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

### HUMAN STUDIES REVIEW BOARD **NOVEMBER 2014**  **PUBLIC MEETING AGENDA** 

**Internet Virtual Meeting** Visual aspects of the meeting at the following website: https://epa.connectsolutions.com/hsrb 

### Audio available by

calling: 866 - 299 - 3188 access code: 2025647189 Wednesday , November 5 , 2014 **HSRB WEB SITE http://www.epa.gov/osa/hsrb/ Docket Telephone: (202) 566**  **1752 Docket Number: EPA** 

**– HQ** **– ORD** **– 201**  **4 –** **0750 9:45 AM**  **HSRB members call in and online 1**  **0 :**  **0 0**  **A M**  ***** **Convene Public Meeting –**  Jim Downing , Designated Federal Officer, EPA

Human Studies Review Board, Office of the Science Advisor **Conference Call operations**

–Rebecca Parkin , Ph.D., MPH, HSRB Chair **Introduction of Board Members**

–Rebecca Parkin , Ph.D. , MPH , HSRB Chair **Opening Remarks**

– Toby Schonfeld , Ph.D., Human Subjects Research Review Official, EPA **Session 1: A new scenario design and associated protocol**  **from the Agricultural Handler Exposure Task Force, LLC describing proposed research to monitor dermal and**  **inhalation exposure of pesticide handlers who manually open containers of granular pesticide products and perform open pour loading of the granules in**  **to application equipment.**  **10: 15**  **A M**  **EPA Science Review Highlights**  **–** Jeff Evans (OPP, EPA) **1 0:25**  **A M**  **Board Questions of Clarification**

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

EPA staff **1 0**  **: 40**  **A M**  **EPA Ethics Review**  **Highlights -**  Ms. Kelly Sherman (OPP, EPA) **10 :**  **50 A** **M Board Questions of Clarification** 

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

EPA staff **11: 0**  **5 A** **M Public Comments**  **11:1 0 AM**  **Board Discussion** Charge to the Board - Science:  Is this study

scientifically

sound, providing reliable data?  If so, is this study

relevant for quantitative use in support of a risk assessment of exposures to agricultural workers applying pesticides ? **Discussant s**  **: Randy Maddalena**  **, Ph.D. and**  **Ed Gbur, Ph.D.** (s tatistics)* Agenda times are app roximate and subject to change depending upon the discussion.

Charge to the Board - Ethics:  Does the study

meet the applicable requirements of 40 CFR part 26 subpart Q? **Discussant: Liza Dawson, Ph.D.**  **12:00 PM**  **Lunch 12:55 PM**  **Reconvene –**  **roll call Session 2:**  **A published report by Frampton et al.**  **(2002) of an intentional exposure human study measuring the effects of**  **nitrogen dioxide exposure on airway and blood cells. 1**  **:0 0**  **P M**  **EPA Science Review Highlights**  **–** LT Jonathan Leshin, Ph.D. (OPP, EPA) **1: 1**  **0 P**  **M Board Questions of Clarification** 

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

EPA staff **1 :**  **25 P**  **M EPA Ethics**  **Review Highlights**  **-** Ms. Kelly Sherman (OPP, EPA) **1:35 PM**  **Board Questions of Clarification**

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

and EPA staff **1 :**  **5 0**  **P M**  **Public Comments 1**  **:55 PM Board Discussion**  Charge to the Board - Science:  Is this study

scientifically

sound, providing reliable data?  If so, is this study

relevant for quantitative use in support of an assessment measuring the effects of nitrogen dioxide exposure on airway and blood cells ? **Discussant s**  **: William Popendorf, Ph.D.**  **and Ed Gbur, Ph.D.** (s tatistics) Charge to the Board - Ethics:  Does the study

meet the applicable requirements of 40 CFR part 26 subpart Q? **Discussant: Liz Heitman, Ph.D.**  **2 :**  **50 PM**  ***** **Adjourn**