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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-5092

2. Registrant Information.

Registrant Reference Number: INRI-270913

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc

Address: 295 Henderson Drive

City: Regina

Prov / State: SK

Country: Canada

Postal Code: S4N 6C2

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. 23178      PMRA Submission No.       EPA Registration No.

Product Name: GLUFOSINATE AMMONIUM TECHNICAL HERBICIDE

  • Active Ingredient(s)
    • GLUFOSINATE AMMONIUM

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 (name and number) - active ingredient technical(Code: (name and number)Testing for acute oral toxicityin the male and female NMRI mouse

Date 01-MAR-81

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

No

3. Type of incident identified in the study

Increased health or environmental risk

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)

Bayer CropScience markets and sells glufosinate as a racemic mixture and has a full and comprehensive toxicology data package on the racemate. Bayer CropScience believes that the toxicology data on the racemic mixture is more pertinent for the safety assessment of the molecule as this is the material to which consumers and spray operators are potentially exposed. However, in addition to the studies on the racemate, several studies performed on the L-isomer were submitted to the US EPA. These studies are provided to PMRA at this time.

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?

For Registrant use only

7. Provide supplemental information here

See cover letter