Document ID: EPA-HQ-OPP-2008-0414-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-12T05:00Z

EPA ICR No. 2195.03                                       OMB Control
No. 2070-0169

ATTACHMENT G

Memorandum on Calculation of Burden and Cost 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                  WASHINGTON, D.C.  20460 

                                            OFFICE OF

PREVENTION, PESTICIDES AND       									          TOXIC SUBSTANCES

             

MEMORANDUM

SUBJECT: 	Information Collection Request (ICR) for the Human Studies
Rule

	Calculation of Burden and Cost

TO:	File

FROM:	Kelly Sherman

	Human Research Ethics Reviewer

	Office of Pesticide Programs

DATE:	September 2, 2008

Burden Hours for Respondents

	EPA sent consultation questions about the burden and cost estimates to
five respondents – the Agricultural Handlers Exposure Task Force
(AHETF), the Antimicrobial Exposure Assessment Task Force II (AEATF),
Carroll-Loye, ICR, Inc., and Grayson.  These five organizations are
experienced in submitting human subjects research to OPP, and are
expected to make additional submissions over the next several years. 
The consultation responses received from these respondents indicated
that EPA’s previous estimates of the burden and cost were too low.  To
calculate new burden and cost estimates for this renewal ICR, EPA relied
upon the estimates provided in the five consultation responses.  EPA
calculated a weighted average of the different responses, recognizing
that some study types are more complicated and costly to conduct than
others.  

	The respondent burden and cost estimates that appear in Table 1 in the
ICR, for research involving intentional exposure of human subjects, are
the weighted averages of the values in Table A (burden hour estimates
for agricultural handler studies, from the AHETF), Table B (burden hour
estimates for antimicrobial exposure studies, from the AEATF), and Table
C (burden hour estimates for insect repellant studies, averaged from the
responses received from Carroll-Loye and ICR, Inc.).  The weighted
average was calculated by multiplying the burden hour estimates that
appear in Tables A, B, and C by the expected number of each type of
study, and then dividing the sum of those products by the total number
of studies of all types expected per year.  The expected number of
studies per year was also determined from the consultation responses. 

	The respondent burden and cost estimates that appear in Table 2 in the
ICR, for all other submitted research with human subjects, are based on
the consultation response from Joel Panara at Grayson.  Mr. Panara is
familiar with submitting completed study reports to EPA for pre-rule
research for which HSRB protocol review is not required, and his
consultation response was based on his billing records for work
performed on several studies to generate the reports necessary to meet
the requirements of the rule.  

Hourly Rates for Respondents

	Four of the five respondents indicated that the hourly rates used by
EPA for calculating the estimated costs are too low.  In determining the
rates, OPP uses a single source of data, the Bureau of Labor
Statistics’ National Industry-Specific Occupational Employment and
Wage Estimates, and selects the appropriate occupational category. 
Using the BLS data allows EPA to be consistent between across sectors
and occupations.  If OPP were to separately research wages for each ICR,
the methodology in determining the wages would not be consistent and the
wage rates could not be compared between sectors and occupations.  Some
wages would be biased high, while others would be biased low.  The BLS
wages are categorized by North American Industry Classification System
(NAICS) codes, and therefore are industry-specific.  They are, however,
national averages.  Therefore, some of the high wages earned by
specialists in high cost localities are offset by others who are less
specialized in lower cost localities.  

The wage rates used in the draft ICR were from NAICS 325300 (Pesticide,
Fertilizer, and Other Agricultural Chemical Manufacturing).  Upon
reconsidering the possible NAICS categories, EPA has concluded that
NAICS 541710 is more appropriate because there are a variety of types of
scientists involved in the human studies ICR, with higher education
requirements than in pesticide manufacturing companies.  The wage rates
in NAICS 541710 are slightly higher than those in NAICS 325300, which
helps to address the comments in the consultation responses indicating
that the hourly rates used by the Agency are too low.

Agency Burden and Costs

	The estimated burden and costs to the Agency are derived from input
from EPA staff members who have prepared reviews for studies that were
presented to the HSRB.  Recognizing that some study types are more
complicated and time consuming to review that others, EPA calculated a
weighted average using the staff time estimates and the expected
frequency of receiving different types of studies.  The values
calculated based on the staff input appear in Tables E, F, and G.  The
weighted averages are provided in ICR Tables 3 and 4.  

Number of Transactions

	The estimated number of transactions is based heavily on the
consultation responses from the five respondents, as well as EPA’s
historical experience and knowledge of upcoming submissions.

