ICR Attachment D - Record of EPA Consultations With Respondents

Final ATTACHMENT D.pdf

Submission of Protocols and study Reports for Environmental Research Involving Human Subjects (40 CFR 26)

ICR Attachment D - Record of EPA Consultations With Respondents

OMB: 2070-0169

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 2070-0169 can be found here:

Document [pdf]

Download: pdf | pdf

EPA ICR No. 2195.03

OMB Control No. 2070-0169
ATTACHMENT D

Record of EPA Consultations With Respondents Regarding the ICR Renewal

David Johnson
Agricultural Handlers Exposure Task Force
Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II
Scott Carroll
Carroll-Loye Biological Research
Robin Todd
ICR, Inc.
Joel Panara
Grayson Research LLC

David Johnson
Ag Handlers Exposure Task Force

Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control # 2070-0169)

Publicly Available Data
a.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?
No. The AHETF data will either supplement the existing data in the Pesticide
Handlers Exposure Database (PHED) or provide all of the data for scenarios that
are not covered in PHED.

If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?
As stated above, the only available data are in PHED. The AHETF data will
supplement rather than duplicate data in PHED.

Frequency of Collection
a.

Can the Agency collect the information less frequently and still produce the same
outcome?
This is not applicable to the AHETF.

Clarity of Instructions
a.

The rule is intended to require respondents to provide certain data for the
Agency’s use. Is it clear from the regulations and other Agency guidance what
you are required to submit and how to submit it? If not, what suggestions do you
have to clarify the information?
The rule gives a general overall explanation on the process but does not cover
exactly what needs to be submitted and how it needs to be submitted. Guidance
on what and how to submit has been gained through trial and error. Once a
procedure is established, this should be documented in some form of guidance
from the EPA. It would also be helpful to have guidance on specific ethical
requirements for conducting occupational exposure monitoring studies to improve
the chances of getting favorable reviews the first time through.

Do you understand that you are required to maintain records?
Yes, keeping detailed records is standard practice for the AHETF as part of the
GLP regulations. However, the volume of records that need to be kept has
1

David Johnson
Ag Handlers Exposure Task Force

increased significantly and there is still some question about exactly what records
need to be documented from an ethical standpoint.
c.

Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?
It is difficult and time-consuming for the AHETF to format the submission
materials due to the large number of documents required for each study (e.g.,
protocols, informed consent forms, recruiting documents, input from experts,
product labels and MSDS, and IRB materials) and the number of protocols that
need to be included with each submission (i.e., all of the protocols covering a
scenario are submitted together). It is virtually impossible to submit the
documents required for each individual study without a great deal of duplication
in the submission package. This duplication is the result of all protocols within a
scenario being very similar with only minor differences from one study to the
next. Therefore, many of the documents will be common to all studies within a
scenario.
The need for a large number of pages is due primarily to the requirement for
including all of the materials and correspondence exchanged between the AHETF
and the IRB. This exchange of material accounts for over half of the submission
and is largely a duplication of the protocols and informed consent forms. For
example, the submission package covering two studies for the June HSRB review
contained about 2300 pages. The submission package being prepared for the
October HSRB review will also contain over 2000 pages covering six studies.
Most of the 2000 pages will consist of materials and correspondence exchanged
with the IRB.

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?
The only form provided by EPA is a checklist of items from the rule that must be
covered for every protocol. The form is taken directly from the Rule and is not
especially difficult to complete, but does take a significant amount of time.

Electronic Reporting and Record keeping
The Government Paperwork Elimination Act requires that agencies make available
electronic reporting alternatives to paper-based submissions. Entities that submit study
protocols and/or reports in response to EPA’s 2006 final rule may elect to submit the
information either on paper or electronically via email, CD, or DVD.
a.

What do you think of electronic alternatives to hard-copy data submissions?
The AHETF prefers electronic submissions.

Are you keeping your records electronically? If yes, in what format?
2

David Johnson
Ag Handlers Exposure Task Force

Yes, records are kept in several forms including MS Word, Excel, Adobe
Acrobat, and e-mail files. Key documents are also stored on a task force server
for easy access by AHETF members.
c.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?
Most of the information is generated electronically, so converting this to hard
copy for the submission would be an additional burden.

Burden and Costs
a.

