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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6714

2. Registrant Information.

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

Address: #100, 3131 - 114th Avenue

City: Calgary

Prov / State: Alberta

Country: Canada

Postal Code: T2Z 3X2

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.       PMRA Submission No. 2006-7491      EPA Registration No.

Product Name: Movento 150 OD

  • Active Ingredient(s)
    • SPIROTETRAMAT

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 Spirotetramat Potential Toxicity to Honey Bees

Date 14-SEP-07

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)

As part of its agricultural development (AD) and stewardship program, Bayer CropScience AG has conducted trials with spirotetramat to evaluate its pollinator compatibility. These trials were not conducted under GLP and formal reports were not prepared, as is typical for field efficacy and development data. Furthermore, the data were collected under experimental conditions (tent, tunnel) that exaggerate actual exposure by confining honey bees to forage only on the treated plants. These AD trials demonstrated that Moventożż has the potential to affect the honey bee brood when the adults of the hive are forced to forage exclusively on flowering crops, specifically after application of Moventożż to the crop at bloom or up to 5 days prior to bloom. Where effects to the honey bee brood were observed, recovery was noted within 2-3 weeks. Although the described trials indicate potential for Moventożż to reduce honey bee brood production, it is important to emphasize that this has only been observed when the honey bees and the hive are artificially confined to the treated crop and, even then, the observed effects are transient (recoverable). Brood effects have not been observed in a higher tiered field study which evaluated the effects to honey bees under realistic field conditions. The field study was submitted to EPA as previously mentioned (Ref: MRID # 469044-62). While the exposure conditions of a tunnel trial are intentionally exaggerated and therefore do not represent the agronomic conditions of use, all of the trials were conducted at use rates similar to those proposed for field use in the USA and Europe. For this reason, we have decided to report them.

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?

Unknown

For Registrant use only

7. Provide supplemental information here

This submission is part of a joint review between Canada, US and Austria to register the new compound (Spirotetramat (2006-6947) and its end use products, Movento 240 SC (2006-7317) and Movento 150 OD (2006-7491) and, is ongoing. No registration decision has been reached thus far.