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

Risk Assessment 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 Assessment Branch 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

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 are part ofthe 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. Typically, causation cannot be determined based on

incident data. However, incident information can be an important feedback loop 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, 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 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 compiles these reports

in IDS. IDS contain 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.

IV. RESULTSIDISCUSSION

IDS records incidents of generally high severity in more detail, in software which we call the

main Incident Data 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

report that provides details about the 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

incident the symptoms were unknown or not specified.

Based on the low frequency and severity of incident cases, 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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