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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3977

2. Registrant Information.

Registrant Reference Number: 42114

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.

PMRA Registration No. 18092      PMRA Submission No.       EPA Registration No.

Product Name: DELTAMETHRIN TECHNICAL INSECTICIDE

• Active Ingredient(s)
  • DELTAMETHRIN

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 Stephan Schmitzer

Date 16-JAN-13

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 deltamethrin technical. BCS has become aware of two studies investigating the acute oral toxicity of deltamethrin technical on honey bees (Schmitzer S., 2013 and Waltersdorfer A., 1996).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.

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 72 hour LD50 reported by Waltersdorfer A., 1996 is much lower than reported in Schmitzers S. However, Schmitzer S., 2013 strictly follows the established OECD 213 guideline while the Waltersdorfer A., 1996 study has major deficiencies. Waltersdorfer A., 1996, provided the test material in a diet paste without solvent rather than in a 50% sucrose solution as is standard protocol. Given the inherently low solubility of deltamethrin (0.2 ppb in water at 20¿¿¿¿C), lack of solvent, and treatment in the form of a diet paste prepared with powdered sugar, honey, and water it is expected that bees were exposed to undissolved deltamethrin. Considering this study does not follow modern testing procedures, the LD50 value is an extrapolation since 50% mortality was not achieved in the study, and bees were proved a diet paste which presumably contained undissolved test material, Bayer CropScience believes the study is unreliable and oral toxicity of deltamethrin to honey bees under laboratory conditions should be based on the Schmitzer S., 2013 study.