                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                      OCTOBER 2013 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 4[th] Floor - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal Drive, Arlington, VA 22202 

                           Tuesday, October 1, 2013

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2013 - 0626
                                       

12:30 PM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
           Introduction of Board Members  - Rebecca Parkin, Ph.D., MPH, HSRB Chair
	Welcome - Glenn Paulson, Ph.D., 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, Deputy Director, OPP, Office of Chemical Safety and Pollution Prevention, EPA

Session 1:	A new scenario design and associated protocol from the Antimicrobial Exposure Assessment Task Force II (AEATF-II) describing proposed research to monitor the dermal and inhalation exposure during manual pouring of solid formulation antimicrobial products. EPA requests the advice of the HSRB concerning whether, if it is revised as suggested in EPA's review and if it is performed as described, this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who pour solid formulation antimicrobial pesticide products, and to meet the applicable requirements of 40 CFR part 26, subparts K and L.

1:00 PM 	EPA Science Review  -  Mr. Tim Leighton, (OPP, EPA), Jonathan Cohen, Ph.D. ICF International 
1:30 PM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
1:50 PM	EPA Ethics Assessment - Ms. Kelly Sherman (OPP, EPA)
2:20 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
2:35 PM 	Public Comments 
2:45 PM	Break
3:00 PM	Board Discussion 

Charge to the Board - Science:

   If the AEATF-II study proposal AEA07 is revised as suggested in EPA's review and if the research is performed as described:

   * Is this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who pour solid formulation antimicrobial pesticide products?

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           

Session 2:	Background presentation on the insect repellent mark program and discussion of future reviews.

3:45 PM 	Presentation  -  Rose Kyprianou and Kelly Sherman, (OPP, EPA)
4:05 PM 	Board Discussion - Rebecca Parkin, Ph.D., MPH (HSRB Chair)

Session 3:	Report from the HSRB Work Group of the Return of Individual Research Results.

4:45 PM 	HSRB Work Group on Return of Individual Research Results Report Presentation - Virginia Ashby Sharpe, Ph.D., Work Group Member
5:05 PM 	Board Discussion - Rebecca Parkin, Ph.D., MPH (HSRB Chair)

5:30 PM* 	Adjourn	
