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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-1086

2. Registrant Information.

Registrant Reference Number: M-758195-01-1

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. 30508      PMRA Submission No.       EPA Registration No.

Product Name: FLUOPYRAM TECHNICAL FUNGICIDE

• Active Ingredient(s)
  • FLUOPYRAM

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 DFO + FLU 375 SC:Acute Oral Toxicity Up-And-Down Procedure in Rats

Date 12-NOV-20

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)

In the acute oral up -down -procedure the oral LD50 of this formulation was estimated to be 1030 mg/kg of body weight. This is a US EPA Toxicity Category III. The oral LD50 for difenoconazole is 1453 mg/kg (Category III) and the oral LD50 for fluopyram is 2000 mg/kg (Category III). These actives are mixed with other actives in other formulations and the oral LD50 for all are a Category Ill. While there was no change in the Category there were deaths in the study. Given the formulation LD50 is lower than for each of the active ingredients this may be potentially reportable.

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