Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-1846
2. Registrant Information.
Registrant Reference Number: M-04-18-13
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.
01-MAY-15
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
01-MAY-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).
Helicopter
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: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- Nervous and Muscular Systems
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.
>30 min <=2 hrs / >30 min <=2 h
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.)
Had severe headache like having a football helmet on that was two sizes too small. Headache started within an hour after spray. Rated 8 out of 10 for pain. Still having pain after being treated on Tuesday at 5 AM. Saw doctor at Walk-in clinic (referred to it as a 3rd tier private medical clinic) and was sent for blood tests (complaining about the long line ups). Dr told him to drink lots of water.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.
No spraying had taken place that day or over the proceeding weekend.