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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1742

2. Registrant Information.

Registrant Reference Number: M-769030-02-1

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. 30219      PMRA Submission No.       EPA Registration No.

Product Name: INDAZIFLAM TECHNICAL HERBICIDE

• Active Ingredient(s)
  • INDAZIFLAM

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 Indaziflam - Short-Term Reproduction Assay with Fathead Minnow (Pimephales promelas) - Amended Final Report -

Date 04-JUN-21

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)

There was a survival effect on the fish during this study at the test concentration of 190 ug/L. The next lowest concentration tested was 64 ug/L. This appears to be lower than the current chronic fish NOEC that PMRA is considering in their risk assessments, thus would meet the criteria for adverse effects reporting.

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

However, this study is not considered appropriate for assessing chronic risk to fish because this is an endocrine screening study, and as such there are a limited number of test concentrations employed and a specific dose-spacing factor, and these constraints do not provide for the type of dose-response analysis that lends to a robust risk assessment endpoint. EPA has previously acknowledged the limitations of this guideline study type (OCSPP 890.1350) for use in risk assessment. The fish short-term reproduction study was conducted to meet endocrine testing requirements for activeingredients in the EU as was an amphibian metamorphosis assay [Snow, A; 2021; Indaziflam - Modified amphibian metamorphosis assay with African clawed frog (Xenopus laevis); M-761878-02-02]. The amphibian metamorphosis assay does not meet the criteria for adverse effects reporting, but we are providing it for completeness of the Indaziflam data package.