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

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 exposure 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

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?

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

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)
10:00 AM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, Principal Investigator/Sponsor
10:30 AM Public Comments

Board Discussion - Day2

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?

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 nanosilvercontaining 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
3:05 PM Board Discussion