4/5/07 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

APRIL 18-20, 2007 *

PUBLIC MEETING

Wednesday, April 18, 2007

Environmental Protection Agency 

Conference Center - Lobby Level 

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

 Arlington, VA 22202 

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

Docket Telephone: (202) 566 1752

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

( 10:00 AM	Convene Meeting and Identification of Board Members – Celia
Fisher, Ph.D. (HSRB Chair)

( 10:15 AM	Welcome – Warren Lux, MD (Human Subjects Research Review
Official, Office of the Science Advisor, EPA) 

( 10:25 AM	Opening Remarks – Mr. Jim Jones (Principal Deputy Assistant
Administrator, Office of Prevention, Pesticides, and Toxic Substances,
EPA) 

( 10:40 AM	Meeting Administrative Procedures - Paul Lewis, Ph.D.
(Designated Federal Officer [DFO], HSRB, OSA, EPA) 

( 10:45 AM	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair) 

( 10:55 AM	EPA Follow-up on HSRB Recommendations – Mr. William Jordan
(EPA, OPP)   

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

( 11:10 AM	Science and Ethics of Repellent Efficacy Studies – Clara
Fuentes, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA) 

( 12:00 PM	Public Comments 

( 12:30 PM	Lunch

( 1:30 PM	Board Discussion 

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

( 2:30 PM	Science and Ethics of Protocol WPC-001– Clara Fuentes, Ph.D.
(OPP, EPA) and Mr. John Carley (OPP, EPA) 

( 3:30 PM	Break

( 3:45 PM	Public Comments 

( 4:15 PM	Board Discussion   

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?

( 5:15 PM	Adjournment  

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

APRIL 18-20, 2007 *

PUBLIC MEETING

Thursday, April 19, 2007

Environmental Protection Agency 

Conference Center - Lobby Level 

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

 Arlington, VA 22202 

( 8:30 AM	Convene Meeting – Celia Fisher, Ph.D. (HSRB Chair)

( 8:40 AM	Follow-up From Previous Day’s Discussion – Mr. William
Jordan (OPP, EPA)  

Completed Patch Test Studies

( 8:50 AM	HSRB Workgroup and EPA Process on CBI Redacted Submissions -
Celia Fisher, Ph.D. (HSRB Chair) and Mr. William Jordan (OPP, EPA) 

Part I. 48-Hour Dermal Irritation Patch Test 

( 9:00 AM	Science and Ethics of 48 Hour Dermal Irritation Patch Test
–Roger Gardner, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA) 

( 10:00 AM	Public Comments 

( 10:30 AM	Break

( 10:45 AM	Board Discussion 

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?

( 12:15 PM	Lunch 

Part II. Repeated Insult Patch Test 

( 1:30 PM	Science and Ethics of Repeated Insult Patch Test –Roger
Gardner, Ph.D. (OPP, EPA) and Mr. John Carley (OPP, EPA) 

( 2:15 PM	Public Comments 

( 2:45 PM	Board Discussion  

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?

( 3:45 PM	Break

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

( 4:00 PM	Framework for Developing Best Practices for Subject
Recruitment for Handler Exposure Research - Mr. John Carley (OPP, EPA)  

( 4:30 PM	Public Comments

( 4:45 PM	Board Discussion 

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.  

( 5:45 PM	Adjournment  

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

APRIL 18-20, 2007 *

PUBLIC MEETING

Friday, April 20, 2007

Environmental Protection Agency 

Conference Center - Lobby Level 

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

 Arlington, VA 22202 

( 8:30 AM	Convene Meeting – Celia Fisher, Ph.D. (HSRB Chair)

( 8:40 AM	Follow-up From Previous Day’s Discussion – Mr. William
Jordan (OPP, EPA)  

Follow-up on AHETF and AEATF Protocols 

( 8:50 AM	EPA’s Need for New Research on Occupational Handler Exposure
- Mr. William Jordan (OPP, EPA), Mr. Jeff Evans (OPP, EPA), Mr. Jeff
Dawson (OPP, EPA), and Mr. Matthew Crowley (OPP, EPA)  

( 10:00 AM	Break

( 10:15 AM	EPA’s Need for New Research on Occupational Handler
Exposure (continued) - Mr. William Jordan (OPP, EPA), Mr. Jeff Evans
(OPP, EPA), Mr. Jeff Dawson (OPP, EPA), and Mr. Matthew Crowley (OPP,
EPA)  

( 11:15 AM	Summary of EPA FIFRA SAP January 2007 Report “Worker
Exposure Methods” – FIFRA SAP Chair and/or Designee 

( 11:45 AM	Public Comments

( 12:15 PM	Lunch 

( 1:15 PM	Board Discussion 

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?

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

( 2:15 PM	Meaning of “Substantial Compliance” – Mr. William Jordan
(OPP, EPA) and Mr. Keith Matthews (OGC, EPA)

( 2:30 PM	Public Comment

( 2:45 PM	Board Discussion 

( 3:15 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:   HYPERLINK
"mailto:lewis.paul@epa.gov"  lewis.paul@epa.gov  

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