Record of Consultations Between the U.S. Environmental Protection Agency
and

Respondents to the Information Collection Request:

“Plant-Incorporated Protectants; CBI Substantiation and Adverse
Effects Reporting”

(Consultations conducted September, 2006)

1. Myrna Q. Sevilla, Ph. D.;  BHN Research

2. Penny Hunst;  Dow Agrosciences

3. Russell Schneider;  Monsanto Co.

15 September 2006

Dear Mr. Torla:

Here are my answers to the questions

Are the data EPA asks for available from another source?

No, I do not think that EPA is asking for data that is available from

another source. In the case of adverse effects, I believe that each

experience is unique for each submitter and that although there may be

similar studies published in scientific journals, the conditions and

parameters at which such are conducted will still be different from that
ofany submitter's.

Are the instructions for submission clear?-Please include any comments
on frequency of information collection here.

The instructions are clear for the reporting of the adverse effects. I
would suggest a similar format for CBI, i.e. there should be a standard
form as to what information should be included in the claim.

Frequency - At the time of submission and any time the CBI status
changes from CBI to non-CBI; Adverse effects - within 30 days and status
report every month until all PIPS sold/distributed are accounted for.

Would you be interested in electronic reporting of data?

Yes, this will make the process faster but only if EPA can guarantee

absolute secure transmission and data storage.

4. Do you find the burden and costs estimates in the ICR realistic? See
the attached tables.

I think the estimates are realistic.

Hope this helps. Let me know if you have any other questions.

Sincerely,

Myrna Sevilla

************************************************************************
****

Myrna Q. Sevilla, Ph. D.

Biotech Coordinator/Molecular Biologist

BHN Research

Mailing Address: PO Box 3267, Immokalee, FL 34142

Physical Address: 25675 Immokalee Rd, Immokalee, FL 34142

Phone: 239-352-1100

Fax: 239-352-1565

Email: mqs@bhnseed.com

Web: www.bhnseed.com

************************************************************************
****

18 September 2006

Penny Hunst

Dow Agrosciences

We are renewing the ICR (information collection request) for the PIP;
CBI Substantiation and Adverse Effects Reporting rule   OMB
No.:2070-0142       EPA ICR No.: 1693.03).  ICR’s are required to be
renewed every three years and we re-estimate burden based on any new
information available to the Agency.  Note that the burden/cost tables
are labeled draft and if we change the estimates prior to submission to
the Office of Management and Budget, we will provide you copies of the
new estimates and an opportunity to comment again.  

Part of this renewal requires EPA to contact at least three persons
whose names and contact numbers will be listed in the ICR document.  I
propose to list email addresses rather than phone numbers.  Please let
me know which you prefer.  You may have access to another phone number
or email address to which such responses would be routed to. Please do
not list my e-mail or phone.  Instead, use the following e-mail address:

			  HYPERLINK "mailto:felusrg@dow.com"  felusrg@dow.com 

Summarized comments will also be included in the ICR document without
identification of the specific source.  Registrants and the Agency now
have had several years of CBI substantiation and several years of no
adverse effects reports. The lack of adverse effects reports implies we
have no information to better estimate the burden of adverse effects
reporting on industry or the Agency.  

We are repeating the original questions with the aim of seeing if the
data required are available from another public source, how often the
information should be collected, are the instructions for data
collection sufficiently clear, thoughts on electronic reporting of data
and the burden and costs of the information.

EPA has changed its method of estimating labor costs for both industry
and EPA. The effect of this method change has been to lower the dollar
burden estimates. 

The CBI Substantiation requires registrants to substantiate and claims
of CBI for PIP registration related submissions.  The Adverse Effects
Reporting requirement requires registrants to submit claims of adverse
effects for exempted PIPs’.  We have yet to receive an adverse effects
report for an exempted PIP.  

The questions follow:

      1.  Are the data EPA asks for available from another source?  Not
that I am aware of.

Are the instructions for submission clear?—Please include any comments
on frequency of  information collection here.  Yes, the instructions are
clear.

Would you be interested in electronic reporting of data?  Yes, it would
be of interest.

Do you find the burden and costs estimates in the ICR realistic? Yes,
however, hourly rates may be a little “light”.  See the attached
tables.

     Please let me thank you in advance for your review of this
information.  

Robert F. Torla,

Economist

20 September 2006

Russell Schneider

Monsanto Co.

We are renewing the ICR (information collection request) for the PIP;
CBI Substantiation and Adverse Effects Reporting rule   OMB
No.:2070-0142       EPA ICR No.: 1693.03).  ICR’s are required to be
renewed every three years and we re-estimate burden based on any new
information available to the Agency.  Note that the burden/cost tables
are labeled draft and if we change the estimates prior to submission to
the Office of Management and Budget, we will provide you copies of the
new estimates and an opportunity to comment again.  

Part of this renewal requires EPA to contact at least three persons
whose names and contact numbers will be listed in the ICR document.  I
propose to list email addresses rather than phone numbers.  Please let
me know which you prefer.  You may have access to another phone number
or email address to which such responses would be routed to.  Summarized
comments will also be included in the ICR document without
identification of the specific source.  Registrants and the Agency now
have had several years of CBI substantiation and several years of no
adverse effects reports. The lack of adverse effects reports implies we
have no information to better estimate the burden of adverse effects
reporting on industry or the Agency.  

We are repeating the original questions with the aim of seeing if the
data required are available from another public source, how often the
information should be collected, are the instructions for data
collection sufficiently clear, thoughts on electronic reporting of data
and the burden and costs of the information.

EPA has changed its method of estimating labor costs for both industry
and EPA. The effect of this method change has been to lower the dollar
burden estimates. 

The CBI Substantiation requires registrants to substantiate and claims
of CBI for PIP registration related submissions.  The Adverse Effects
Reporting requirement requires registrants to submit claims of adverse
effects for exempted PIPs’.  We have yet to receive an adverse effects
report for an exempted PIP.  

The questions follow:

      1.  Are the data EPA asks for available from another source?  NO

Are the instructions for submission clear?—Please include any comments
on frequency of  information collection here.  YES

Would you be interested in electronic reporting of data?  YES, IF
CONFIDENTIAL INFORMATION COULD BE PROTECTED.

Do you find the burden and costs estimates in the ICR realistic?  See
the attached tables.  THEY LOOK ACCEPTABLE.  HOWEVER, IN THE ADVERSE
REPORTING SECTION I THINK YOU NEED TO ADD THE COST OF DATA COLLECTION
FOR POISON CONTROL CENTERS AND ANIMAL POISON CONTROL CENTER.  OFTEN
THESE SERVICES REQUIRE CONTRACTS AND COSTS CAN BE QUITE HIGH.   IN OUR
CASE WE SPEND ABOUT $150,000 PER YEAR TO HELP US WITH THIS EFFORT.

     Please let me thank you in advance for your review of this
information.  

Robert F. Torla,

Economist