The labor rates EPA will use to estimate costs for regulated entities are taken from
the May 2007 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 32530 (Pesticide, Fertilizer, and Other Agricultural
Chemical Manufacturing), published by the Bureau of Labor Statistics. The BLS
rates for this industry are $103/hour for management, $71/hour for technical staff,
and $41/hour for clerical staff. Do you think these labor rates are appropriate?
Can you suggest another NAICS code that would be more appropriate?
The rates used by EPA are about half what it is costing the AHETF. The
technical and management work of the AHETF is done by professional research
scientists so a classification for researchers with MS or PhD degree requirements
would be more appropriate. The more applicable rates are $225, $175, and $50
per hour for the management, technical, and clerical classifications.

EPA will estimate annual costs by multiplying the estimated average cost of
burden hours associated with each of several classes of activities by the estimated
number of times each year that class of activity is expected to be performed.
Please enter in Table 1 on the next page your estimates of the incremental
paperwork burden in hours by management, technical, and clerical staff
associated with each occurrence of each activity listed. Base your estimates on
your experience since the rule became effective in 2006, and on your projections
for the paperwork and recordkeeping burden of each activity over the period
covered by the ICR renewal—i.e., between February 1, 2009 and January 31,
2012.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

David Johnson
Ag Handlers Exposure Task Force

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule
Average Burden Hours
Per Occurrence
Activities

Rule familiarization and
training1
Prepare and submit protocol
for IRB review2
Prepare and submit protocol
for EPA and HSRB review3
Document ethical conduct
of a completed study for
which EPA and the HSRB
have reviewed the protocol4
Document ethical conduct
of a completed study for
which EPA and the HSRB
have not reviewed the
protocol5
Store, file, and maintain
records6
TOTALS

Total Per Response

Tech.
$71

Clerical
$41

Hours

EPABased
Cost ($)

Actual
AHETF
Cost ($)

2,150

4,500

400

33,025

78,125

800

930

65,230

155,250

1300

1400

99,500

241,250

710

1,750

135

2520

190

2845

200,615

480,875

Mgt.
$103

475

Notes for Table 1:
1
Consider this a one-time activity. Enter your estimate of what your total burden will be for rule
familiarization and training during 2009-2012. Since the AHETF is already familiar with the
rule, you may have little additional burden for this activity.
This will not be a one-time activity due to new people coming on board and normal turn-over
of personnel. This will be an ongoing activity every year. Implementing future studies will
require the AHETF to hire additional technical and clerical people to handle the increased
work load with a requirement for training these personnel.
2

Estimate your average paperwork burden of preparing for a single IRB review which would not
have occurred but for the requirements of the human studies rule. Consider IRB reviews both
before and after EPA/HSRB review.
There is a significant increase in the hours required for both IRB and EPA/HSRB review, but
it is difficult to separate what part of this is attributable to the IRB and what part is
attributable to EPA/HSRB. For example, there is an increase in the amount of documentation
that now needs to be exchanged with the IRB, but much of this increase is a direct result
HSRB decisions.

David Johnson
Ag Handlers Exposure Task Force

Notes for Table 1 (cont.):
3

Estimate your average paperwork burden to prepare for submission to EPA a single field-study
protocol proposing research involving intentional exposure of human subjects. Distribute the
burden associated with developing a scenario design across all protocols in the scenario.
The AHETF believes it is more appropriate to provide the hours by scenario rather than by
study for several reasons. The AHETF will be conducting up to five studies applicable to a
single handler use scenario. The protocols will be very similar, differing primarily in the
specific study location and crop. The HSRB requested that a scenario sampling plan plus the
five protocols for that scenario be submitted each time as a single submission. Logistically,
all of the material for the scenario could be written as a single protocol; it is broken into
individual protocols only because of the HSRB request. This, in turn, results in significant
duplication of effort and paper work that increases the costs. When the studies are
completed, the results from all studies in a scenario will be analyzed and submitted in a
monograph report for the entire scenario. With the similarities and duplications among the
protocols, dividing the costs for a scenario by the number of studies within that scenario
would be an underestimate of the cost for a single protocol.

Estimate your average paperwork burden to document the ethical conduct of a single study for
submission to EPA when the protocol has already been reviewed by EPA and the HSRB.

Estimate your average paperwork burden to document the ethical conduct of a completed study
for submission to EPA for which the protocol was not previously reviewed by EPA and the
HSRB.
All present and future protocols will be reviewed by EPA (e.g. observational studies) and/or
HSRB. The ethical conduct of observational studies will be the same as for other studies.

Estimate your average paperwork burden for managing and archiving records of each submitted
protocol or study report.

