                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD
                    January 14, 2015 PUBLIC MEETING AGENDA
                                       
                           Internet Virtual Meeting
            The meeting will be conducted at the following website:
                     https://epa.connectsolutions.com/hsrb
                                       
                          Wednesday, January 14, 2015

                  HSRB WEB SITE http://www.epa.gov/osa/hsrb/
                       Docket Telephone: (202) 566 1752
                  Docket Number: EPA - HQ - ORD - 2014 - 0882
                                       
9:50 AM	HSRB members login online

10:00 AM*	Convene Public Meeting  -  Jim Downing, Designated Federal Officer, EPA Human Studies Review Board, Office of the Science Advisor
	Virtual Meeting 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:	Review and Approval of the HSRB Final Report of the November 5, 2014 Meeting 

10:15 AM 	Public Comments 
10:20 AM	Board Discussion of Draft Final Report

Session 2:	A published report: Ezratty, Veronique et al. (2014) Repeated Nitrogen Dioxide Exposures and Eosinophilic airway Inflammation in Asthmatics: A Randomized Crossover Study. Environmental Health Perspectives. Volume 122, Number 8, August 2014. (MRID 49519201)

10:40 AM 	EPA Science Review Highlights  -  LT Jonathan Leshin, Ph.D. (OPP, EPA)
10:50 AM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
11:05 AM	EPA Ethics Review Highlights - Ms. Kelly Sherman (OPP, EPA)
11:15 AM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), and EPA staff
11:30 AM 	Public Comments 
11:35 AM	Board Discussion

Charge to the Board - Science:

   * Is this study scientifically sound, providing reliable data?
   * If so, is this study adequate for quantitative use in support of an inhalation risk assessment for the use of nitrogen dioxide as a medical equipment sterilant?

Discussants: Randy Maddalena, Ph.D. (George Fernandez, 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.

12:45 PM 	Lunch

1:30 PM	Reconvene  -  roll call

Session 3:	A published report: Spak, C.J. et al. (1989) Tissue Response of Gastric Mucosa after Ingestion of Fluoride. Karolinska Institute, Huddinge University Hospital, Huddinge, Sweden. British Medical Journal. 298:1686-7. (MRID 49489101)

1:35 PM 	EPA Science Review Highlights  -  Jaime D'Agostino, Ph.D., (Health Effects Division, OPP, EPA)
1:45 PM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
2:00 PM	EPA Ethics Review Highlights - Ms. Kelly Sherman (OPP, EPA)
2:10 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), and EPA staff
2:25 PM 	Public Comments 
2:35 PM	Board Discussion

Charge to the Board - Science:

   * Is this study scientifically sound, providing reliable data?
   * If so, is this study adequate for quantitative use in support of an acute dietary risk assessment for fluoride?

Discussants:  Ken Ramos, M.D., Ph.D. (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: Jewel Halanych, M.D., M. Sc.

Session 4:	A published report: Hansson, T. and Roos, B. (1987). The Effect of Fluoride and Calcium on Spinal Bone Mineral Content: A Controlled, Prospective (3 years) study. Sahlgren's Hospital, University of Gothenberg, Sweden. Calcified Tissue International. 40:315-317. (MRID 49489102)

3:25 PM 	EPA Science Review Highlights  -  Jaime D'Agostino, Ph.D., (Health Effects Division, OPP, EPA)
3:30 PM 	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), EPA staff
3:45 PM	EPA Ethics Review Highlights - Ms. Kelly Sherman (OPP, EPA)
3:55 PM	Board Questions of Clarification  -  Rebecca Parkin, Ph.D., MPH (HSRB Chair), and EPA staff
4:10 PM 	Public Comments 
4:15 PM	Board Discussion

Charge to the Board - Science:

   * Is this study scientifically sound, providing reliable data?
   * If so, is this study adequate for qualitative use in support of an acute dietary risk assessment for fluoride?

Discussants: Will Popendorf, Ph. D. (Jun Zhu, Ph.D., statistics)

Charge to the Board - Ethics:

   * Does the study meet the applicable requirements of 40 CFR part 26 subpart Q?

Discussant: Suzanne Rivera, Ph.D., M.S.W.

5:00 PM* 	Adjourn	
