Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2463

2. Registrant Information.

Registrant Reference Number: Foray 48B Incident 06-07-2024

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.

05-JUN-24

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

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. 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: Male

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Headache

• General
  • Symptom - Fatigue

• Respiratory System
  • Symptom - Respiratory congestion
  • Symptom - Sore throat

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?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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)

Unknown

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: [Name] [Email] Residence: [Address], Canada; 2.6 km east from spray block boundary. Were you indoors with doors / windows shut during the first treatment? Indoors, windows open, but were out in the community (town of [Town] a further east and north of residence) by 8am. Symptoms: My perfectly healthy family, within 1 day of the first spray, exhibited the following symptoms: cough, nausea, headache, fatigue, congestion, and sore throat. The hardest hit was ill for 2 weeks, and my healthiest, who never gets sick, was out for 4 days. Did symptoms show up after the 2nd and 3rd treatments? One person's symptoms showed up after 1st treatment. Other family members symptoms showed up after 2nd treatment. No members affected after 3rd treatment. Approximate ages of individuals in family and if all had the same symptoms. Mid teens, pre teens, 40s and 50s. All had same symptoms, to varying degrees. Known sensitivities or allergies. Only known allergies for hardest hit member - hay fever. No known allergies for any others How quickly did symptoms resolve? Hardest hit member was sick for 3 weeks, with a lingering cough still today. Other members symptoms resolved within 5-7 days, again, with a cough lingering longest.

To be determined by Registrant

14. Severity classification.

Moderate

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Headache

• General
  • Symptom - Fatigue

• Respiratory System
  • Symptom - Respiratory congestion
  • Symptom - Sore throat

4. How long did the symptoms last?

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

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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)

Unknown

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: [Name] [Email] Residence: [Address], Canada; 2.6 km east from spray block boundary. Were you indoors with doors / windows shut during the first treatment? Indoors, windows open, but were out in the community (town of [Town] a further east and north of residence) by 8am. Symptoms: My perfectly healthy family, within 1 day of the first spray, exhibited the following symptoms: cough, nausea, headache, fatigue, congestion, and sore throat. The hardest hit was ill for 2 weeks, and my healthiest, who never gets sick, was out for 4 days. Did symptoms show up after the 2nd and 3rd treatments? One person's symptoms showed up after 1st treatment. Other family members symptoms showed up after 2nd treatment. No members affected after 3rd treatment. Approximate ages of individuals in family and if all had the same symptoms. Mid teens, pre teens, 40s and 50s. All had same symptoms, to varying degrees. Known sensitivities or allergies. Only known allergies for hardest hit member - hay fever. No known allergies for any others How quickly did symptoms resolve? Hardest hit member was sick for 3 weeks, with a lingering cough still today. Other members symptoms resolved within 5-7 days, again, with a cough lingering longest.

To be determined by Registrant

14. Severity classification.

Moderate

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: Unknown

Age: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Headache

• General
  • Symptom - Fatigue

• Respiratory System
  • Symptom - Respiratory congestion
  • Symptom - Sore throat

4. How long did the symptoms last?

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

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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)

Unknown

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: [Name] [Email] Residence: [Address], Canada; 2.6 km east from spray block boundary. Were you indoors with doors / windows shut during the first treatment? Indoors, windows open, but were out in the community (town of [Town] a further east and north of residence) by 8am. Symptoms: My perfectly healthy family, within 1 day of the first spray, exhibited the following symptoms: cough, nausea, headache, fatigue, congestion, and sore throat. The hardest hit was ill for 2 weeks, and my healthiest, who never gets sick, was out for 4 days. Did symptoms show up after the 2nd and 3rd treatments? One person's symptoms showed up after 1st treatment. Other family members symptoms showed up after 2nd treatment. No members affected after 3rd treatment. Approximate ages of individuals in family and if all had the same symptoms.Mid teens, pre teens, 40s and 50s. All had same symptoms, to varying degrees. Known sensitivities or allergies. Only known allergies for hardest hit member - hay fever. No known allergies for any others How quickly did symptoms resolve? Hardest hit member was sick for 3 weeks, with a lingering cough still today. Other members symptoms resolved within 5-7 days, again, with a cough lingering longest.

To be determined by Registrant

14. Severity classification.

Moderate

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: Unknown

Age: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Headache

• General
  • Symptom - Fatigue

• Respiratory System
  • Symptom - Respiratory congestion
  • Symptom - Sore throat

4. How long did the symptoms last?

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

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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)

Unknown

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: [Name] [Email] Residence: [Address], Canada; 2.6 km east from spray block boundary. Were you indoors with doors / windows shut during the first treatment? Indoors, windows open, but were out in the community (town of [Town] a further east and north of residence) by 8am. Symptoms: My perfectly healthy family, within 1 day of the first spray, exhibited the following symptoms: cough, nausea, headache, fatigue, congestion, and sore throat. The hardest hit was ill for 2 weeks, and my healthiest, who never gets sick, was out for 4 days. Did symptoms show up after the 2nd and 3rd treatments? One person's symptoms showed up after 1st treatment. Other family members symptoms showed up after 2nd treatment. No members affected after 3rd treatment. Approximate ages of individuals in family and if all had the same symptoms.Mid teens, pre teens, 40s and 50s. All had same symptoms, to varying degrees. Known sensitivities or allergies. Only known allergies for hardest hit member - hay fever. No known allergies for any others How quickly did symptoms resolve? Hardest hit member was sick for 3 weeks, with a lingering cough still today. Other members symptoms resolved within 5-7 days, again, with a cough lingering longest.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.