Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-3049
2. Registrant Information.
Registrant Reference Number: 20180705
Registrant Name (Full Legal Name no abbreviations): Bayer CropScienc Inc.
Address: Suite 200, 160 Quarry Park Blvd SE
City: CCalgary
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 Insecticide
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 Flupyradifurone SL 200 (200 g/L) Acute Eye Irritation Study in Rabbits.
Date 09-SEP-15
2. a) Is an extension needed to translate the document?
No
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)
BCS is submitting new information to PMRA related to Sivanto Prime Insecticide. This information is being submitted for PMRA's own review as it has the potential to impact the hazard labeling for this product.
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