RESPONDENT BURDEN HOUR ESTIMATES

Table A.  Agricultural Handler Exposure Studies – Burden Hour
Estimates from AHETF’s Consultation Response

Activities	Average Burden Hours Per Occurrence	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	2	2	2	6	506

Prepare and submit protocol for IRB review	5	80	10	95	6,950

Prepare and submit protocol for EPA and HSRB review	15	240	26	276	20,682

Document ethical conduct of a completed study for which EPA and the HSRB
have reviewed the protocol	10	260	10	285	20,780

Store, file, and maintain records	0	2	0	2	48,918



Table B.  Antimicrobial Exposure Studies – Burden Hour Estimates from
AEATF’s Consultation Response, with the adjustment described in
footnote 1

Activities	Average Burden Hours Per Occurrence	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	2	2	2	6	506

Prepare and submit protocol for IRB review	24	120	40	184	13,752

Prepare and submit protocol for EPA and HSRB review	40	320	40	400	30,560

Document ethical conduct of a completed study for which EPA and the HSRB
have reviewed the protocol	24	80	24	148	10,160

Store, file, and maintain records	8	16	16	40	2,944

Table C.  Insect Repellant Studies – Burden Hour Estimates from an
Average of the Consultation Responses from Carroll-Loye and ICR, Inc.,
with the adjustment described in footnote 2

Activities	Average Burden Hours Per Occurrence	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	1	1	1	3	253

Prepare and submit protocol for IRB review	54	54	24	132	12,402

Prepare and submit protocol for EPA and HSRB review	20	27	42	89	6,495

Document ethical conduct of a completed study for which EPA and the HSRB
have reviewed the protocol	20	42	26	88	6,918

Store, file, and maintain records	3	6	1	10	894

Table D.  Documentation of Ethical Conduct of a Completed Study for
which EPA and HSRB have NOT reviewed the Protocol (per requirements at
§26.1303) – Burden Hour Estimates Based on Consultation Response from
Joel Panara at Grayson (a laboratory with experience with submitting
this type of info)

Activities	Average Burden Hours Per Occurrence	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Document ethical conduct of a completed study for which EPA and the HSRB
have not reviewed the protocol	5	16	8	29	2,194

For ICR Table 1

Weighted Average Burden and Cost Estimates for Respondents – Research
Involving Intentional Exposure of Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	2	4	2	8	652

Prepare and submit protocol for IRB review	31	83	33	147	11,723

Prepare and submit protocol for EPA and HSRB review	25	181	37	243	18,217

Document ethical conduct of a completed study for which EPA and the HSRB
have reviewed the protocol	19	113	21	153	11,753

Document ethical conduct of a pre-rule study for which EPA and the HSRB
have not reviewed the protocol	5	16	8	29	2,194

Store, file, and maintain records	4	8	6	18	1,388

Total per response	86	405	107	598	45,927

Annual Burden:	598 hours per protocol or completed study * 34 protocols
or 				completed studies per year = 20,332 hours

Annual Costs:		$45,927 per study * 34 protocols or completed studies per
year = 				$1,561,518

For ICR Table 2

Table 2. Respondent Burden and Cost Estimates – All Other Submitted
Research with Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	1	1	0	2	211

Prepare and Submit Ethics Information of Completed Human Studies to EPA
0	8	1	9	626

Store, file, and maintain records	0	0	1	1	42

Total per response	1	9	2	12	879

Annual Burden:	12 hours per study * 20 studies submitted per year = 240
hours

Annual Costs:		$879 per study * 20 studies submitted per year =
$17,580Agency Burden Hour Estimates: Technical Staff

Table E.  Protocol Review

Study Type	Average Annual Number of Protocols	Average Number of Hours
Per Protocol Review	Total Number of Hours

AHETF	4	160	640

AEATF	5	120	600

Repellant Efficacy	6	80	480

Other Types of Post-Rule Intentional Exposure Studies	1	80	80

Weighted Average Number of Hours per Protocol Review	113 hours per
protocol

Estimated Annual Number of Protocol Reviews	16

Table F.  Review of Completed Studies

Study Type	Average Annual Number of Completed Study Reviews	Average
Number of Hours Per Completed Study Review	Total Number of Hours

AHETF	4	80	320

AEATF	5	60	300

Repellant Efficacy	6	40	240

Other Types of Post-Rule Intentional Exposure Studies	1	40	40

Pre-Rule Completed Intentional Exposure Studies that Measure or Identify
a Toxic Effect	2	60	120

Weighted Average Number of Hours per Protocol Review	57 hours per
completed study

