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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0600

2. Registrant Information.

Registrant Reference Number: M-679155-01-1

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

Address: Suite 200, 160 Quarry Park Boulevard 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. 26232      PMRA Submission No.       EPA Registration No.

Product Name: FOE 5043 TECHNICAL HERBICIDE

  • Active Ingredient(s)
    • FLUFENACET

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 Determination of the residues of trifluoroacetic acid in/on wheat, spring and the processedfractions (bran; gluten; middlings; shorts; starch; wheat germ; white flour; whole meal andwholemeal bread) after Spraying of Flufenacet SC 508.8 in the Field in Germany andUnited Kingdom

Date 25-FEB-20

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)

Report No. M-679155-01-1: Residue analysis of wheat and wheat processed commodities after application of flufenacet for a metabolite that is currently not part of the Canadian residue definition for enforcement or risk assessment. Report No. M-679404-01-1: Residue analysis of barley and barley processed commodities after application of flufenacet for a metabolite that is currently not part of the Canadian residue definition for enforcement or risk assessment.

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

Wheat and barley raw and processed commodity samples are analyzed for a metabolite that is currently not part of the Canadian residue definition for enforcement or risk assessment purposes after application of Flufenacet. Quantifiable residues were detected in wheat/barley grain and wheat/barley processed commodities. Flufenacet is not registered on wheat or barley in Canada.