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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-7041

2. Registrant Information.

Registrant Reference Number: 1737081

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.

12-DEC-15

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

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. 62719-31

Product Name: Tordon RTU Herbicide

  • Active Ingredient(s)
    • 2,4-D (PRESENT AS AMINE SALTS : DIMETHYLAMINE SALT, DIETHANOLAMINE SALT, OR OTHER AMINE SALTS)
      • Guarantee/concentration 20.9 %
    • PICLORAM (PRESENT AS AMINE SALTS)
      • Guarantee/concentration 5.4 %

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?

Unknown

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

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Chest pain
  • Respiratory System
    • Symptom - Irritated throat
  • General
    • Symptom - Death
    • Symptom - Diaphoresis
  • Respiratory System
    • Symptom - Coughing
    • Symptom - Pneumonia
    • Symptom - Acute respiratory distress syndrome
  • Cardiovascular System
    • Symptom - Other
    • Specify - myocardial infarction

4. How long did the symptoms last?

Persisted until death

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

9

Day(s) / Jour(s)

7. Exposure scenario

Unknown

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

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?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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.)

Caller s husband had been spraying diluted product approximately 10 days before being diagnosed with myocardial infarction. He subsequently had open heart surgery for a sextuple (6) cornary bypass. Following surgery he developed pneumonia and was eventually diagnosed with Acute Respiratory Distress Syndrome (ARDS). The patient passed away on 11/25/2015. The patient had a prior history of hypertension and Type II Diabetes. The physicians had indicated to the patient s wife that they did not feel that the herbicide spraying was the cause.

To be determined by Registrant

14. Severity classification.

Death

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 cannot 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. When considering the body of regulatory data as well as the weight of scientific peer reviewed evidence involving the contents of this herbicide, any relationship between the use of this product and development of a severe life thereatening heart disease is inconceivable and lacks any biological plausibility. First, the ingredients are not known to be cardiotoxic even with incidental contact during application, but more importantly, the type of physiological abnormality described with regard to this patient s diagnosed disease is chronic in its development where several months to years are required before overt clinical signs and symptoms become manifest. Another aspect of this case is that there was no point of a known or well defined exposure to the herbicide during application. Even had casual or incidental contact with the herbicide occurred, such profound life threatning illness as reported in this case is unexpected.