Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1853

2. Registrant Information.

Registrant Reference Number: W-04-15-7

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.

18-APR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

17-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)

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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

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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).

Aerial sprayed via a 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: Female

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

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Headache

• Respiratory System
  • Symptom - Coughing
  • Symptom - Nasal congestion

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.)

Sprayed this morning. Has two small children who were looking out an open window during the spray. Awoke to sound of R/W. Children now have runny nose and coughing. Had to leave the house and get away from the area. Was sprayed Friday morning. She slept with bedroom window open. Opened front door to see what was happening. She had a headache from the day before, a sore throat and congested. Left area and went to (location) for fresh air and symptoms cleared up. Today, headache and congestion returned. Her (age) old son has a plugged nose and is coughing. Other child already had a plugged nose before treatment started.

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

• Respiratory System
  • Symptom - Runny nose
  • Symptom - Coughing
  • Symptom - Nasal congestion
  • Specify - plugged nose

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.)

Sprayed this morning. Has two small children who were looking out an open window during the spray. Awoke to sound of R/W. Children now have runny nose and coughing. Had to leave the house and get away from the area. Was sprayed Friday morning. She slept with bedroom window open. Opened front door to see what was happening. She had a headache from the day before, a sore throat and congested. Left area and went to (location) for fresh air and symptoms cleared up. Today, headache and congestion returned. Her (age) old son has a plugged nose and is coughing. Other child already had a plugged nose before treatment started.

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

• Respiratory System
  • Symptom - Coughing
  • Symptom - Runny nose
  • Symptom - Nasal congestion
  • Specify - plugged nose

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.)

Sprayed this morning. Has two small children who were looking out an open window during the spray. Awoke to sound of R/W. Children now have runny nose and coughing. Had to leave the house and get away from the area. Was sprayed Friday morning. She slept with bedroom window open. Opened front door to see what was happening. She had a headache from the day before, a sore throat and congested. Left area and went to (location) for fresh air and symptoms cleared up. Today, headache and congestion returned. Her (age) old son has a plugged nose and is coughing. Other child already had a plugged nose before treatment started.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.