US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

JANUARY 2012 PUBLIC MEETING AGENDA

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive, Arlington, VA 22202 

Thursday, January 26, 2012

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

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2011–0954

9:45 AM*	Convene Public Meeting – Jim Downing, Designated Federal
Officer, EPA Human Studies Review Board, Office of the Science Advisor

Introduction of Board Members – Sean Philpott, Ph.D., HSRB Chair

	Welcome - Warren Lux, M.D., Director, Program in Human Research Ethics,
Office of the Science Advisor, EPA

	Opening Remarks – Steven Bradbury, Ph.D., Director, Office of
Pesticide Programs (OPP), Office of Chemical Safety and Pollution
Prevention, EPA

	Follow-up on Previous HSRB Recommendations – Mr. William Jordan, OPP,
Office of Chemical Safety and Pollution Prevention, EPA

Session 1:	A new scenario design and associated protocol from the
Agricultural Handler Exposure Task Force (AHETF) describing proposed
research to measure dermal and inhalation exposure to workers who mix,
load, and apply liquid pesticides with powered handgun equipment.

10:00 AM 	EPA Science Review – Mr. Jeff Evans, (OPP, EPA) 

10:25 AM 	Board Questions of Clarification – Sean Philpott, Ph.D.
(HSRB Chair), EPA, Principal Investigator/Sponsor

10:55 AM	EPA Ethics Assessment - Ms. Kelly Sherman (OPP, EPA)

11:15 AM	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair), EPA, Principal Investigator/Sponsor

11:35 AM 	Public Comments 

11:50 AM	Board Discussion 

Charge to the Board - Science: 

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of workers mixing, loading, and applying
pesticides in managed horticultural facilities using powered handgun
equipment?

Charge to the Board - Ethics: 

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

12:30 PM* 	Lunch

Session 2:	A completed scenario monograph and study report from the
Antimicrobial Exposure Assessment Task Force II (AEATF) in which the
dermal and inhalation exposure of professional janitorial workers was
monitored as they applied a liquid antimicrobial pesticide product for
indoor surface disinfecting using a pressurized aerosol can.

  

1:30 PM* 	EPA Science Review – Mr. Tim Leighton (OPP, EPA), Jonathan
Cohen, Ph.D., ICF International

1:55 PM 	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair), EPA, Principal Investigator/Sponsor

2:20 PM	EPA Ethics Assessment - Ms. Kelly Sherman (OPP, EPA)

2:45 PM	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair), EPA, Principal Investigator/Sponsor

3:10 PM 	Public Comments

3:25 PM	Board Discussion

Charge to the Board - Science:

Was the research reported in the Antimicrobial Exposure Assessment Task
Force II (AEATF) completed aerosol study report faithful to the design
and objectives of the protocol and governing documents of AEATF?

Has EPA adequately characterized, from a scientific perspective, the
limitations on these data that should be considered when using the data
in estimating the exposure of professional janitorial workers who apply
liquid antimicrobial pesticide products to indoor surfaces using
pressurized aerosol cans?

Charge to the Board - Ethics:

Does available information support a determination that the study was
conducted in

substantial compliance with subparts K and L of 40 CFR Part 26?

4:20 PM	An update from the Work Group on Return of Individual Research
Results

4:30 PM	Adjournment

*Agenda times are approximate and subject to change depending upon the
discussion.

