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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3835

2. Registrant Information.

Registrant Reference Number: 657688

Registrant Name (Full Legal Name no abbreviations): Dow AgroSciences Canada Inc.

Address: 450-1st Street SW, Suite 2100

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2P 5H1

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

Human

4. Date registrant was first informed of the incident.

13-AUG-10

5. Location of incident.

Country: UNITED STATES

Prov / State: IDAHO

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. 62719-86

Product Name: Curtail M Herbicide

  • Active Ingredient(s)
    • CLOPYRALID
      • Guarantee/concentration 5 %
    • MCPA (PRESENT AS ESTERS)
      • Guarantee/concentration 43.4 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - Out Home / Rés - à l'ext.maison

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Yes

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

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Arrhythmia
    • Symptom - Bradycardia
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

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

Application

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

7/5/2010 Caller is a physician treating a patient who applied the product earlier today. The patient was spraying weeds with the product, and does not report any known exposure to the product during application. The patient developed ataxia, vomiting, and diarrhea. 7/7/2010 Callback attempted to the original caller. A message was left requesting follow up information. 7/8/2010 The original caller reports that the patient was transferred to another hospital. The patient developed persistent vomiting, persistent diarrhea, and weakness. The patient eventually developed a third degree heart block. Caller stated that there was no definitive diagnosis that he knows of, but has not received an update from the other facility.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. The product use history is extremely vague and lacks any description of a known or defined point of direct exposure to this product. Even had casual or incidental contact with this product occurred, such illness would be unexpected. Sustained skin contact with this herbicide is typically associated with dermatitis and this condition was not reported in this case. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredients used in this product such a causal relationship appears to be scientifically implausible.