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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0556

2. Registrant Information.

Registrant Reference Number: 577349

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.

21-DEC-09

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

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. 62719-480

Product Name: Surmount Herbicide

  • Active Ingredient(s)
    • FLUROXYPYR 1-METHYLHEPTYL ESTER
      • Guarantee/concentration 10.64 %
    • PICLORAM (PRESENT AS AMINE SALTS)
      • Guarantee/concentration 13.24 %

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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Ranch

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.

Other

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Other
    • Specify - Unspecified Respiratory Condition

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

1

Week(s) / Semaine(s)

7. Exposure scenario

Non-occupational

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

Other

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

None

10. Route(s) of exposure.

Unknown

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.)

12/21/2009 Caller's brother began using the product at their ranch in March 2009. The caller states that the applications took place during windy conditions such that her brother would get some of the diluted herbicide on his clothing. He did not wear protective gear. After applications, the brother would reportedly leave the discarded contaminated clothing laying in a pile in the cabin. A few months later, their mother began to develop an unspecified respiratory condition and has been hospitalized off and on since June 2009. The caller was not able to elaborate any further on the nature of the respiratory illness. Some of the hospitalizations lasted a week or longer. She has had a tracheotomy tube placed and is currently on a ventilator. She has never smoked or had previous respiratory problems. She had no confirmed exposure to the product, and the treating physicians do not believe that any causal exposure to the product is involved with her current medical condition. It is not clear when the mother was in the cabin relative to when the contaminated clothing was left in the cabin before washing. The mother has a prior history of hypertension which was being treated with prescription medication.

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. Any relationship between the use of this product and the delayed development of the complications reported in this case is inconceivable and lacks and biological plausibility. Secondly, 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. 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.