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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2011-2050

2. Registrant Information.

Registrant Reference Number: 2011-05

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.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

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. 28965      PMRA Submission No.       EPA Registration No.

Product Name: Dicamba

  • Active Ingredient(s)
    • DICAMBA (PRESENT AS ACID, AMINE SALT, ESTER, OR SODIUM SALT)

7. b) Type of formulation.

Liquid

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 VII: Scientific Study

1. Study Reference

Title Metabolism of 14C-Dicamba in Dicamba-Tolerant Cotton

Date 03-MAY-11

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Presence of a component or derivitive

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

Monsanto has conducted a metabolism study in which radiolabeled dicamba was applied to a cotton line modified to be tolerant to the herbicide dicamba. Preliminary findings from this study identified minor metabolites which have not previously been reported for dicamba in previously investigated cotton substrates. These metabolites were identified in the cotton gin byproducts raw agricultural commodity.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

31-DEC-11

For Registrant use only

7. Provide supplemental information here

In general, there are no hazard concerns with these metabolites. Furthermore, the metabolite levels shown above were found on the cotton gin byproduct (i.e., cotton gin trash) fraction which is not a commodity used or traded for direct human consumption, and has limited use as livestock feed. Accordingly, any exposure to these metabolites is anticipated to be negligible. In conclusion, these metabolites are not relevant for consideration in a risk assessment, nor do they have any impact on the existing hazard endpoints utilized by EPA in the regulation of dicamba. These findings may be refined in the final report of the metabolism study.