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

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

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