David Johnson
Ag Handlers Exposure Task Force

Please estimate in Table 2 below the frequency with which you expect to incur the
paperwork burden associated with each class of activity described in Table 1.
Your responses will be combined with those from others in EPA’s revised burden
estimate. Please explain any assumptions underlying your estimates.
Table 2
Respondent Burden Estimates:
Estimated Frequency of Activities

Activities

Projected Number of Occurrences
by Year
Feb 2009- Feb 2010- Feb 2011Jan 2010
Jan 2011
Jan 2012

Prepare and submit protocol for
IRB review1
Prepare and submit protocol for
EPA and HSRB review2
Document ethical conduct of a
completed study for which EPA
and the HSRB have reviewed the
protocol3
Document ethical conduct of a
completed study for which EPA
and the HSRB have not reviewed
the protocol4
Store, file, and maintain records5

Notes for Table 2:
1
Estimate the number of IRB submissions that would not have occurred but for the
requirements of the human studies rule, including those both before and after
EPA/HSRB review.
2
Count as one occurrence a scenario design and all associated field study protocols
reviewed by the HSRB at the same meeting.
3
Count each field exposure study reported separately to EPA.

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree?
The AHETF agrees.

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

AMERICAN CHEMISTRY COUNCIL
BIOCIDES PANEL
ANTIMICROBIAL EXPOSURE ASSESSMENT TASK FORCE II
AEATF RESPONSE TO EPA’S CONSULTATION FOR OPP ICR
SUBMISSION OF PROTOCOLS AND STUDY REPORTS FOR ENVIRONMENTAL
RESEARCH INVOLVING HUMAN SUBJECTS
(OMB CONTROL # 2070-0169)
July 12, 2008
1.

Publicly Available Data
a.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?
Response: No. The AEATF data will either supplement the existing data
collected as part of the Popendorf et al., 1992 study* (a study sponsored by the
Chemical Manufacturers Association or CMA, now the American Chemistry
Council or ACC), or data in the U.S. EPA’s Pesticide Handlers Exposure
Database (PHED). Alternatively, AEATF plans to provide data for additional
antimicrobial use scenarios that are either not available in Popendorf et al., 1992
or PHED data sources, or these data will supplement these data sources. The
AEATF has described the limitations of existing data and the need for
confirmatory or additional data in a “governing document,”** which has been
submitted to EPA’s Office of Pesticide Programs (OPP) and the Human Studies
Review Board (HSRB).
*Popendorf, W., M. Selim, and B.C. Kross. 1992. Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study. University of Iowa,
Institute of Agricultural Medicine and Occupational Health. Iowa City, Iowa.
**Antimicrobial Exposure Assessment Task Force II (AEATF II), VOLUME 5,
Governing Document for a Multi-Year Antimicrobial Chemical Exposure
Monitoring Program. Interim Draft Document. February 13, 2008.

If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?
Response: As stated above, the only available data are in Popendorf et al.,
1992, and PHED. Both of these data sets are in EPA’s files. The AEATF data
will provide additional scenario-specific data or supplement existing data, rather
than duplicate those data in either Popendorf et al. 1992 or PHED.

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

Frequency of Collection
a.

Can the Agency collect the information less frequently and still produce the same
outcome?
Response: These data have been identified by EPA in various reregistration
eligibility decision documents as being needed. Antimicrobial registrants also
will need these data during registration reviews currently underway at EPA.
Thus, these data need to be generated as rapidly as possible for regulatory
decision making.

Clarity of Instructions
a.

The rule is intended to require respondents to provide certain data for the
Agency’s use. Is it clear from the regulations and other Agency guidance what
you are required to submit and how to submit it? If not, what suggestions do you
have to clarify the information?
Response: The rule gives a general, overall explanation on the process, but
does not cover exactly what needs to be submitted and how it needs to be
submitted. Guidance on what and how to submit has been gained through a draft
EPA PR Notice, helpful dialogue with EPA staff, and trial and error. Once a
procedure is established, this should be documented in some form of guidance or
final PR Notice from the EPA.
Further, guidance needs to be provided on EPA’s requirements for exposure
monitoring data, since the only currently available guidance, the OPPTS Series
875 Guidelines, has been superseded by requirements that have been imposed as
a result of the regulation that is the subject of this ICR request.

Do you understand that you are required to maintain records?
Response: Yes. Generating and maintaining detailed records is standard
practice for the AEATF as part of GLP regulations and compliance with
regulations regarding studies involving human studies.

Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?
Response: It is difficult and extremely time-consuming for the AEATF to format
the submission materials due to the large number of documents required for each
study (e.g., protocol and associated study (scenario) design document, informed
consent form, recruiting documents, appendices including product labels and
MSDS, IRB-related materials and correspondence, and updates to the AEATF
governing document).
The need for a large number of pages is due primarily to the requirement for
including all of the materials and correspondence exchanged between the AEATF
2

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

and the IRB, including all versions of a protocol(s) that were reviewed and
revised. This exchange of material accounts for over half of the submission and is
largely a duplication of the protocols and informed consent forms.
d.

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?
Response: The only form provided by EPA is a checklist of items from a draft
PR Notice that must be covered for every protocol submission. The AEATF uses
this form and it is reasonably logical. The form represents a method for crossreferencing various required information sources defined in the rule and their
respective locations in a protocol submission (which is a multi-volume set of
documents). Thus, this form requires a substantial amount of time to complete.

Electronic Reporting and Record Keeping
The Government Paperwork Elimination Act requires that agencies make available
electronic reporting alternatives to paper-based submissions. Entities that submit study
protocols and/or reports in response to EPA’s 2006 final rule may elect to submit the
information either on paper, or electronically, via email, CD, or DVD.
a.

What do you think of electronic alternatives to hard-copy data submissions?
Response:

The AEATF prefers electronic submissions.

Are you keeping your records electronically? If yes, in what format?
Response: Yes. Records are kept in several forms including MS Word, Excel,
Adobe Acrobat, and e-mail files. Key documents are also stored on a task force
server for easy access by AEATF members.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?
Response: Most of the information is generated electronically, so converting
this to hard copy for the submission would be an additional burden.

Burden and Costs
a.

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

Response: The rates for clerical staff are approximately appropriate but should
be increased to $50 to reflect Washington, D.C., area rates. The rates for
technical and management services for AEATF are approximately 2-fold higher
that those listed above and should be increased to $175 and $225, respectively.
The technical and management staff is made up of professional research and
applied scientists with specialized expertise so a classification for persons with
Masters or Doctoral degree requirements would be more appropriate.
b.

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule

Average Burden Hours Per Occurrence*

Activities
Rule familiarization and
training (per protocol)1
Prepare and submit protocol
for IRB review2
Prepare and submit protocol
for EPA and HSRB review3
Document ethical conduct of a
completed study for which
EPA and the HSRB have
reviewed the protocol4
Document ethical conduct of a
completed study for which
EPA and the HSRB have not
reviewed the protocol
Store, file, and maintain
records5

Management
$103
($255 rev.)**

Technical
$71
($175 rev.)**

Total Per Response

Clerical
$41
($50 rev.) **

Total
Hours

Cost ($)

Realistic
Cost ($)***

$3,836.00

$8,700.00

120

184

$12,632.00

$28,400.00

320

400

$28,480.00

$67,000.00

128

$9,136.00

$20,600.00

128

$9,136.00

$20,600.00

$2,616.00

$5,400.00

*These rates are unrealistically low based upon fully loaded rates. Based on AEATF experience to data the rates should be
225/hr, 175/hr and 50/hr for management, technical and clerical, respectively. Thus, using the more realistic rates
experienced by AEATF, the more realistic overall cost estimate is 2-fold higher (see estimates in "Realistic Cost ($)” column
of Table 1).
**Revised hourly rates used to develop cost estimated in column entitled Realistic Cost.
***These cost estimates do not include hours contributed by registrant company management and technical staff; if these
hours were included, the “Realistic Cost ($).”

Notes for Table 1:
1
This is an estimate of the average burden per protocol activity. During a 4-year period
some personnel “turnover” is expected each year. Further, based on AEATF
experience, this task involves different persons for each protocol given that scenariosspecific studies require different expertise. The involvement of 3 management, 8
technical, and 2 clerical persons are assumed. The management and technical persons
include both consultants and company/industry staff. In addition, while AEATF is
already familiar with the rule in general, time is still required for this task because the
submission process is still being “optimized” or changed, because different individuals
may be involved from one submission to another.
2
This is an estimate of the average paperwork burden of preparing for a single IRB
review, which would not have occurred except for the requirements of the human
studies rule. It considers IRB reviews both before and after EPA/HSRB review. This
task includes consultants only. This task includes the study protocol and related
informed consent materials, and responses to reviews of these materials. This task does
not include review by the California EPA for those studies conducted in California.

