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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2893

2. Registrant Information.

Registrant Reference Number: Prosar case 1-15068612

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.

Domestic Animal

4. Date registrant was first informed of the incident.

03-JUL-07

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. 73049-39

Product Name: DiPel Pro DF Insecticide

  • Active Ingredient(s)
    • BACILLUS THURINGIENSIS BERLINER SSP KURSTAKI STRAIN HD-1

7. b) Type of formulation.

Granular

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - Out Home / Rés - à l'ext.maison

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

A pest control company had sprayed the product onto a consumer's yard and the product may have drifted into a Koi pond.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Fish / Poisson

3. Breed

Koi

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify The product may or may not have drifted into a Koi pond

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-15068612: The reporter, a pest control operator, called on 7/3/07 to report the application of a product containing the active ingredient Bacillus Thuringiensis subsp. kurstaki to a consumers yard. According to the reporter, the product had been sprayed and may have drifted into the consumers Koi pond. The consumer had reported that a number of Koi had died. The reporter inquired about the safety profile of the product in terms of potential toxicity to fish. While no specific information could be found, a recommendation was made to test the pH of the pond as the product had a fairly low pH (4.1) that could have altered the water conditions. A follow-up call was made later on the same day to pass along additional information. A review of relevant studies suggested that the toxicity of this product to fish as applied would have been non-existent. A suggestion was made to review the history of products applied in the area of the pond as pyrethroids, neonicitinoids, etc. are both common and highly toxic to fish.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here