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 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CAS No.: 133-07-3 

40CFR: NA 

FROM: Shanna Recore, Industrial Hygienist 

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 

Christina Scheltema, Chemical Review Manager 

Risk Management & Implementation 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 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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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 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. 

III. BACKGROUND 

For this evaluation, the OPP Incident Data System (IDS) was utilized to retrieve pesticide 

incident data on the active 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 of the database search is to identify potential patterns in 

the frequency and severity of the health effects attributed to folpet 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 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. 

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. 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. 

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In Aggregate IDS, 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 for this 

report. 

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 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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