US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

JANUARY 2011 PUBLIC MEETING

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive, Arlington, VA 22202 

January 26, 2011

9:15 AM*	Convene Public Meeting and Review Administrative Procedures –
Jim Downing (Designated Federal Officer, EPA Human Studies Review Board,
Office of the Science Advisor)

9:20 AM	Opening Remarks - Dr. Warren Lux, Director of the Program in
Human Research Ethics (Office of the Science Advisor)

9:25 AM	Introduction and Identification of Board Members – Sean
Philpott, Ph.D. (HSRB Chair) 

9:30 AM 	OPP Welcome and Follow-up on Previous HSRB Recommendations –
Mr. William Jordan (OPP, EPA)

Session 1:	Agricultural Handler Exposure Task Force (AHETF) report of a
completed scenario monograph and study reports of five field studies
measuring the dermal and inhalation exposure of workers applying liquid
spray pesticides to tree or trellis crops using closed cab airblast
equipment.

9:40 AM 	EPA Science and Ethics Reviews – Mr. Matthew Crowley (OPP,
EPA) and Ms. Kelly Sherman (OPP, EPA) 

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

10:55 AM	Break

11:10- AM 	Public Comments 

11:25 AM	Board Discussion - Science

Charge to the Board: 

Was the research reported in the Agricultural Handler Exposure Task
Force (AHETF) completed monograph report and associated field study
reports faithful to the design and objectives of the protocol, SOPs, and
governing documents?

Has the Agency adequately characterized, from a scientific perspective,
the limitations on these data that should be considered when using the
data in estimating exposure of those who apply conventional pesticides
with closed cab airblast equipment?

12:30 PM 	Lunch

1:15 PM	Board Discussion Continued - Ethics

Charge to the Board:

Does available information support a determination that the studies were
conducted in substantial compliance with subparts K and L of 40 CFR Part
26?

Session 2:	Agricultural Handler Exposure Task Force (AHETF) scenario
design and associated protocol describing proposed research to monitor
exposure of workers who mix and load pesticides formulated as wettable
powders.

2:15 PM	EPA Science and Ethics Reviews – Mr. Jeff Evans (OPP, EPA) and
Ms. Kelly Sherman (OPP, EPA) 

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

3:15 PM	Public Comments

3:30 PM	Break

3:45 PM	Board Discussion

Charge to the Board:

If the revised AHETF scenario and field study proposal AHE80 is revised
as suggested in

EPA’s review and if the research is performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of handlers who perform open mixing and
loading of pesticide end use products formulated as wettable powders?

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

5:15 PM	Adjournment

*Agenda times are approximate and subject to change. For further
information, please contact the Designated Federal Officer for this
meeting, Jim Downing, via telephone: (202) 564-2468 or email:  HYPERLINK
"mailto:downing.jim@epa.gov" downing.jim@epa.gov 