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

Please note that the AEATF plans to submit 18 protocols; thus, this per protocol cost
estimate would be multiplied by 18 for the total cost.
This is an estimate of the average paperwork burden to prepare for submission to EPA
a single field-study protocol proposing research involving intentional exposure of
human subjects. It considers involvement of the study director, at least two technical
experts, a manager and a clerical person. The task burden includes the effort
associated with developing a scenario design document for a given scenario and
related protocol(s).
While the AEATF does not yet have direct experience with this task yet, the estimate
provided represents a best estimate for the average paperwork burden to document the
ethical conduct of a single study for submission to EPA when the protocol has already
been reviewed by EPA and the HSRB.
This is an estimate for the average paperwork burden for managing and archiving
records of each submitted protocol or study report.
Please estimate in Table 2 below the frequency with which you expect to incur the
paperwork burden associated with each class of activity described in Table 1. Your
responses will be combined with those from others in EPA’s revised burden estimate.
Please explain any assumptions underlying your estimates.
Table 2
Respondent Burden Estimates:
Estimated Frequency of Activities

Activities
Prepare and submit protocol for
IRB review1
Prepare and submit protocol for
EPA and HSRB review2
Document ethical conduct of a
completed study for which EPA
and the HSRB have reviewed the
protocol3

Projected Number of Occurrences
by Year
Feb 2009- Feb 2010- Feb 2011Jan 2010
Jan 2011 Jan 2012
5

5
4
(includes 2
protocols
approved
in 2008)

0
4

0
5

0
9

Document ethical conduct of a
completed study for which EPA
and the HSRB have not reviewed
the protocol
Store, file, and maintain records

Notes for Table 2:
1
This represents the estimated number of IRB submissions.
2
In the case of AEATF, each scenario includes one study.
3
This represents each completed field exposure study submitted to EPA.
6

Hasmukh Shah
Antimicrobial Exposure Assessment Task Force II

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree?
Response:

The AEATF agrees.

Are there other activities or incremental costs associated with the paperwork
burden imposed by the human studies rule, not listed in the tables but which
should be accounted for?
Response: The AEATF believes that increased costs will be incurred to conduct
exposure monitoring studies as a direct result of changes by EPA to the
previously relied upon guidance in the OPPTS Series 875 Guidelines in
implementing the human studies rule. These changes impact, among other
activities, study design and sampling methods, and can be traced to the process
involved in with the human studies rule. These changes result in significant
increases in the burden associated with conducting exposure monitoring studies.
The costs associated with the changes should be included in the estimate of
incremental costs for each study performed in compliance with the human studies
rule. The AEATF does not believe that these incremental costs have been
considered in any other existing ICR, including the ICR authorizing Data CallIns.
*

For further information, please contact Has Shah at [email protected] or
703-741-5637.

Scott Carroll
Carroll-Loye Biological Research

Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control # 2070-0169)

Publicly Available Data
a.

Are 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? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?

Frequency of Collection
a.

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

Clarity of Instructions
a.

Do you understand that you are required to maintain records?

Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?

a.
What do you think of electronic alternatives to hard-copy data submissions?
Generally value for efficiency of preparation and transmission, possibly saving of paper.
b.
Are you keeping your records electronically? If yes, in what format?

Formatted: Font color: Blue

Scott Carroll
Carroll-Loye Biological Research

Yes, in formats of software programs used for their creation: MS Word, MS Excel, SAS.
Also Adobe pdf. Multiple electronic backups. Note that we also keep printed
hardcopies in secure storage.
c.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?

As our sponsors generally execute the formal submissions, I can only state referentially that we
use electronic compilation to more efficiently provide electronic and printed reports to
clients.
5.

Formatted: Indent: Left: 0",
Hanging: 0.5"

Burden and Costs
a.

Much of the science we perform is relatively low tech and straightforward. Accordingly, I agree
with the rate for technical staff. We don’t have sufficient experience with clerical staff to
comment on that category. Note that we use management rates that are much higher. The
level of expertise and ability required to operate a contract laboratory in the current
regulatory environment has exceeded the capacity of most established entities for a score
of months. Working within the HSRB framework has required capacities well beyond
those formerly required for the generation of entomological registration data. They have
included the development of new scientific tests and new approaches to risk evaluation
and minimization, the comprehension of the vocabulary, intentions, goals, and
subcultural dynamics of the field bioethics, groping to understand the political pressures
on EPA staff and the interactions of EPA staff and HSRB members, as well as the
creation of protocols that meet wholly unprecedented demands on our field. Accordingly,
our management rates are more comparable to those levied by consulting attorneys or
physicians. Much of this work is beyond the capacity of technical staff and must be
undertaken directly be management.
b.

