Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-5909

2. Registrant Information.

Registrant Reference Number: 3065920

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

Address: 160 Quarry Park Boulevard SE, Suite 200

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

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

Human

4. Date registrant was first informed of the incident.

18-SEP-21

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

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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PMRA Registration No. 15255      PMRA Submission No.       EPA Registration No.

Product Name: DRIONE INSECTICIDE POWDER

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS
  • SILICA AEROGEL

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

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Burning eye

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Insomnia

• Respiratory System
  • Symptom - Respiratory congestion
  • Symptom - Shortness of breath

• Skin
  • Symptom - Burning skin

• Respiratory System
  • Symptom - Difficulty Breathing

• Eye
  • Symptom - Irritated eye

• Respiratory System
  • Symptom - Nasal congestion

• Skin
  • Symptom - Irritated skin

4. How long did the symptoms last?

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

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

No

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)

Other

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.

Unknown

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

9/18/2021 Caller reports that a pest control company sprayed the product in her apartment for the first time on 8/24/2021 and again on 9/13/2021. They closed all the windows and doors so the apartment wasn't ventilated. Caller has been having trouble breathing, trouble sleeping, nasal congestion, a burning sensation on her skin, and a burning sensation in her eyes. Caller has been taking Wellbutrin and Ativan that were previously prescribed to her. Her symptoms are ongoing at this time. Caller was talking in full and complete sentences. 9/24/2021 Call back to the original caller for follow up. Her symptoms resolved on their own on approximately 9/19/2021.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

It is unclear when the symptoms started in regards to the possible exposures to the products. While dermal exposure to pyrethroids in high enough concentrations can cause a burning sensation on the skin the patient was using Wellbutrin and Ativan to treat her symptoms and she has underlying anxiety so it is likely she thought her anxiety was causing or contributing to her symptoms as well. She also has a history of trouble sleeping, sensitivity to chemical smells and fibromyalgia all of which could contribute to her symptoms. Finally, it is important to note she reported the use of six other products. Her symptoms did abate 6 days after the last product use and re-challenge has not been attempted at the time of the call.