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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1725

2. Registrant Information.

Registrant Reference Number: M-292573-01-1

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

Address: Suite 200, 160 Quarry Park Boulevard SE

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

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.

PMRA Registration No. 26141      PMRA Submission No.       EPA Registration No.

Product Name: ISOXAFLUTOLE TECHNICAL

• Active Ingredient(s)
  • ISOXAFLUTOLE

PMRA Registration No. 29068      PMRA Submission No.       EPA Registration No.

Product Name: THIENCARBAZONE-METHYL TECHNICAL HERBICIDE

• Active Ingredient(s)
  • THIENCARBAZONE-METHYL

PMRA Registration No. 29072      PMRA Submission No.       EPA Registration No.

Product Name: CYPROSULFAMIDE MANUFACTURING USE CONCENTRATE

• Active Ingredient(s)
  • CYPROSULFAMIDE

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 Isoxaflutole + thiencarbazone-methyl + cyprosulfamide SC 103 (50+20+33) G: Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artificial soil with 5% peat

Date 13-SEP-07

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)

This study appears to meet the criteria for adverse effects reporting because the chronic NOEC is greater than 10 times lower than the LC50 from an acute earthworm study with a similar formulation (Leicher, T.: Thiencarbazone-methyl Isoxaflutole Cyprosulfamide SC 90 225 150 g/l: Acute Toxicity to Earthworms (Eisenia fetida) tested in Artificial Soil with 5 % Peat. Bayer CropScience AG, unpublished report No.: LRT/Rg-A-75/06, November 21, 2006 (PMRA 1420550).

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

The endpoints from this study do not raise risks of concern. Another earthworm study (Bayer report M-450435-01-1) has been included as supplemental study. The study has been conducted with Isoxaflutole (AE B197278) technical and does not meet the criteria for adverse effects reporting, but we are providing it for completeness of the Isoxaflutole data package.