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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-2686

2. Registrant Information.

Registrant Reference Number: M-586163-01-2

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.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 264-1052

Product Name: ADAMENT 50 WG FUNGICIDE

  • Active Ingredient(s)
    • TEBUCONAZOLE
    • TRIFLOXYSTROBIN (CGA 279202)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 264-849

Product Name: Absolute 500 SC Fungicide

  • Active Ingredient(s)
    • TEBUCONAZOLE
    • TRIFLOXYSTROBIN (CGA 279202)

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 Trifloxystrobin + tebuconazole SC 300 (100+200 g/L) acute toxicity test to Trichogramma

Date 27-NOV-13

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 24-hr LR50 toward Trochogramma of 12.2 g/ha (1.22 x 10-4 mg/cm2) is more than 2x lower than the predicted toxicity of the formulation based on the proportion of the active ingredient components of the formulation (i.e. tebuconazole and trifloxystrobin) and their reported toxicity to non-target arthropods as reported in their respective EFSA conclusion documents. The Finney mixture calculation was used to ascertain that the MDR was 2 and, thus, this LR50 was deemed potentially reportable. References: 1. EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the pesticide risk assessment of the active substance trifloxystrobin. EFSA Journal 2017;15(10):4989, 29 pp. 2. EFSA (European Food Safety Authority), 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance tebuconazole. EFSA Journal 2014;12(1):3485, 98 pp.

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

This study report is in Chinese.