Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2101

2. Registrant Information.

Registrant Reference Number: 2020-06-19-001

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

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.

05-JUN-20

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

04-JUN-20

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 Biological Insecticide Aqueous Suspension

• 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

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

The BC Ministry of Forests, Natural Resources and Lands (MoF) was conducting a multi-application Gypsy Moth eradication program in several locations in southern BC this Spring (May-June 2020). Foray 48B was applied aerially @ 4L/ha to these forested areas. The x treatment area was appr 165 ha, and to be treated 3X

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

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea

4. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Occupational

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

Application

Contact with treated area

Amount of time between application and contact 18

Hour(s) / Heure(s)

What was the activity? monitoring of aerial application in/adjacent to treatment area

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

Long-sleeve shirt

Long pants

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 h

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.)

The MoF worker was monitoring the aerial application of Foray to the treatment area; there were 3 treatments carried out: May 16, May 27 and June 3. She would have been exposed to the aerial application was she was in and/or adjacent to the treatment area, monitoring deposition, alerting any bystanders that might appear etc. After the third and final treatment (June 3, 5:00-6:15 am), she returned to her normal activities. Later that evening, when in her residence, she experienced diarrhea and vomiting.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

We have been in communication with the MoF employee and she indicated that other than the exposure to the Btk, her daily activities, meals eaten etc on June 3 were all 'normal.' The next day (June 4) she felt fine and was able to continue with her daily routine. She also indicated that she had similar levels of exposure to the Btk while monitoring the applications during all three treatments.