Attachment G-1: Consultation- Bayer

EPA Questions Asked in Consultation for the 6(a)(2) ICR:
Name ___Gerret Van Duyn______________, Company__Bayer CropScience LP______
Date______3/13/2014___________________, e-mail address [email protected]__

(1)

Publicly Available Data
a) Is the data that the Agency seeks available from any public source, or already collected
by another office at EPA or by another agency?
Incident and internally conducted study data is available only through Bayer
CropScience. Some data, such as those conducted by universities, is publically
available to the EPA upon request.
b) 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?)
Some data is available publically. University data is located at the researching
university. Other data is available through state poison control centers, or state
administrative departments (e.g. Department of Agriculture). Also, information
collected as part of litigation (both civil and criminal) can sometimes be located via
court filings in the respective jurisdiction(s).

(2)

Frequency of Collection
a) Can the Agency collect the information less frequently and still produce the same
outcome?
It is unusual to receive comments back from the agency on any incident (less than 20
requests for additional information since October 2007 usually to clear up
administrative details.) Should this response rate be normal, all incidents can be
reported on a quarterly basis with nearly the same results.

(3)

Clarity of Instructions
a) The ICR is intended to require that respondents provide certain data so that the Agency
can utilize them.
b) 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?
Instructions are usually clear as represented in 40 CFR 159, 40 CFR 152.50(f)(3) and
guidance documents. However, some circumstances result in interpretations which
need resolution. Examples are:
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1. Review of publically available information and requirement to submit to the EPA. The
regulations currently read that information indexed in a database available to EPA is
not reportable….however, these regulations have not been updated to account for the
advent of the internet, search engines, or other information can be located now by
EPA or any member of the public if desired.
2. The extent to which EPA consults or relies upon data from “Sister” agencies such as
USDA, CDC, etc. and what information EPA is “assumed” to have (such as FDA detects
of residues during routine inspections of food in the commercial channels) and the
registrant’s responsibilities as a result.
3. Clarification on H-C class incidents – which are generally intended to communicate to
the agency more serious non-permanent incident symptoms or allergenic
potential….however, should someone go to the hospital (an indication of the
perceived seriousness of the symptoms) but have only a symptom which is minor in
nature should the coding of the incident be on the perceived symptom or on the
reported symptom?
c) Do you understand that you are required to maintain records?
Yes. Bayer CropScience maintains 6(a)(2) records for the life of the registration, and
beyond as specified in 40 CFR 169.
d) Considering that there is no required submission format, is it difficult to submit
information in ways that are clear, logical and easy to complete?
Not usually. Incidents are placed in the standard reporting format, and studies are
outlined in accordance with 40 CFR 159. The format of the report is only difficult
when certain information is not available.
e) Regarding the Voluntary Incident Reporting Forms, do you use them? Are they clear,
logical, and easy to complete?
Yes, voluntary incident reporting forms are the standard format which Bayer
CropScience uses.
(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. The U.S. E.P.A. Office of Pesticide Programs has a
program for electronic study submissions, and is currently developing plans for systems
to support electronic incident reporting. The Agency is also concerned to protect FIFRA
CBI as well as personal information.
a) 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?
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1) Would you be more inclined to submit CBI on diskette, CD, or DVD, or via web
rather than on paper?
Bayer supports the use of electronic submission. As an economically viable means
of communicating CBI, submission of studies on a CD or portable electronic storage
device (preferably with an encryption key) would be good. The current ePRISM
system is also highly utilized and is good as metadata can automatically be
assigned to study reports and other data to help the agency efficiently go through
reports, CBI, and other materials to execute its duty.
Since the last ICR, Bayer has participated in ePRISM submissions for 6(a)(2) studies
which continue to make both Bayer and the EPA more efficient through higher
utilization of tools and processes.
Aside from studies, the provision of incident reports in electronic format (e.g. PDF
files) would save considerable time, and allow for electronic archiving of data
rather than both electronic and hardcopy archiving. The EPA would also not have
to invest in scanning and electronically converting such information reducing costs
and time to the US Government. Finally, should a system be generated where
processes such as XML transfer or other means of communicating metadata be
developed, Bayer could establish direct links to the EPA system to upload this
information in its most current form with no respect to timeline making such
information more current to the agency. It would also eliminate duplicative typing
and potential typographical errors of data captured, and would allow for a broader
number of data fields to be available to the agency. Such data could be converted
into any number of useful products for registration activities, pre-screened CBI
FOIA request, or other labor saving products.
2) What benefits would electronic submission bring you in terms of burden
reduction or greater efficiency in compiling the information?
Benefits include but are not limited to:
i. Reduction of formatting errors
ii. Reduction of paper / hardcopy form
iii. More timely compilation of data (no need to put data into standardized
forms)
iv. More accurate data (reduction of copy/paste errors, typographical
errors, or transcription errors)
v. Better archiving (electronic records vs. hardcopy logs)
(5)

