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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0437

2. Registrant Information.

Registrant Reference Number: 31642676

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

Address: 350 Albert St, Suite 315

City: Ottawa

Prov / State: ON

Country: Canada

Postal Code: K1R 1A4

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

Human

4. Date registrant was first informed of the incident.

19-JAN-10

5. Location of incident.

Country: UNITED STATES

Prov / State: DELAWARE

6. Date incident was first observed.

04-AUG-09

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. 71995-23

Product Name: Roundup Weed and Grass Killer 1 Ready to Use

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Guarantee/concentration 1.92 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

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).

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Renal System
    • Symptom - Other
    • Specify - In hospital with kidney problems

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?

Unknown

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)

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 his (age) mother is in the hospital with kidney problems. The son is calling to see if Roundup could be a factor in her illness. He states that in the last 6 months, his mom has used 4 containers of the Roundup Weed and Grass Killer Ready to Use. No actual ingestion, nor dermal exposure. The son is concerned that she may have inhaled some. MRPC discussed the product toxicity. The symptoms do not correspond with the expected response to the product. Roundup is not volatile, no fumes or vapor exposure expected. Continue under the care of MD.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

This was originally reported via the (state) Regional Poison Center in August and then sent to Monsanto US who then reported it in the US October 14, 2009 and sent the report to Monsanto Canada January 19, 2010. The Incident reporting process and personnel in the US have changed which led to this delay in the Canadian report. Steps are being put in place to report to Canada in a timely manner.