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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2464

2. Registrant Information.

Registrant Reference Number: M-658146-01-1

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.


PMRA Registration No. 31450      PMRA Submission No.       EPA Registration No.


  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.

10. Site pesticide was applied to (select all that apply).

Site: Unknown / Inconnu

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?


Subform VII: Scientific Study

1. Study Reference

Title Acute Contact Toxicity Test with Flupyradifurone SL 200 with the Solitary Leafcutter Bee(Megachile rotundata L.) in the Laboratory (non-GLP study)

Date 30-APR-19

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


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)

Acute contact toxicity endpoint (LD50) for a solitary bee species (Megachile rotundata) is 2x lower than previously reported for the honey bee Apis mellifera (PMRA report number 2236691).

5. a) Was the study discontinued before completion?


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 observed response of Megachile rotundata is explained by the lack of CYP9Q, CYP9BU, or functional homologues impairing the ability of the organism to efficiently detoxify flupyradifurone. Megachile rotundata is the only species of bee known to date to lack these enzymes and recent efforts by Bayer have demonstrated tolerance of other non-Apis bee species to flupyradifurone (i.e., Bombus terrestris, Osmia bicornis, Osmia cornuta). The potential for Megachile rotundata to be exposed to residue levels of flupyradifurone that are of toxicological concern is expected to be low given the application or timing restrictions on crops that are known to use managed Megachile rotundata.