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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2394

2. Registrant Information.

Registrant Reference Number: M-444475-01-1

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. 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 Metabolism of [thiadiazole-5-14C] Flufenacet in Wheat

Date 07-JAN-13

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)

Bayer is submitting new information to the PMRA related to FOE 5043 Technical Herbicide. This information is not necessarily a new adverse effect of the subject chemical, but is rather new information submitted for PMRA's own review and evaluation because the data meet PMRA's administrative reporting criteria. This Study Report is entitled Metabolism of [thiadiazole-5-14C]Flufenacet in wheat. It documents a new metabolite or degradate from a different radiolabel position. This information is being submitted to the PMRA in compliance with the Agency's 6(a)(2) reporting requirements.

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

The corresponding DACO number for this study is 6.3 Plants, as per the Guidance for Developing Datasets for Conventional Pest Control Product Applications. As we were unable to select the DACO no. 6.3 from the available DACO list above, we selected 7.8 as the DACO number.