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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2684

2. Registrant Information.

Registrant Reference Number: M-408075-01-1

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.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 432-1465

Product Name: RONSTAR FLO HERBICIDE

  • Active Ingredient(s)
    • OXADIAZON

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 Oxadiazon SC 380 g/L, Effects on the vegetative vigour of ten species of non-target terrestrial plants (Tier 2)

Date 23-MAY-11

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 is a vegetative vigor study with formulation Oxadiazon SC 380 - it is considered to be similar to Ronstar FLO, a formulation registered in both the US and Canada. The lowest ER25 endpoint for monocots from this study was 0.669 lb a.i./A for oat, which is greater than the current endpoint of 0.37 lb a.i./A for monocots for oat. The dicot endpoint was 0.0146 lb a.i./A (cucumber), which is ~3.4x less than the current endpoint of 0.05 lb a.i./A (lettuce). The study is potentially reportable for the dicot endpoint.

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

This study may be considered relevant to the Canadian risk assessment.