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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-6235

2. Registrant Information.

Registrant Reference Number: M-808250-01-1

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.

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

Product Name:

• Active Ingredient(s)
  • FOSETYL-AL
  • PROPAMOCARB HYDROCHLORIDE

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 FST+PPC SL 840 (310+530 g/L): Toxicity to the single cell green alga Raphidocelis subcapitata Korshikov under laboratory conditions

Date 09-MAR-22

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 green algal study with FST + PPC SL 840 (310+530 g/L) met reportability criteria for Canada due to lower endpoints as compared to the previously reported green alga study with propamocarb. The lower endpoints do not affect the risk assessment for propamocarb as the level of concern was low for adverse effects to aquatic non-vascular plants. Additionally, the lower endpoint could be a result of either fosetyl (FST) or propamocarb (PPC) in the formulation however the likelihood for these active ingredients occurring together is very low as no combination products exist for Canada. Furthermore, there are no tank mixes possible with these individual active ingredients as each have a different GAP.

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 EC50 and NOEC from this study are lower than the previously reported values. However, since PMRA does not use the algae NOEC in the risk assessment, there is no impact on the safety determination for propamocarb.