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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2102

2. Registrant Information.

Registrant Reference Number: M-704606-01-1

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.

Active(s)

PMRA Registration No. 30508      PMRA Submission No.       EPA Registration No.

Product Name: FLUOPYRAM TECHNICAL FUNGICIDE

  • Active Ingredient(s)
    • FLUOPYRAM
      • Guarantee/concentration 98.7 %

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 AE C656948-benzamide - Repeated Exposure to Honey Bee Larvae (Apis mellifera L.) under Laboratory Conditions

Date 29-JUL-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 metabolite AE C656948-benzamide (fluopyram-benzamide). The study reports statistically significant deviation in emergence of two treatment groups relative to the control resulting in a NOEC of 12.7 mg ai/kg food (NOED = 2.0g ai/larva).

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