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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5705

2. Registrant Information.

Registrant Reference Number: M-614062-01-1

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. 17293      PMRA Submission No.       EPA Registration No.

Product Name: NORTRON FLOWABLE HERBICIDE

• Active Ingredient(s)
  • ETHOFUMESATE

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 Effects on the vegetative vigor of Glycine max and Raphanus sativus - two species of non-target terrestrial plants (Tier 2) - ethofumesate SC 500 g/L

Date 06-FEB-18

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 a study that was conducted with ethofumesate SC 500 g/L, the EC25 (IR25) and EC50 (IR50) values for shoot length of Glycine max (soybean) were calculated to be 45.3 g a.s. (active substance)/ha and 355.7 g a.s./ha, respectively. These values were below the previous EC25 and EC50 shoot length values for soybean which were 162 g a.s./ha and 949.6 g a.s./ha, respectively. Similarly, the EC25 (IR25) and EC50 (IR50) values for shoot dry weight of soybean were calculated to be 116 g a.s./ha and 972.7 g a.s./ha, respectively. These values were below the previous EC25 and EC50 shoot dry weight values for soybean which were 423 g a.s./ha and 3596.5 g a.s./ha, respectively. In the same study, the EC25 (IR25) value for shoot length of Raphanus sativus (radish) was calculated to be 269.8 g a.s./ha. This value was below the previous EC25 shoot length value for radish which was 4920 g a.s./ha. Similarly, the EC25 (IR25) value for shoot dry weight of radish was calculated to be 104.6 g a.s./ha. This value was below the previous EC25 shoot dry weight value for radish which was 255.8 g a.s./ha.

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 initial risk assessment determined that terrestrial plants were sensitive to ethofumesate in which endpoint effects (shoot length and dry weight) for monocots and dicots were established. Therefore, the lower EC25 and EC50 endpoint values for soybean and radish do not change the risk assessment for Nortron SC (ethofumesate).