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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0851

2. Registrant Information.

Registrant Reference Number: M-051722-04-1

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

Address: Suite 200, 160 Quarry Park Blvd 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. 27526      PMRA Submission No.       EPA Registration No.

Product Name: TRIFLOXYSTROBIN TECHNICAL FUNGICIDE

  • Active Ingredient(s)
    • TRIFLOXYSTROBIN (CGA 279202)

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 [Glyoxyl-Phenyl-(U)-14C]-CGA 279202 : Mobility and Degradation in Soil in Outdoor Lysimeters

Date 13-JUL-01

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Presence of a component or derivitive

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 enclosed reports include an outdoor lysimeter study using radio-labeled trifloxystrobin where two metabolites, NOA 413161 and NOA 413163 were identified in leachate samples. Associated environmental fate studies are also included. These two metabolites have been identified previously in submitted crop residue reports but not in the environmental fate package. The mammalian toxicity data available on these metabolites indicate a low level of concern. The ecological toxicity data also indicate no or minimal activity at concentrations tested, and are therefore of low concern for ecological health. Bayer can provide a list of available studies upon request.

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

Outdoor lysimeter study with radio-labeled trifloxystrobin