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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

April 1, 2015

MEMORANDUM

SUBJECT: Materials for Review by the Human Studies Review Board for its 

April 22-23, 2015 Meeting

TO: Jim Downing 

Designated Federal Official

Human Studies Review Board

Office of Science Advisor (8105R)

FROM: Kelly Sherman

Human Research Ethics Review Officer

Office of the Director

Office of Pesticide Programs (7501P)

This memorandum describes the materials that the Environmental Protection Agency’s 

(EPA’s) Office of Pesticide Programs is providing for review by the Human Studies Review 

Board (HSRB or Board) at the meeting scheduled for April 22-23, 2015. At this meeting, EPA 

will ask the Board to address scientific and ethical issues surrounding two topics, each of which 

is discussed further below: 

1. A report from the Agricultural Handler Exposure Task Force (AHETF) of completed

research monitoring the exposure of workers applying pesticides to utility rights-of-way 

using backpack and handgun spray equipment. 

2. A new protocol from S.C. Johnson & Son, Inc. describing proposed efficacy testing in the 

field of various S.C. Johnson skin-applied mosquito repellent products.
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1. AHETF Completed Study AHE400: Exposure of Workers Applying Pesticides to 

Utility Rights-of-Way using Backpack and Handgun Spray Equipment: 

In October 2010, the HSRB reviewed a protocol for research to measure the levels of 

dermal and inhalation exposure received by pesticide applicators who spray pesticides in utility 

rights-of-way using backpack and handgun spray equipment. Following favorable EPA and 

HSRB reviews of the protocol, and after revisions to address EPA and HSRB comments, this 

research was conducted between May 2011 and September 2013. The completed reports and 

monograph were submitted to EPA in October 2013.If the data for this scenario are accepted by 

EPA, the resulting data will be added to the Agricultural Handler Exposure Database (AHED®). 

EPA intends to use these data generically to estimate daily dermal and inhalation exposures of

workers who treat utility rights-of-way using backpack and handgun spray equipment. 

Because this research involved scripted exposure, it meets the regulatory definition of

“research involving intentional exposure of a human subject” and thus is covered by subparts K

and L of EPA’s amended rule for the protection of human subjects of research. The rule at 40

CFR §26.1303 requires the submitter of reports of completed human research to document its

ethical conduct. The rule at 40 CFR §26.1604 requires EPA to “review the material submitted

under §26.1303 and other available, relevant information, and [to] document its conclusions

regarding the scientific and ethical conduct of the research.” The rule at 40 CFR §26.1604

further requires EPA to submit the data and EPA’s review to the HSRB if it decides to rely on 

the data.

EPA has reviewed the AHETF completed study report, IIRB correspondence report, and

monographs, and has concluded that the research provides scientifically sound, useful

information, and was conducted in substantial compliance with the ethics requirements at 40

CFR part 26, subparts A through L.

Charge Questions:

1. Was the research reported in the Agricultural Handler Exposure Task Force (AHETF) 

completed monograph reports and associated field study report for AHE400 faithful to 

the design and objectives of the protocol, SOPs, and governing documents? 

2. Has the Agency adequately characterized, from a scientific perspective, the limitations on 

these data that should be considered when using the data in estimating exposure of those 

who apply liquid pesticide sprays to utilities rights-of-way using backpack or handgun 

spray equipment? 

3. Does available information support a determination that the studies were conducted in 

substantial compliance with subparts K and L of 40 CFR Part 26? 
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Documents for Review for AHETF Completed Study (AHE400):

Author File or Folder Name Description

AHE400 Study Report 9-

17-14.pdf

AHETF submission of the field and analytical results 

for backpack and handgun monitoring. This single 

report covers monitoring for both scenarios.

*However, each scenario has its own monograph 

report.

Backpack ROW 

Monograph 9-29-14 

Final.pdf

AHETF submission of the backpack scenario utilizing 

backpack-specific data from “AHE400 Study Report 9-

17-14.pdf”

Handgun-ROW 

Monograph 9-29-14 

Final.pdf

AHETF submission of the handgun scenario utilizing 

handgun-specific data from “AHE400 Study Report 9-

17-14.pdf”

IRB Correspondence 

Report for Study AHE400 

- Final 9-8-14.pdf

IRB correspondence.

AHE400 AaiH 

Calculations 3-18-14 Post 

QA.xlsx

AHETF description and analysis spreadsheet 

calculating how much active ingredient is handled by 

each worker.

BP-ROW Data - FF 

Adjusted 9-5-14 Post QA -

for EPA 10-14-14.xlsx

AHETF spreadsheet compilation of backpack data

AHETF

HG-ROW Data - FF 

Adjusted 9-5-14 Post QA -

for EPA 10-14-14.xlsx

AHETF spreadsheet compilation of handgun data

Excel workbooks (folder)

Folder containing 31 Excel files showing dosimeter 

results for each worker, including field fortification 

analysis and adjustments.

SAS Files AHE400-BP 

(folder)

Folder containing 5 statistical software programming 

files (SAS) and 1 .csv file. Pertains to Appendices E 

and F of “Backpack ROW Monograph 9-29-14 

Final.pdf”.

