Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-5438

2. Registrant Information.

Registrant Reference Number: CA201501196

Registrant Name (Full Legal Name no abbreviations): Novartis Animal Health Canada Inc.

Address: 2000 Argentia Rd, Suite 400, Plaza 3

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 1V9

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

Domestic Animal

4. Date registrant was first informed of the incident.

27-AUG-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

20-AUG-15

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)

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PMRA Registration No. 30336      PMRA Submission No.       EPA Registration No.

Product Name: Agita 10WG Commercial Soluble Granules

• Active Ingredient(s)
  • (Z)-9-TRICOSENE
  • THIAMETHOXAM

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1250

Units: g/L

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

Site: Agricultural-Indoor / Agricole-intérieur

Préciser le type: Poultry House

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

The diluted product was applied to the walls but also on the egg carrying belt, which is off label.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Bird - Poultry / Oiseau - Volaille

3. Breed

unknown

4. Number of animals affected

4000

5. Sex

Unknown

6. Age (provide a range if necessary )

0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Reproductive System
  • Symptom - Other
  • Specify - Reduced Eggs Hatchability

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On 27 Aug 2015, the company representative contacted the call center regarding a reproduction issue in layer hens in a poultry house following application of thiamethoxam commercial wettable granules (Agita 10 WG-125g/L). A verbal history was obtained. The poultry house, housed 8000* layer hens. On 1 Aug 2015, a farm employee prepared the suspect product per label recommended dilution to be sprayed in the premises for the control of flies:125gm/100ml. The prepared solution was sprayed on the walls as well as on the egg carrying belt. Following application, the carrying belt became sticky and the employee persisted in rinsing the belt for 4 days. On 20 Aug 2015, 21 days after application of the product, a 50% drop in hatching was noted, which was not a usual occurrence at that site. The age of the dead embryos was between 12 to 16 days to expected hatching. The problem persisted for the next 4 days, until 23 Aug 2015. Embryos from affected eggs were sent to the laboratory for testing. The attending veterinarian presumed that the pesticide may have been absorbed through the egg shells and caused the death of the embryos. At the time of completing this report the laboratory results were pending. The company will file additional information when provided.

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To be determined by Registrant

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

Major

19. Provide supplemental information here

Assessment: Timing possible. Not fitting pharmacodynamics. All other possible causes not ruled out. Laboratory results may be helpful. Inconclusive.(01)