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, russell.p.schneider@monsanto.com 

2.) Mr. Nick Storer, Dow AgroSciences, nstorer@dow.com 

3.) Tracy Rood, Senior Regulatory Manager, Pioneer Hi Bred, INC., A Dupont 

Company, tracy.rood@pioneer.com 
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: "Storer, Nicholas (N)" <nstorer@dow.com>

To: Robert Forrest/DC/USEPA/US@EPA

Date: 06/14/2010 01:53 PM

Subject: 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: Forrest.Robert@epamail.epa.gov

[mailto:Forrest.Robert@epamail.epa.gov] 

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. an excerpt of the proposed burden section 6 of the ICR

renewal

 (See attached file: Section 6 Excerpt-Consultations-doc

 (See attached file: ICR_Section 6.doc)

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

docket)

 (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

Forrest.Robert@EPA.gov or by phone at (703) 308-9376
1

Sample Consultation Questions OPP ICR Renewals 

EPA Questions asked in Consultation 

(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? 

$ 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? 

(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? 

$ 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? 

(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? 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, 
2

$ 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? 

(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? 

$ 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?