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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1301

2. Registrant Information.

Registrant Reference Number: SC1009063

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.

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

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.

PMRA Registration No. 28804      PMRA Submission No.       EPA Registration No.

Product Name: Frontline XL Herbicide

• Active Ingredient(s)
  • FLORASULAM
  • MCPA (PRESENT AS ESTERS)

7. b) Type of formulation.

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Peripheral Neuropathy

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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)

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.)

July 17, 2012 Physician calling regarding a patient she has not yet seen or evaluated and was told that the patient has worked with this herbicide product in the past and has an issue with worsening peripheral neuropathy. It is unclear if the patient already had a history of peripheral neuropathy prior to his use of Frontline XL and that he is alleging a worsening of the neuropathy. The details of his usage of the product are not known. The physician wants to know the active ingredient in product and is concerned that the product may contain an organophosphate so would like to rule this out. The product Ingredients were discussed. The physician was informed that the herbicide does not contain an organophosphate.

To be determined by Registrant

14. Severity classification.

Moderate

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. Also, the reporting physician had not actually seen or examined the patient therefore the information provided is based on a vague recounting of events by the patient. Even had casual or incidental contact occurred during the normal use of this herbicide, neuropathy would not be an expected outcome. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the ingredients used in this product a causal relationship appears to be scientifically implausible.