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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-1932
2. Registrant Information.
Registrant Reference Number: M-05-12-29
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.
12-MAY-155. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
17-APR-15Product 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.
4Units: 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?
YesSubform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Other
2. Demographic information of data subject
Sex: Male
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- Respiratory System
- Symptom - Asthma
- Symptom - Nasal congestion
4. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
5. Was medical treatment provided? Provide details in question 13.
Yes
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.
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.)
Adverse effects on his asthmatic (age) yr old son and he and his wife. Sons symptoms were severe sinus congestion and asthma, adults symptoms were lethargy and sore throat. They do not have asthma. His son has visited the healthy breathing centre to help him deal with his asthma attack. The childs symptoms occurred shortly after the first spray and have lasted the three weeks of the treatment. He and his wifes symptoms were on the 2nd day of the spray.
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.
Other
2. Demographic information of data subject
Sex: Female
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Sore throat
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)
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.
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.)
Adults symptoms were lethargy and sore throat. He and his wifes symptoms were on the 2nd day of the spray.
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.
Other
2. Demographic information of data subject
Sex: Male
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Sore throat
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)
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.
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.)
Adults symptoms were lethargy and sore throat. He and his wifes symptoms were on the 2nd day of the spray.
To be determined by Registrant
14. Severity classification.
Minor
