Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-1248
2. Registrant Information.
Registrant Reference Number: 22623-001
Registrant Name (Full Legal Name no abbreviations): ARYSTA LIFESCIENCE NORTH AMERICA, LLC
Address: 15401 Weston Parkway, Suite 150
City: Cary
Prov / State: NC
Country: USA
Postal Code: 27513
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.
EPA Registration No. Unknown
Product Name:
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 EVALUATION OF THE MUTAGENIC ACTIVITY OF DME SULFOXIDE ACID IN THE SALMONELLA TYPHIMURIUM REVERSE MUTATION ASSAY AND THE ESCHERICHIA COLI REVERSE MUTATION ASSAY (WITH INDEPENDENT REPEAT)
Date 16-DEC-09
2. a) Is an extension needed to translate the document?
No
3. Type of incident identified in the study
Presence of a component or derivitive
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)
Metabolite(s) not previously identified at the time of initial registration.
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
On November 20, 2014, Arysta LifeScience North America, LLC, became aware of several new studies on clethodim technical herbicide that had been previously undertaken to support the addition of new crops to the clethodim label in Europe. The new studies are submitted to the PMRA at this time.