                      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 - 2014 - 0750
                                       
9:45 AM	HSRB members call in and online

10:00 AM*	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 into application equipment.

10:15 AM 	EPA Science Review Highlights  -  Jeff Evans (OPP, EPA)
10:25 AM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
10:40 AM	EPA Ethics Review Highlights - Ms. Kelly Sherman (OPP, EPA)
10:50 AM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff 
11:05 AM 	Public Comments 
11:10 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?

Discussants: Randy Maddalena, Ph.D. and Ed Gbur, Ph.D. (statistics)

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.

1:00 PM 	EPA Science Review Highlights  -  LT Jonathan Leshin, Ph.D. (OPP, EPA)
1:10 PM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
1:25 PM	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
1:50 PM 	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?

Discussants: William Popendorf, Ph.D. and Ed Gbur, Ph.D. (statistics)


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	
