Document ID: EPA-HQ-ORD-2010-0617-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-09-08T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

Thursday, September 9, 2010

1:30 pm -3:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF 

DRAFT JUNE 23, 2010 HSRB MEETING REPORT

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

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2010–0617

Meeting location via telephone only

Dial in number 866-299-3188; conference code 2025647189 

1:30 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer, HSRB, OSA, EPA)

1:40 PM	Meeting Administrative Procedures – Jim Downing, DFO

1:45 PM	Meeting Process –Sean Philpot, Ph.D. (HSRB Chair)

1:50 PM	Public Comments

2:00 PM	Board Discussion and Decision on Final Report – Sean Philpot,
Ph.D. (HSRB Chair)

The Board’s response to EPA charge questions presented at the June 23,
2010 meeting.

Completed Carroll-Loye Biological Research, Inc. Study LNX-002: Field
Repellency of Two Picaridin-Based Personal Insect Repellents to Black
Flies 

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? 

Completed Carroll-Loye Biological Research, Inc. Study LNX-003:
Laboratory Repellency of Two Picaridin-Based Personal Insect Repellents
to Two Species of Ticks 

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? 

Revised Product Performance Test Guidelines for Insect Repellents to be
Applied to Human Skin

The Board recommended several changes or clarifications, including:

Removal of the maximum-likelihood method requirement in the data
analysis section;

Clarification of recommendations regarding the use of positive controls,
particularly with respect to the number of controls and the rationale
for including them in the study;

Careful consideration of recommendations regarding the recruitment and
inclusion of so-called ‘vulnerable’ populations, including racial
and ethnic minorities; and

Encouraging the use of study designs that will enable investigators to
collect data that will allow quantitative measurement of the repellent
efficacy during the complete protection period.

2:55 PM	Summary and Next Steps – Sean Philpot, Ph.D. (HSRB Chair) and
Jim Downing (DFO)

3:00 PM 	Adjournment

* Please be advised that agenda times are approximate. 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

  PAGE  2