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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2685

2. Registrant Information.

Registrant Reference Number: M-554249-02-2

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.

PMRA Registration No.       PMRA Submission No. 2021-0639      EPA Registration No.

Product Name: DFF SC 500 Herbicide

• Active Ingredient(s)
  • DIFLUFENICAN

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 1 to the study report - Calculation of minimum detectable differences for the study - Outdoor aquatic mesocosm study with diflufenican 500 SC (500 g a.s./L)

Date 20-APR-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)

The study concluded that there were no direct effects on macrophytes up to the highest treatment level (9 g a.i./L). However, there were potential indirect effects on Lemna sp. over the last six weeks of the study at 3 9 g a.s./L. There was a trend toward recovery, but since the initial effects were delayed no full recovery could be demonstrated during the study period. Based on this finding, the NOEC for Lemna was determined to be 1.5 g a.i./L. There are no calculated ER50 values associated with mesocosm studies.

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 Study Report has been submitted for review under the pending registration application: sub. no. 2021-0639. Applicability to the risk assessment will depend upon PMRA's evaluation of the study for relevance.