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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4303

2. Registrant Information.

Registrant Reference Number: F-05-13-6

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.

11-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

13-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

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.

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Coughing
  • Nervous and Muscular Systems
    • Symptom - Anxiety
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Anal discharge
  • Respiratory System
    • Symptom - Bronchitis

4. How long did the symptoms last?

Unknown / Inconnu

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)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

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.)

History of chronic bronchitis and PTSD. Smokes marijuana for medicinal purposes. Reporting Anxiety, coughing black phlegm, anal discharge and bronchitis. Saw physician. Taking: Dexpedrine, Flovent HSA, Biaxin, Marijuana, Salbutamol HSA. Exposure 3-4 weeks ago.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.