EXPLANATORY HISTORY APPENDIX III

On May 21, 2009, the Agency issued the Phase 5 Reregistration
Eligibility Decision (RED) Document Product Data Call-In Notice pursuant
to section 4(g)(2)(B) of FIFRA, which required the registrants of
products containing Pyrethrins 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 Document Product Data Call-In Notice (PDCI) is a basis for
suspension under section 3(c) (2) (B) of FIFRA.

Paul A. Keane & Associates (hereinafter referred to as “Paul Keane”)
the authorized agent for the Pyrethrum Board of Kenya, received the
Pyrethrins RED and Product Data Call-In, as evidenced by the submission
of the 90-Day Response, Requirements Status and Registrant’s Response
Form, dated October 13, 2009.  In the cover letter for the 90-Day
Response, Paul Keane specifically referenced the May 21, 2009 PDCI.  On
the form, the Pyrethrum Board of Kenya indicated an intention to submit
data to support their pyrethrins product, EPA Registration Number
4713-5.  On March 19, 2010, Paul Keane submitted acute toxicity and
product chemistry data to support reregistration.   Those data were
reviewed and the acute toxicity data were found to be acceptable, but
the product chemistry data were found to be deficient, as described in
the Agency review by Nina Simeonova on March 9, 2011.  In an Agency
letter from Moana Appleyard on March 11, 2011 to Mary Beth Endres of
RegWest, the product chemistry review of March 9, 2011, was included. 
The Agency letter also stated that the required data were due within 10
days from receipt of the letter.

On May 11, 2012, the Pyrethrum Board of Kenya changed their authorized
agent to RegWest Company, LLC (hereinafter referred to as
“RegWest”).    RegWest submitted data to the Agency on June 13,
2012.  The data were reviewed by Maria Piansay on June 19, 2012. 
According to the review, the Confidential Statement of Formula was
deficient as well as data on 830.6313, Storage Stability; data on
830.6317, Corrosion Characteristics; and data on 830.6320, Stability to
metals and metal ions.   These deficiencies were reported to Kim Davis
of RegWest in an Agency letter from Moana Appleyard, dated June 25,
2012, and the registrant was required to submit the data within 10 days
of receipt of the Agency’s letter.    

Repeated agency communications via email from Moana Appleyard on
September 9, 2013 and February 3, 2014, requested the overdue data from
RegWest.  On February 5, 2014, RegWest responded to the emails with a
declaration from the company that they will pay their maintenance fees
for 2014.  Moana Appleyard replied by email on February 5, 2014 that the
product would be suspended if the outstanding data was not submitted to
the Agency.  On July 4, 2014, RegWest sent an email to Moana Appleyard
stating an intention to conduct the required studies over the next year.
  Moana Appleyard responded with an email stating the Agency’s
intention to suspend the product until the data are submitted and
determined to be acceptable.   

The required data to support product reregistration for the affected
pyrethrins product remain overdue at this time.  Therefore, this Notice
of Intent to Suspend is being issued for EPA Registration Number 4713-5.


 

