Flumiclorac‐Pentyl Registration Review Focus Meeting

Conference Call Summary

Thursday, March 28, 2013; 11 am – 12 pm (Eastern time)

EPA Attendees:

Pesticide Re‐evaluation Division:  Monica Wait (Chemical Review Manager), Tracy Perry

Health Effects Division:  Will Donovan

Environmental Fate and Effects Division:  Greg Orrick, Nick Federoff, Jean Holmes, Brian

Anderson, Paul Mastradone

Biological and Economic Analysis Division: Michelle Ranville, Claire Paisley‐Jones

Valent USA Corporation Attendees (via teleconference):

Joe Powell, Registration and Regulatory staff

Dr. John Pawlak, Field staff

Dr. Richard Allen, Laboratory staff

Discussion Topics:

 Flumiclorac‐pentyl label clarifications for burndown uses and non‐agricultural use sites (ex.

maximum annual application rates, retreatment intervals).

Discussion:  EPA and Valent discussed two flumiclorac‐pentyl labels (EPA Reg # 59639‐82

and 59639‐122) where maximum annual application rates and application intervals

are not specified for burndown and non‐agricultural applications.  Valent indicated

that they will add this information to the product labels.  Discussion included specific

use directions that Valent offered as likely additions to the labels, including a

maximum annual application rate for all uses (burndown plus post‐emergence) of

0.054 lbs a.i./A and a reapplication interval for all uses of 14 days.

Follow up actions:

1. EPA will e‐mail Valent a Microsoft Word version of the use pattern table which was

provided as a PDF prior to the meeting.

2. Valent will fill in the missing label parameters, as discussed during the meeting, on

the use pattern table.  Valent will send the completed table and a letter to EPA with

a written commitment to revise product labels to reflect rates and application

intervals as specified in the use pattern table.  [Submission of revised labels as an

official label amendment will occur later in registration review after any additional

label statements or potential mitigation have been identified.]

 Data requirement for soil adsorption / desorption study for IMCA degradate (GLN

835.1230).
Discussion:  EPA acknowledged receipt of Valent’s March 15, 2013 letter which included

additional information regarding a previously submitted flumiclorac acid (i.e., IMCA)

adsorption / desorption study (MRID 42169845), in response to EPA’s letter to

Valent of January 14, 2013.  EPA stated that a cursory review of the additional

information looked promising to fulfill the data requirement.  However, EPA noted

that all supporting data need to be submitted in a guideline compliant format per

PRN 2011‐3 and fully reviewed in order to be relied upon for risk assessment.  EPA

also recommended calculating KOC values at the 2nd rather than the 1st time step in

the 1st and 3rd soils in Table 1, which is the latest time step at which IMCA was near

or greater than 90% of the applied test compound.

Follow up actions:

1. Valent will submit the additional information, in guideline compliant format, to EPA

(as an addendum to the original 1991 study submission, MRID 42169845) by July 15,

2013.

 Data requirement for environmental chemistry methods (ECM) and independent laboratory

validations (ILV) for flumiclorac‐pentyl in soil and water

Discussion:  EPA acknowledged receipt of Valent’s March 15, 2013 letter which included

additional information regarding the flumiclorac‐pentyl ILVs in soil and water, as

requested by EPA’s letter to Valent of January 14, 2013.  EPA stated that based on

the information in Valent’s letter, it appears that the same LC mass spec was used to

analyze the samples for the ECMs and ILVs, and as such, the ILVs are not

independent.  EPA stated that ILVs could not be upgraded based on this information.  

Valent stated that their laboratory recently obtained a second LC mass spec and

inquired if the ILVs were redone on this equipment, if that would be acceptable to

EPA.  EPA responded in the affirmative.

Follow up actions:

1. Valent will re‐run the soil and water ILV analyses using a different LC mass spec (and

different study director, staff, and other laboratory equipment) than those that

analyzed the ECM samples and submit the information to EPA by July 15, 2013.

 Is the wettable powder product (EPA Reg # 59639‐100) packaged in water soluble bags?  

Are any flumiclorac‐pentyl products formulated as granulars?

Discussion:  Valent confirmed that the wettable powder product is packaged in water

soluble bags.  Valent stated that flumiclorac‐pentyl products are formulated as

emulsifiable concentrates and one wettable powder.  There are no granular

products.

Follow up actions:

1. EPA will consider this information when conducting the upcoming registration

review preliminary risk assessments.