Estimated Annual Number of Completed Study Reviews	18

Table G.  Ethics Reviews for Pre-Rule Completed Studies Not Requiring
HSRB Review

Study Type	Average Annual Number of Reviews	Avg. Number of Hours Per
Review	Annual Burden Hour Estimate

Pre-Rule completed studies that do NOT measure or identify a toxic
effect	20	4	80 hours

Burden Hour Estimates: Management and Clerical

Management:

Assume 2 hours for Protocol Reviews and Completed Study Reviews

Assume zero hours for Ethics Reviews for studies not requiring HSRB
Review

Clerical

Assume 2 hours for Protocol Reviews and Completed Study Reviews

Assume 1 hour for Ethics Reviews for studies not requiring HSRB Review

For ICR Table 3

Table 3.  Weighted Average Burden and Cost Estimates for Agency –
Research Involving Intentional Exposure

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$103	Technical

$71	Clerical

$41	Hours	Cost ($)

Rule familiarization and training	2	2	0	4	348

Primary Review of Scientific and Ethical Aspects of a Protocol	1	113	0
114	8,126

Primary Review of Ethical Aspects of a Completed Study Report	1	57	0	58
4,150

Secondary Review of Scientific and Ethical Aspects of a Protocol or
Review of Ethical Aspects of a Completed Study

4,144*

Store, file, and maintain records	0	0	2	2	82

Total per protocol or completed study	4	172	2	178	16,850

* Cost of HSRB members working on the HSRB report (collectively spending
240 hours per HSRB report in FY 2008, compensated at the rate of
$53/hour), plus the cost of EPA Office of the Science Advisor technical
staff working on the HSRB report (171 hours per report, at the technical
staff rate of $71/hour).  Each HSRB report covers an average of 6
protocols and/or completed studies per report.

 

Annual Burden:  	178 hours per study or protocol * 34 protocols or
completed studies = 6,052 hours

Annual Costs:		16,850 * 34 protocols or completed studies = $572,900

Number of Transactions: February 2009 - January 2012

AHETF Monitoring Program

The AHETF monitoring program defines 33 scenarios, each of which will
typically involve 5 field studies.  About 80 field studies will be
needed to complete the program.  

The AHETF plans to complete the program within 5 years.  

~30 scenarios in 5 years = ~ 6 scenarios & 6 protocols per year.

For each protocol, there will be a completed study report approximately
1 year later = ~ 6 completed reports per year.

Note that approximately 50% of the time, protocols will need to go to
the HSRB twice, either because the AHETF chooses to present field
studies associated with one scenario at two different HSRB meetings, or
because the protocol is not reviewed favorably during the first visit to
the HSRB.  

Original EPA Estimate (prior to consultation):  6 scenario-specific
protocols and 6 scenario-specific study reports per year

AHETF Estimate (from consultation):  4 protocols and 4 study reports per
year

Figures used in ICR:  4 protocols and 4 study reports per year, based on
AHETF’s consultation response

AEATF Monitoring Program

The AEATF monitoring program defines 17 scenarios, each of which will
typically involve a single field study. Some will likely be
observational and thus will not need to undergo HSRB review –
according to Tim L.  

The AEATF plans to complete the program within 5 years 

~15 scenarios / 5 years = ~ 3 protocols per year.

For each protocol, there will be a completed study report, approximately
1 year later = ~ 3 completed reports per year.

Original EPA Estimate (prior to consultation):  3 scenario-specific
protocols and 3 scenario-specific study reports per year

AEATF Estimate (from consultation): 5 protocols and 5 study reports per
year

Figures used in ICR:  5 protocols and 5 study reports per year, based on
AEATF’s consultation response

Insect Repellent Efficacy Testing

For the past two years we have averaged about 3 protocols or completed
studies at each HSRB meeting.  

This is about half the steady-state demand under current requirements.

Therefore, ~ 3 protocols per year.  

For each protocol, there will be a completed study report, approximately
1 year later = ~ 3 completed reports per year.

Original EPA Estimate (prior to consultation):  6 protocols and 6
completed studies per year 

Carroll-Loye Estimate: an average of 4 protocols and 4 study reports per
year

ICR, Inc. Estimate: an average of 2 protocols and 2 study reports per
year

Figures used in ICR:  6 protocols and 6 study reports per year, adding
together the Carroll-Loye and ICR, Inc. estimates

Other Post-Rule Studies

These could include exposure studies from sources other than the task
forces, ADME studies, skin patch tests of irritation or sensitization,
systemic toxicity tests, or others.  

