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

### HUMAN STUDIES REVIEW BOARD **APRIL 201 5**  **PUBLIC MEETING AGENDA**  **Environmental Protection Agency Conference Center** Lobb y Level - One Potomac Yard (South Bldg.) 2777 S. Cry stal Drive, Arlington, VA 22202 

### Wednesday , April 22, 2015 **HSRB WEB SITE http://www.epa.gov/osa/hsrb/ Docket Telephone: (202) 566 1752**  **Docket Number: EPA**

**– HQ**  **– ORD**  **– 201**  **5 –** **0145 Webcast of the HSRB Meeting**  The Webcast of the meeting is at the following website: https://epa.connectsolutions.com/hsrb **1: 0**  **0 P**  **M** ***** **Convene Public Meeting –**  Jim Downing , Designated Federal Officer, EPA

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

–Liza Dawson , Ph.D. , HSRB Chair **Welcome**

– Thomas A. Burke, PhD, MPH , Science Advisor, EPA **Session 1: Completed Study and Monograph R** **eport for Backpack and Handgun**

**Application of Liquid Spray in Utility Rights of Way (Agricultural Handlers**  **Exposure Task Force) 1:**  **2 0**  **P M**  **EPA Science Review –**  Mr. Mathew Crowley , ( Health Effects Division, OPP,

EPA) **2 :**  **05 P**  **M Board Questions of Clarification** 

– Li za Dawson , Ph.D., (HSRB Chair), EPA, and

Principal Investigator/Sponsor **2 :**  **3 0**  **P M**  **EPA Ethics Review**  **-** Ms. Kelly Sherman (OPP, EPA) **2 :**  **45 P**  **M Board Questions of Clarification** 

– Li za Dawson , Ph.D., (HSRB Chair), EPA,

Principal Investigator/Sponsor **3 :**  **00 PM**  **Break 3**  **: 15**  **P M**  **Public Comments 3**  **: 25**  **PM Board Discussion**  Charge to the Board - Science: 1. Was the research reported in the Agricultural Handler Exposure Task Force (AHETF) completed monograph reports and associated field study report for AHE400 faithful to the design and objectives of the protocol, SOPs, and governing documents? 2. Has the A gency 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 liquid pesticide sprays to utilities rights - of - way using backpack or handgun spray equipment? **Discussant:** William Popendorf, Ph.D. ( George Fernandez, Ph.D. , statistics )* Agenda times are app roximate and subject to change depending upon the discussion.

Charge to the Board - Ethics: 3. Does available information support a determination that the studies were conducted in substantial compliance with subparts K and L of 40 CFR Part 26? **Discussant:** Elizabeth Heitman, Ph.D. **4: 50**  **PM Adjourn** * Agenda times are app roximate and subject to change depending upon the discussion. **US ENVIRONMENTAL PROTECTION AGENCY** 

### HUMAN STUDIES REVIEW BOARD **APRIL 201 5**  **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 , April 23, 2015 **HSRB WEB SITE http://www.epa.gov/osa/hsrb/ Docket Telephone: (202) 566 1752**  **Docket Number: EPA**

**– HQ**  **– ORD**  **– 201**  **5 –** **0 145**  **Webcast of the HSRB Meeting** The Webcast of the meeting is at the following website: https://epa.connectsolutions.com/hsrb **9:00 A** **M** ***** **Convene Public Meeting –**  Jim Downing , Designated Federal Officer, EPA

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

– Liza Dawson , Ph.D., HSRB Chair **Follow -**  **up on Previous Day’s Discussion**  **–** Ms . Kelly Sherman , OPP, Office of Chemical Safety and Pollution Prevention, EPA **Session 1: Protocol for Field Testing of skin**  **applied mosquito repellent products (SC**

**Johnson) 9:10**  **A M**  **EPA Science Review –**  Mr. Kevin Sweeney , ( Registration Division, OPP, EPA) **9 :**  **30 A** **M Board Questions of Clarification** 

– Li za Dawson , Ph.D., (HSRB Chair), EPA, and

Principal Investigator/Sponsor **10 :**  **0 0**  **A M**  **EPA Ethics Review**  **-** Ms. Kelly Sherman (OPP, EPA) **10:2 0**  **A M**  **Board Questions of Clarification**

– Li za Dawson , Ph.D., (HSRB Chair), EPA, and

Principal Investigator/Sponsor **10 :**  **45 A** **M Public Comments**  **10 :**  **55 PM**  **Break 11**  **: 0**  **5 A** **M Board Discussion**  If the SCJ study proposal is revised as suggested in EPA’s science and ethics reviews and if the research is performed as described: Charge to the Board - Science:  Is this research is likely to generate scientifically reliable data, useful for assessing the efficacy of these insect repellent pesticide products ? **Discussant:** Randy

Maddalena, Ph.D. (Jun Zhu, Ph.D. , statistics )* 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? **Discussant:** Gary

Chadwick, Pharm.D., M.P.H, C.I.P. **12 :**  **0 5**  **PM Adjourn**