Attachment D- Consultation Responses

EPA ICR No. 1693.09
Docket ID: EPA-HQ-OPP-2017-0440

OMB Control No. 2070-0142
November 28, 2017

Attachment D
Record of Consultations for OPP ICR: “Plant-Incorporated Protectants; CBI Substantiation
and Adverse Effects Reporting,”
(OMB No. 2070-0142, EPA No. 1693.09)

I.

Representative(s) Consulted:
1. Kara S. Giddings
Monsanto Company
700 Chesterfield Pkwy West
St. Louis, MO 63017
(636) 737-9544
[email protected]
2. Matthew Pence
J.R. Simplot Company
5369 W. Irving St.
Boise, ID 83706
(208) 780-6040
[email protected]
3. Katie Davis
Syngenta Crop Protection, LLC
9 Davis Drive
Research Triangle Park, NC 27709-2257
(919) 226-7374
[email protected]

II.

Consultation Questions
1. Publicly Available Data


Is the information that the Agency seeks available from any public source or already collected
by another office at EPA or by another agency?
1. No
2. No
3. No



If yes, where can you find the data?
1. N/A
2. N/A
3. N/A

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EPA ICR No. 1693.09
Docket ID: EPA-HQ-OPP-2017-0440

OMB Control No. 2070-0142
November 28, 2017

2. Frequency of Collection


Can the Agency collect the information less frequently and still produce the same outcome?
1. In our opinion, the frequency of every three years is appropriate.
2. No.
3. The frequency is sufficient.

3. Clarity of Instructions


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

Based on the instructions (regulations, PR Notices, etc.), is it clear what you are required
to do and how to submit the data?
1. Yes
2. Yes
3. Syngenta has limited experience, if any, in utilizing these specific instructions for
PIPs, and therefore is not in a position to make suggestions on how to clarify them.

o

If not, what suggestions do you have to clarify the instructions?
1. N/A
2. N/A
3. N/A



Do you understand that you are required to maintain records?
1. Yes
2. Yes
3. Yes



Considering that there is no required submission format, is it difficult to submit information in
ways that are clear, logical and easy to complete?
1. No
2. No, the flexibility of the format allows for clarity of presentation regardless of the type of
information being submitted.
3. Syngenta has limited experience, if any, utilizing these specific processes for PIPs. In general
Syngenta has found that it is clear, logical, and easy to provide EPA with requested
information.

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EPA ICR No. 1693.09
Docket ID: EPA-HQ-OPP-2017-0440



OMB Control No. 2070-0142
November 28, 2017

Regarding any pesticide registration forms, do you use them? Are they clear, logical, and easy to
complete?
1. Yes, Monsanto Company uses the appropriate pesticide registration forms which we find
clear, logical, and easy to complete.
2. We use the forms and they are clear and easy to complete.
3. Syngenta has limited experience, if any, utilizing these forms to submit the information
discussed within this ICR for PIPs. In general, for PIP registration purposes, Syngenta has
found that it is easy to utilize EPAs pesticide registration forms.

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 was that, before September 2015, the Agency was 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, magnetic media-based submissions (e.g., diskette, CD-ROM, etc.),
and through EPA’s new Pesticide Submissions Portal (PSP).
1. Monsanto Company has transitioned to making all PIP submissions as applicable to the PSP
electronic reporting method.
2. Electronic alternatives for recordkeeping and data submission simplify the submission
process. Documents are more easily maintained, searched, and retrieved using electronic
formats. Paper use and/or waste is reduced.
3. Syngenta has utilized the PSP for submission of original registration documents and
documents associated with compliance with terms and conditions of existing registrations.
Syngenta strongly supports electronic submissions as a way to reduce the burden of
generating and maintaining paper based records.



Are you keeping your records electronically? If yes, in what format?
1. Yes, Monsanto Company maintains electronic records of all PIP submissions in a PDF format.
2. Yes, as Word documents (.docx, .xlsx) and in portable document format (.pdf).
3. Yes, PDF, Microsoft Word, and Microsoft Excel are used.

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EPA ICR No. 1693.09
Docket ID: EPA-HQ-OPP-2017-0440



OMB Control No. 2070-0142
November 28, 2017

Have you used the new Pesticide Submissions Portal to submit the information being collected in
this ICR?
o

If yes, how long did it take you to create a login and a password through the
Central Data Exchange (CDX) reporting site? How long did it take you to submit the
information related to this ICR in the PSP?
1. In our experience, it took approximately 1.0 hours to establish login and
password credentials through CDX. The actual submission was less in time
equaling approximately 0.5 hour.
2. No.
3. No, Syngenta has used the PSP only for submission of original registration
documents and documents associated with compliance with terms and
conditions of existing registrations. … 10-15 minutes… Not applicable.



Since the Agency started offering an electronic reporting option through EPA’s CDX reporting site,
would you be more inclined to submit the information associated with this ICR in PSP or on
diskette than on paper?
1. Yes
2. Yes
3. Syngenta would be more inclined to utilize the PSP.



What benefits would electronic submission bring you in terms of burden reduction or
greater efficiency in compiling the information?
1. The benefit of making electronic submission reduces the burden of time to gather
information, review information, and make the submission.
2. Electronic submissions would reduce burdens associated with cost and time for
printing, compiling, and shipping.
3. Since Syngenta has begun using the PSP, Syngenta has been able to eliminate the
need for hard copy documents associated with EPA registrations in most cases.

5. Burden and Costs


Are the labor rates accurate?
1. Yes
2. Yes
3. Syngenta has limited experience, if any, utilizing these specific processes for PIPs. Therefore,
for questions in Section 5, Syngenta is not in a position to determine the accuracy of labor
rates, capital costs, and/or other burdens associated with these processes.

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EPA ICR No. 1693.09
Docket ID: EPA-HQ-OPP-2017-0440



OMB Control No. 2070-0142
November 28, 2017

The Agency assumes there is no capital cost associated with this activity. Is that correct?
1. Yes
2. Yes
3. Syngenta has limited experience, if any, utilizing these specific processes for PIPs. Therefore,
for questions in Section 5, Syngenta is not in a position to determine the accuracy of labor
rates, capital costs, and/or other burdens associated with these processes.



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?
1. Yes
2. Yes
3. Syngenta has limited experience, if any, utilizing these specific processes for PIPs.
Therefore, for questions in Section 5, Syngenta is not in a position to determine the accuracy
of labor rates, capital costs, and/or other burdens associated with these processes.



Have you incurred additional paperwork burden as a result of third party disclosure
requirements involving disclosing product specific information to potential users and the
general public through the pesticide label?
1. No.
2. No
3. Syngenta has limited experience, if any, utilizing these specific processes for PIPs.
Therefore, for questions in Section 5, Syngenta is not in a position to determine the
accuracy of labor rates, capital costs, and/or other burdens associated with these
processes.



Are there other costs that should be accounted for that may have been missed?
o

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.
1. No burden and cost estimates were found to be substantially different from EPA’s.
2. No.
3. Syngenta has limited experience, if any, utilizing these specific processes for PIPs.
Therefore, for questions in Section 5, Syngenta is not in a position to determine the
accuracy of labor rates, capital costs, and/or other burdens associated with these
processes.

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