Document ID: EPA-HQ-ORD-2010-0381-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-06-24T04:00Z

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:  
HYPERLINK "mailto:downing.jim@epa.gov"  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