Formatted: Indent: Left: 0",
Hanging: 0.5"

Scott Carroll
Carroll-Loye Biological Research

for unit costs over the period covered by the ICR renewal—i.e., between February
1, 2009 and January 31, 2012.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

We have no specific records that permit precise characterization of the paperwork
increment resulting from the Human Studies Rule. A few months into the process, I
began relating that the overall ‘before’ versus ‘after’ work increment for my
business (including and beyond paperwork) was eight-fold. The values actually
inserted into Table 1 are general guesses in which I mainly tried not to
underestimate the amount of additional time required, as I typically do by a factor
of a few hundred percent when planning individual projects.

Formatted: Font: Italic

Formatted: Left, Indent: Left:
0.94", Tabs: Not at 0"

Scott Carroll
Carroll-Loye Biological Research

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule

Activities
Rule familiarization and
training1
Prepare and submit protocol
for IRB review2
Prepare and submit protocol
for EPA and HSRB review3
Document ethical conduct
of a completed study for
which EPA and the HSRB
have reviewed the protocol4
Store, file, and maintain
records5

Average Burden Hours Per
Occurrence
Management Technical Clerical
$103
$71
$41

Total Per
Response
Cost
Hours
($)

100

150

12K

Formatted: Centered

100

175

15K

Formatted: Centered

100

Formatted: Centered

100

Formatted: Centered

Notes for Table 1:
1

Consider this a one-time activity. Enter your estimate of what your total burden will be for rule
familiarization and training during 2009-2012. Since you are already familiar with the rule,
you may have little additional burden for this activity.
2
Estimate your average paperwork burden of preparing for a single IRB review which would not
have occurred but for the requirements of the human studies rule. Consider IRB reviews both
before and after EPA/HSRB review.
3
Estimate your average paperwork burden of preparing a single submission to EPA of a protocol
proposing research involving intentional exposure of human subjects. Treat each repellent
testing protocol as a single protocol, however many test materials may be involved.
4
Estimate your average paperwork burden to document the ethical conduct of a single study for
submission to EPA when the protocol has already been reviewed by EPA and the HSRB.
Treat all reports reflecting a single execution of one protocol as a single activity, however
many test materials may be involved.
5
Estimate your average paperwork burden for managing and archiving records of each submitted
protocol or study report.

Note that the values inserted in Table 1 include costs associated with meeting the
burdens of increased intensity of science review by the HSRB and EPA staff, as that
judgment is a fundamental aspect of the Rule (to be balanced against the ethical
liabilities, making the two elements inextricably interactive). Related to this, the
absence of a request for more comprehensive characterization of the added costs for
reporting study results to the agency is perplexing. In particular, for the fourth row
of Table 1, this increment in science-scrutiny would approximately repeat (double)
the value listed for the ethical elements.

Scott Carroll
Carroll-Loye Biological Research

Activities

Projected Number of Occurrences
by Year
Feb 2009- Feb 2010- Feb 2011Jan 2010
Jan 2011
Jan 2012

Notes for Table 2:
1
Count IRB submissions that would not have occurred but for the requirements of the
human studies rule, including those both before and after EPA/HSRB review.
2
Count each repellent testing protocol as a single occurrence, however many test
materials it may involve.
3
Count each executed repellent protocol only once, however many test materials or
physical study volumes it may involve.
4
This count will probably be the sum of the other numbers in the column
Deleted: ¶

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree?

No–

Moderate capital costs are entailed in the areas of both electronic and paper
storage capacity and security. We have invested >$1000 in these contexts, but
our first steps are stop-gaps. At some point soon we may need a new room
dedicated to hardcopy storage. Double-sided printing of consent forms is
extremely important to save storage space, and we spent $1000 on a printer
that does that reliably and quickly.

Deleted: ¶

Formatted: Font: Not Italic

Robin Todd
ICR, Inc

Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control # 2070-0169)

Publicly Available Data
a.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?

ICR INC RESPONSE:
If ‘data’ means repellency data on human generated in compliance with current EPA
regulations, for given repellent products, then it is not available from any known public
source
b.
If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?
ICR INC RESPONSE
N/A
2.

Frequency of Collection
a.

Can the Agency collect the information less frequently and still produce the same
outcome?
ICR INC RESPONSE
This would further delay what it is already a very slow process..
3.

Clarity of Instructions
a.

