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* Agenda times are approximate and sub ject to change. For further information, please contact the Designated Federal Officer for this meeting, Jim Downing, via telephone: (202) 564
- 2468 or email: downing.jim@epa.gov

US ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD APRIL 2011 PUBLIC MEETING AGENDA Holiday Inn National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Wednesday, April 13, 2011 9:00 AM* Convene Public Meeting and Review Administrative Procedures

– Mr. Jim

Downing (Designated Federal Officer [DFO], EPA Human Studies Review Board, Office of the Science Advisor [OSA] ) Introduction and Identification of Board Member s
– Dr. Sean Philpott (HSRB Chair) Welcome
- Dr. Warren Lux (Director of the Program in Human Research Ethics, OSA, EPA) Opening Remarks

– Steven Bradbury , Ph.D. (Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention, EPA) Office of Pesticide Programs (OPP) Follow- up on Previous HSRB Recommendations

– Mr. William Jordan (OPP, EPA) Session 1: Completed AHETF research on exposure of workers applying pesticide sprays

using open - cab airblast equipment. 9:30 AM EPA Science and Ethics Reviews

– Mr. Matthew Crowley (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA) 10:30 AM Board Questions of Clarification

– Dr. Sean Philpott (HSRB Chair) 11:00 AM Public Comments 11:15 AM Break 11:30 AM Board Discussion - Science Charge to the Board: Was the research reported in the Agricultural Handler Exposure Task Force (AHETF) completed monograph report and associated field study reports faithful to the design and objectives of the protocol, SOPs, and governing documents? Has EPA adequatel y characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating exposure of those who apply pesticides with open cab airblast equipment?* Agenda times are approximate and subje ct to change. For further information, please contact the Designated

Federal Officer for this meeting, Jim Downing, via telephone: (202) 564
- 2468 or email: downing.jim@epa.gov 12:15 PM Board Discussion - Eth ics Charge to the Board: Does available information support a determination that the studies were conducted in substantial compliance with subparts K and L of 40 CFR Part 26? 12:45 PM Lunch Session 2: A published report (Gulson et al. 2010) of an intentional exposure human

study measuring dermal absorption of zinc oxides contained in sunscreens. 1:30 PM EPA Science and Ethics Reviews

– Dr. Jessica Ry man (OPP, EPA) and Ms. Laura Parsons (OPP, EPA) 2:15 PM Board Questions of Cla rification

– Dr. Sean Philpott (HSRB Chair) 2:45 PM Public Comments 3:00 PM Board Discussion - Science Charge to the Board: Is the Gulson et al. (2010) study scientificall y sound, providing reliable data? If so, is the Gulson et al. (2010) study relevant for qualitative use in support of an assessment of the absorption of zinc oxide through the skin? 3:45 PM Break 4:00 PM Board Discussion - Ethics Charge to the Board: Is there adequate information to determine that the Gulson et al. (2010) study was conducted in substantial compliance with procedures at least as protective as those in subparts A
- L of EPA’s regulation at 40 CFR Part 26? Session 3: Reconsideration of two concerns previously raised by the HSRB

in its June 2009 review of an intentional human dosing study with chlorpyrifos (Kisicki et al., 1999); additional pertinent information was made available by the sponsor related to these two concerns. 4:30 PM Introduction of Topic - Dr. Sean Philpott (HSRB Chair) 4:45 PM Board Discussion

– Science

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* Agenda times are approximate and sub ject to change. For further information, please contact the Designated Federal Officer for this meeting, Jim Downing, via telephone: (202) 564
- 2468 or email: downing.jim@epa.gov Issues for Discussion: Do the recommendations provided b y the HSRB at its June 2009 meeting and in its subsequent report regarding the reliability of data on the urinary

metabolite trichloropy

ridinol in th e Kisicki et al. (1999) study change in light of the new information provided? Do the recommendations provided b y the HSRB at its June 2009 meeting and in its subsequent report regarding the level of absorption of chlorp yrifos in the Kisicki et al. (1999) study

change in light of the new information provided? 5:30 PM Adjournment* Agenda times are approximate and subje ct to change. For further information, please contact the Designated

Federal Officer for this meeting, Jim Downing, via telephone: (202) 564
- 2468 or email: downing.jim@epa.gov US ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD APRIL 2011 PUBLIC MEETING AGENDA Holiday Inn National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Thursday, April 14, 2011 10:00 AM* Convene Public Meeting

– Mr. Jim Downing (DFO, HSRB, OSA)

Introduction and Identification of Members

– Dr. Sean Philpott (HSRB Chair) Follow - up from Previous Day

– Mr. William Jordan (OPP, EPA) Session 1: Completed AEATF research on exposure of professional janitorial workers

when wiping indoor surfaces with an antimicrobial pesticide. 10:15 AM EPA Science and Ethics Reviews

– Mr. Timothy L eighton (OPP, EPA) and Ms. Kelly Sherman (OPP, EPA) 11:00 AM Board Questions of Clarification

– Dr. Sean Philpott (HSRB Chair), EPA,

Principal Investigator/Sponsor 11:30 AM Public Comments 11:45 AM Board Discussion - Science Charge to the Board: Was the research reported in the Antimicrobial Exposure Assessment Task Force II (AEATF) completed wipe study report faithful to the design and objectives of the protocol and governing documents of AEATF? Has EPA adequatel y characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating exposure of those who clean indoor surfaces with antimicrobial pesticides using a trigger
-bottle and wipes or ready- wipes? 12:30 PM Board Discussion - Ethics Is the research likel y to meet the applicable requirements of 40 CFR part 26, subparts K and L ? 1:00 PM Adjournment