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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1931

2. Registrant Information.

Registrant Reference Number: M-05-02-20

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-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

12-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).

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

  • Skin
    • Symptom - Itchy skin
  • Respiratory System
    • Symptom - Coughing
  • Skin
    • Symptom - Irritated skin
  • Respiratory System
    • Symptom - Wheezing

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)

Application

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

Firstly for background, I do have many allergies (mainly environmental) and asthma which I'm sure is relevant, although when I am healthy, I very seldom am affected by asthma.I was unaware of the first round of spraying at the time, but was outside on my upstairs deck. I was sitting with my back facing southwestbound in a muskoka chair. The helicopter approached from that direction on a northeastbound line and by the time I stood up and turned around to see, it was overhead. I was sprayed (more like misted) directly as it overflew. Almost immediately (before I walked the 12 feet to re-enter the house) I began coughing. I am no stranger to coughing (asthma allegies), but this was a very hard, uncontrollable, cough that was actually a little bit scary (especially because I did not know about the spraying occurring). The coughing fit lasted the better part of five minutes, much of it bouts of coughing that led to gagging and dry heaves. I also found that my arms (which were bare) were quite itchy and irritated very quickly. I showered and continued with my day, but the lung irritation and arm itching were persistent and lasted until bedtime that night. I was coughing and wheezing for the full day. I have not had an asthma episode without relief from a rescue inhaler, and although the symptoms were similar, the inhaler did nothing to relieve my discomfort (leading me to believe that asthma was not the culprit, besides the fact that an asthma attack out of the blue when I am healthy, as I was at the time, is very out of character).

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.