UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

Monday, December 13, 2010

3:00 pm -5:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

DRAFT OCTOBER 27/28, 2010 HSRB MEETING REPORT

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

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2010–0919

Meeting location via telephone only

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

3:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer, HSRB, OSA, EPA)

3:10 PM*	Meeting Administrative Procedures – Jim Downing, DFO

3:15 PM	Meeting Process –Sean Philpott, Ph.D. (HSRB Chair)

3:20 PM	Public Comments

3:30 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
27/28, 2010 meeting.

Carroll-Loye Biological Research, Inc. Protocol No Mas 003, a Field
Efficacy Test of PMD and Lemongrass Oil-based Repellent “No Mas”
Against Mosquitoes.

Charge to the Board:

If the proposed field repellency study protocol No Mas 003 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 efficacy of the tested material in repelling
mosquitoes?

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

A new scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) to measure dermal and inhalation
exposure to applicators who use backpack sprayers or hand gun sprayers
to apply pesticides in utility rights-of-way.

Charge to the Board:

If the proposed Agricultural Handler Exposure Task Force (AHETF)
Right-of-Way application scenario and field study protocol AHE400 is
revised as suggested in EPA’s review and if it is performed as
described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of workers who apply pesticides in utility
rights-of-way with backpack or hand gun sprayers?  

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

Completed scenario monograph and study report from the Antimicrobial
Exposure Assessment Task Force II (AEATF–II): Dermal and Inhalation
Exposure of Professional Janitorial Workers Applying Liquid
Antimicrobial Products to Indoor Floors Using Bucket and Mop

Charge to the Board:

In the completed scenario monograph and study report AEA03 from the
Antimicrobial Exposure Assessment Task Force II (AEATF–II):

Was the research reported in the Antimicrobial Exposure Assessment Task
Force II (AEATF–II) completed study report AEA03 and associated
supplemental reports faithful to the design and objectives of the
protocol and governing documents of AEATF-II? 

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 antimicrobial
floor-cleaning products with mop and bucket? 

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

Revised scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
monitor exposure of workers who mix and load pesticides formulated as
wettable powders in water-soluble packaging

Charge to the Board:

If the revised AHETF scenario and field study proposal AHE120 is revised
as suggested in EPA’s review, and if it is performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of handlers who mix and load pesticides in
water-soluble packaging?

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

4:55 PM	Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and
Jim Downing (DFO)

5:00 PM 	Adjournment

* Please be advised 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

  PAGE  1 

