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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2765

2. Registrant Information.

Registrant Reference Number: M-610383-01-1

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. 30361      PMRA Submission No.       EPA Registration No.


  • Active Ingredient(s)
      • Guarantee/concentration 100 g/L
      • Guarantee/concentration 18 g/L

PMRA Registration No. 30364      PMRA Submission No.       EPA Registration No.


  • Active Ingredient(s)
      • Guarantee/concentration 61.4 g/L
      • Guarantee/concentration 38.4 g/L
      • Guarantee/concentration 76.8 g/L

7. b) Type of formulation.

Application Information

8. Product was applied?


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?


Subform VII: Scientific Study

1. Study Reference

Title Prothioconazole FS 25 G:Effects (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory

Date 21-DEC-17

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


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)

Acute contact and oral honeybee LD50 values were determined to be lower than the endpoints currently being used.

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

Bayer would like to note that the lower contact LD50 value as reported is within the range identified as practically non-toxic to bees (11 g/bee). In addition, the colony level studies do not suggest adverse effects to bee colonies from exposure to prothioconazole. This study is for seed treatment formulations for which significant contact exposure is not expected.