8/9/07	 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING 

AUGUST 14, 2007 

3:00 pm -5:00 pm (Eastern Time)

HSRB MEETING FOR REVIEW AND APPROVAL OF 

DRAFT APRIL 18-20, 2007 HSRB MEETING REPORT *

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

Docket Telephone: (202) 566 1752

Docket Number: EPA-HQ-ORD-2007-0216

Meeting location via telephone only

Members of the public may obtain the call in number at 202-564-5275

( 3:00 PM	Introduction and Identification of Board Members – Celia
Fisher, Ph.D. (HSRB Chair) 

( 3:10 PM	Meeting Administrative Procedures - Paul Lewis, Ph.D.
(Designated Federal Officer, HSRB, OSA, EPA) 

( 3:15 PM	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair)

( 3:20 PM	Public Comments

( 3:30 PM	Board Discussion and Decision on Report - Celia Fisher, Ph.D.
(HSRB Chair)

Completed Repellent Efficacy Studies: IR3535 Aerosol (EMD-003.3 and
EMD-004.3)

 

EMD-003.3: Tick Repellency with Aerosol Spray Formulations

a.   Is this study sufficiently sound, from a scientific perspective, to
be used to assess the repellent efficacy of the formulation tested
against ticks?  

b.   Does available information support a determination that this study
was conducted in substantial compliance with subparts K and L of EPA
regulations at 40 CFR part 26?

EMD-004.3: Mosquito Repellency with Aerosol Spray Formulations

a.   Is this study sufficiently sound, from a scientific perspective, to
be used to assess the repellent efficacy of the formulation tested
against mosquitoes?  

b.   Does available information support a determination that this study
was conducted in substantial compliance with subparts K and L of EPA
regulations at 40 CFR part 26?

Carroll-Loye Mosquito Repellent Efficacy Protocol WPC-001

a. 	If the proposed research described in Protocol WPC-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear likely to generate scientifically
reliable data, useful for assessing the efficacy of the test substances
for repelling mosquitoes? 

b.  If the proposed research described in Protocol WPC-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear to meet the applicable requirements of
40 CFR part 26, subparts K and L?

Research Conducted After April 7, 2006: Meaning of “Substantial
Compliance” with 40 CFR Part 26

	(no charge question)

Completed Patch Test Studies

Part I. 48-Hour Dermal Irritation Patch Test 

a.   Is this study sufficiently sound, from a scientific perspective, to
be used as part of a weight-of-evidence assessment to evaluate the
potential of the formulations tested to irritate human skin?  

b.   Is there clear and convincing evidence that the conduct of this
study was fundamentally unethical or significantly deficient relative to
the ethical standards prevailing at the time the research was conducted?

Part II. Repeated Insult Patch Test 

a.   Is this study sufficiently sound, from a scientific perspective, to
be used to be used as part of a weight-of-evidence assessment to
evaluate the potential of the formulations tested to cause sensitization
of human skin?  

b.   Is there clear and convincing evidence that the conduct of this
study was fundamentally unethical or significantly deficient relative to
the ethical standards prevailing at the time the research was conducted?

Framework for Developing Best Practices for Subject Recruitment for
Handler Exposure Research

a.  What additional elements of the process of recruiting and enrolling
subjects in handler exposure research should be addressed in a “Best
Practices Framework”?

b.  For each of the elements in the “Best Practices Framework,”
please identify any additional sources of guidance that could be useful
for an investigator who is designing a process for recruiting and
enrolling subjects in handler exposure research.  

Follow-up on AHETF and AEATF Protocols 

Recognizing that protocol-specific science and ethics issues will be
addressed in later HSRB meetings, EPA has attempted to explain the basis
for its conclusion that additional information on exposure for people
who mix, load, and apply pesticides (handlers) would be useful in EPA's
regulatory decision-making and therefore new research would be valuable.
 Do the materials provided by EPA regarding the quality of the
scientific data currently available for assessing exposures for handlers
contain useful information to establish the societal value of proposed
new handler exposure research, assuming individual protocols would
generate scientifically valid information?  

What additional information, if any, would the Board want with respect
either to handler research in general or to individual protocols?

(4:45 PM	Summary and Next Steps - Celia Fisher, Ph.D. (HSRB Chair) and
Paul Lewis, Ph.D. (Designated Federal Officer, HSRB, EPA) 

( 5:00 PM 	Adjournment

*  Please be advised that agenda times are approximate. For further
information, please contact the Designated Federal Officer for this
meeting, Paul Lewis via telephone: (202) 564-8381 or email:
lewis.paul@epa.gov 

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