Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-1920
2. Registrant Information.
Registrant Reference Number: F-04-30-21
Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation
Address: 870 Technology Way
City: Libertyville
Prov / State: Illinois
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-APR-15
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
30-APR-15
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
- Active Ingredient(s)
- BACILLUS THURINGIENSIS BERLINER SSP KURSTAKI STRAIN HD-1
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: Forest - Woods / Forêt et boisés
Préciser le type: Aerial
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
Per the applicator the product was aerial sprayed via a helicopter from approximately 100 feet. All sprays take place in the early morning and stop by 7:30 AM.
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 - Fatigue
- Specify - tiredness
- Ear
- Symptom - Tinnitus
- Specify - buzzing in ear
- General
- Symptom - Other
- Specify - debilitated
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)
Other
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.
Skin
Respiratory
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.)
Got really sick on Sat, and Mon and Tuesday. She describes herself as chemically sensitive. She needs to wear a respirator when using home cleaning products. Felt super tired, buzzing in ear, nauseous, debilitated.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.