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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0341

2. Registrant Information.

Registrant Reference Number: 32029789

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.

18-JAN-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

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. 71995-29

Product Name: Roundup Weed and Grass Killer Concentrate Plus

  • Active Ingredient(s)
    • DIQUAT
    • GLYPHOSATE
      • Guarantee/concentration 18 %

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: 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: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Fatigue
  • Gastrointestinal System
    • Symptom - Nausea
  • General
    • Symptom - Weakness
  • Nervous and Muscular Systems
    • Symptom - Shakiness
  • Blood
    • Symptom - Leukocytosis
  • General
    • Symptom - Sweating

4. How long did the symptoms last?

>6 mos / > 6 mois

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

Yes

6. a) Was the person hospitalized?

Unknown

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 her son used Roundup in June and July during the hottest months in (state). He was using the Roundup 18% (unknown how it was diluted) and a Spectricide product at about the same time to deal with weeds and fleas. He would sweat a lot, caller suspected from the extreme heat. Around that same time he developed, extreme fatigue, nausea, weakness, shakiness, elevated WBC 27,000. A lot of lab work and tests were done. He was seen by a hematologist/oncologist - "toxic granules" in bone marrow. He was referred to an infectious disease specialist but nothing conclusive to determine the cause of the elevated WBC and symptoms. Now the WBC is around 19,000. Caller is concerned about her son's use of Roundup. She denies any mishaps but wonders about overspray and perhaps inhalation of the product. MRPC discussed the product toxicity. The symptoms do not correspond with expected response to the product. Advised the caller to remain under the care of MD. MRPC offered to provide PMD, oncologist/ hematologist, infectious disease or other consulting physicians with information and guidelines upon request.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.