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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3073

2. Registrant Information.

Registrant Reference Number: ProPharma Group case #1-43941628

Registrant Name (Full Legal Name no abbreviations): Syngenta 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.

28-APR-16

5. Location of incident.

Country: UNITED STATES

Prov / State: MINNESOTA

6. Date incident was first observed.

28-APR-16

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. Unknown

Product Name: Treated Corn Seed

  • Active Ingredient(s)
    • ABAMECTIN
      • Unknown
    • AZOXYSTROBIN
      • Unknown
    • FLUDIOXONIL
      • Unknown
    • METALAXYL-M (MEFENOXAM)
      • Unknown
    • SEDAXANE
    • THIABENDAZOLE
      • Unknown
    • THIAMETHOXAM
      • Unknown

7. b) Type of formulation.

Other (specify)

Treated corn 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

Sheep / Mouton

3. Breed

Mixed Breed

4. Number of animals affected

2

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

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Specify - Down, unable to get up
    • Symptom - Muscle tremors

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?

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

1-43941628 - The reporter, an animal owner, indicated that his sheep may have been exposed to corn seed treated with the active ingredients thiabendazole, thiamethoxam, mefenoxam, fludioxonil, azoxystrobin, abamectin, and sedaxane. The evening before contact with the registrant, the reporter indicated that two of his female, adult, mixed breed sheep of unknown age and weight accidently ate an unknown amount of the product. On the day of contact with the registrant, the sheep had tremors and were unable to get up. The reporter was advised to get veterinary attention for the sheep and to treat them symptomatically as abamectin toxicity might explain the sheep's symptoms. Multiple follow-up calls were placed to assist the reporter and his veterinarian in treatment of the sheep, but they died somewhere between the day of initial contact and eight days after initial contact. No additional 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

Animal's Owner

2. Type of animal affected

Sheep / Mouton

3. Breed

Mixed Breed

4. Number of animals affected

65

5. Sex

Unknown

6. Age (provide a range if necessary )

0.12

7. Weight (provide a range if necessary )

50

lbs

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 - Muscle tremors
  • Eye
    • Symptom - Other
    • Specify - Buggy eyes
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Opisthotonos
  • 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.

17. Provide any additional details about the incident

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

1-43941628 - The reporter, an animal owner, indicated that his sheep may have been exposed to corn seed treated with the active ingredients thiabendazole, thiamethoxam, mefenoxam, fludioxonil, azoxystrobin, abamectin, and sedaxane. The evening before contact with the registrant, the reporter indicated 65 of his 8-week-old, 50-pound, mixed breed sheep of unknown gender accidently ate an unknown amount of the product. On the day of contact with the registrant, some of the sheep had tremors and were unable to get up; others were dead. The reporter was advised to get veterinary attention for the sheep and to treat them symptomatically as abamectin toxicity might explain the sheep's symptoms. Some of the sheep developed additional symptoms of buggy eyes and opisthotonos. Multiple follow-up calls were placed to assist the reporter and his veterinarian in treatment of the sheep. All died somewhere between the day of initial contact and eight days after initial contact. No additional 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

Animal's Owner

2. Type of animal affected

Sheep / Mouton

3. Breed

Mixed Breed

4. Number of animals affected

2

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 - Muscle tremors
    • Symptom - Difficulty getting up
    • Specify - Down, unable to get up

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

14. a) Was the animal hospitalized?

No

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

1-43941628 - The reporter, an animal owner, indicated that his sheep may have been exposed to corn seed treated with the active ingredients thiabendazole, thiamethoxam, mefenoxam, fludioxonil, azoxystrobin, abamectin, and sedaxane. The evening before contact with the registrant, the reporter indicated two of his female, adult, mixed breed sheep of unknown age and weight accidently ate an unknown amount of the product. On the day of contact with the registrant, the sheep had tremors and were unable to get up. The reporter was advised to get veterinary attention for the sheep and to treat them symptomatically as abamectin toxicity might explain the sheep's symptoms. Multiple follow-up calls were placed to assist the reporter and his veterinarian in treatment of the sheep. During a follow-up eight days after initial contact, the sheep were doing well. No additional 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