the AHS, and therefore this study does not provide information for this report. 

### III. RESULTS/DISCUSSION

a. IDS (Incident Data System) OPP's IDS includes reports of alleged human health incidents from various sources, includi ng 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. It should be noted there is one incidents reported as a lawsuit to IDS that is not considered in this report. 

### IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:

Page 2 of4o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific s. 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 active ingredient (as opposed to pesticide products with multiple active ingredients) 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, 2008 to September 11 ,20 13, there were no incidents reported for single chemical only in the database. There was 1 incident reported involving more than one chemical. This incident was classified as minor severity. In Aggregate IDS , from January 1, 2008 to September 11 , 2013, there were no reported incidents involving fenamidone. Overall , there are few incidents involving fenarnidone reported to IDS.



### b. SENSOR-Pesticides The SENSOR

-Pesticides database covers 11 states from 1998-2009, although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of sources , including: reports from local Poison Control Centers , state Department ofLabor 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-Pesticides focuses on occupational pesticide incidents , and is of particular value in providing that information. The state coordinator at each ofthe 11 respective state Departments of Health conducts case followup activities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting , the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A SENSOR-Pesticides query finds one case involving fenamidone. The case occurred in California in 2009 and was a school teacher was "exposed via drift from an adjacent field that was being sprayed by a helicopter". The case was low in severity; the case reported ocular, gastrointestinal and nervous system symptoms.



### 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 formulationiscoping phase of the process and, if appropriate, fully reviewed in the risk

Page 3 of4assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Fenamidone is not included 

### in the AHS, and therefore this study does not provide information for this report. 

### IV. CONCLUSION Based on the low f requency and low severity ofinc ident cases reported for fenamidone in both IDS and 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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