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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2300

2. Registrant Information.

Registrant Reference Number: Foray 48B Incident 05-10-2024

Registrant Name (Full Legal Name no abbreviations): Valent BioSciences LLC

Address: 1910 Innovation Way

City: Libertyville

Prov / State: IL

Country: USA

Postal Code: 60048

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

Human

4. Date registrant was first informed of the incident.

30-MAY-24

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

10-MAY-24

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. 24977      PMRA Submission No.       EPA Registration No.

Product Name: Foray 48B Biological Insecticide Aqueous Suspension

  • Active Ingredient(s)
    • BACILLUS THURINGIENSIS SUBSPECIES KURSTAKI (ALL STRAINS)

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: L/ha

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

Site: Pub. Area - Outdoor/Zone publique - ext

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?

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Headache
  • Respiratory System
    • Symptom - Sore throat
  • Gastrointestinal System
    • Symptom - Stomach pain

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?

7. Exposure scenario

Non-occupational

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

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?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

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

1. When did the symptoms first occur and how long did they last? Both times about 3 - 5 hours later (headache and sore throat). The upset stomach happened a day or two later. 2.How did exposure occur a was she indoors with doors and windows closed? The first time (May 10) she was in the house but had one window open. The second time (May 23) she had her windows open because the spraying happened on a day without any notice. She closed them once she heard the plane but she went outside a few hours after the spraying to water a hanging basket. The symptoms lasted a few days but her stomach is still not well.3. Does she have any known allergies or sensitivities to airborne particulates or odors? The only allergy she has ever had was to ragweed when she was younger and lived in Ontario.4. What is her current health status? Physically very healthy according to her latest round of blood work.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.