12/21/06 DRAFT 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

JANUARY 24, 2007 *

PUBLIC MEETING

Sheraton Crystal City Hotel 

1800 Jefferson Davis Highway

Arlington, VA 22202

703 486 1111

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

Docket Telephone: (202) 566 1752

Docket Number: EPA-HQ-ORD-2006-0998

( 8:30 AM	Introduction and Identification of Board Members – Celia
Fisher, Ph.D. (HSRB Chair)

( 8:45 AM	Welcome – George Gray, Ph.D. (EPA Science Advisor) 

( 8:55 AM	Opening Remarks – Mr. Jim Jones (Director, Office of
Pesticide Programs, OPPTS) EPA) 

( 9:05 AM	Meeting Administrative Procedures - Paul Lewis, Ph.D.
(Designated Federal Officer [DFO], HSRB, OSA, EPA) 

( 9:10 AM	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair) 

( 9:25 AM	Update on EPA Follow-up of HSRB Recommendations – Mr.
William Jordan (EPA, OPP)   

Insect Repellent Completed Efficacy Studies EMD-003 and EMD-004

( 9:35 PM	Science and Ethics of Insect Repellent Completed Efficacy
Studies EMD-003 and EMD-004 - Clara Fuentes, Ph.D. (OPP, EPA) and Mr.
John Carley (OPP, EPA) 

( 10:15 AM	Break  

( 10:30 AM	Public Comments 

( 11:00 AM	Board Discussion  

EMD-003.1 and EMD-003.2: Tick Repellency with Lotion and Pump Spray
Formulations

a.   Are these studies sufficiently sound, from a scientific
perspective, to be used to assess the repellent efficacy of the
formulations tested against ticks and mosquitoes?  

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

EMD-004.1 and EMD-004.2: Mosquito Repellency with Lotion and Pump Spray
Formulations

a.   Are these studies sufficiently sound, from a scientific
perspective, to be used to assess the repellent efficacy of the
formulations tested against ticks and mosquitoes?  

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

( 12:30 PM	Lunch 

Insect Repellent Efficacy Protocol SCI-001

( 1:30 PM	Science and Ethics of Insect Repellent Efficacy Protocol
SCI-001– Mr. Kevin Sweeney (OPP, EPA) and Mr. John Carley (OPP, EPA) 

( 2:30 PM	Public Comments 

( 3:00 PM	Break  

( 3:15 PM	Board Discussion

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

( 4:30 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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