*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

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

HUMAN STUDIES REVIEW BOARD (HSRB) 

PUBLIC TELECONFERENCE MEETING 

AGENDA 

Tuesday, May 24, 2011 

1:00 pm - 3:00 pm (Eastern Time)* 

HSRB MEETING FOR REVIEW AND APPROVAL OF THE 

DRAFT APRIL 13-14, 2011 HSRB MEETING REPORT AND A DRAFT LETTER 

FROM AN HSRB WORKGROUP ON PROVIDING RESEARCH 

PARTICIPANTS WITH INDIVIDUALIZED STUDY RESULTS 

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

Docket Telephone: (202) 566 1752 

Docket Number: EPA–HQ–ORD–2011–0418 

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, HSRB, OSA, EPA) 

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 April 13-14, 2011 

meeting. 

Completed AHETF research on exposure of workers applying pesticide sprays using 

open‐cab airblast equipment. 

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 EPA 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 pesticides with open cab airblast equipment? 

 Does the available information support a determination that the studies were 

conducted in substantial compliance with subparts K and L of 40 CFR Part 26? 
*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

Completed AEATF research on exposure of professional janitorial workers when 

wiping indoor surfaces with an antimicrobial pesticide. 

Charge to the Board: 

 Was the research reported in the Antimicrobial Exposure Assessment Task Force 

II (AEATF) completed wipe 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 

exposure of those who clean indoor surfaces with antimicrobial pesticides using a 

triggerspray bottle and wipes or readytouse wipes? 

 Does the available information support a determination that the study was 

conducted in substantial compliance with subparts K and L of 40 CFR Part 26? 

Assessment of Published Research Study by Gulson et al. (2010): Small Amounts of 

Zinc from Zinc Oxide Particles in Sunscreens Applied Outdoors Are Absorbed 

through Human Skin. 

Charge to the Board 

 Is the Gulson et al. (2010) study scientifically sound, providing reliable data? 

 If so, is the Gulson et al. (2010) study relevant for qualitative use in support of an 

assessment of the absorption of zinc oxide through the skin? 

 Is there adequate information to determine that the Gulson et al. (2010) study was 

conducted in substantial compliance with procedures at least a protective as those 

in subparts A - L of EPA’s regulation at 40 CFR Part 26? 

Reconsideration of two concerns previously raised by the HSRB in its June 2009 

review of an intentional human dosing study with chlorpyrifos (Kisicki et al., 1999); 

additional pertinent information was made available by the sponsor related to these 

two concerns. 

Issues for Discussion: 

 Do the recommendations provided by the HSRB at its June 2009 meeting and in 

its subsequent report regarding the reliability of data on the urinary metabolite 

trichloropyridinol in the Kisicki et al. (1999) study change in light of the new 

information provided?

 Do the recommendations provided by the HSRB at its June 2009 meeting and in 

its subsequent report regarding the level of absorption of chlorpyrifos in the 

Kisicki et al. (1999) study change in light of the new information provided? 

2:30 PM Draft letter from an HSRB workgroup on providing research 

participants with individualized study results

2:55 PM Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and Jim 

Downing (DFO) 

3:00 PM Adjournment