The rule is intended to require respondents to provide certain data for the
Agency’s use. Is it clear from the regulations and other Agency guidance what
you are required to submit and how to submit it? If not, what suggestions do you
have to clarify the information?
ICR INC RESPONSE
Some of the regulations are quite clear; others are not. However, the different (often
conflicting) interpretations of these regulations by different EPA staff members and
HSRB members are disturbing, and sometimes counter-productive and confusing. Some
of the advice from the HSRB members and the EPA staff members has been clear and
helpful.
b.
Do you understand that you are required to maintain records?
ICR INC RESPONSE
Yes
c.
Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?

Robin Todd
ICR, Inc

ICR INC RESPONSE
Yes
d.

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?
ICR INC RESPONSE
There is one form. We have to use it. It is fairly clear, logical, and easy to complete
4.

Electronic Reporting and Record keeping
The Government Paperwork Elimination Act requires that agencies make available to the
public electronic reporting alternatives to paper-based submissions. Entities that submit
study protocols and/or reports in response to EPA’s 2006 final rule may elect to submit
the information either on paper or electronically via email, CD, or DVD.
a.
What do you think of electronic alternatives to hard-copy data submissions?
ICR INC RESPONSE
Good idea.
b.
Are you keeping your records electronically? If yes, in what format?
ICR INC RESPONSE
Most records can be kept this way; some must remain as paper hardcopy. Wordperfect,
Word and pdf.
c.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?
ICR INC RESPONSE
Yes, except that EPA’s spam filter kicks our submissions back, forcing us to use the old
fashioned, paper intensive, expensive courier method (carbon footprint is huge!)
5.

Burden and Costs
a.

Robin Todd
ICR, Inc

Please enter in Table 1 on the next page your estimates of the incremental
paperwork burden in hours by management, technical, and clerical staff
associated with each occurrence of each activity listed. Base your estimates on
your experience since the rule became effective in 2006, and on your projections
for unit costs over the period covered by the ICR renewal—i.e., between February
1, 2009 and January 31, 2012.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

Robin Todd
ICR, Inc

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule

Average Burden Hours Per
Occurrence
Management Technical Clerical
$103
$71
$41
1

Total Per
Response
Cost
Hours
($)
3

Notes for Table 1:
1

Consider this a one-time activity. Enter your estimate of what your total burden will be for rule
familiarization and training during 2009-2012. Since ICR is already familiar with the rule,
you may have little additional burden for this activity.
ICR INC RESPONSE
Very difficult to estimate; significant time required only if rule changes or if we hire new staff.
2

Estimate your average paperwork burden of preparing for a single IRB review which would not
have occurred but for the requirements of the human studies rule. Consider IRB reviews both
before and after EPA/HSRB review.
3
Estimate your average paperwork burden of preparing a single submission to EPA of a protocol
proposing research involving intentional exposure of human subjects. Treat each repellent
testing protocol as a single protocol, however many test materials may be involved.
ICR INC RESPONSE
The extra work that goes into the IRB submission preparation is because of the HSRB/ EPA
requirements. The protocol and ICD have become larger and more detailed due to trying to
comply with the regulations and interpretations of these regulations by different EPA and
HSRB staff members. Required changes following all submissions usually necessitates an
additional submission to the IRB. All of this paperwork must be tracked and included in each
submission.
4

Estimate your average paperwork burden to document the ethical conduct of a single study for
submission to EPA when the protocol has already been reviewed by EPA and the HSRB.
Treat all reports reflecting a single execution of one protocol as a single activity, however
many test materials may be involved.
ICR INC RESPONSE

Robin Todd
ICR, Inc

There is now the requirement to submit recruitment scripts, and expanded final reports. Estimate
your average paperwork burden for managing and archiving records of each submitted
protocol or study report.

c.
Please estimate in Table 2 below the frequency with which you expect to
incur the paperwork burden associated with each class of activity described in Table 1. Your
responses will be combined with those from others in EPA’s revised burden estimate. Please
explain any assumptions underlying your estimates.
ICR INC ASSUMPTIONS
The new Final Rule has so greatly increased the time and effort needed to conduct human
repellency studies that most companies have stopped running tests, either by contractors or
by the companies themselves, that it is likely that there will be far fewer studies than before
the Rule came into effect (2006).

