Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-0878
2. Registrant Information.
Registrant Reference Number: M-663903-01-1
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.
Active(s)
PMRA Registration No. 29657
PMRA Submission No.
EPA Registration No.
Product Name: Tembotrione Technical Herbicide
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 Tembotrione - Chronic toxicity test with Asellus aquaticus (21d) - Semi-static exposure
Date 04-JUN-19
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)
The study report is entitled "Tembotrione - Chronic toxicity test with Asellus aquaticus (21d) - Semi-static exposure" (DART: M-663903-01-1). The study reports a set of regulatory end-points for a species of freshwater invertebrate not previously tested for assessing risk of Tembotrione to aquatic organisms and meets the criteria for reporting. However, the new end-point is higher (lower toxicity) than the existing end-points for freshwater vascular plants, and marine invertebrates already considered in the current Risk Assessment for Tembotrione.
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