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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0374

2. Registrant Information.

Registrant Reference Number: M-826549-01-1

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. 31450      PMRA Submission No.       EPA Registration No.

Product Name: FLUPYRADIFURONE TC

• Active Ingredient(s)
  • FLUPYRADIFURONE

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 Feeding Inhibition test with Cloeon dipterum exposed to Flupyradifurone (non-GLP study)

Date 14-DEC-22

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)

Larvae of the mayfly, Cloeon dipterum, were exposed to six waterborne concentrations of flupyradifurone (and control) in three different aquatic exposure scenarios under semi-static conditions. In each exposure scenario, there were twenty replicates per control and treatment group with one larvae per replicate. Results indicated that under exposure scenarios A (144 hours of flupyradifurone exposure), B (120 hours of flupyradifurone exposure), and C (104 hours of flupyradifurone exposure), mortality and immobility of larvae was increased relative to controls at concentrations 22.5 g a.i./L. Under all three exposure scenarios, partial mortality was observed at 22.5 and 33.8 g a.i./L flupyradifurone, and near complete or complete mortality was observed at concentrations of flupyradifurone 50.6 g a.i./L.

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 study was designed to provide toxicity data for development and calibration of an ecological effects model and not with the purpose of deriving regulatory endpoints. The study design included fasting and non-fasting phases. Additionally, the study period included total exposure times ranging from 104 to 144 hours, which is greater than standard acute toxicity test designs with aquatic invertebrates, which generally measure mortality over 48 hours.