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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1929

2. Registrant Information.

Registrant Reference Number: M-05-07-26

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.

07-MAY-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

18-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: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Headache
    • Specify - severe migraines
  • Gastrointestinal System
    • Symptom - Stomach cramps
  • Respiratory System
    • Symptom - Difficulty Breathing
    • Specify - severe breathing

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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.)

He has had severe migraines, diarrhea, stomach cramps, severe breathing problems following April 18th (7 AM) treatment. Went to the doctor on 20th and was treated for cold symptoms with Prednisone and the symptoms subsided over time. However, symptoms returned again nearly immediately on April 30th (7AM) starting with a severe headache even before he got out of bed. In both treatments, he had left his windows open. He lives near the area where the drift from the Long Ranger may have reach him. On Saturday, May 2nd he was sprayed again and was again really affected on Sunday. All day he had severe stomach pains and diarrhea. He is taking liquid Advil for his headache

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

PREVIOUS HEALTH CONDITION: he is on long term disability because of a toxic exposure to Hydrogen Sulfide gas. He suffered severe damage to his mucosa, had edema, cant sweat, and is now extremely sensitive to airborne irritants