ATTACHMENT H:

Response to EPA on ICR Burden Consultation

(Record of Consultation Correspondence)

From:

"SCHNEIDER, RUSSELL P" <russell.p.schneider@monsanto.com>

Subject:

RE: ICR for Tolerance Petitions

Anthony,

The only thing I would correct is the last sentence of the abstract.  
It should say "exemption from the requirement of a tolerance" not "to
have a tolerance".  

I can not comment on the estimated costs, but would agree they have
increased.  Regardless, the action, either a tolerance request, or the
request for an exemption from the requirement of a tolerance, must be
completed and must be completed in a manner acceptable to the EPA.  I
don't see how this can be confrontational.

Russ

From:

greg.watson@syngenta.com 

Subject:

FW: ICR for Tolerance Petitions

Dear Anthony,

Sorry for the delay in getting this back to you; I was working on it ast
week - & somehow lost the comments that I had added to the file. y
comments have been inserted into the document using the WordPerfect
comment function (i.e., when you see the gray GRW, my comments are
included there).

As far as the cost estimates, I think that these are in line with
current costs.  In fact, yesterday when I was attending the Southern
Weed Science Society meeting I was told  that IR-4 budgets about
$110,000 for a residue trial series for a commodity.  I think the caveat
comment that the cost that you list is an average is important, as a
crop grouping petition would be more costly than a single crop & some
methods cost more than others to run for the analytical phase.

Hope this helps . . .  

Best Regards,

Greg Watson

State Regulatory Affairs & Federal Label Support Team Lead 

Syngenta Regulatory Affairs

ph 336 632 2993 or 800 334 9481 ext 2993

mobile 336 707 7162

fax 336 632 2884

From:

Dan Kunkel <kunkel@AESOP.Rutgers.edu> 

Subject:

RE: ICR for Tolerance Petitions

Dear Anthony,

Please note that by in large IR-4 only conducts and submits Residue
studies to EPA.  I have reviewed your table 1, 2, and 3 for Annual
Respondent Burden/Cost Estimates.  I feel that these tables are
accurate.  Considering that IR-4 submits approximately half of all
petitions submitted to EPA each year would indicate that we submit
approximately 75 of the average number of 150 petitions per year. 
Considering that the IR-4 budget received from USDA in 2005 was $14.9
(CSREES and ARS) Million then removing monies for other programs like
ornamentals etc.  Our Residue program is around $10 Million which is
very close to half of your total annual cost ($23,973,150, Table 3
Petitioners Cost).  Although IR-4 studies often require fewer field
trials, we often provide a greater number of studies in each petition.  
Therefore, again I feel that the numbers you provided are comparable to
IR-4 overall cost.

Thanks for requesting our input.

Dan

Daniel Kunkel, Ph.D.

IR-4 Program, Rutgers University

kunkel@aesop.rutgers.edu

732/932-9575 x616#

http://ir4.rutgers.edu/