All would require submission of a protocol before execution and of a
completed report after execution; both the protocol and the report would
require both EPA and HSRB review.

Estimate: 1 protocol and 1 completed study per year. (This is likely an
over-estimate)

Pre-Rule Completed Studies which measure or identify a toxic effect

2 categories:

New submissions requiring submission of §26.1303 information

Studies retrieved from the literature or from other sources, not subject
to §26.1303.  

There is likely to be a steady trickle of these studies –
approximately 1 case every-other meeting

One case may include multiple individual studies with the same chemical

Estimate: 2 cases per year (requiring study review, but not protocol
review)

Pre-Rule Completed Studies which do not measure or identify a toxic
effect 

These studies do not go to the HSRB, but they do require an EPA ethics
review. 

Historical level: 20 reviews per year

Assume workload to remain constant over the time period of the ICR

Estimate: 20 per year (requiring EPA ethics review only – not HSRB
review)

TOTAL TRANSACTIONS PER YEAR:

16 protocols per year requiring EPA & HSRB review

AHETF, AEATF, Insect Repellant, and one additional type of post-rule
intentional exposure study

18 completed study reports per year requiring EPA & HSRB review 

16 completed study reports for which there was previous protocol review

2 pre-rule studies that measure or identify a toxic effect

20 studies/year requiring EPA ethics review, but not HSRB review
(pre-rule studies that do not measure or identify a toxic effect)

 Values taken from table titled “Calculation of IPC per Human Study
Based on AHETF Experience” in the AHETF’s follow-up consultation
response submission, sent via email from David Johnson to Kelly Sherman
on 8-15-08.

 Values taken from table titled “Calculation of IPC per Human Study
Based on AHETF Experience” in the AHETF’s follow-up consultation
response submission, sent via email from David Johnson to Kelly Sherman
on 8-15-08.

 Values taken from table titled “Calculation of IPC per Human Study
Based on AHETF Experience” in the AHETF’s follow-up consultation
response submission, sent via email from David Johnson to Kelly Sherman
on 8-15-08.

 Values taken from table titled “Table 1: Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule” from the
AHETF’s original consultation response submission.  The AHETF’s
values, which were provided “per scenario” rather than “per
study,” were divided by five to obtain per study amounts.

 Values taken from table titled “Calculation of IPC per Human Study
Based on AHETF Experience” in the AHETF’s follow-up consultation
response submission, sent via email from David Johnson to Kelly Sherman
on 8-15-08.  

 For the activity “Rule Familiarization and Training,” the AEATF
estimated 12 management hours, 32 technical hours, and 8 clerical hours,
based on expected personnel turnover.  Time spent training new staff is
not properly attributed to the paperwork and recordkeeping burdens of
the rule.  This is a one-time activity.  Since the AEATF is familiar
with the rule, its costs for this activity should be small.  Instead of
using AEATF’s reported numbers, KS used the numbers reported by the
AHETF (2 hrs. for each category).

 For the activity “Rule Familiarization and Training,” Carroll-Loye
estimated 50 management hours, 100 technical hours, and 10 clerical
hours.  This is a one-time activity, and since Carroll-Loye is familiar
with the rule, its costs for this activity should be small.  Thus,
instead of using an average of Carroll-Loye’s and ICR, Inc.’s
numbers, OPP used only the numbers provided by ICR, Inc. for this
activity.

 Comments from the AHETF, AEATF, and ICR, Inc., indicated an average of
2 hours for management, 2 hours for technical, and 2 hours for clerical
for the activity “Rule Familiarization and Training.”  The Agency
considers this burden to be representative of the time expenditure by
experienced submitters.  But EPA recognizes that there may be new
inexperienced entities that may need to spend more time on “Rule
Familiarization and Training.”  In order to capture the total burden
and cost across all submitters, both experienced and inexperienced, OPP
assumed that, in addition to the experienced submitters, there would be
one new submitter per year, and that a new submitter would spend 4
management hours, 16 technical hours, and 2 clerical hours on “Rule
Familiarization and Training.”  The weighted average, covering both
experienced and inexperienced submitters, is 2 management hours, 4
technical hours, and 2 clerical hours.

 Ag handler study estimates based on information from J. Evans, M.
Crowley and J. Carley (EPA/OPP). Antimicrobial exposure study estimates
based on information from T. Leighton, C. Walls, and J. Carley
(EPA/OPP).  Insect repellant study estimates based on information from
C. Fuentes, K. Sweeney, and J. Carley (EPA/OPP).  Other study type
estimates based on information from J. Carley, B. Jordan, and K.
Sherman.