Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-2132
2. Registrant Information.
Registrant Reference Number: M-753795-02-1
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. 32107
PMRA Submission No.
EPA Registration No.
Product Name: Luna Sensation
- Active Ingredient(s)
- FLUOPYRAM
- Guarantee/concentration 250 g/L
- TRIFLOXYSTROBIN
- Guarantee/concentration 250 g/L
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 Amendment No. 1 to Final ReportFluopyram + trifloxystrobin SC 500 (250+250 g/L):Chronic Oral Toxicity Test (10-Day Feeding) to the Honey Bee, Apis mellifera L.under Laboratory Conditions
Date 31-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 The chronic oral toxicity of Fluopyram + Trifloxystrobin SC500 to adult honey bee (Apis mellifera) was investigated in a study performed in accordance with OECD No 245. The study reported a NOEDD of 16.73g formulation/bee/day. A repeat of this study is scheduled to be performed during the bee testing season of 2021.
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