Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2741

2. Registrant Information.

Registrant Reference Number: M-812991-01-1

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

Address: Suite 200, 160 Quarry Park Boulevard SE

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.

Active(s)

PMRA Registration No. 31452      PMRA Submission No.       EPA Registration No. 264-1141

Product Name: Sivanto Prime

  • Active Ingredient(s)
    • FLUPYRADIFURONE

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 Effect of flupyradifurone SL 200 (200 g/L) on seedling emergence and growth of eleven species of non-target terrestrial plants under greenhouse conditions (tier 1)

Date 23-MAY-22

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)

Tier 1 seedling emergence and growth test completed according to OECD 208 guidance which reports statistically significant difference, less than 25%, from controls for single test species.

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

Study reports ER25 292 g as/ha for all tested species. A statistically significant deviation from the control was observed for a single test species. This is not expected to alter the risk conclusions and may represent the expected variation for the tested species rather than an effect of the test compound.