Attachment D_Record of Consultations

Attachment D: Record of Consultations
This attachment is available as part of the electronic docket EPA-HQ-OPP-2013-0494 and is part
of the ICR’s Supporting Statement.

List of individuals/companies contacted.
1. Name:
Title:
Co:
Phone:
E-mail:
Comment:

Jamie Staley
Registration Manager
Pioneer Hi-Bred International, Inc.
515-535-6946
[email protected]
No comment provided

2. Name:
Title:
Co:
Phone:
E-mail:
Comment:

Dan Jenkins
U.S. Agency Regulatory Affairs Lead
Monsanto Company
202-383-2851
[email protected]
No comment provided

3. Name:
Tiltle:
Co:
Phone:
E-mail:
Comment:

Nicholas Storer, Ph.D.
Global Leader, Scientific & US Regulatory Affairs
Dow AgroSciences LLC
301 946 1721
[email protected]
See attached

Consultation Questionnaire for OPP ICR:
Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting
OMB Control # 2070-0142)
A list of the consultation questions asked and the responses thereto become a part of the
electronic public comment docket for this ICR renewal. Thus, a list of questions asked the
respondents and the responses received, written comments, verbal responses or e-mail, etc.
will become a part of the electronic public comment docket for this ICR renewal.

(1)

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?
Not to our knowledge
$

(2)

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
$

Is the submission of CBI Substantiation Claims or Adverse Effects Reports too
frequent?
Submission is required only as situations arise and is therefore not too frequent
(3)

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?

Requirements are clear
$
Yes
(4)

Do you understand that you are required to maintain records?

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? Would you be interested in pursuing electronic reporting?
1

Electronic submission, if secure and CBI maintained, using a simple and flexible format,
and a simple process, would be acceptable.
$
Yes

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,
$

What benefits would electronic submission bring you in terms of burden
reduction or greater efficiency in compiling the information?
Reduced duplication of work, decreased administration associated with physical
documents
(5)

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? 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. Burden and costs of reporting are minimal fiven
the documentation requirements
Are there other costs that should be accounted for that may have been missed?
No.

2