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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2458

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16007207

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: N1G4Z3

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

Domestic Animal

4. Date registrant was first informed of the incident.

10-APR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

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.       PMRA Submission No.       EPA Registration No.

Product Name: seed treatment nematicide

  • Active Ingredient(s)
    • ABAMECTIN

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

Product Name: Cruiser seed treatment insecticide

  • Active Ingredient(s)
    • THIAMETHOXAM

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

Product Name: CST seed-delivered fungicide

  • Active Ingredient(s)
    • AZOXYSTROBIN
    • FLUDIOXONIL

7. b) Type of formulation.

Other (specify)

Treated cotton seed (the active ingredients used to treat the seeds are liquids)

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: Cotton Seed

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

AVICTA Complete Pak is a promotional combination of three separately registered products: AVICTA seed treatment nematicide (Abamectin), Cruiser seed treatment insecticide (Thiamethoxam), and Dynasty CST seed-delivered fungicide (Azoxystrobin, Fludioxonil, and Mefenoxam). The combination had been used to treat cotton seed.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Unknown

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Respiratory System
    • Symptom - Pulmonary edema
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Unspecified neurological signs
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

specify There was no witnessed exposure, but the cattle had access to the treated seed and it was presumed they ingested it

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-16007207: The reporter contacted the registrant on 4/10/08. A farmer had emptied out his cotton planter, which had been filled with about 100 lbs of last year's unused treated cotton seed. The seed had been treated with a product containing the active ingredients Abamectin, Thiamethoxam, Azoxystrobin, Fludioxonil, and Mefenoxam. About 1 week later, 2 of his 18 cattle had died. All showed clinical signs of pulmonary edema and unspecified neurological signs. The attending veterinarian believed the symptoms indicated poisoning but could not find any toxic plants or other obvious causes. While there was no witnessed exposure, the cattle had access to the unused treated seed and it was presumed they ingested it. The active ingredients of the seed treatment were discussed with the attending veterinarian, who felt that the neurological signs he was seeing were consistent with an overdose of Ivermectin (an analogue of Abamectin). A recommendation was made to the veterinarian that the state Department of Agriculture should be contacted before considering any sale or use of the rest of the cattle in the herd.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Avicta ST is not registered or sold in Canada and abamectin is not registered as a seed treatment in Canada

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Unknown

4. Number of animals affected

16

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Respiratory System
    • Symptom - Pulmonary edema
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - unspecified neurological signs

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

specify There was no witnessed exposure, but the cattle had access to the treated seed and it was presumed they ingested it.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-16007207: The reporter contacted the registrant on 4/10/08. A farmer had emptied out his cotton planter, which had been filled with about 100 lbs of last year's unused treated cotton seed. The seed had been treated with a product containing the active ingredients Abamectin, Thiamethoxam, Azoxystrobin, Fludioxonil, and Mefenoxam. About 1 week later, 2 of his 18 cattle had died. All showed clinical signs of pulmonary edema and unspecified neurological signs. The attending veterinarian believed the symptoms indicated poisoning but could not find any toxic plants or other obvious causes. While there was no witnessed exposure, the cattle had access to the unused treated seed and it was presumed they ingested it. The active ingredients of the seed treatment were discussed with the attending veterinarian, who felt that the neurological signs he was seeing were consistent with an overdose of Ivermectin (an analogue of Abamectin). A recommendation was made to the veterinarian that the state Department of Agriculture should be contacted before considering any sale or use of the rest of the cattle in the herd.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here