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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2129

2. Registrant Information.

Registrant Reference Number: Foray 48B Incident 05-13-2024 - 1

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.

23-MAY-24

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

03-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: Unknown

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Insomnia
    • Specify - Sleep problems
  • Skin
    • Symptom - Inflammation of the skin
  • Respiratory System
    • Symptom - Irritated throat

4. How long did the symptoms last?

Unknown / Inconnu

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

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.

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.)

On May 3rd, severe sleep problems started. Missed several days of work (7-9 days). May 4th left upper eyelid inflamed. Throat irritation. Exposure: Indoors during spray; outdoors between 9-10 am, May 2nd dropping off son 1 km from spray area. Lives at [Intersection] which is 2.5km from either [Location] or [Location] spray blocks. Last year's spray had sleep disturbances but can't remember having other symptoms. Sensitive to gluten and dairy, endocrine disruptors.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.