Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1841

2. Registrant Information.

Registrant Reference Number: PROSAR case: 1-40270509

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.

16-APR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

15-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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: unknown

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. But the patient who was sprayed disputes this distance and believes the helicopter was only about 50 feet up. The applicator indicated that the system may average the topography and because the patients home is on the top of a hill the helicopter may have been less than 100 feet up in that particular location.

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Chest congestion
  • Symptom - Coughing

• Nervous and Muscular Systems
  • Symptom - Muscle pain

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Drift from the application site

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

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.)

1-40270509 - The reporter indicated that he was exposed to an insecticide containing the active ingredient Bacillus Thuringiensis Berliner ssp Kurstaki strain hd-1. The reporter stated the product was applied by aerial application from a helicopter to a neighbors field one day prior to initial contact with the registrant and during application the reporter was inadvertently sprayed and he inhaled the product. He immediately started coughing and his chest became congested. He was coughing soo severely that his back muscles and chest became sore. The firefighters and paramedics came and took him to the hospital where he stayed for several hours and a chest x-ray and blood work was run. The results of these tests were not indicated. On the day of initial contact the patient had gone to work as usual but he was still coughing and congested. On follow-up call, one day later, the reporter indicated that he is still coughing and congested and he is not getting any relief from inhalers. His doctor was trying to expedite his appointment with the pulmonologist. On follow-up call, seven days after the exposure, the reporter indicated that he was about the same. He had gone to see a pulmonologist who discussed the possibility that he might have asthma but no definitive diagnosis had been made. Caller also indicated that he would be off work for the next 2 months due to his illness. On follow-up call, fourteen days after the exposure, the reporter indicated that his symptoms were about the same although he was not producing as much phlegm when he coughed. He had been prescribed numerous medications by his pulmonologist and was also receiving treatments at the clinic. No additional information is available

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.