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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0522

2. Registrant Information.

Registrant Reference Number: 201832340 01

Registrant Name (Full Legal Name no abbreviations): Nichino America, Inc

Address: 4550 Linden Hill Road suite 501

City: Wilmington

Prov / State: DE

Country: USA

Postal Code: 19808

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. 32340      PMRA Submission No.       EPA Registration No.

Product Name: BUPROFEZIN TECHNICAL

• Active Ingredient(s)
  • BUPROFEZIN

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 Buprofezin Hydrolysis Under Simulated Processing Conditions

Date 08-SEP-06

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)

A model processing study demonstrated that anliine could be formed under high temperature and acidic conditions. Higher tier studies, which evaluated crops that had been treated with buprofezin and underwent processing, showed that aniline concentrations were either below the LOQ or not detected.

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

In October 2016, Nichino America, Inc (NAI) learned of a WHO Technical Barrier to Trade Notification by the EU, which proposed to restrict the use of buprofezing in the EU to non-edible crops due to concern over the potential formation of aniline under acidic and high temperature processing conditions. In early 2017, NAI became aware of the underlying data generated by our parent company Nihon Nohyyaku Co Ltd. NNC which was the basis for the EUs concern. A model processing study demonstrated that aniline could be formed under high temperature and acidic conditions. Higher tier studies, which evaluated crops that had been treated with buprofezin and underwent processing, showed that aniline concentrations were either below the LOQ or not detected. The US EPAs Human Health Draft Risk Assessment for Registration Review states the agency has no concerns about aniline in processed food that were treated with buprofezin.