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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0201

2. Registrant Information.

Registrant Reference Number: CER05501/06

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: Matador 120EC + ALTO 100SL (cyproconazole)

  • Active Ingredient(s)
    • CYHALOTHRIN-LAMBDA

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 Cyproconazole - Residue Levels on Soybeans (Hay and Seed) from Trials Conducted in Canada during 2006

Date 07-NOV-07

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

No

3. Type of incident identified in the study

Presence of a component or derivitive

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 Canada, Inc. is informing the PMRA of preliminary results from the analytical phase report of the residue study, CER05501/06, in progress in Canada. The study is being conducted to provide residue chemistry data for cyproconazole in or on soybeans (hay and seed) after treatment with two applications of ALTO 100SL alone. Residue chemistry data for lambda-cyhalothrin and R157836 in or on soybeans is also being generated after 3 post-emergent applications of MATADOR 120EC insecticide, the first two in TM combination with ALTO 100SL fungicide. This study was suppose to be used to provide residue data for registration of the new AI cyproconazole on soybeans alone and in TM with MATADOR 120EC. Recently, the business priority has changed and Syngenta Canada is not going to pursue the domestic registration of the cyproconazole alone and in the mixture with lambda-cyhalothrin. Based on the results of the analytical phase report, CER05501/06, the detectable residues of the epimer R157836 in soybean seed were found in the analyzed samples from one site, T182, Paris, ON, Zone 5. The residues of epimer R157836 were 0.013 ppm in the sample T182 09 PLOT 4, and 0.015 ppm in the sample T182 10 PLOT5. The residues results from this particular site would be considered above the Canadian MRL of 0.02 ppm (which is the combination of the LOQs of 0.01 ppm for the parent and the epimer) for the lambda-cyhalothrin in soybean seed. No detectable residue of the epimer R157836 were found in any of other tested sites (the residues were below LOD level of 0.0033 ppm). Residue for lambda-cyhalothrin in soybean seed were all ND (below 0.00239 ppm). To confirm the original results, the samples from the site T182 were re-extracted and re-analyzed in duplicates. The residues of epimer R157836 were detected at the level of 0.0082, 0.012 and 0.011 ppm in the re-analyzed samples.

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

Lamda-Cyhalotrhin is registered in Canada for users on Soybeans, however, cyproconazole is not going to be registered in Canada for domestic users on soybeans.