Document ID: EPA-HQ-OPP-2010-0848-0028
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-01-23T05:00Z

ATTACHMENT III - EXPLANATORY APPENDIX  

On June 16, 2009, the Agency issued the Phase 5 Reregistration
Eligibility Decision (RED) Product Data Call-In Notice pursuant to
sections 4(g)(2)(B) of FIFRA which required the registrants of products
containing MGK-264 used as an active ingredient to develop and submit
certain data.  The data/information were determined to be necessary to
satisfy the reregistration requirements of section 4(g).  Failure to
comply with the requirements of a Phase 5 Reregistration Eligibility
Decision Product Data Call-In Notice (PDCI) is a basis for suspension
under section 3(c) (2) (B) of FIFRA.

CTX Cenol Corporation received the MGK-264 RED/PDCI, as evidenced by the
US Postal Service domestic return receipt card which was signed and
dated on June 25, 2009. The 90-day response to the PDCI was received by
the Agency on September 14, 2009.  The 8-month response for this product
(which was required to be submitted by March 16, 2010) has not been
received by the Agency.  On April 25, 2012, the Risk Management and
Implementation Branch V, Chemical Review Manager, Veronica Dutch, sent a
certified letter to Mr. Bart Baker, Vice President of CTX Cenol
Corporation and informed him that  CTX Cenol Corporation’s required
8-month PDCI response for the MGK-264 product (EPA Reg. No. 45385-93)
was overdue. In the letter, it was stated that the Application for
Reregistration (EPA Form 8570-1), two copies of the Confidential
Statement of Formula (CSF), five copies of the draft labels,
Certification with Respect to Citation of Data (EPA Form 8570-34), and
Data Matrix (EPA Form 8570-35) needed to be submitted for the product
within 10 days from CTX’s receipt of the letter or a Notice of Intent
to Suspend would be issued.  CTX Cenol Corporation received the April
25, 2012 letter, as evidenced by the US Postal Service domestic return
receipt card, which was dated and signed by Amie S. Meeken on May 2,
2012.     

 

To date, the 8-month response, and the product specific data required
for this product have not yet been received by the Agency.  Therefore,
this Notice of Intent to Suspend is being issued.