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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3963

2. Registrant Information.

Registrant Reference Number: 20150305

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Blvd 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. 27423      PMRA Submission No.       EPA Registration No.

Product Name: FORAMSULFURON TECHNICAL HERBICIDE

  • Active Ingredient(s)
    • FORAMSULFURON

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 Lemna gibba G3 - Growth inhibition test with foramsulfuron OD 22.5 (22.5 g/L) under static conditions

Date 02-SEP-14

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)

BCS is submitting new information to PMRA related to Foramsulfuron Technical. This information is not necessarily a new adverse effect of the subject chemical, but is rather new information submitted for agencys own review and evaluation. The Study Report title is Lemna gibba G3 - Growth inhibition test with foramsulfuron OD 22.5 (22.5 g/L) under static conditions. The difference in the NOECs is likely due to the treatment level spacing factors used in test design. Testing with TGAI resulted in a lower growth rate EC50 vs. the current study foramsulfuron OD 22.5 growth rate EC50, giving no indication that L. gibba is more sensitive to the formulation than the TGAI. BCS believes this value has minimal impact on the risk assessment as formulations do not runoff as intact mixtures and should not be used to represent an aquatic exposure scenario as a result of runoff. Also, no direct applications of foramsulfuron to water bodies, TGAI or formulation, are allowed on the label.

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