Burden and Costs
a) Are the labor rates accurate?
Based upon EPA’s estimate of 264,957 hours worked, and annual cost burden of
$15,940,734, an hourly estimate of $60.16 / hour is calculated1. Bayer CropScience

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Excludes capital investment or maintenance and operational costs, as per 79 FR 6898

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has calculated this same rate to be as low as $133.09 / hour and as high as $192.02 /
hour depending on the function utilized to conduct 6(a)(2) screening. This labor rate is
inclusive of overhead which includes capital expenditures, and other investments that
EPA does not consider.
b) The Agency assumes there is no capital cost associated with this activity. Is that correct?
No. Bayer has significant investments in capital in the form of electronic reporting
requirements, data servers, and dedicated trending / analysis programs which add
significantly to the hourly rate and therefore the total cost. Additionally there is the
cost of transportation (vehicles) and other expenses with having personnel in the field
to investigate incidents, and coordinate responses to these incidents. For its
comments here, Bayer takes the average hourly rate amongst all divisions involved in
6(a)(2) screening to calculate its costs at 70% of the capital inclusive labor rate at the
low end to be $93.16 / hour.
c) 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.
No. Bayer’s estimate only bears the cost of electronic infrastructure capital (not
counting vehicles and other capital investments) and time for incident input and
investigation, as well as adverse effects screening of studies. Bayer calculated the cost
of compliance using the data below. Data was collected through survey of the
responsible individuals, as well as reporting from electronic archiving systems, which
capture and control information to ensure compliance with 6(a)(2) requirements.
Bayer has made improvements to its infrastructure which has cut down on the manual
labor required to process 6(a)(2) incidents versus comments made during the last ICR.
Hours per year for study review2:
Hours per year for Incidents3:

556
262

Capital costs of data systems:
Labor Costs:

$617,500
$76,204

Total Costs:
Total Hours:

$693,704
818

Cost per Hour:

$693,704 / 818 = $93.16

2

Average of number of internal studies reviewed from 1/1/2009 to 12/31/2013 (2,241 studies) multiplied by the
average time provided by R&D functions to review such studies (43 minutes / study). This cost excludes
publication reviews and other non-BCS “study” information.
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Average of number of incidents reviewed and investigated from 1/1/2009 to 12/31/2013 multiplied by an
average review time of 7 minutes + all outside vendor and other associated costs with collection of such data, but
excluding capital investments which are accounted for in Bayer’s labor rate.

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d) Are there other costs that should be accounted for that may have been missed?
Working Cost of Capital4:
Annual Costs:
Opportunity Costs:

7.8%
$693,704
$693,704 x 7.8% = $54,108

This is a conservative estimate, as it only calculates the cost of the funding dedicated
to compliance activities, if it were invested in a vehicle returning an expected rate of
return for the marketplace.

4

BCS expected rate of return based on 2009 Bayer AG annual report

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