Table 2
Respondent Burden Estimates:
Estimated Frequency of Activities

Activities

Projected Number of Occurrences
by Year
Feb 2009- Feb 2010- Feb 2011Jan 2010
Jan 2011
Jan 2012

ICR INC note – each occurrence is a study i.e. predict that we will run 2 studies per year
Notes for Table 2:
1
Count IRB submissions that would not have occurred but for the requirements of the
human studies rule, including those both before and after EPA/HSRB review.
ICR Inc note: even prior to the New Rule, ICR was submitting all its human repellent
study protocols to an IRB .
2

Count each repellent testing protocol as a single occurrence, however many test
materials it may involve.
3
Count each executed repellent protocol only once, however many test materials or
physical study volumes it may involve.
4
This count will probably be the sum of the other numbers in the column

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree?
ICR Inc Response; yes.

Robin Todd
ICR, Inc

d. Are there other activities or incremental costs associated with the paperwork
burden imposed by the human studies rule, not listed in the tables but which
should be accounted for?
Time and expense of having to attend HSRB meetings, possibly EPA meetings, and
consultation with outside contractors.

Joel Panara
Grayson Research LLC

Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control # 2070-0169)

Publicly Available Data
a.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency? No.

If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well? Not applicable.

Frequency of Collection
a.

Can the Agency collect the information less frequently and still produce the same
outcome? No.

Clarity of Instructions
a.

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

Is it difficult to format the information for submission so that it is clear, logical
and easy to understand? No.

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete? Guidance documents have been provided
and were helpful.

What do you think of electronic alternatives to hard-copy data submissions? We
prefer electronic submissions.

Joel Panara
Grayson Research LLC

Are you keeping your records electronically? If yes, in what format? Yes.
Documents are usually generated in Microsoft Office files and stored/submitted as
pdf documents. We currently still archive paper copies.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information? Yes, electronic submission
reduces the burden of compliance.

Burden and Costs
a.

The labor rates EPA will use to estimate costs for regulated entities are taken from
the May 2007 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 32530 (Pesticide, Fertilizer, and Other Agricultural
Chemical Manufacturing), published by the Bureau of Labor Statistics. The BLS
rates for this industry are $103/hour for management, $71/hour for technical staff,
and $41/hour for clerical staff. Do you think these labor rates are appropriate?
No, billing rates for management and technical staff are lower than our typical
billing rates. Clerical staff rates are appropriate. Can you suggest another NAICS
code that would be more appropriate? No.

EPA will estimate annual costs by multiplying the estimated average cost of
burden hours associated with each of several classes of activities by the number of
times each year that activity is expected to be performed.
Please enter in Table 1 on the next page your estimates of the incremental
paperwork burden in hours by management, technical, and clerical staff
associated with each occurrence of each activity listed. Base your estimates on
your experience since the rule became effective in 2006, and on your projections
for paperwork burdens over the period covered by the ICR renewal—i.e., between
February 1, 2009 and January 31, 2012.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

Joel Panara
Grayson Research LLC

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule

Activities
Rule familiarization and
training1
Document ethical conduct
of a completed study for
which EPA and the HSRB
have not reviewed the
protocol2
Store, file, and maintain
records3

Average Burden Hours Per
Occurrence
Management Technical Clerical
$103
$71
$41

Total Per
Response
Cost
Hours
($)

774

1,979

551

The estimates provided are based on billing records for additional work performed on several
studies to generate supplemental reports necessary to meet the rule.
Notes for Table 1:
1

Joel Panara
Grayson Research LLC

Activities

Projected Number of Occurrences
by Year
Feb 2009- Feb 2010- Feb 2011Jan 2010
Jan 2011
Jan 2012

Document ethical conduct of a
completed study for which EPA
and the HSRB have reviewed the
protocol

Store, file, and maintain records

Estimated number of occurrences is based on projected maximum capacity for the years noted.
d.

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree? Yes.

Are there other activities or incremental costs associated with the paperwork
burden imposed by the human studies rule, not listed in the tables but which
should be accounted for? No. Please note Table 1 asks for burden estimates for
studies whose protocols were NOT reviewed by EPA/HSRB prior to conduct (i.e.
pre-rule studies). Table 2 asks for frequency associated with studies whose
protocols WERE reviewed by EPA/HSRB. The incremental costs for studies
initiated post-rule will be higher than those outlined in Table 1. The frequency
associated with studies whose protocols were not reviewed by EPA/HSRB will be
lower than outlined in Table 2.

File Type	application/pdf
File Title	Microsoft Word - Final ATTACHMENT D.doc
Author	jhogue
File Modified	2008-10-01
File Created	2008-10-01