* Agenda times are app roximate and subject to change depending upon the discussion. **US ENVIRONMENTAL PROTECTION AGENCY** 

### HUMAN STUDIES REVIEW BOARD **JANUARY 201**  **2 PUBLIC MEETING**  **AGENDA Environmental Protection Agency Conference Center**  Lobb y Level - One Potomac Yard (South Bldg.) 2777 S. Cry stal Drive, Arlington, VA 22202 Thursday , January 26 , 201 2 **HSRB WEB SITE http://www.epa.gov/osa/hsrb/ Docket Telephone: (202) 566 1752**  **Docket Number: EPA**

**– HQ** **– ORD** **– 2011**  **– 0954**  **9:45 AM** * **Convene Public Meeting –**  Jim Downing , Designated Federal Officer, EPA

Human Studies Review Board, Office of the Science Advisor **Introduction of Board Members**

– S ean Philpott, Ph.D., HSRB Chair **Welcome** - Warren Lux, M.D., Director, Program in Human Research Ethics, Office of the Science Advisor, EPA **Opening Remarks –**  Steven Bradbury , Ph.D., Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention, EPA **Follow -**  **up on Previous HSRB Recommendations –**  Mr. William Jordan, OPP, Office of Chemical Safety and Pollution Prevention, EPA **Session 1: A new scenario design and associated protocol fro**  **m the Agricultural Handler**

**Exposure Task Force (AHETF) describing proposed research to measure dermal and inhalation exposure to workers who mix, load, and apply liquid**  **pesticides with powered handgun equipment. 10:0**  **0 AM**  **EPA Science Review**  **–** Mr. Jeff Evans, (OPP, EPA) **1 0**  **:2 5**  **AM Board Questions of Clarification** 

– Sean Philpott, Ph.D. (HSRB Chair), EPA,

Principal Investigator/Sponsor **1 0**  **: 55**  **AM EPA Ethics**  **Assessment -**  Ms. Kelly Sherman (OPP, EPA) **11: 15**  **AM Board Questions of Clarification** 

– Sean Philpott, Ph. D. (HSRB Chair), EPA,

Principal Investigator/Sponsor **11:35 AM**  **Public Comments 11:50**  **AM Board Discussion**  Charge to the Board - Science :  Is the research likel y to generate scientifically reliable data, useful for assessing the exposure of workers mixin g, loading, and applying pesticides in managed horticultural facilities using powered handgun equipment?* Agenda times are app roximate and subject to change depending upon the discussion.

Charge to the Board - Ethics :  Is the research likel y to meet the applicable requirements of 40 CFR part 26, subparts K and L ? **12:30 PM** ***** **Lunch Se**  **ssion 2: A completed scenario monograph and study report from the Antimicrobial** 

**Exposure Assessment Task Force II (AEATF) in which the dermal and inhalation exposure of professional janitorial workers was monitored as they**  **applied a liquid antimicrobial pe sticide product for indoor surface disinfecting**  **using a pressurized aerosol can. 1:30 PM**  ***** **EPA Science Review –**  Mr. Tim L eighton (OPP, EPA) , Jonathan Cohen, Ph.D.,

IC F International **1: 5**  **5 PM Board Questions of Clarification** 

– Sean Philpott, Ph.D. (HSRB Chair), EPA,

Principal Investigator/Sponsor **2 :**  **20 PM**  **EPA Ethics Assessment -**  Ms. Kelly Sherman (OPP, EPA) **2 :**  **4 5 PM**  **Board Questions of Clarification**

– Sean Philpott, Ph.D. (HSRB Chair), EPA,

Principal Investigator/Sponsor **3 :**  **10 PM**  **Public Comments 3**  **: 25**  **PM Boar**  **d Discussion** Charge to the Board - Science :  Was the research reported in the Antimicrobial Exposure Assessment Task Force II (AEATF) completed aerosol study report faithful to the design and objectives of the protocol and governing documents of AEATF?  Ha s EPA adequatel y characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating the exposure of professional janitorial workers who apply liquid antimicrobial pesticide products to in door surfaces using pressurized aerosol cans? Charge to the Board - Ethics:  Does available information support a determination that the study was conducted in substantial compliance with subparts K and L of 40 CFR Part 26? **4:20 PM An**  **u pdate from the Wor**  **k Group on Return of Individual Research Results 4**  **: 3**  **0 PM**  **Adjournment**