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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1819

2. Registrant Information.

Registrant Reference Number: 2020-06-11-001

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.


4. Date registrant was first informed of the incident.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.


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.


PMRA Registration No. 24977      PMRA Submission No.       EPA Registration No.

Product Name: Foray 48B Biological Insecticide Aqueous Suspension

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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 town of Pelham contracted an aerial applicator to apply Foray 48B to control gypsy moth that had caused significant defoliation in the Town in 2019 . The area treated was a forested residential sector of the town. The contractor has been applying Foray for over 25 years and the pilot has sprayed tens of thousands of hectares with Foray 48B to control a variety of defoliators; they are well experienced and the helicopter is outfitted with state of the art equipment: rotary atomizers, DGPS with auto on/off, flight tracking features etc.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?


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: Unknown / Inconnu

3. List all symptoms, using the selections below.


  • Gastrointestinal System
    • Symptom - Other
    • Specify - 'Stomach problems', no detailed description provided.

4. How long did the symptoms last?

Unknown / Inconnu

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


6. a) Was the person hospitalized?


6. b) For how long?

7. Exposure scenario


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

Contact with treated area

Amount of time between application and contact 24

Hour(s) / Heure(s)

What was the activity? gardening, in or adjacent to the treatment area

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


10. Route(s) of exposure.


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.)

Mother and daughter were gardening the day after parts of their neighbourhood had been aerially sprayed with Foray 48B to control Gypsy Moth. The front of their residential property was sprayed, but the backyard was not. The helicopter made 2 passes along the street to protect the sidewalk trees and the street scape. Two days after the spraying the family members contacted the Town and the project manager asking for advice on 'what they could use to neutralize the bacteria that they seem to have ingested.'

To be determined by Registrant

14. Severity classification.


15. Provide supplemental information here.

We contacted the Town and provided contact information to be forwarded to the family members that alleged to be experiencing a reaction to the Foray 48B spray. We had no response from the family in question. Their property was treated a second time a week later, and there were no concerns expressed to the Town or to Valent BioSciences after the 2nd application. The application pilot checked his time stamped GPS flight file and he was spraying this area at 6 am and he did not see anyone outside during his pre-treatment reconnaissance flight at that time of the day. We followed up again with the Town Manager and the Project Manager after the 2nd application asking for further details and for permission or advice on contacting the family in question. We also asked if there were any issues raised during the second treatment. The Town had emailed the residents after the first application about their concerns but there was no reply from the residents.