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)
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.