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 

training1 2 2 2 6 506

Prepare and submit protocol 

for IRB review2 5 80 10 95 6,950

Prepare and submit protocol 

for EPA and HSRB review3 15 240 26 276 20,682

Document ethical conduct 

of a completed study for 

which EPA and the HSRB 

have reviewed the protocol4

10 260 10 285 20,780

Store, file, and maintain 

records5 0 2 0 2 48,918

 

1 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.

2 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.

3 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.

4 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.

5 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. 
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 

training6 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

 

6 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).
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 

training7 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

 

7 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.
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 

training8 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

 

8 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.
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 Staff9

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

 

9 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. 
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

1. 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

2. 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

3. 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

4. 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)

5. 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)

6. 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

o AHETF, AEATF, Insect Repellant, and one additional type of post-rule 

intentional exposure study

 18 completed study reports per year requiring EPA & HSRB review 

o 16 completed study reports for which there was previous protocol review

o 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)