                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                       APRIL 2014 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal Drive, Arlington, VA 22202 

                            Tuesday, April 8, 2014

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2014 - 0189
                                       

10:00 AM*	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  -  Mr. William Jordan, Deputy 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:	AEATF-II Protocol: A Study for Measurement of Potential Dermal and Inhalation Exposure During Manual Pouring of Two Solid Formulations Containing an Antimicrobial

10:20 AM 	EPA Science Review  -  Mr. Tim Leighton (OPP, EPA)
10:50 AM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
11:00 AM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
11:20 AM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
11:30 AM 	Public Comments 
11:40AM	Board Discussion

   If the AEATF-II study proposal AEA07 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 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?
           
12:30 PM 	Lunch


Session 2:	AEATF-II Protocol: A Study for Measurement of Potential Dermal and Inhalation Exposure During Application of Latex Paint Containing an Antimicrobial Pesticide Product Using a Brush and Roller for Indoor Surface Painting

1:30 PM 	EPA Science Review  -  Mr. Tim Leighton (OPP, EPA)
2:00 PM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
2:10 PM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
2:30 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
2:40 PM 	Public Comments 
2:50 PM	Board Discussion 

   If the AEATF-II study proposal AEA09 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 exposure of those who apply latex paint containing an antimicrobial pesticide using a brush or roller?

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           
3:35 PM	Break


Session 3: 	AEATF Protocol: Determination of Removal Efficiency of 1,2-Benzisothiazol-3(2H)-one (BIT) from Hand Surfaces Using an Isopropyl Alcohol/Water Wipe and Wash Procedure

3:45 PM 	EPA Science Review  -  Mr. Tim Leighton (OPP, EPA)
4:10 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
4:20 PM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
4:40 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
4:30 PM 	Public Comments
4:40 PM 	Board Discussion

   If the AEATF-II study proposal AEA08 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 likely to generate scientifically reliable data, useful for determining the removal efficiency of BIT from the hands due to dermal exposure associated with the use of latex paint and non-paint liquid solutions containing containing BIT?

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           
5:30 PM* 	Adjourn	

                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                       APRIL 2014 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal Drive, Arlington, VA 22202 

                           Wednesday, April 9, 2014

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2014 - 0189
                                       

9:30 AM*	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
           Follow-up on Previous Day's Discussion  -  Mr. William Jordan, Deputy Director, OPP, Office of Chemical Safety and Pollution Prevention, EPA

Session 1:	Laboratory Evaluation of Bite Protection From Repellent Impregnated Clothing for the United States Military

9:40 AM 	EPA Science Review  -  Mr. Kevin Sweeney (OPP, EPA) 
10:25 AM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
10:40 AM	EPA Ethics Review - Ms. Kelly Sherman (OPP, EPA)
11:00 AM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA, Principal Investigator/Sponsor
11:10 AM	Public Comments 
11:20 AM	Board Discussion 

   If the 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 the protocol "Laboratory Evaluation of Bite Protection From Repellent Impregnated Clothing for the United States Military" likely to generate scientifically reliable data, useful for estimating the level of mosquito bite protection provided by two different textiles treated with etofenprox?

Charge to the Board - Ethics:

   * Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L?
           
12:15 PM	Lunch 


Session 2:	Background presentation on the Repellency Awareness Graphic and possible implications for the HSRB.

1:15 PM 	Presentation  -  Ms. Rose Kyprianou and Ms. Kelly Sherman, (OPP, EPA)
1:35 PM 	Board Questions of Clarification - Rebecca Parkin, Ph.D., MPH (HSRB Chair)

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

2:00 PM 	HSRB Work Group on Return of Individual Research Results Report Presentation  -  Sean Philpott, Ph.D., Work Group Chair
2:20 PM 	Board Discussion - Rebecca Parkin, Ph.D., MPH (HSRB Chair)
2:50 PM	Topics for next HSRB Meeting (June 10-12, 2014)  -  Ms. Kelly Sherman (OPP, EPA)
3:00 PM		Adjourn 

