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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1893

2. Registrant Information.

Registrant Reference Number: 2017-5919-IR2

Registrant Name (Full Legal Name no abbreviations): Nippon Soda Co., Ltd.

Address: 2-1, 2-Chome Ohtemachi

City: Chiyoda-ku, Tokyo

Country: Japan

Postal Code: 100-8165

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.

Active(s)

PMRA Registration No.       PMRA Submission No. 2017-5919      EPA Registration No.

Product Name: Picarbutrazox Technical

  • Active Ingredient(s)
    • PICARBUTRAZOX

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 PROJECT 2967W: AEROBIC SOIL METABOLISM OF[TETRAZOLE-5-14C]PICARBUTRAZOX IN ILLINOIS SOIL

Date 11-MAY-18

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 a new aerobic soil metabolism study being conducted for registration of picarbutrazox in Europe, TT-3 was found at 34.5%AR in soil. Even though the percentage of TT-3 is not higher in this new study than previously found in other environmental fate studies with picarbutrazox, the registrant informed the PMRA in May of 2018 because because TT-3 was not detected in other soil studies. The study was submitted to the PMRA on September 18, 2018 under submission 2017-5919.

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

The study attached is already on file at the PMRA under submission 2017-5919.