### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM
Date: November 30,2010
SUBJECT: Carfentrazone-ethyl: Review ofHuman Incidents
PC Code: 128712 Decision No.: 440433 Petition No.: NA RiskAssessment Type: NA TXRNo.:NA MRIDNo.:NA DP Barcode: D382672 Registration No.: NA Regulatory Action: NA CaseNo.:NA CAS No.: 128639-02-1 40 CFR: NA Ver.Apr.08 

### FROM: Shanna Recore, Industrial Hygienist

## ~~t~ Toxicology and Epidemiology Branch Health Effect Division (7509P)
THROUGH: Mary Manibusan, Branch Chief \/

# a Toxicology and Epidemiology Branch \\: Health Effects Division (7509P)
TO: Kelly Lowe, Risk Assessor Risk AssessmentBranch I Health Effects 

### Division (7509P) and Jose Gayoso, Chemical Review Manager Pesticide Re-evaluation Division (7508P)
I. CONCLUSION Based on the low frequency and severity ofincident cases, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incidentinformation and ifa concern is triggered, additional analysis will be included in the risk assessment.

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### II. ACTION REQUESTED
This review is intendedto fulfill our requirementto docket summaries ofincident data that were reported to the Agency, as well as to ensure human incident data, and the Agricultural Health Study are part ofthe problem formulation phase ofregistration review. Reports ofadverse 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 connectionbetween the two) is validated. Typically, causation cannotbe determinedbased on incident data. However, incident information can be an important feedback loop to the Agency

- incidents ofsevere outcome, or a suggestedpattern ortrend among less severe incidents can signal the Agency to further investigate aparticular chemical or product. Observational epidemiology studies relate the risk ofdisease, 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, both the OPP Incident Data System (IDS) was consulted for pesticide incident data on the active ingredient carfentrazone-ethyl (PC Code 128712). The purpose ofthe database searches is to identify potential patterns on the frequency and severity ofthe health effects attributed to carfentrazone-ethyl exposure. The IDS includes reports ofalleged 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 containreports from across the U.S. and most incidents have all relevantproduct information recorded. Reports submittedto the IDS represent anecdotal reports or allegations only, unless otherwise statedin the report.


### IV. RESULTSIDISCUSSION
IDS records incidents ofgenerally high severity in more detail, in software which we call the main IncidentData System. This system stores incident data for death, major and moderate incidents, and it includes more details about the location, date and nature ofthe incident. The less severe human incidents are reported by registrants as counts we call aggregate summaries and recorded in separate software. For IDS aggregate summaries, from January 1,2002 to May 27,2010, there are thirty seven cases reported for carfentrazone-ethyl, Because it falls within the categories reported as counts (which includes minor, unknown or no effects), there is no unique reportthat provides details aboutthe incident and single chemical incidents are not distinguished from multiple chemical incidents. For the main IDS, from January 1,2002 to October 7,2010, there is one case reported for single chemical carfentrazone-ethyl only in the database. For this incidentthe symptoms were unknown or not specified.
Based on the low frequency and severity ofincident cases, there does not appearto be a concern at this time that wouldwarrant further investigation. The Agency will continue to monitorthe incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

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