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.