*Agenda times are approximate and subject to change depending upon the discussion.

US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

APRIL 2015 PUBLIC MEETING AGENDA

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive, Arlington, VA 22202 

Wednesday, April 22, 2015

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2015–0145

Webcast of the HSRB Meeting

The Webcast of the meeting is at the following website:

https://epa.connectsolutions.com/hsrb

1:00 PM* Convene Public Meeting – Jim Downing, Designated Federal Officer, EPA 

Human Studies Review Board, Office of the Science Advisor

Introduction of Board Members –Liza Dawson, Ph.D., HSRB Chair

Welcome – Thomas A. Burke, PhD, MPH, Science Advisor, EPA

Session 1: Completed Study and Monograph Report for Backpack and Handgun 

Application of Liquid Spray in Utility Rights of Way (Agricultural Handlers 

Exposure Task Force)

1:20 PM EPA Science Review – Mr. Mathew Crowley, (Health Effects Division, OPP, 

EPA)

2:05PM Board Questions of Clarification – Liza Dawson, Ph.D., (HSRB Chair), EPA, and 

Principal Investigator/Sponsor

2:30 PM EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)

2:45 PM Board Questions of Clarification – Liza Dawson, Ph.D., (HSRB Chair), EPA, 

Principal Investigator/Sponsor

3:00 PM Break

3:15 PM Public Comments 

3:25 PM Board Discussion 

Charge to the Board - Science:

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? 

Discussant: William Popendorf, Ph.D. (George Fernandez, Ph.D., statistics)
*Agenda times are approximate and subject to change depending upon the discussion.

Charge to the Board - Ethics:

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? 

Discussant: Elizabeth Heitman, Ph.D.

4:50 PM Adjourn
*Agenda times are approximate and subject to change depending upon the discussion.

US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

APRIL 2015 PUBLIC MEETING AGENDA

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive, Arlington, VA 22202 

Thursday, April 23, 2015

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2015–0145

Webcast of the HSRB Meeting

The Webcast of the meeting is at the following website:

https://epa.connectsolutions.com/hsrb

9:00 AM* Convene Public Meeting – Jim Downing, Designated Federal Officer, EPA 

Human Studies Review Board, Office of the Science Advisor

Introduction of Board Members – Liza Dawson, Ph.D., HSRB Chair

Follow-up on Previous Day’s Discussion – Ms. Kelly Sherman, OPP, Office of 

Chemical Safety and Pollution Prevention, EPA

Session 1: Protocol for Field Testing of skin applied mosquito repellent products (SC 

Johnson)

9:10 AM EPA Science Review – Mr. Kevin Sweeney, (Registration Division, OPP, EPA)

9:30 AM Board Questions of Clarification – Liza Dawson, Ph.D., (HSRB Chair), EPA, and 

Principal Investigator/Sponsor

10:00 AM EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)

10:20 AM Board Questions of Clarification – Liza Dawson, Ph.D., (HSRB Chair), EPA, and 

Principal Investigator/Sponsor

10:45 AM Public Comments 

10:55 PM Break

11:05 AM Board Discussion

If the SCJ study proposal is revised as suggested in EPA’s science and ethics reviews and if 

the research is performed as described:

Charge to the Board - Science:

 Is this research is likely to generate scientifically reliable data, useful for assessing the 

efficacy of these insect repellent pesticide products?

Discussant: Randy Maddalena, Ph.D. (Jun Zhu, Ph.D., statistics)
*Agenda times are approximate and subject to change depending upon the discussion.

Charge to the Board - Ethics:

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

and L?

Discussant: Gary Chadwick, Pharm.D., M.P.H, C.I.P.

12:05 PM Adjourn