Document ID: EPA-HQ-OPP-2012-0633-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-12-14T05:00Z

Bifenazate Registrant Focus Meeting Notes 
                          July 24, 2012, 2:00-3:00 pm
EPA Participants 
BEAD: Cynthia Doucoure, Donald Atwood, John Faulkner
EFED: James Hetrick, Dana Spatz (Branch Chief), Katherine Stebbins
HED: Anwar Dunbar, David Hrdy (BC), Kelly Lowe, Anna Lowit, Elizabeth Mendez 
PRD: Cathryn Britton (Team Leader), Garland Waleko
RD: John Hebert, Barbara Madden 

Chemtura Participants 
Shaila Rao, Senior Toxicologist
Shari Long, Ecotoxicologist
Uwe Wanner, Global Manager: Bio/Chemistry Services 
Roy Russell, Human Exposure Scientist
R. Tim Weiland, Registration Specialist

   1. Introductions, Registration Review process overview 
-The purpose of Registration Review is not to re-do the risk assessments completed for registration, but to update the assessments where needed, based on current information. 
-Where possible, PRD will coordinate with the current PRIA action. RD has the lead on the PRIA action, and PRD is the lead for Registration Review. Regardless of what happens with the PRIA action, Registration Review will continue as scheduled. 

-Registration Review Schedule:
         * Docket opens at the end of December 2012, and the Preliminary Work Plan (PWP) publishes identifying what data will likely be needed to update the risk assessment. 
         * The comment period on the PWP closes at the end of Feb 2013. 
         * The Final Work Plan will incorporate comments and will publish in May 2013. 
         * A Data Call-in would go out (following review by other agencies) between January and March 2014. 
         * Study timelines vary (2 -4 years) and the risk assessment will be completed following data submission, which will be followed by a comment period and a final Reg Review decision (2018 -2020). 
         * The registrant is encouraged to submit relevant information and/or comments on the PWP during the public comment period.
            

   2.  Use, label clarifications, and EFED data needs
- No further clarification needed on BEAD response to registrant comments on the label data table. 
-For Homeowner label 400-517, the application instructions are to mix (1/2) teaspoon of the product per gallon of water. No information is given on the spray volume per area.  Chemtura suggested using a finishing spray volume of 400 gal/A, as is indicated on labels 400-508 and 400-509, which results in a rate of 0.5 lb a.i./acre.  If Chemtura wishes to include this rate on label 400-517, this can be discussed with RD. 
-EFED data that would be helpful to fully characterize the parent/degradates and reduce uncertainty include: 
         * Aerobic soil metabolism  -  EPA only has one study with one soil. Registrant will provide EU soil data (registrant reports parent and degradate -both rapidly degrade). 
         * Aerobic aquatic metabolism  -  registrant is currently evaluating the studies conducted for the EU and will provide what they have.   
         * Adsorption, desorption of parent compound. Difficult to measure but registrant will look into what data was used for EU registration. Registrant noted that in the past, using worst case assumptions (i.e., Koc=1) has not hit EU triggers despite strict groundwater standards. 
         * Fish bioaccumulation  -  registrant does not have this information and will follow up with either a study or a rationale as to why a study is not needed. 
         * Degradates 3598 and 1989 - Both degradates have activity (especially 3589), registrant will provide batch equilibrium data on 3598 and 1989.  
         * Ecotox. Studies appear in EU database for both D-3598 and D-1989 at: http://sitem.herts.ac.uk/aeru/footprint/en/index.htm. These studies would be helpful to have ASAP.
         * Any studies that address OCSPP series 835 or 850 guidelines (or the equivalent OECD guidelines) may be helpful. The registrant will submit what they have. 
            
   3. HED and RD update on PRIA action status  
-HED and RD discussed current PRIA actions with the registrant.  

   4. Wrap up and Next Steps 
 Preliminary Work Plan (PWP) will be posted when docket opens in December 2012
 Registrant should submit all studies that will assist EPA in completing the PWP to Garland Waleko in PRD, waleko.garland@epa.gov. 
 All information related to the current PRIA action should be submitted to the RD Project Manager, John Hebert, hebert.john@epa.gov.