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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2015-0002

2. Registrant Information.

Registrant Reference Number: B002/123238

Registrant Name (Full Legal Name no abbreviations): Amvac Chemical Corporation

Address: 4695 MacArthur Court, Suite 1200

City: Newport Beach

Prov / State: California

Country: USA

Postal Code: 92660

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. 19399      PMRA Submission No.       EPA Registration No. 5481-469

Product Name: Vapam Technical

  • Active Ingredient(s)
    • METAM-SODIUM

PMRA Registration No. 6453      PMRA Submission No.       EPA Registration No. 5481-466

Product Name: Vapam Liquid Solution Soil Fumigant

  • Active Ingredient(s)
    • METAM-SODIUM

PMRA Registration No. 13139      PMRA Submission No.       EPA Registration No. 5481-470

Product Name: Pole-Fume

  • Active Ingredient(s)
    • METAM-SODIUM

PMRA Registration No. 29128      PMRA Submission No.       EPA Registration No. 5481-468

Product Name: Vapam HL

  • Active Ingredient(s)
    • METAM-SODIUM

PMRA Registration No. 29770      PMRA Submission No.       EPA Registration No.

Product Name: Pole-Fume HL

  • Active Ingredient(s)
    • METAM-SODIUM

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 Combined Chronic Toxicity/Carcinogenicity with MITC

Date 02-AUG-13

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)

The histopathology on the tissue/organs of the interim sacrifice animals and unscheduled deaths that occurred up to month 12 of the study has been completed, and we are submitting potentially referable findings, including body weights, organ weights, hematology, clinical chemistry, histopathology, and other findings. Please note that these data are not audited.

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?

31-OCT-14

For Registrant use only

7. Provide supplemental information here

On October 28, 2013, Amvac Chemical Corporation submitted this incident report via Health Canada's web portal and Federal Express. Because the incident report did not receive an incident report number at that time, Amvac is re-filing this incident report. Status update: We are reporting nasal and lung pathology results from A Combined Inhalation Chronic Toxicity and 24-Month Carcinogenicity Study of Methyl Isothiocyanate (MITC) in Rats. A Pathology Peer Review was conducted by (name), LLC for the respiratory tract findings in the study described herein. The final incidence data for the nasal and lung findings are not yet available as a result of this Peer Review, and, therefore, there are no tabular data to provide at this time. We have been informed of the preliminary results of the Peer Review, which are being reported herein.