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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6619

2. Registrant Information.

Registrant Reference Number: M-574214-01-1

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)
    • DIFLUFENICAN
    • 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 Diflufenican + Flufenacet SC 600 (200+400 g/L) Effects on the seedling emergence and growth of ten speciesof non-target terrestrial plants (Tier 2)

Date 16-SEP-16

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)

Non-relevant co-formulation for Canada with Diflufenican and Flufenacet. Per interpretation of PMRA guidance this study is being submitted despite Diflufenican not being registered in Canada. The lowest ER25 for the most sensitive plant species tested is lower in this study than in previously submitted studies with Flufenacet. However, this is not expected to change the risk conclusion since this coformulation is not registered in Canada.

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