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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0601

2. Registrant Information.

Registrant Reference Number: M-650694-01-1

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. 33713      PMRA Submission No.       EPA Registration No.

Product Name: TETRANILIPROLE 200SC TURF INSECTICIDE

• Active Ingredient(s)
  • TETRANILIPROLE

PMRA Registration No. 33711      PMRA Submission No.       EPA Registration No.

Product Name: VAYEGO 200SC INSECTICIDE

• Active Ingredient(s)
  • TETRANILIPROLE

PMRA Registration No. 34488      PMRA Submission No.       EPA Registration No.

Product Name: CL73507 200 SC INSECTICIDE

• Active Ingredient(s)
  • TETRANILIPROLE

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 Determination of the residues of tetraniliprole and its metabolite tetraniliprole-N-methyl-quinazolinone in bee relevant matrices collected from succeeding crops following applications of tetraniliprole SC 200 G (200 g/L) via soil incorporation - Field phase conducted with maize, buckwheat, mustard and phacelia in Northern France

Date 11-FEB-19

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

New health or environmental hazard

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 a recent review of pollinator residue work for tetraniliprole, we believe that the study entitled, Determination of the residues of Tetraniliprole and its metabolite Tetraniliprole-N-methyl-quinazolinone in bee relevant matrices collected from succeeding crops following applications of Tetraniliprole SC 200 G (200 g/L) via soil incorporation. Field phase conducted with Maize, Buckwheat, Mustard and Phacelia in Northern France (2019, Bayer no. M-650694-01-1) may meet the criterion for reportability under Incident Reporting. In this study, tetraniliprole and metabolite residues were measured in buckwheat, with residues in pollen ranging from below the Level of Detection (LOD) to 2.5 ppb. The highest residue reported in pollen was 2 times higher than residues in buckwheat pollen that were previously reported to EPA and PMRA. In this study, residues in mustard were also measured, with residues in pollen ranging from 1.1 to 6.5 ppb. The highest value obtained in this study was 6.5 ppb where previously, levels were below the level of detection.

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

In a recent review of pollinator residue work for tetraniliprole, we believe that the study entitled, Determination of the residues of Tetraniliprole and its metabolite Tetraniliprole-N-methyl-quinazolinone in bee relevant matrices collected from succeeding crops following applications of Tetraniliprole SC 200 G (200 g/L) via soil incorporation. Field phase conducted with Maize, Buckwheat, Mustard and Phacelia in Northern France (2019, Bayer no. M-650694-01-1) may meet the criterion for reportability under Incident Reporting Regulation. In this study, tetraniliprole and metabolite residues were measured in buckwheat, with residues in pollen ranging from below the Level of Detection (LOD) to 2.5 ppb. The highest residue reported in pollen was 2 times higher than residues in buckwheat pollen that were previously reported to EPA and PMRA. In this study, residues in mustard were also measured, with residues in pollen ranging from 1.1 to 6.5 ppb. The highest value obtained in this study was 6.5 ppb where previously, levels were below the level of detection. However, these residues do not pose any risk to bees as compared to the colony feeding study. The NOEC from the colony feeding study (624 ppb) is 96 times higher than the resulting calculation for nectar exposure and 1400 times higher than the resulting calculation for pollen exposure when extrapolating to a nectar-equivalents study endpoint.There was an additional study conducted during the same timeframe using a similar methodology (Residues of BCS-CL73507 in Guttation Fluid, Nectar and Pollen of Flowering Rotational Crops in Western Germany, 2018, Bayer Report No. M-620354-01-1). This study does not meet the criteria for reporting under Incident Reporting Regulation, but we are providing it as supplemental information relevant to this submission.