UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

AGENDA

Wednesday, January 11, 2012

1:00 pm - 4:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

DRAFT OCTOBER 19-20, 2011 HSRB MEETING REPORT

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

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2011–0953

Meeting location via telephone only

Dial in number 866-299-3188; conference code 2025647189 

1:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer, EPA HSRB, OSA)

1:10 PM*	Meeting Administrative Procedures – Jim Downing, DFO

1:15 PM	Meeting Process – Sean Philpott, Ph.D. (HSRB Chair)

1:20 PM	Public Comments

1:30 PM	Board Discussion and Decision on Final Report – Sean Philpott,
Ph.D. (HSRB Chair)

The Board’s response to EPA charge questions presented at the October
19-20, 2011 meeting.

A new scenario design and associated protocol from the Antimicrobial
Exposure Assessment Task Force II (AEATF-II), describing proposed
research to monitor the dermal and inhalation exposure of workers while
pouring liquid antimicrobial pesticide products from both conventional
and reduced-splash containers.

Charge to the Board:

If the AEATF liquid pour study proposal 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 individuals who manually pour liquid
antimicrobial products?

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

A new scenario design and associated protocols from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
measure dermal and inhalation exposure to workers who use closed system
equipment to load liquid pesticide products from returnable and
non-returnable containers.

Charge to the Board: 

If the AHETF closed system liquid loading study proposal 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 workers using closed systems to load
liquid pesticide products from returnable or non-returnable containers?

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

A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas
003) to evaluate the field repellent efficacy against mosquitoes of a
product containing 16% para-methane-3,8-diol and 2% lemongrass oil.

Charge to the Board: 

Is the CLBR completed study No Mas 003 sufficiently sound, from a
scientific perspective, to be used to estimate the duration of complete
protection against mosquitoes provided by the tested repellent?

Does available information support a determination that the study No Mas
003 was conducted in substantial compliance with 40 CFR Part 26,
subparts K and L?

A published report by Moiemen et al (2011) of an intentional exposure
human study measuring dermal absorption of silver from the use of
nanosilver-containing wound dressings to treat major burns.

Charge to the Board: 

Is the Moiemen (2011) study scientifically sound, providing reliable
data? 

If so, can the Moiemen (2011) study be used to support the Agency's
conclusion that the dermal absorption factor for silver from nanosilver
on human skin is less than 0.1%?

Is there adequate information to support a determination that the study
was conducted in substantial compliance procedures at least as
protective as those at subparts A-L of 40 CFR Part 26?

3:55 PM	Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and
Jim Downing (DFO)

4:00 PM 	Adjournment

*Note that agenda times are approximate. For further information, please
contact the Designated Federal Officer for this meeting, Jim Downing via
telephone: (202) 564-2468 or email: downing.jim@epa.gov

