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Incident Report
Subform I: General Information
1. Report Type.
Update the report
Incident Report Number: 2009-0202
2. Registrant Information.
Registrant Reference Number: 120808-01 DTF
Registrant Name (Full Legal Name no abbreviations): Industry Task Force II on 2,4-D Research Data (members: Agro-Gor Corporation, Dow AgroSciences and Nufarm USA, Inc.)
Address: 1900 K Street, NW
City: Washington
Prov / State: DC
Country: USA
Postal Code: 2006-1108
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. 2004-3086 EPA Registration No.
Product Name: 2,4-D Acid
- Active Ingredient(s)
- 2,4-D (PRESENT AS ACID)
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 2,4-D: F1-Extended One Generation Dietary Toxicity Study in CRL: C (SD) Rats
Date 08-DEC-08
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)
On behalf of its members and affiliates, the Industry Task Force II on 2,4-D Research Data ("Task Force") [ whose current members include Agro-Gor Corporation, Dow AgroSciences, and Nufarm USA, Inc.], this confirms that the Task Force previously submitted to PMRA preliminary results from the 2,4-D F1 Extended One-Generation Reproduction and DNT study ("study"). The Task Force is sponsoring this study to satisfy PMRA' s 2,4-D post-RVD Data Call-In ("DCI") requirements for reproduction and DNT studies. Preliminary findings from the study were reported to PMRA in slides submitted by the Task Force to PMRA/HED representatives via email on November 14, 2008 in advance of an Agency meeting later that day at Reston Hyatt, Reston, VA to discuss the study, and also on November 26, 2008 in advance of a conference call with PMRA/HED representatives later that day to again discuss the study. While the Task Force does not believe that the preliminary information from the study constitutes an "unreasonable adverse effect on man or the environment," we trust that the PMRA/HED placed the slides and provided information in the official files and records of PMRA, and therefore, constitute previously submitted information.
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-JAN-10
