Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-0376

2. Registrant Information.

Registrant Reference Number: 2450075

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 QUARRY PARK BLVD. SE Suite 200

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

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

Human

Domestic Animal

4. Date registrant was first informed of the incident.

28-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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)

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PMRA Registration No. 32524      PMRA Submission No.       EPA Registration No.

Product Name: TEMPRID SC INSECTICIDE

• Active Ingredient(s)
  • BETA-CYFLUTHRIN
  • IMIDACLOPRID

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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: Res. - In Home / Rés. - à l'int. maison

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Yes

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Ear
  • Symptom - Tinnitus

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

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

Contact with treated area

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

5/28/2019 Caller reports that her sofa was soaked with what she believes was the product by a pest control professional in July 2018 in a cottage. At that time, her dog seemed to be dropping its head downwards, but this seemed to resolve without intervention. For the following several months, caller sat on the dry sofa with bare arms and legs. Caller returned to the cottage in April 2019, and found that the damp air had dampened the sofa. For about the past 6 months, caller has had ringing in her ears.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Direct exposure to this herbicide is not evident in this incident. The delayed onset of the patient symptoms after application is not suggestive of toxicity nor would they be expected symptoms should contact to airborne spray have occurred. Usually complications such as immediate onset of acute eye, skin and respiratory irritation may be seen following exposure to spray drift but these symptoms were not reported in this incident. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

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 - Subdued

• Nervous and Muscular Systems
  • Symptom - Abnormal posture
  • Specify - dropping head downward

12. How long did the symptoms last?

Unknown / Inconnu

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?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

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

5/28/2019 Caller reports that her sofa was soaked with what she believes was the product by a pest control professional in July 2018 in a cottage. At that time, her dog seemed to be dropping its head downwards, but this seemed to resolve without intervention. For the following several months, caller sat on the dry sofa with bare arms and legs. Caller returned to the cottage in April 2019, and found that the damp air had dampened the sofa. For about the past 6 months, caller has had ringing in her ears.

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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