Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-2510

2. Registrant Information.

Registrant Reference Number: CA2018_000558

Registrant Name (Full Legal Name no abbreviations): Elanco Canada Ltd

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G 4T2

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

Human

4. Date registrant was first informed of the incident.

14-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-MAY-18

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 10 WG 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.

Unknown

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

Site: Other / Autre

Préciser le type: Five barns were sprayed with the product

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 II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Nasal congestion

• Cardiovascular System
  • Symptom - Chest tightness

4. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Work within the barn

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Approximately one hour after being in a ventilated barn sprayed with Agita, a pregnant female human, experienced chest tightness and stuffy nose. At the time of reporting, approximately three hours after exposure, the patient reported the signs had subsided; no treatment had been initiated.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.