Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2782

2. Registrant Information.

Registrant Reference Number: SC985077

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

Address: Suite 2100, 450 - 1st Street S.W.

City: Calgary

Prov / State: Alberta

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.

04-JUN-12

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

30-MAY-12

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. 62719-40

Product Name: Element 4 Specialty Herbicide

  • Active Ingredient(s)
    • TRICLOPYR
      • Guarantee/concentration 61.6 %

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: Agricultural field

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

Please refer to section 13 on subform II or section 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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Joint pain
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
  • General
    • Symptom - Pain
    • Specify - Lumbar Pain
  • Skin
    • Symptom - Paresthesia
  • Nervous and Muscular Systems
    • Symptom - Paralysis
    • Specify - descending paralysis

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?

5

Day(s) / Jour(s)

7. Exposure scenario

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

6/4/2012 Caller is a pharmacist at a hospital treating a farmer that applied product on 5/29/2012. Around 24 hours later, the patient began to feel weak, developed paresthesia in the face and legs, and lumbar pain. The only information they have is that he had used the product previously, however, there is no history indicating any point of defined exposure. The only significant prior medical history is hypertension and acid reflux. The patient's clinical status has declined since his admission and he now appears to be displaying descending paralysis. He has been moved to a higher level unit for medical care. 6/6/2012 Callback attempted to the original caller. A message was left requesting follow up information. 6/7/2012 Callback attempted to the original caller. A message was left requesting follow up information.

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 herbicide and appears to be based on speculation.. Even had casual or incidental contact with this herbicide occurred during application, such a profound and insidious illness is unexpected and not consistent with the known toxicological profile of triclopyr. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredient used in this product a causal relationship appears to be biologically implausible.