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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4595

2. Registrant Information.

Registrant Reference Number: 2008Sep Glycine

Registrant Name (Full Legal Name no abbreviations): Monsanto

Address: 800 N. Lindbergh Blvd.

City: Saint Louis

Prov / State: Missouri

Country: United States of America

Postal Code: 63167

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.       PMRA Submission No.       EPA Registration No. 524-421

Product Name: Glyphosate Technical (Wetcake)

  • Active Ingredient(s)
    • GLYPHOSATE

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 VII: Scientific Study

1. Study Reference

Title 2008 Analytical Profile of Glyphosate Technical (Wetcake)/MON 77973 From Monsanto Sao Jose Dos Campos Plant

Date 02-JUL-08

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)

Impurity Detected at Levels Above 0.1%: Glycine.

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?

Unknown

For Registrant use only

7. Provide supplemental information here

Due to a process improvement in Monsanto's glyphosate manufacturing process, trace amounts of an impurity have been detected in Glyphosate Technical (Wetcake), EPA Reg. No. 524-421. Preliminary results from a five-batch analysis indicate that this impurity is detected at levels above 0.1 percent by weight. Upon final completion of the analysis, Monsanto intends to update the relevant confidential statement(s) of formula ("CSF") for the product(s) identified. At that point in time, a copy of the five-batch analysis will be submitted to PMRA along with the request to modify the CSF.