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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0405

2. Registrant Information.

Registrant Reference Number: 1193-68031

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection Canada, Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G 4Z3

3. Select the appropriate subform(s) for the incident.

Residues in Food

4. Date registrant was first informed of the incident.

01-JUN-09

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

Unknown

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. 26153      PMRA Submission No.       EPA Registration No.

Product Name: Quadris

  • Active Ingredient(s)
    • AZOXYSTROBIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Potato

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Method of application is unknown. Suspected off-label use.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform V: Residues in Food

1. Pesticide(s) and degradate(s) analysed for

Azoxystrobin

2. Concentration of pesticide/degradate in food

.777

Units ppm

3. Corresponding limit of detection

.001

Units ppm

4. Sample Type

Raw Agricultural commodity

5. Method of analysis (include if a confirmatory method was used in addition to the screening method)

US FDA did the analysis using standard methodology.

Sample Information

6. What is the reason the sample was collected (e.g. complaint, inspection, process monitoring)?

Routine inspection at US border

7. What organization collected the sample?

Other

8. From what point in the distribution channel was the sample taken?

In Transit

9. How large was the food commodity from which the sample was taken?

120 BG

10. How many samples were taken?

Unknown

11. How large was the sample size?

Unknown

12. What action was taken based on the violative residue?

Unknown

For Registrant use only

14. Provide supplemental information here

On June 01, 2009 Syngenta was advised by a potato shipper of a report that they had received from the FDA indicating residues of azoxystrobin above the US tolerance on yellow potatoes sourced from a grower in their area (US and CDN MRLs both 0.03 ppm). The potatoes were sampled at US customs. Syngenta US had to request the analytical results from the US FDA under the Freedom of Information Act in the US. The FDA report (received by Syngenta Canada on July 7/09) indicated a residue of azoxystrobin of 0.777 ppm. Given the level of residues reported, it is suspected that off-label applications of azoxystrobin were made to the potatoes.