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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-2136
2. Registrant Information.
Registrant Reference Number: M-681092-02-1
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. 30508 PMRA Submission No. EPA Registration No.
Product Name: FLUOPYRAM TECHNICAL FUNGICIDE
- Active Ingredient(s)
- FLUOPYRAM
- Guarantee/concentration 98.7 %
- FLUOPYRAM
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 Report Fluopyram: Aerobic Metabolism / Degradation and Time - Dependent Sorption in 6 Soils
Date 24-MAR-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)
The degradation and time-dependence of sorption of [phenyl-UL-14C] Fluopyram was studied in six European soils under aerobic conditions in the laboratory in the dark at 20 2 C (mean 19.4 C) and 55 5% (mean 53.8%) of the respective maximum water holding capacity of soils for 118 days. Kinetic analysis showed 50% degradation times (DT50) for fluopyram of 464, and 501 days for 2 soils and 1000 days for 4 soils. Note: Previously submitted studies had a DT50 range of 162-747 days. The new half-life and adsorption data were incorporated into EPA and PMRA water exposure models, resulting in slightly higher water exposure values but no change in the human or environmental risk conclusions. (New kinetic analyses were performed for the soils with reported DT50 values 1000 day to generate DT50 values for the water exposure modeling.)
5. a) Was the study discontinued before completion?
No