SAS Files AHE400-HG 

Scenario (folder)

Folder containing 3 statistical software programming 

files (SAS) and 1 .csv file. Pertains to Appendices E 

and F of “Handgun-ROW Monograph 9-29-14

Final.pdf”.

AHETF GD Version 2-8-

12-10 with changes 

accepted.pdf

The AHETF’s “Governing Document” outlining, for 

all potential scenarios, the overarching approach to 

monitoring pesticide handlers. Includes sampling 

design and sample size estimations.
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Documents for Review for AHE400 Completed Study (continued):

Author File or Folder Name Description

AHETF

AHETF SOP Manual 12JAN2015 EPA 

Version.pdf

AHETF Standard Operating Procedures 

(SOPs). These SOPs are a good source 

of information about how many aspects 

of the research are conducted.

AHE400 MU Plan 6-04-10.pdf

2010 AHETF submission outlining the 

monitoring plan and protocol for the 

completed studies under current review.

EPA

49472001.DER_AHE400_BP and HG 

ROW_Field-Analytical Review.doc

EPA’s review of “AHE400 Study 

Report 9-17-14.pdf”. Currently in draft 

form, to be finalized following any 

comments from the April 2015 HSRB 

meeting report.

49478601.DER_AHE1012_Backpack 

ROW_Monograph Review.doc

EPA’s review of “Backpack ROW 

Monograph 9-29-14 Final.pdf”.

Currently in draft form, to be finalized 

following any comments from the April 

2015 HSRB meeting report.

49478602.DER_AHE1013_Handgun 

ROW_Monograph Review.doc

EPA’s review of “Handgun-ROW 

Monograph 9-29-14 Final.pdf”.

Currently in draft form, to be finalized 

following any comments from the April 

2015 HSRB meeting report.

EPA Review_AHE1012_BP-ROW 

Data.xlsx

EPA spreadsheet compilation of 

backpack data – based on the AHETF 

submission “BP-ROW Data - FF 

Adjusted 9-5-14 Post QA - for EPA 10-

14-14.xlsx”

EPA Review_AHE1013_HG-ROW 

Data.xlsx

EPA spreadsheet compilation of 

handgun data – based on the AHETF 

submission “HG-ROW Data - FF 

Adjusted 9-5-14 Post QA - for EPA 10-

14-14.xlsx”

EPA Ethics Review of Completed Study 

AHE400.pdf

EPA’s review of ethics issues for 

completed report.

EPA Science and Ethics Review of 

AHE400 ROW final 9-30-10.pdf

EPA protocol review (covering both 

science and ethics), prepared prior to the 

October 2010 HSRB meeting.

HSRB

HSRB October 2010 Meeting Minutes.pdf Minutes of the HSRB meeting when the 

protocol for this study were reviewed. 

HSRB October 2010 Meeting Report.pdf HSRB’s report for the protocol review 

of this study.
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2. S.C. Johnson & Son, Inc. Protocol – Field Testing of S.C. Johnson Personal 

Mosquito Repellent Products to Support their use of the EPA Repellency Awareness 

Graphic: 

The Board will also consider a new protocol from S.C. Johnson & Son, Inc. describing 

proposed research to determine the complete protection time of up to eighteen EPA-registered 

S.C. Johnson skin-applied repellent products in the field against wild adult mosquito populations.

Because the proposed research involves scripted exposure, it meets the regulatory definition of 

“research involving intentional exposure of a human subject” and thus is covered by subparts K 

and L of EPA’s amended rule for the protection of human subjects of research. The rule at 40 

CFR §26.1125 requires a sponsor or investigator to submit to EPA, before conducting a study 

involving intentional exposure of human subjects, the protocol and related materials describing 

the proposed human research. In addition, EPA’s regulation at 40 CFR §26.1603 requires EPA 

to perform science and ethics reviews of the submitted proposal and to seek HSRB review of the 

proposed research. EPA has reviewed the protocol, and has concluded that the research, with 

minor revisions, is likely to generate scientifically sound, useful information and to meet the 

applicable provisions of the EPA regulations in 40 CFR part 26, subparts K and L. The charge 

questions and documents being transmitted to the HSRB for review are listed below.

Charge Questions: 

If the S.C. Johnson & Son, Inc. protocol is revised as suggested in EPA’s review and if the 

research is performed as described:

1. Is the protocol “Field Testing of S.C. Johnson Personal Mosquito Repellent Products to 

Support their Use of the EPA Repellency Awareness Graphic” likely to generate 

scientifically reliable data, useful for estimating the complete protection time of various 

EPA-registered S.C. Johnson skin-applied mosquito repellents in the field against wild adult 

mosquito populations?

2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and 

L?

Documents for Review: 

a. EPA Science and Ethics Review of a Protocol for Field Testing of S.C. Johnson SkinApplied Mosquito Repellent Products (dated March 31, 2015) (39 pages)

b. S.C. Johnson Protocol Submission (dated February 27, 2015) (676 pages)