Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2483

2. Registrant Information.

Registrant Reference Number: 2018-06-15-001

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

Address: 870 Technology Way

City: Libertyville

Prov / State: Illinois

Country: United States of America

Postal Code: 60048

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

Human

4. Date registrant was first informed of the incident.

18-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

15-JUN-18

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. 24976      PMRA Submission No.       EPA Registration No.

Product Name: Foray 76B Biological Insecticide

• Active Ingredient(s)
  • BACILLUS THURINGIENSIS SUBSPECIES KURSTAKI (ALL STRAINS)

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PMRA Registration No. 27099      PMRA Submission No.       EPA Registration No.

Product Name: BioProtec HP

• Active Ingredient(s)
  • BACILLUS THURINGIENSIS SUBSPECIES KURSTAKI (ALL STRAINS)

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7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

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

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

To be determined by Registrant

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

Unknown

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

• Skin
  • Symptom - Dermatitis

4. How long did the symptoms last?

<=30 min / <=30 min

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)

Other

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

Long-sleeve shirt

Goggles

Chemical resistant gloves

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

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

Skin exposure when cleaning spray equipment. Both Foray 76B and BioProtec HP are used at this spray base, the employee doesn't know which product is involved. During cleaning activities after the morning operation session, the employee received some product which has started to dry up (thicker than normal) equivalent to the size of a quarter, on his wrist . Directly after the exposure he used a no rinse soap to remove the Btk on his wrist; water wasn't used in combination with the soap to clean up the product on his skin. When he came back to the hotel about 3-4 hours after exposure, he took a shower and went to bed. He then began to scratch his wrist and noticed that the skin was reddish. He put cold water on his wrist and everything returned to normal quickly. He did not go to see the doctor and considered the incident closed. He just wanted to report the incident as prescribed in SOPFIM internal health and safety procedures

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

None