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.