Attachment D - Record of Consultations

ICR ATTACHMENT D
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.) Dr. Russell P. Schneider, Senior Director, Regulatory Affair and Policy,
Monsanto Company, [email protected]
2.) Mr. Nick Storer, Dow AgroSciences, [email protected]
3.) Tracy Rood, Senior Regulatory Manager, Pioneer Hi Bred, INC., A Dupont
Company, [email protected]

Fw: Plant Incorporated Protectant ICR Reveiw and consultation
Robert Forrest to: Scott Drewes

06/15/2010 08:17 AM

Cc: Mike Mendelsohn, Alan Reynolds

Scott, this is Dow's response.

----- Forwarded by Robert Forrest/DC/USEPA/US on 06/15/2010 08:15 AM ----From:
To:
Date:
Subject:

"Storer, Nicholas (N)"
Robert Forrest/DC/USEPA/US@EPA
06/14/2010 01:53 PM
RE: Plant Incorporated Protectant ICR Reveiw and consultation

Mr. Forrest
I have sent these documents around our biotech regulatory leaders.
Unfortunately, we do not feel able to provide meaningful input. We feel
that the CBI time estimates appear to be about right, though we do not
have good estimates ourselves. For the adverse effects reporting, we
have not had experience with this in relation to the types of products
covered; however, based on experience with other adverse effects
reporting, we feel the time estimates are likely to be low.
I am sorry that we are not able to provide anything more informative on
these. Please feel free to get in touch again if you have additional
questions.
Best regards
Nick Storer
Dow AgroSciences LLC
-----Original Message----From: [email protected]
[mailto:[email protected]]
Sent: Monday, 07 June, 2010 12:41 PM
To: Storer, Nicholas (N)
Subject: Plant Incorporated Protectant ICR Reveiw and consultation
Mr. Nick Storer
Dow AgroSciences
Mr. Storer
It was good to talk to you today and we very much appreciate your
participation in consultation for the Information Collection Request
(ICR) for Plant Incorporated Protectant (PIP), Confidential Business
Information (CBI) Substantiation and Adverse Effects Reporting. Below
you will find additional information regarding background, action
outline, relevant attachments, link to the docket, and a contact name
and number.
Background
The Environmental Protection Agency's (EPA), Office of Pesticide Program
(OPP) is proposing to renew for another three years the ICR for PIPs CBI
Substantiation and Adverse Effects Reporting (OMB No. 2070-0142, EPA

No.1693.06). ICR's are required to be renewed every three years and we
re-estimate burden based on any new information available to the Agency.
Action
In an effort to actively seek input from respondents to this ICR, EPA is
contacting you to ask for your feedback regarding this Information
Collection Request (ICR). Please use the " Consultation Questions" form
attached when crafting your response. Also, please note that your
comments/feedback along with your name and e-mail address, will appear
in a publicly available document along with your name and e-mail address
( the Docket for this ICR action). Your response to this request would
be most appreciated within the next week or two (by June 24, if
possible), however, if your response comes in after that time frame, the
Agency will enter your response directly into the Docket.
Attachments
I am attaching the following documents:
1.

the list of consultation questions
(See attached file: Consultation Questions.doc
(See attached file: consultation questions.doc)

2.
renewal

an excerpt of the proposed burden section 6 of the ICR
(See attached file: Section 6 Excerpt-Consultations-doc
(See attached file: ICR_Section 6.doc)

3.
docket)

and a copy of the proposed ICR (the same copy that is in the

(See attached file:
DRAFT_PIP_ICR_Supporting Statement_2010 03 30.doc)
"The Agency has established a public docket for this ICR under Docket
NO. EPA-HQ-OPP-2010-0281, which is available for on line viewing at
www.regulations.gov. The docket contains links to the attachments cited
in the ICR proposal."
Direct link to the Federal Register Notice:
http://www.regulations.gov/search/Regs/home.html#documentDetail?R=090000
6480ab35fe
If you have any additional questions, you may contact me via e-mail
[email protected] or by phone at (703) 308-9376

Sample Consultation Questions OPP ICR Renewals
EPA Questions asked in Consultation
(1)

(2)

Publicly Available Data
$

Is the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?

$

If yes, where can you find the data? (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are available, but
that they don=t meet our data needs very well?)

Frequency of Collection
$

(3)

(4)

Is the submission of CBI Substantiation Claims or Adverse Effects Reports too
frequent?

Clarity of Instructions
$

The ICR is intended to require that respondents provide certain data so that the
Agency can utilize them.

$

Based on the instructions (regulations, PR Notices, etc.), is it clear what you are
required to do and how to submit such data? If not, what suggestions do you have
to clarify the instructions?

$

Do you understand that you are required to maintain records?

$

Are there forms associated with this process? Do you use them? Are they clear,
logical, and easy to complete?

Electronic Reporting and Record keeping
The Government Paperwork Elimination Act requires agencies make available to the
public electronic reporting alternatives to paper-based submissions by 2003, unless there
is a strong reason for not doing so. One such reason is that, at the present time, the
Agency is unable to ensure the security of CBI that might be transmitted over the
Internet.
$

$

What do you think about electronic alternatives to paper-based records and data
submissions? Current electronic reporting alternatives include the use of web
forms@/XML based submissions via the Agency’s Internet site and magnetic
media-based submissions, e.g., diskette, CD-ROM, etc. Would you be interested
in pursuing electronic reporting?
Are you keeping your records electronically? If yes, in what format?

Although the Agency does not offer an electronic reporting option because of CBI-related
security concerns at this time,
1

$
$

(5)

Would you be more inclined to submit CBI on diskette (CD or DVD) than on
paper?
What benefits would electronic submission bring you in terms of burden
reduction or greater efficiency in compiling the information?

Burden and Costs
The following questions refer to Tables 1 and 2 in Section 6 of the ICR (see the Section 6
excerpt that is attached). Tables 1 and 2 provide EPA’s estimate of the average
respondent burden and cost estimates for Substantiation of CBI Claims and Adverse
Effects Reporting, respectively

.
$
$

$

The Agency assumes there is no capital cost associated with this activity. Is that
correct?
Bearing in mind that the burden and cost estimates include only burden hours and
costs associated with the paperwork involved with this ICR, e.g., the ICR does not
include estimated burden hours and costs for conducting studies, are the estimated
burden hours and labor rates accurate? If you provide burden and cost estimates
that are substantially different from EPA’s, please provide an explanation of how
you arrived at your estimates.
Are there other costs that should be accounted for that may have been missed?

2