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: Jamie Staley

Title: Registration Manager

Co: Pioneer Hi-Bred International, Inc.

Phone: 515-535-6946

E-mail: Jamie.staley@pioneer.com

Comment: No comment provided

2. Name: Dan Jenkins

Title: U.S. Agency Regulatory Affairs Lead

Co: Monsanto Company

Phone: 202-383-2851

E-mail: Daniel.j.jenkins@monsanto.com

Comment: No comment provided

3. Name: Nicholas Storer, Ph.D.

Tiltle: Global Leader, Scientific & US Regulatory Affairs

Co: Dow AgroSciences LLC

Phone: 301 946 1721

E-mail: nstorer@dow.com

Comment: See attached
1

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

$ 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?) 

(2) 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

$ Do you understand that you are required to maintain records? 

Yes

(4) 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? 
2

Electronic submission, if secure and CBI maintained, using a simple and flexible format, 

and a simple process, would be acceptable.

$ Are you keeping your records electronically? If yes, in what format?

Yes

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.