* Agenda times are app roximate and subject to change depending upon the discussion. US ENVIRONMENTAL PROTECTION AGENCY



### HUMAN STUDIES REVIEW BOARD

NOVEMBER 2014 PUBLIC MEETING AGENDA

Internet Virtual Meeting

Visual aspects of the meeting at the following website:

https://epa.connectsolutions.com/hsrb



### Audio available by calling:

866

- 299

- 3188 access code: 2025647189

Wednesday

, November 5 , 2014

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone: (202) 566 1752

Docket Number: EPA

– HQ

– ORD

– 201 4

– 0750

9:45 AM HSRB members call in and online

1 0 : 0 0 A M * Convene Public Meeting

– Jim Downing

, Designated Federal Officer, EPA

Human Studies Review Board, Office of the Science Advisor

Conference Call 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: A new scenario design and associated protocol from the Agricultural Handler

Exposure Task Force, LLC describing proposed research to monitor dermal and

inhalation exposure of pesticide handlers who manually open containers of granular

pesticide products and perform open pour loading of the granules in to application

equipment.

10: 15 A M EPA Science Review Highlights

– Jeff Evans (OPP, EPA)

1 0:25 A M Board Questions of Clarification

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

EPA staff

1 0 : 40 A M EPA Ethics Review Highlights

- Ms. Kelly Sherman (OPP, EPA)

10 : 50 A M Board Questions of Clarification

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

EPA staff

11: 0 5 A M Public Comments

11:1 0 AM Board Discussion

Charge to the Board

- Science:

 Is this study scientifically sound, providing reliable data?

 If so, is this study relevant for q uantitative use in support of a risk assessment of

exposures to agricultural workers applying pesticides ?* Agenda times are app roximate and subject to change depending upon the discussion.

Charge to the Board

- Ethics:

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

12:00 PM Lu nch

12:55 PM Reconvene

– roll call

Session 2: A published report by Frampton et al. (2002) of an intentional exposure human

study measuring the effects of nitrogen dioxide exposure on airway and blood cells.

1 :0 0 P M EPA Science Review Highlights

– LT Jonathan Leshin, Ph.D. (OPP, EPA)

1: 1 0 P M Board Questions of Clarification

– Rebecca Parkin , Ph.D. , MPH (HSRB Chair),

EPA staff

1 : 25 P M EPA Ethics Review Highlights

- Ms. Kelly Sherman (OPP, EPA)

1:35 PM Board Questions of Clarification

– Rebecca Parkin

, Ph.D. , MPH (HSRB Chair),

and EPA staff

1 : 5 0 P M Public Comments

1 :55 PM Board Discussion

Charge to the Board

- Science:

 Is this study scientifically sound, providing reliable data?

 If so, is this study relevant for quantitative use in support of an assessment measuring the

effects of nitrogen dioxide exposure on airway and blood cells ?

Charge to the Board

- Ethics:

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

2 : 50 PM * Adjourn