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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1834

2. Registrant Information.

Registrant Reference Number: PROSAR Case #: 1-25590942

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection Canada, Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G4Z3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

14-MAR-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Karate (non-specific)

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN
      • Unknown

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Death

4. How long did the symptoms last?

Persisted until death

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

Poisoning from ingestion of the pesticide

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

1-25590942- The caller indicates potential exposure of a family member to an insecticidal product containing the active ingredient lambda-cyhalothrin. The reporter indicates she is the family member of (age) female which may have had the product intentionally added to an alcoholic beverage and ingested that beverage. The caller indicated the potential exposure took place two years ago and in another country. She did not provide specifics with regard to date, location or product. It was not clarified by the caller whether this was a malicious act, accidental act, or intentional self harm. It was not indicated whether this was an observed or suspected exposure. The product was identified by a nonspecific name but precise formulation or EPA registration numbers were not provided. The caller was not able to provide information about the volume ingested, the onset of symptoms, or any treatments that may have been provided the patient. The caller merely stated the patient passed away and that the hospital did draw blood tox tests. The caller further sated an autopsy was performed and Karate showed up on the toxicology screens as well as alcohol. The caller stated she was attempting to build a case to show that the product was added to alcohol and provided to the affected individual for consumption. The caller was unable/unwilling to provide additional information. When asked for clarification regarding circumstances surrounding the exposure and product identification the caller declined and indicated she would call back at a later time. The caller disconnected at that point. No further information is available. Consistency is difficult to assess with the scant information provided by the caller, but typically neuroexcitation is a prominent feature of systemic pyrethroid intoxication. This is notably absent from the callers history. No further information is available.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

This Incident Report is being filed based on PMRA's current interpretation of the Incident Reporting Regulations. There is no direct evidence of exposure. The caller indicates the material 'may' have been added to an alcoholic drink. There is no indication whether it was accidental, malicious or self-administered. There were no symptoms provided. The caller was not forthcoming with information that may help to elucidate the situation.