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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6008

2. Registrant Information.

Registrant Reference Number: PROSAR Case # 1-24614220

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.

04-NOV-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

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. 100-1321

Product Name: Avicta Duo Cotton

  • Active Ingredient(s)
    • ABAMECTIN
      • Guarantee/concentration 12.4 %
    • THIAMETHOXAM
      • Guarantee/concentration 28.1 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 100-1177

Product Name: Dynasty CST

  • Active Ingredient(s)
    • AZOXYSTROBIN
      • Guarantee/concentration 6.64 %
    • FLUDIOXONIL
      • Guarantee/concentration 1.11 %
    • METALAXYL-M (MEFENOXAM)
      • Guarantee/concentration 3.32 %

7. b) Type of formulation.

Other (specify)

treated seed

Application Information

8. Product was applied?

No

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 III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

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

1-24614220- The reporter, a veterinarian, indicates exposure of four patients to cotton seed treated with the active ingredients abamectin, thiamethoxam, azoxystrobin, fludioxonil and mefenoxam. The caller reports three Angus cattle (Subform III, #2) have presented to him with the primary complaint of ataxia. He indicated the animals had possibly eaten an unknown amount of the product within the past 24-48 hours. He reported that one (or more) animal was dead on the farm (Subform III, #1). It was unknown when or how the animal died. No exposure was observed. On presentation the veterinarian had incomplete product identification information, it was impossible for the registrant to determine the active ingredient or product involved with the information provided. It was recommended the veterinarian obtain a more thorough history and product identification information and contact the registrant back for specific recommendations. The veterinarian was advised generally treated seed has a low potential for harm when ingested by livestock. It is quite often the grain or seed itself rather than the treatments that can be problematic. The veterinarian did not further contact the registrant. In this circumstance cottonseed has the potential to impart gossypol toxicity irrespective of any seed treatment. On routine follow up the veterinarian indicated two of the three animals had spontaneously resolved and one remained ataxic. He did not provide further information. At a later date it was discovered the producer/farmer had also contacted the registrant in a different department. He had indicated a bag of the product had been unwittingly dropped in the field while being transported. It was accessible to the animals, but no ingestion was observed. One animal had died but it was dead for several days at the point at which it had been discovered, cause of death is unknown. The owner indicated the dead animal may not have ingested the product. Three animals were observed staggering and brought to the veterinarian. The veterinarian emptied their stomachs and did find cotton seed in the contents. The producer had contacted the registrant the day following their treatment with the veterinarian and he reported they were eating and seemed OK?. No further information is available


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

angus

4. Number of animals affected

3

5. Sex

Female

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

  • Nervous and Muscular Systems
    • Symptom - Ataxia

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

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

1-24614220- The reporter, a veterinarian, indicates exposure of four patients to cotton seed treated with the active ingredients abamectin, thiamethoxam, azoxystrobin, fludioxonil and mefenoxam. The caller reports three Angus cattle (Subform III, #2) have presented to him with the primary complaint of ataxia. He indicated the animals had possibly eaten an unknown amount of the product within the past 24-48 hours. He reported that one (or more) animal was dead on the farm (Subform III, #1). It was unknown when or how the animal died. No exposure was observed. On presentation the veterinarian had incomplete product identification information, it was impossible for the registrant to determine the active ingredient or product involved with the information provided. It was recommended the veterinarian obtain a more thorough history and product identification information and contact the registrant back for specific recommendations. The veterinarian was advised generally treated seed has a low potential for harm when ingested by livestock. It is quite often the grain or seed itself rather than the treatments that can be problematic. The veterinarian did not further contact the registrant. In this circumstance cottonseed has the potential to impart gossypol toxicity irrespective of any seed treatment. On routine follow up the veterinarian indicated two of the three animals had spontaneously resolved and one remained ataxic. He did not provide further information. At a later date it was discovered the producer/farmer had also contacted the registrant in a different department. He had indicated a bag of the product had been unwittingly dropped in the field while being transported. It was accessible to the animals, but no ingestion was observed. One animal had died but it was dead for several days at the point at which it had been discovered, cause of death is unknown. The owner indicated the dead animal may not have ingested the product. Three animals were observed staggering and brought to the veterinarian. The veterinarian emptied their stomachs and did find cotton seed in the contents. The producer had contacted the registrant the day following their treatment with the veterinarian and he reported they were eating and seemed OK. No further information is available


To be determined by Registrant

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

Moderate

19. Provide supplemental information here