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

10:50 AM

EPA Science and Ethics Reviews - Clara Fuentes, Ph.D. (OPP, EPA) and Ms. Kelly Sherman (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.

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

• 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

1:30 PM

EPA Science and Ethics Reviews - Mr. Tim Leighton (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA)

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.

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:

• 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

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)

9:15 AM

EPA Science and Ethics Reviews - Mr. Jeff Evans (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA)

Session 1: A new scenario design and associated protocol 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.

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

• 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

1:30 PM

EPA Science and Ethics Reviews - Jessica Ryman, Ph.D. (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA)

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.

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

• 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 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?

3:45 PM

Adjournment