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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:
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 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