Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-2974

2. Registrant Information.

Registrant Reference Number: 2014-VBC-1

Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation

Address: 870 Technology Way

City: Livertyville

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.

08-JUL-14

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

08-JUL-14

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. 24978      PMRA Submission No.       EPA Registration No.

Product Name: Foray 48B Biological Insecticide Aqueous Suspension

• 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.

Unknown

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).

The application was done aerially. The direct application was not the cause of the incident.

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.

Other

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Itchy skin
  • Symptom - Red skin

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

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.

Skin

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.)

Forest

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Two individuals who work for the (Province) Ministry of Natural Resources were working with the product for forestry applications. They provided ground support, recirculating and loading the product and fueling the aircraft. Additionally they had 80 minibulk containers that were rinsed for recycling (rinsate pumped into aircraft) with high pressure fire hoses. Shifts were 8 hrs per night, 5 days a week. Both men reported itchy arms and cheeks, with mild reddening after they had carried out the powerwashing. Only gogles were worn during that operation. The medical clinic diagnosed mild dermatitis and recommended an OTC anti-histamine. No respiratory symptoms were reported.

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

• Skin
  • Symptom - Itchy skin
  • Symptom - Red skin

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

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.

Skin

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.)

Forest

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Two individuals who work for the (Province) Ministry of Natural Resources were working with the product for forestry applications. They provided ground support, recirculating and loading the product and fueling the aircraft. Additionally they had 80 minibulk containers that were rinsed for recycling (rinsate pumped into aircraft) with high pressure fire hoses. Shifts were 8 hrs per night, 5 days a week. Both men reported itchy arms and cheeks, with mild reddening after they had carried out the powerwashing. Only gogles were worn during that operation. The medical clinic diagnosed mild dermatitis and recommended an OTC anti-histamine. No respiratory symptoms were reported.