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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6713

2. Registrant Information.

Registrant Reference Number: 20051041/F2-BFEU and 20061138/F2-BFEU

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 4Z3

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.       EPA Registration No.

Product Name: A9807C

  • Active Ingredient(s)
    • FLUDIOXONIL
    • METALAXYL-M (MEFENOXAM)
    • THIAMETHOXAM

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 A field study with A10590C treated maize seed and with A9807C treated winter oilseed rape seed, investigating the effects of honey bees over three years in NORTHERN FRANCE.

Date 03-AUG-07

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

No

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)

In accordance with the Incident Reporting provisions of PCPA 2002 reporting requirements, Syngenta Crop Protection, Inc. is informing the PMRA of preliminary results from the second year of two three-year field studies in progress in FRANCE. The studies are being conducted to investigate potential effects on honey bees from maize and oilseed rape seed treated with a thiamethoxam formulation. Syngenta AG, Basel, Switzerland is conducting a suite of five honey bee field trials (2 in oilseed rape, 3 in maize) over three years in FRANCE. Each year the test organisms (6 colonies per site) are exposed to crops grown from seed treated with a thiamethoxam formulation. These trails are being conducted with a thiamethoxam formulation that is not registered in CANADA. No differences in the parameters studies on the bees were observed during the first year at any of the five trial sites. In the second year, three out of six colonies in one of the two treated oilseed rape trial sites had only done (male) brood present after over-wintering. No differences in the parameters studies were seen at the other oilseed rape trial site or in the control colonies of either oilseed rape trial. In one of the three maize trial sites, four out of six colonies in the treated maize plot failed to successfully raise a new queen following colony splitting. No differences in the parameters studied were seed in the other two maize trials or in the control colonies of all three maize trials. The results seen in these trials are equivocal and the available data do not necessarily indicate a treatment effect. In both no differences in the parameters studies were observed in first year of study, and only one trial site in each study showed differences in the second year. Further, previously submitted data do not indicate the potential for a treatment related effect. The suite of trials is continuing into a third year as planned and the results of this study will be submitted when available.

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

Thiamethoxam is registered in Canada for seed treatment uses although this specific seed treatment formulation is neither registered nor is it planned to be registered in Canada in the future. [The study 'Two field trials to determine the effects of HELIX seed treatement on honeybees foraging on canola flowers' is attached to this IR as support/rationale. This study was done in Alberta, Canada to determine the effects of HELIX seed treatment on honeybees foraging on canola flowers. The study was done following typical bee management practices in Canada. The bees were not affected by foraging on canola flowers grown from seed treated with HELIX liquid seed treatment. All exposed hives thrived and grew during this study. There were no observable on bee foraging activity, no evidence of repellency, loss of co-ordination or disorientation. There was no apparent effect on brood pattern or egg laying. The bees from all hives in the exposed groups were observed actively foraging in the HELIX-treated canola. Bee mortality was low and not related to the treatment. ]