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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-5304

2. Registrant Information.

Registrant Reference Number: M-754099-01-1

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. 28952      PMRA Submission No.       EPA Registration No.


  • 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 Spirotetramat - Short-Term Reproduction Assay with Fathead Minnow(Pimephales promelas)

Date 01-SEP-20

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


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)

A study was conducted with spirotetramat according to the U.S. EPA OCSPP 890.1350/OECD TG 231 guidelines following Good Laboratory Practices (GLP). This study, :Spirotetramat-Short-Term Reproduction Assay with Fathead Minnow (Pimephales promelas) (DART No. M-754099-01-1), is a chronic 21-day study intended to screen for interference of a substance with the hypothalamic-pituitary-gonadal (HPG) axis. No effects were observed in the study consistent with interference with the HPG axis. In the highest test level, 0.48 mg/L, a 50% reduction in male survival was observed at test termination. No effects were observed at the next lowest test level, 0.15 mg/L. The current most sensitive chronic fish endpoint is a NOAEC of 0.534 mg/L, based on a fathead minnow early life stage study with reduced fry survival. As the fish short term reproduction assay is an endocrine screening assay not designed or intended to produce quantitative no effect levels, Bayer does not believe that results from this study are suitable for setting hazard endpoints to be used in an ecological risk assessment.

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

This study is also being submitted to the USEPA under 6(a)2 reporting requirements according to 40 CFR 159.165(b)(2 ) .