Attachment N -Consultation

Attachment E
Summary of Consultations
This attachment is available as part of the electronic docket EPA-HQ-OPP-2015-0715 and is
part of the ICR’s Supporting Statement

I. Companies Contacted:
A. Charlotte Sanson, Bayer
Charlotte.sanson@bayer.com
(919) 549-2824
B. Dan Kunkel, Ph.D.
IR-4 Program, Rutgers University
kunkel@AESOP.Rutgers.edu
732-932-9575
C. John Abbott, Syngenta
john.abbott@syngenta.com

1

II. Consultation Questions:
(1)

Publicly Available Data
$
$

(2)

Is the data that the Agency seeks for your product(s) 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 are not specific to your package/bait station?)

Frequency of Collection
$

(3)

Can the Agency collect this information less frequently and still produce the same
outcome?

Clarity of Instructions
$

$
$
(4)

Based on the regulations, PR Notices, Agency webpages, etc., is it clear what type
of information you are required to submit 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 for the life of the
pesticide product registration?
Is the submission format 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.
$
$

(5)

Can the information be submitted electronically? If not, would you be interested
in this option?
Are you keeping your records electronically? If yes, in what format?

Burden and Costs
•

Are the burden hours in the table below accurate? The table provides EPA’s estimate of
management, technical, and clerical burden hours per petition. In each row, the total cost
is the sum of the estimated burden hours times the hourly rate for each personnel
category.

•

Bearing in mind that the burden and cost estimates include only burden hours and costs
associated with the paperwork involved with submitting tolerance petitions. Burden
means the total time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal agency. This
2

includes the time needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train personnel to be
able to respond to a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the information. If you
provide burden estimates different from EPA’s, please provide an explanation of how
you arrived at your estimates.
Table I

ACTIVITIES

Review FFDCA regulations
CFR citation; PRN 97-1
Conduct Field Trial
Prepare Petition
Read Notice of any petition
deficiency
Prepare response
Maintain information
TOTAL BURDEN

HOURS and RATES
Mgmt.
$141/hr
25

Tech.
Cler.
$76/hr $39/hr
48
24

252
42
1

1,080
30
1

2
1
323

44
8
1,211

3

25
116
1
12
14
192

COSTS
(per petition)
Total
Hours
97
1,357
188
3
58
23
1,726

Total Costs
$9,587
$137,886
$15,460
$305
$4,778
$1,565
$169,581

III. Response provided by Dan Kunkel, IR-4
(1)

(2)

Publicly Available Data
$

Is the data that the Agency seeks for your product(s) available from any public
source, or already collected by another office at EPA or by another agency?
By in large, our data are available to the public upon request. A listing of our data
is available at our website. We submit most all of our data to EPA-OPP. It is not
a duplication. Sometimes FOIA requests are used to get our information. IR-4
keeps archives for the life of an EPA registered product.

$

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 are not specific to your package/bait station?)
In basic terms, we are a public institution and our research is funded by USDA.
Therefore, yes our data are available publically.

Frequency of Collection
$

(3)

(4)

Can the Agency collect this information less frequently and still produce the same
outcome?
No we make the submissions to request a pesticide tolerance. As growers request
tolerances, IR-4 submits them to EPA.

Clarity of Instructions
$

Based on the regulations, PR Notices, Agency webpages, etc., is it clear what type
of information you are required to submit and how to submit such data? If not,
what suggestions do you have to clarify the instructions?
Yes

$

Do you understand that you are required to maintain records for the life of the
pesticide product registration?
Yes and therefore, we maintain archives of all of our data for the life of the
pesticide product. IR-4 follows the 8-60 guidelines for OPPTS (OCSPP).

$

Is the submission format clear, logical, and easy to complete? Yes

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.
$

Can the information be submitted electronically? If not, would you be interested
in this option?
4

Yes and we submit all of our reports electronically to EPA. Prior to December
2015 all our submission were done on a CD. Now IR-4 is using the Portal for
almost all submissions. The Portal is more forgiving and makes it easier to
quickly correct mistakes of names and typos.
$

(5)

Are you keeping your records electronically? If yes, in what format?
Most of our recent submissions (past 10 years) are available electronically,
however we have paper copies of all data and reports in archives.

Burden and Costs
•

Are the burden hours in the table below accurate? The table provides EPA’s estimate of
management, technical, and clerical burden hours per petition. In each row, the total cost
is the sum of the estimated burden hours times the hourly rate for each personnel
category.
Yes, they are pretty close to our estimates. Please see adjustments for preparing
responses, our cost is less compared to industry since our data are directed to the area of
pesticide residues on crops only.

•

Bearing in mind that the burden and cost estimates include only burden hours and costs
associated with the paperwork involved with submitting tolerance petitions. Burden
means the total time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train personnel to be
able to respond to a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the information. If you
provide burden estimates different from EPA’s, please provide an explanation of how
you arrived at your estimates.
Table I

ACTIVITIES

Review FFDCA regulations
CFR citation; PRN 97-1
Conduct Field Trial
Prepare Petition
Read Notice of any petition
deficiency
Prepare response
Maintain information
TOTAL BURDEN

HOURS and RATES
Mgmt.
$141/hr
25

Tech.
Cler.
$76/hr $39/hr
48
24

252
55
1

1,080
30
1

2
1
336

44
8
1,211
5

25
116
1
2
14
192

COSTS
(per petition)
Total
Hours
97
1,357
201
3
20
23
1,739

Total Costs

$130,000
$48,000
$283
$1700
$1,500
$