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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1373

2. Registrant Information.

Registrant Reference Number: M-624477-01-1

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. 29657      PMRA Submission No.       EPA Registration No.

Product Name: Tembotrione Technical Herbicide

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


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?


Subform VII: Scientific Study

1. Study Reference

Title Tembotrione - Honey Bee (Apis mellifera L.) 22 Day Larval Toxicity Test (Repeated Exposure)

Date 26-APR-18

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


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)

No prior information on Tembotrione toxicity to honey bee larva is available. The Study Report entitled Tembotrione - Honey bee (Apis mellifera L.) 22 day larval toxicity test (repeated exposure) describes the findings from a chronic larvae test following the OECD guidance document 239. The study determined a NOEC level of 79.2 mg a.i./kg of food and an EC50 of 291 mg a.i./kg of food, corresponding to a cumulative NOED of 12.2 ug a.i./larva and an ED50 of 44.8 ug a.i./larva. Effects were reported in the two highest test levels in the study (226 and 643 mg a.i./kg, corresponding to 34.8 and 99.0 ug a.i. per larvae). Notably, the risk assessment passes the Tier I screening with BeeREX for the current application rates of tembotrione in two registered Bayer products, Laudis and Vios G3.

5. a) Was the study discontinued before completion?


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