                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                       APRIL 2015 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal 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 - 2015 - 0145
                          Webcast of the HSRB Meeting
            The Webcast of the meeting is at the following website:
                     https://epa.connectsolutions.com/hsrb
                                       
1:00 PM*	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 Report for Backpack and Handgun Application of Liquid Spray in Utility Rights of Way (Agricultural Handlers Exposure Task Force)

1:20 PM 	EPA Science Review  -  Mr. Mathew Crowley, (Health Effects Division, OPP, EPA)
2:05PM 	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, and Principal Investigator/Sponsor
2:30 PM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
2:45 PM	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, Principal Investigator/Sponsor
3:00 PM	Break
3:15 PM 	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 Agency 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)

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


                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                       APRIL 2015 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal 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 - 2015 - 0145
                          Webcast of the HSRB Meeting
            The Webcast of the meeting is at the following website:
                     https://epa.connectsolutions.com/hsrb
                                       
 9:00 AM*	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 AM 	EPA Science Review  -  Mr. Kevin Sweeney, (Registration Division, OPP, EPA)
9:30 AM	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, and Principal Investigator/Sponsor
10:00 AM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
10:20 AM	Board Questions of Clarification  -  Liza Dawson, Ph.D., (HSRB Chair), EPA, and Principal Investigator/Sponsor
10:45 AM	Public Comments 
10:55 PM	Break
11:05 AM	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)

Charge to the Board - Ethics:

   * Is the research likely 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.

12:05 PM 	Adjourn
