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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-5297

2. Registrant Information.

Registrant Reference Number: M-770024-01-1

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.

PMRA Registration No. 24563      PMRA Submission No.       EPA Registration No.

Product Name: FOSETYL-AL TECHNICAL

• Active Ingredient(s)
  • FOSETYL-AL

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 Fosetyl-Aluminium Technical - Modified Amphibian Metamorphosis Assay with African Clawed Frog (Xenopus laevis)

Date 28-MAY-21

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)

There were a number of endpoints (snout-vent length, mean hind limb length, mean whole body wet weight, and increase in time to Stage 62) which were significantly reduced at the 1.1 mg/L treatment level. The next lowest concentration tested was 0.097 mg/L. This appears to be lower than the current chronic fish NOEC that PMRA is considering in their risk assessment and thus would meet the criteria for adverse effects reporting.

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 modified amphibian metamorphosis assay was conducted to meet endocrine testing requirements for active ingredients in the EU. The study met reportability criteria under Canadian adverse effects reporting guidelines. The aquatic risk assessment for fosetyl-al determined that there was a low chronic risk to fish and the lower endpoint for the amphibian metamorphosis assay does not change this conclusion.