1

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 __gerret.vanduyn@bayer.com__ 

(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: 
2

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? 
3

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 

 

1

 Excludes capital investment or maintenance and operational costs, as per 79 FR 6898 
4

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

: 556 

Hours per year for Incidents3: 262 

 

Capital costs of data systems: $617,500 

Labor Costs: $76,204 

Total Costs: $693,704 

Total Hours: 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. 

3

 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. 
5

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

Working Cost of Capital4

: 7.8% 

Annual Costs: $693,704 

Opportunity Costs: $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