US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

JUNE 2010 PUBLIC MEETING

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive, Arlington, VA 22202 

JUNE 23, 2010

10:00 AM Convene Meeting and Administrative Procedures – Jim Downing 

(Designated Federal Officer, EPA Human Studies Review Board, Office of 

the Science Advisor) 

10:05 AM* Introduction and Identification of Board Members – Sean Philpott, 

Ph.D. (HSRB Chair) 

10:15 AM Welcome –Pai-Yei Whung, Ph.D. (Chief Scientist, Office of the Science 

Advisor) 

10:20 AM Opening Remarks – Steven Bradbury, Ph.D. (Director, Office of Pesticide 

Programs (OPP), Office of Chemical Safety and Pollution Prevention, EPA) 

10:25 AM EPA Follow-up on Previous HSRB Recommendations – Mr. William 

Jordan (OPP, EPA)

Completed Carroll-Loye Biological Research, Inc. Study LNX-002: Field Repellency of 

Two Picaridin-Based Personal Insect Repellents to Black Flies 

10:30 AM EPA Science and Ethics Reviews – Mr. Kevin Sweeney (OPP, EPA) and Mr. 

John Carley (OPP, EPA) 

11:00 AM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, 

Principal Investigator/Sponsor 

11:30 AM Public Comments 

11:45 AM Board Discussion 

Charge to the Board:

1. Is the CLBR study LNX-002 sufficiently sound, from a scientific perspective, to be used 

to estimate the duration of complete protection against black flies provided by the tested 

repellents? 

2. Does available information support a determination that study LNX-002 was conducted 

in substantial compliance with subparts K and L 40 CFR Part 26? 

12:15 PM Lunch 
Completed Carroll-Loye Biological Research, Inc. Study LNX-003: Laboratory 

Repellency of Two Picaridin-Based Personal Insect Repellents to Two Species of Ticks

1:15 PM EPA Science and Ethics Reviews – Mr. Kevin Sweeney (OPP, EPA) and Mr. 

John Carley (OPP, EPA) 

1:45 PM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, 

Principal Investigator/Sponsor 

2:15 PM Public Comments 

2:30 PM Board Discussion 

Charge to the Board:

1. Is the CLBR study LNX-003 sufficiently sound, from a scientific perspective, to be used 

to estimate the duration of complete protection against ticks provided by the tested 

repellents? 

2. Does available information support a determination that study LNX-003 was conducted 

in substantial compliance with subparts K and L 40 CFR Part 26? 

3:00 PM Break

3:15 PM OPP Presentation: Revised Product Performance Test Guidelines for 

Insect Repellents to be Applied to Human Skin – Mr. John Carley (OPP, 

EPA) and Mr. William Jordan (OPP, EPA), with Clara Fuentes, Ph.D. (OPP, 

EPA), and Mr. Kevin Sweeney (OPP, EPA)

3:45 PM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair)

4:15 PM OPP Presentation: Settlement Agreement in Litigation Against EPA’s 

Human Studies Rule – Mr. William Jordan (OPP, EPA)

4:45 PM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair)

5:15 PM Preview of Upcoming Meetings - Ms. Kelly Sherman (OPP, EPA)

5:20 PM Adjournment 

* Agenda times are approximate and subject to change. For further information, please 

contact the Designated Federal Officer for this meeting, Jim Downing, via telephone: 

(202) 564-2468 or email: downing.jim@epa.gov

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

Docket Telephone: (202) 566-1752

Docket Number: EPA-HQ-ORD-2010-0381