### US ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD JUNE 2010 PUBLIC MEETING Environmental Protection Agency Conference Center Lobb y Level
- One Potomac Yard (South Bldg.) 2777 S. Crystal Drive, Arlington, VA 22202

JUNE 2 3 , 2010 10 : 0 0 AM Co nvene Meeting and Administrative Procedures

– Jim Downing

(Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor) 10 : 0 5 AM * Introduction and Identification of Board Members

– Sean Philpott,

Ph.D. (HSRB Chair) 10:1 5 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 Follo w - 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 10:3 0 AM EPA Science and Ethics Revi ews – 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 LunchCompleted 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 Publi c 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 - 20 10 - 0381