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: 2010-4908

2. Registrant Information.

Registrant Reference Number: 31870402

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

Address: 180 Kent Street, Suite 810

City: Ottawa

Prov / State: ON

Country: Canada

Postal Code: K1P 0B6

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

Human

4. Date registrant was first informed of the incident.

15-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

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. 524-445

Product Name: Roundup Herbicide

  • Active Ingredient(s)
    • GLYPHOSATE

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Unknown / Inconnu

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.

Other

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Rash

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?

No

6. b) For how long?

7. Exposure scenario

Unknown

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.

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 states she used Roundup concentrate (unknown formulation) about 4-5 weeks ago. No actual dermal contact. Wore gloves that went almost to her elbow. The caller states that she was very careful not to get any on her skin but wonders if Roundup vaporizes. She was also on antibiotics for a couple of weeks about this time. She has a rash on both arms from her wrist to just past her elbows. The MD has given her 2 medicated lotions to use. MRPC discussed the product toxicity. The symptoms do not correspond with expected response to the product. MRPC advised caller to follow up with PMD. Woman called back the next day for further reassurance. She states she used the Roundup product at the end of June. No dermal exposure. She developed a splotchy red rash on both forearms from wrist to elbows after a two week course of antibiotic- amoxicillin for an infection. MD has taken a biopsy but no result. She has several topical medications being used at this time. MRPC reviewed that the symptoms are not expected to be related to the use of the product. Discussed other possible cause for symptoms. MRPC offered to speak to the MD if any questions about Roundup.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.