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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1957

2. Registrant Information.

Registrant Reference Number: Foray 48B Incident 05-06-2024

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.

07-MAY-24

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

06-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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Pain
    • Symptom - Metallic taste in the mouth
  • Respiratory System
    • Symptom - Stuffy nose
    • Symptom - Sore throat
  • Nervous and Muscular Systems
    • Symptom - Headache

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)

Drift from the application site

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.)

[Name] [Phone number][Road], North end of [Lake] on [Island], BCShe lives 2.6 km away from the treatment boundary down wind. Sore throat, slight headache, metallic taste in mouth and stuffy nose, all occurred around 15 minutes after spraying was completed.Called and she says she felt the symptoms come on within 15 minutes of the treatment beginning. She has seasonal allergies although is not suffering from them at the moment. She describes herself as chemically sensitive. Three hours later she said her throat was still a bit sore but getting better.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

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

  • General
    • Symptom - Pain
  • Respiratory System
    • Symptom - Respiratory irritation
  • General
    • Symptom - Fatigue
    • Symptom - Flu-like symptoms
  • Nervous and Muscular Systems
    • Symptom - Headache
  • Respiratory System
    • Symptom - Other
    • Specify - Upper respiratory discomfort
  • General
    • Symptom - Lethargy

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)

Drift from the application site

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.)

[Phoen number][Name][Address]Woman on [Island], BC Headaches all day and upper respiratory discomfort. Extremely tired and feels like she may be getting a flu.Talked to her and she was appreciative of the information provided. She lives 4.6 km N and slightly West of the spray block and says she woke up with a headache and lethargy and wasnat aware of the treatment until looking on the Salt Spring Exchange website (where all SSIs get their local news, apparently). She drove through the area at 8 AM and went to work and had a headache all day, came home and slept for 11 hours. 27 hours later, her condition is ok with only a slight headache feeling.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.