Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2024-2133
2. Registrant Information.
Registrant Reference Number: Foray 48B Incident 05-15-2024
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
Domestic Animal
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.
11-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: Male
Age: >12 <=19 yrs / >12 <=19 ans
3. List all symptoms, using the selections below.
System
- Nervous and Muscular Systems
- Respiratory System
- Symptom - Sore throat
- Symptom - Stuffy nose
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.)
Dog (Doberman, 8 yrs.) stopped eating, on Saturday following spray May 10. Eats grass and sticks, etc. Still drinking but vomited several times Sat through Monday. Good now. Dog was in backyard after the spray. Children: [age]- son woke up fine, by 8:15 wasn't feeling good - allergy symptoms - headache, sore throat, still stuffy, no allergies, other [age] son, day later, felt unwell, slept 14 hours, missed school, feeling fine now. No cold symptoms. Mother; stuffed up nose; left area for work during day. Husband - exhausted. He and kids are in spray area all day. Windows were closed. Went outside immediately after spray. [Age] old parents.
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: Male
Age: >12 <=19 yrs / >12 <=19 ans
3. List all symptoms, using the selections below.
System
- General
- Symptom - Discomfort
- Symptom - Malaise
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)
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.)
Dog (Doberman, 8 yrs.) stopped eating, on Saturday following spray May 10. Eats grass and sticks, etc. Still drinking but vomited several times Sat through Monday. Good now. Dog was in backyard after the spray. Children: [age]- son woke up fine, by 8:15 wasn't feeling good - allergy symptoms - headache, sore throat, still stuffy, no allergies, other [age] son, day later, felt unwell, slept 14 hours, missed school, feeling fine now. No cold symptoms. Mother; stuffed up nose; left area for work during day. Husband - exhausted. He and kids are in spray area all day. Windows were closed. Went outside immediately after spray. [Age] old parents.
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: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
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
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.)
Dog (Doberman, 8 yrs.) stopped eating, on Saturday following spray May 10. Eats grass and sticks, etc. Still drinking but vomited several times Sat through Monday. Good now. Dog was in backyard after the spray. Children: [age]- son woke up fine, by 8:15 wasn't feeling good - allergy symptoms - headache, sore throat, still stuffy, no allergies, other [age] son, day later, felt unwell, slept 14 hours, missed school, feeling fine now. No cold symptoms. Mother; stuffed up nose; left area for work during day. Husband - exhausted. He and kids are in spray area all day. Windows were closed. Went outside immediately after spray. [Age] old parents.
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: Male
Age: >19 <=64 yrs / >19 <=64 ans
3. List all symptoms, using the selections below.
System
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
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.)
Dog (Doberman, 8 yrs.) stopped eating, on Saturday following spray May 10. Eats grass and sticks, etc. Still drinking but vomited several times Sat through Monday. Good now. Dog was in backyard after the spray. Children: [age]- son woke up fine, by 8:15 wasn't feeling good - allergy symptoms - headache, sore throat, still stuffy, no allergies, other [age] son, day later, felt unwell, slept 14 hours, missed school, feeling fine now. No cold symptoms. Mother; stuffed up nose; left area for work during day. Husband - exhausted. He and kids are in spray area all day. Windows were closed. Went outside immediately after spray. [Age] old parents.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Doberman
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Anorexia
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Spray drift / Dérive de pulvérisation
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Dog (Doberman, 8 yrs.) stopped eating, on Saturday following spray May 10. Eats grass and sticks, etc. Still drinking but vomited several times Sat through Monday. Good now. Dog was in backyard after the spray. Children: [age]- son woke up fine, by 8:15 wasn't feeling good - allergy symptoms - headache, sore throat, still stuffy, no allergies, other [age] son, day later, felt unwell, slept 14 hours, missed school, feeling fine now. No cold symptoms. Mother; stuffed up nose; left area for work during day. Husband - exhausted. He and kids are in spray area all day. Windows were closed. Went outside immediately after spray. [Age] old parents.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here