UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: July 31, 2012 

### SUBJECT: Folpet : Review of Human Incidents
PC Code: 08160 I Decision No.: 467599 Petition No.: NA Risk Assessment Type : N A TXRNo.: NA MRIDNo.:NA DP Barcode: 0403989 Reg istration No.: NA Regulatory Action: NA Case No .: NA CAS No.: 133-07-3 40CFR: NA 

### FROM: Shanna Recore, Industrial Hygie nist Toxicology and Epidemiology Branch Health Effect Division (7509P) 

### THROUGH: David Miller, Acting Branch Chief Toxicology and Epidemiology Branch Health Effects Division (7509P) 

### TO: Jessica Kidwell, Risk Assessor Risk Assessment Branch IV Health Effects Division (7509P) and Chris tina Scheltema, Chemical Review Manager Risk Management & Implementa tion Branch III Pesticide Re-evaluation Division (7508P) 

### I

. CONCLUSION Ver.Apr.08

Based on the low frequency and severity of incident cases reported for folpet, there does not appear to be a concern at this time that would warrant further investigation. The Agenc y 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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### 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 ofregistration 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 bet ween 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 Agenc y to further investigate a particular chemical or product. Observational epidemiolo gy studies relate the risk of disease, 

### e.g., cancer, and expos ure to an agent such as a pesticide product in the general popula ti on or specific s ub-groups like pesticide applicators. 

### III. BACKGROUND For this evaluat ion , the OPP Incident Data System (IDS) was utilized to retrieve pesticide incident data on the act ive ingredient folpet (PC Code 081601). Folpet is a fungicide used to control scab (sphaceloma) on avocados and wood rot fungi, mold/mildew, and spoilage fungi on wood and other surfaces. The purpose ofthe database search is to identify potentia l patterns in the frequency and severity of the health effects attributed to folpet exposure. The ID S includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) report s 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 mo st inc idents have all relevant product information recorded. Reports submitted to the IDS repre sent 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 find ings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in th e problem formulation/scoping phase ofthe 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 resu lting 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 abo ut the location, date and nature ofthe incident. Main IDS incidents involving only one pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide. 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.

Page 2 of3In Aggregate ID S, from January 1, 2007 to June 13,2012, there were 6 reported incidents involving folpet. For the Main IDS, from January 1, 2007 to June 13, 2012, there were no incidents reported for folpet in the database. Folpet is not included in the AHS, and therefore this study does not provide information fo r thi s report. Based on the low frequency and severity ofincident cases reported for folpet, 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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