Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6300

2. Registrant Information.

Registrant Reference Number: 3095444

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.

23-OCT-21

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)

---

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

Product Name: DRIONE INSECTICIDE POWDER

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

---

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: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Insomnia

• Skin
  • Symptom - Tingling 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.

Yes

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

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?

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

12. Time between exposure and onset of symptoms.

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

10/23/2021 Caller rents an apartment that is infested with bed bugs. The building was treated on 10/18/2021, and he left his apartment as directed. When he returned home, there was a white powder on his furniture and bed. When he is in bed he develops an intense tingling sensation on his legs, arms, and torso that is making it hard for him to sleep. He saw his doctor a couple of days prior to the call, and was told he was reacting to something in the product and it should be removed. He was also told not to stay at his apartment until the product was removed. The pest control company came to remove the product with a cloth and plain water. He insisted they also vacuum a little. His symptoms have continued. 11/3/2021 Call back from the original caller. Caller has seen his primary care doctor three times. No tests have been performed. He has been prescribed an unspecified skin medication. When has has the tingling, he cannot sleep. Caller is now staying in a hotel. Since staying at the hotel, his symptoms have resolved. They redevelop when he enters back into the apartment. Caller is still working to have someone come to clean the product.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

A temporal relationship exists between the exposure and onset of symptoms. The active ingredient, pyrethrin, has been known to cause a temporary paraesthesia reaction that some individuals describe as a tingling sensation. He has been evaluated by a physician and reported the physician feels the product may be contributing to his symptoms. The patient's symptoms resolve when he is away from the areas treated with the product and upon re-challenge the symptoms re-occur.