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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-1910

2. Registrant Information.

Registrant Reference Number: 2017-5919-IR1

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.

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).

Site: Unknown / Inconnu

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 Preliminary Confined Rotational Crop and Field Rotational Crop Study Results with [TTZ-14C]NF-171

Date 30-APR-19

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)

An additional confined crop rotation study (CRC) with the TTZ label was required for the EU registration. Metabolites TT-1 and TT-3 (along with 3 unknown metabolites), were found and verified by HPLC in amounts above 10%. They have not been reported in previous CRC and Field Rotational Crop studies that are currently under evaluation at the EPA and the PMRA in support of the proposed registration. Efforts to identify the 3 unknown metabolites are underway. In addition, residues of metabolite TT-1 greater than 0.01 mg/kg and TT-3 up to 0.3 mg/kg were detected in a number of commodities in the ongoing field rotational crop study for the EU.

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?

Unknown

For Registrant use only

7. Provide supplemental information here

A summary of the preliminary findings was provided to the PMRA via teleconference on April 25, 2019 and through ePRS on April 26, 2019 under the ongoing submission 2017-5919. There is no study report to attach to this reporting form, which is required, therefore the cover letter is attached.