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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2025-2110

2. Registrant Information.

Registrant Reference Number: Earthworm Study Incident Report

Registrant Name (Full Legal Name no abbreviations): Elemental Enzymes Ag Turf, LLC

Address: 1685 Galt Industrial Blvd

City: St. Louis

Prov / State: MO

Country: USA

Postal Code: 63132

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

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

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. 35426      PMRA Submission No.       EPA Registration No. 92188-2

Product Name: FLG22-BT Peptide Technical

• Active Ingredient(s)
  • FLG22-BT PEPTIDE

PMRA Registration No. 35425      PMRA Submission No.       EPA Registration No. 92188-7

Product Name: Vismax(TM) Seed Treatment

• Active Ingredient(s)
  • FLG22-BT PEPTIDE

PMRA Registration No. 35427      PMRA Submission No.       EPA Registration No. 92188-4

Product Name: Vismax(TM) Row Crop

• Active Ingredient(s)
  • FLG22-BT PEPTIDE

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

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 VII: Scientific Study

1. Study Reference

Title Reproduction Toxicity Test of Flg22-Bt Peptide Technical to Earthworm, Eisenia fetida

Date 03-DEC-24

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

New health or environmental hazard

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

In this study on earthworms Eisenia fetida (OECD 222), two effects were observed:(1) Earthworm mortality at concentrations of 1000 mg Flg22-Bt Peptide Technical/kg soil. No mortality or negative effects were observed at the next lowest dose tested, 500 mg/kg soil.(2) Decreased earthworm reproduction at concentrations above 26.5 mg Flg22-Bt Peptide Technical/kg soil (NOEC).This information is submitted to PMRA for review and evaluation because it meets reporting criteria. Reporting this incident does not suggest that this study presents findings of an increased health or environmental risk for the active ingredient Flg22-Bt Peptide based on Elemental Enzymes' knowledge of its known characteristics.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

Though adverse responses were observed to the technical grade active ingredient, the doses required to cause the adverse responses exceeds the environmental exposure caused by the labelled application rate by at least 100-fold.