Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5520

2. Registrant Information.

Registrant Reference Number: CAN-ZZELANCO-CA2023_001311

Registrant Name (Full Legal Name no abbreviations): Elanco

Address: 1919 Minnesota Court, Suite 401

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L5N 0C9

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

Domestic Animal

4. Date registrant was first informed of the incident.

04-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

04-JUL-23

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. 25674      PMRA Submission No.       EPA Registration No.

Product Name: Cylence 1%

• Active Ingredient(s)
  • CYFLUTHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: %

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

Site: Animal / Usage sur un animal domestique

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

On 4 Jul 2023 Elanco was made aware of a possible adverse effect of CyLence Pour on Insecticide (Cyfluthrin) in a herd. On 4 Jul 2023 the producer administered 16 ml of CyLence to each of the 35 cows (misuse type: overdose: maximum dose is 12 ml per cow).

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

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Holstein

4. Number of animals affected

35

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Other
  • Specify - Annoyed

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Wiggling and swishing tails more than usual

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

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

Later on 4 Jul 2023, the producer noted the 35 Holstein dairy cows were annoyed as evidenced by them wiggling and swishing their tails more than usual (agitation). On 5 Jul 2023 the producer reported the cows had returned to normal.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here