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Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2021-2211

2. Registrant Information.

Registrant Reference Number: M-738909-02-1

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

Address: Suite 200, 160 Quarry Park Blvd S.E.

City: Calgary

Prov / State: Alberta

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. 32107      PMRA Submission No.       EPA Registration No.

Product Name: LUNA SENSATION

• Active Ingredient(s)
  • FLUOPYRAM
  • TRIFLOXYSTROBIN (CGA 279202)

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 Amendment No.1 to Final Report - Fluopyram + trifloxystrobin SC 500 (250+250 g/L):Honey Bee (Apis mellifera L.) Larval Toxicity Test following Repeated Exposure under laboratory conditions

Date 11-SEP-20

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)

Lower chronic endpoint than previously submitted This study investigates the potential adverse effects on honey bee (Apis mellifera) larva associated with repeated, chronic, exposure to the Fluopyram + Trifloxystrobin SC500 following the OECD guidance document 239. The study reports a NOEC of 240.48 mg formulation/kg food (NOED = 37.03g formulation/larva), which is lower than endpoints previously submitted.

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