Document ID: EPA-HQ-ORD-2011-0693-0025
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-10-25T04:00Z

US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                      OCTOBER 2011 PUBLIC MEETING AGENDA
                                       
               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal Drive, Arlington, VA 22202 

                          Wednesday, October 19, 2011
                                       
10:30 AM*	Convene Public Meeting and Review Administrative Procedures  -  Jim Downing , Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
           Introduction and Identification of Board Members  -  Sean Philpott, Ph.D., HSRB Chair
	Welcome - Mary Greene, Ph.D., Deputy Director, Office of the Science Advisor
	Opening Remarks  -  Steven Bradbury, Ph.D., Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention, EPA
	OPP Follow-up on Previous HSRB Recommendations  -  Mr. William Jordan, OPP, EPA

Session 1:	A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas 003) to evaluate the field repellent efficacy against mosquitoes of a product containing 16% para-methane-3,8-diol and 2% lemongrass oil.

10:50 AM 	EPA Science and Ethics Reviews  -  Clara Fuentes, Ph.D. (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA) 
11:20 AM 	Board Questions of Clarification  -  Sean Philpott, Ph.D. (HSRB Chair), EPA, Principal Investigator/Sponsor
11:40 AM 	Public Comments 
11:50 AM	Board Discussion 

Charge to the Board: 

   * Is the CLBR completed study No Mas 003 sufficiently sound, from a scientific perspective, to be used to estimate the duration of complete protection against mosquitoes provided by the tested repellent?

   *       Does available information support a determination that the study No Mas 003 was conducted in substantial compliance with 40 CFR Part 26, subparts K and L?

12:45  PM 	Lunch

Session 2:	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 of workers while pouring liquid antimicrobial pesticide products from both conventional and reduced-splash containers.  

1:30 PM	EPA Science and Ethics Reviews  -  Mr. Tim Leighton (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA) 
2:30 PM	Board Questions of Clarification  -  Sean Philpott, Ph.D. (HSRB Chair), EPA, Principal Investigator/Sponsor
3:00 PM	Public Comments
3:15 PM	Break
3:30 PM	Board Discussion

Charge to the Board:

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

   * Is the research likely to generate scientifically reliable data, useful for assessing the exposure of individuals who manually pour liquid antimicrobial products?

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

5:00 PM	Adjournment

                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                          OCTOBER 2011 PUBLIC MEETING

               Environmental Protection Agency Conference Center
                 Lobby Level - One Potomac Yard (South Bldg.) 
                  2777 S. Crystal Drive, Arlington, VA 22202 

                          Thursday, October 20, 2011
                                       
9:00 AM*	Convene Public Meeting and Review Administrative Procedures  -  Jim Downing (Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor)
           Introduction and Identification of Board Members  -  Sean Philpott, Ph.D. (HSRB Chair)
	Follow-up from Previous Day  -  Mr. William Jordan (OPP, EPA)
	
Session 1:	A new scenario design and associated protocols from the Agricultural Handler Exposure Task Force (AHETF) describing proposed research to measure dermal and inhalation exposure to workers who use closed system equipment to load liquid pesticide products from returnable and non-returnable containers. 
 
9:15 AM	EPA Science and Ethics Reviews  -  Mr. Jeff Evans (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA) 
10:00 AM	Board Questions of Clarification  -  Sean Philpott, Ph.D. (HSRB Chair), EPA, Principal Investigator/Sponsor
10:30 AM	Public Comments
10:45 AM	Break
11:00 AM	Board Discussion

Charge to the Board: 

If the AHETF closed system liquid loading study proposal is revised as suggested in EPA's review and if the research is performed as described:

   * Is the research likely to generate scientifically reliable data, useful for assessing the exposure of workers using closed systems to load liquid pesticide products from returnable or non-returnable containers?

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

12:30 PM 	Lunch

Session 2:	A published report by Moiemen et al (2011) of an intentional exposure human study measuring dermal absorption of silver from the use of nanosilver-containing wound dressings to treat major burns.   

1:30 PM 	EPA Science and Ethics Reviews  -  Jessica Ryman, Ph.D. (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA) 
2:15 PM 	Board Questions of Clarification  -  Sean Philpott, Ph.D. (HSRB Chair), EPA 
2:40 PM 	Public Comments 
2:50 PM	Break
3:05 PM	Board Discussion

Charge to the Board: 

         * Is the Moiemen (2011) study scientifically sound, providing reliable data? 

         * If so, can the Moiemen (2011) study be used to support the Agency's conclusion that the dermal absorption factor for silver from nanosilver on human skin is less than 0.1%?
            
   *             Is there adequate information to support a determination that the study was conducted in substantial compliance procedures at least as protective as those at subparts A-L of 40 CFR Part 26?

4:30 PM	Adjournment