**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