*Note that agenda times are approximate. For further information, please contact the Designated Federal Officer for this meeting, Jim Do wning via telephone: (202) 564-2468 or email: downing.jim@epa.gov UNITED STATES ENVIRONMEN TAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFER ENCE MEETING
AGENDA

Tuesday, May 24, 2011 1:00 pm - 3:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE DRAFT APRIL 13-14, 2011 HSRB MEETI NG REPORT AND A DRAFT LETTER
FROM AN HSRB WORKGROUP ON PROVIDING RESEARCH
PARTICIPANTS WITH INDIVIDUALIZED STUDY RESULTS

HSRB WEB SITE http://www.epa.gov/osa/hsrb/ Docket Telephone: (202) 566 1752 Docket Number: EPA–HQ–ORD–2011–0418

Meeting location via telephone only Dial in number 866-299-3188; conference code 2025647189

1:00 PM Convene Meeting and Identification of Board Members – Jim Downing (Designated Federal Officer, HSRB, OSA, EPA) 1:10 PM* Meeting Administrative Procedures – Jim Downing, DFO 1:15 PM Meeting Process –Sean Philpott , Ph.D. (HSRB Chair)
1:20 PM Public Comments 1:30 PM Board Discussion and Decision on Final Report – Sean Philpott, Ph.D. (HSRB Chair)

The Board’s response to EPA charge ques tions presented at the April 13-14, 2011 meeting.

Completed AHETF research on exposure of wo rkers applying pesticide sprays using

open
‐ cab airblast equipment.

Charge to the Board:

 Was the research reported in the Agri cultural 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 adequately characterized, from a sc ientific 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?

 Does the available information support a determination that the studies were conducted in substantial compliance with subparts K and L of 40 CFR Part 26?*Note that agenda times are approximate. For further information, please contact the Designated Federal Officer for this meeting, Jim Do wning via telephone: (202) 564-2468 or email: downing.jim@epa.gov Completed AEATF research on exposure of professional janitorial workers when wiping indoor surfaces with an antimicrobial pesticide.

Charge to the Board:

 Was the research reported in the Antimicrobial Exposure Assessment Task Force II (AEATF) completed wipe study report fait hful to the design and objectives of the protocol and governing documents of AEATF?

 Has EPA adequately characterized, from a sc ientific 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 triggerspray bottle and wipe s or readytouse wipes?

 Does the available information suppor t a determination that the study was conducted in substantial compliance with subparts K and L of 40 CFR Part 26?

Assessment of Published Research Study by Gulson et al. (2010): Small Amounts of
Zinc from Zinc Oxide Particles in Sunscreens Applied Outdoors Are Absorbed through Human Skin.

Charge to the Board

 Is the Gulson et al . (2010) study scientifically sound, providing reliable data?

 If so, is the Gulson et al . (2010) study relevant for qual itative use in support of an assessment of the absorption of zinc oxide through the skin?

 Is there adequate information to determine that the Gulson et al . (2010) study was conducted in substantial compliance with pr ocedures at least a protective as those in subparts A - L of EPA’s re gulation at 40 CFR Part 26?

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.

Issues for Discussion:

 Do the recommendations provided by the HSRB at its June 2009 meeting and in its subsequent report regarding the reliab ility of data on the urinary metabolite trichloropyridinol in the Kisicki et al. (1999) study change in light of the new information provided?

 Do the recommendations provided by the HSRB at its June 2009 meeting and in its subsequent report regarding the level of absorption of chlorpyrifos in the Kisicki et al. (1999) study change in light of the new information provided?

2:30 PM Draft letter from an HSRB workgroup on providing research participants with individualized study results

2:55 PM Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and Jim Downing (DFO) 3:00 PM Adjournment