Document ID: EPA-HQ-OPP-2014-0415-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-25T04:00Z

Pyraflufen-ethyl: Focus Meeting with Nichino America Notes

   I. Participants:
         a. EPA  -  Steven Snyderman (PRD), Tracy Perry (PRD), Patricia Parrott (PRD), Kristin Rury (HED), Christine Olinger (HED), Nancy Dodd (HED), Kathryn Montague (RD), Justin Housenger (EFED), Allen Vaughan (EFED), Mohammed Rahman (EFED), Arnet Jones (BEAD), Jihad Alsadek (BEAD), Sunil Ratnayake (BEAD) [over phone]
         b. USDA  -  Julius E. Fajardo [over phone]
         c. Nichino America  -  Bill Berti, Dustin Simmons
            
   II. Agenda discussion points:
         a. Questions on general uses of pyraflufen-ethyl nationwide.
                 i. Nichino provided the participants with a detailed explanation of pyraflufen-ethyl usage by product (ET/VIDA 2.5% EC/L, ET 2% SC/VENUE, and ET 4.0%/EC ETX) including a rationale for recent market trends. Some of this information confirmed BEAD usage information that will be provided to the public in the docket opening. Uses of pyraflufen-ethyl included the following:
                     I. Use for cotton defoliation.
                     II. Use on permanent crops such as raisins grapes, wine grapes, tree nuts, and tree fruit.  The product is typically applied in combination with another foliarly active broadspectrum herbicide which has grass activity. 
                     III. Use for pre-plant weed control in corn, soybeans, cotton, and peanuts. 
                     IV. Post-emergence control of broadleaf weeds in wheat.
                     V. Uses on commercial turf and ornamental, this however, is not labeled on any Nichino end-use products.
                        
         b. Usage discussion on registration 71711-7 (ET Herbicide/Defoliant (2.5%EC))

         c. Discussion of ecotoxicology studies that appear to show differences in effects between the inert ingredients of a "blank" formulation and the technical grade active ingredient (TGAI).  EPA will provide MRID numbers for several studies for Nichino to review. 
 
         d. Clarification of label uncertainties.
                 i. Nichino went over all three labels to discuss and clarify several of the application parameters we felt were unclear on the label. 

         e. Questions on available data that hasn't been submitted to the agency? Specifically, is there any data available on the degradates of pyraflufen-ethyl (E-2 and E-3).
                 i. Nichino plans on providing several studies that the Agency does not have including at least one study on the E-2 degradate.
            
   III. Nichino America follow up items:
         a. Nichino plans on looking into clarifying parts of the label EPA deemed as unclear. This will be done as part of the ongoing label amendment process, updating the labels to be clear and consistent with their other labels. 
            
         b. Nichino will look into their ET (2.5% EC) formulation and get back to EPA regarding available ecotoxicity information related to inert ingredients. 

         c. Nichino will look to see if further studies are available on pyraflufen-ethyl degradates E-2 and E-3 as well as additional data on the E-1 degradate.
            
   IV. Anticipated registration review time-line:
         a. Docket opens along with publishing of Preliminary Work Plan: June 2014
         b. Close of public comment period: August 2014
         c. Final Work Plan is published: November 2014
         d. Issue Data Call-in: January-March 2015
         e. Data submission: January-March 2017
         f. 60-day public comment period for draft Risk Assessments: July-September 2018