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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6045

2. Registrant Information.

Registrant Reference Number: M-657940-01-1

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

Address: 160 Quarry Park Boulevard SE Suite 130

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. 28589      PMRA Submission No.       EPA Registration No.

Product Name: SPIROMESIFEN TECHNICAL INSECTICIDE-MITICIDE

• Active Ingredient(s)
  • SPIROMESIFEN

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 Spiromesifen enol: Effects of a repeated (chronic) exposure on honey bee (Apis mellifera) larvae in an in vitro laboratory testing design

Date 23-APR-19

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

No

3. Type of incident identified in the study

New health or environmental hazard

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)

An in vitro chronic honey bee larvae study was conducted with the enol metabolite of spiromesifen according to the OECD Guidance Document on Honey Bee Larval Toxicity Test, Repeated Exposure OECD Series on Testing Assessment No. 239. The NOEC was determined to be 1.3 mg a.i./kg diet. This endpoint is lower than the other honey bee endpoints determined for spiromesifen parent or enol metabolite.

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

Refinements to the risk assessment based on colony feeding study and field residue determinations should result in a conclusion of limited risk to pollinators.