Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2575

2. Registrant Information.

Registrant Reference Number: 2

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

Address: 870 Technology Way

City: Libertyville

Prov / State: IL

Country: USA

Postal Code: 60048

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

06-MAY-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

02-MAY-10

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. 73049-427

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

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Alleged Incident History: On April 30, the first morning of the treatment, lines 34-51 were sprayed and on subsequent days (May 5), lines 25-33, 52-59, (May 6) lines 2-24, 60-65, and (May 7) lines 66-81 were flown. The residence in question was flown over on May 6. Flight logs from these applications are included herein. Subsequent applications, as noted below, were also conducted. On Wednesday May 5, (name), of BC Ministry of Forests and Range, received a telephone call from a resident of the treatment area (Bird Road, near lines 12-15) who indicated that her (age) son spitting up blood on May 2 and had required medical attention from his respirologist. She indicated that he is immuno-compromised and suffers from a very rare condition (Addison's Disease); he is one of about 10 cases in Canada. She thought that perhaps her son may have been exposed to the Btk treatment on April 30 and was seeking some answers to his current medical situation. She had been in contact with the local Health Authority, who in turn contacted Health Canada - PMRA. After the conversation with the Bird Road resident, (name) spoke with (name) of Health Canada - PMRA re appropriate measures, if any, to take, (name) contacted Valent BioSciences Corporation (VBC) on Thursday May 6 for further information and inquired about the possibility of obtaining a Foray Btk strain sample to compare to swab samples reportedly collected by Vancouver Coastal Health. Although the local Vancouver Public Health was reportedly in communication with the BC Centre for Disease Control, there have been no communications between any of the local health authorities and BCMFR and/or Valent BioSciences. In the course of subsequent investigations by MFR, it became apparent that the young man's residence was not treated on April 30, and in fact, the aircraft was no closer than 800 metres to their young man's residence that day and weather records taken in the treatment area and from YVR indicate that wind speed and direction precluded any drift.

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing up blood

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

Non-occupational

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

Unknown

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

Backround: Due to the presence of European Gypsy Moth egg masses and the threat of a possible Quarantine, the BC Ministry of Forests & Range (BCMFR) decided to conduct a local European Gypsy Moth eradication program centered in northwest Richmond BC, immediately east of the Vancouver International Airport (YVR), and south of the Fraser River. Three aerial applications of Foray 4B (each @ 50 CLU/4.0/ha) were planned with spray timing determined by a degree-day based biological development model, BioSim. This application program was well planned and involved staff from several federal and provincial government agencies as well as input from Transport Canada, the City of Richmond, and the local department of public health (Vancouver Coastal Health-Richmond). BCMFR has extensive experience in mounting these campaigns, having been involved in periodic gypsy moth eradication program since 1992. These programs are well executed, based on sound scientific criteria, and great efforts are invested in public outreach to ensure that all residents in the affected area have been advised and are aware of the program. (1-800 Moth line, ListServe, MFR web-site, print advertising, media advisories, and an Open House in the treatment area are all part of the communication strategy.) BioSim indicated that the first application should be conducted on Friday April 30, and a small twin-engine aircraft, crewed by an experienced licensed application team started the applications. The aircraft is equipped with a Digital Global Positioning System (Satloc), which is specialized navigation equipment that is installed in most application aircraft working in North America. The DGPS provides accurate aircraft guidance across the spray block, monitors pesticide output, and indicates spray line intervals (approximately 80 lines) and treatment boundaries. Dedicated program staff include a communications manager (name) working at MFR headquarters in Victoria, an operations manager (name) located in the treatment area monitoring weather and spray deposition, and an airbase manager (name) overseeing pesticide handling and loading of the aircraft at the nearby Boundary Bay Airport. Bird Road Resident, pg 2. Due to the small size of the aircraft, and application time restrictions due to potential airspace conflicts with Vancouver airport and early morning vehicular traffic, several mornings are required to complete the program in entirely. All applications are conducted between sunrise and 7:30am.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.