UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

OCTOBER 20-21, 2009  

PUBLIC MEETING

OCTOBER 20, 2009 

Environmental Protection Agency 

Conference Center - Lobby Level 

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

 Arlington, VA 22202 

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

Docket Telephone: (202) 566 1752

Docket Number: EPA-HQ-ORD-2009-0658

10:30 AM	Convene Meeting and Administrative Procedures – Paul Lewis,
Ph.D. (Designated Federal Officer, EPA Human Studies Review Board,
Office of the Science Advisor)

10:35 AM	Introduction and Identification of Board Members –  Sean
Philpott, Ph.D. (HSRB Chair)

10:45 AM	Welcome – Kevin Teichman, Ph.D. (Acting Science Advisor,
Office of the Science Advisor) 

10:50 AM	Opening Remarks – Mr. Steve Owens (Assistant Administrator,
Office of Prevention, Pesticides and Toxic Substances, EPA) 

10:55 AM	Opening Remarks – Debbie Edwards, Ph.D. (Director, Office of
Pesticide Programs (OPP), Office of Prevention, Pesticides and Toxic
Substances, EPA) 

11:00 AM	EPA Follow-up on Pesticide Specific HSRB Recommendations – 
Mr. William Jordan (OPP, EPA)

Published reports of pyrethrins/pyrethroids research completed before
enactment of EPA’s expanded human studies rule (40 CFR part 26:
Protection of Human Subjects)

11:05 AM	EPA Science and Ethics Reviews – Ms. Sarah Winfield (OPP,
EPA), Ms. Carol Christensen (OPP, EPA), and Ms. Kelly Sherman (OPP,EPA)

12:00 PM	Lunch  

1:00 PM	EPA Science and Ethics Reviews (continued)

		Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair)

			EPA -			

1:30 PM	Public Comments   

1:45 PM	Board Discussion 

Newton & Breslin study (1983)

  

Is the Newton & Breslin study scientifically sound, providing reliable
data?

If so, is the Newton & Breslin study relevant to an assessment of the
proposition that exposures to pyrethrins/pyrethroids may be associated
with asthmatic or allergic respiratory responses?

If so, what limitations of the Newton & Breslin study should be taken
into account by EPA in assessing the proposition that exposures to
pyrethrins/ pyrethroids may be associated with asthmatic or allergic
respiratory responses?

Is there clear and convincing evidence that the conduct of the Newton &
Breslin study was fundamentally unethical, or that its conduct was
significantly deficient relative to standards prevailing when it was
conducted?

Lisi study (1992)

  

Is the Lisi study scientifically sound, providing reliable data?

If so, is the Lisi study relevant to an assessment of the proposition
that exposures to pyrethrins/pyrethroids may be associated with allergic
contact dermatitis or sensitization responses?  

If so, what limitations of the Lisi study should be taken into account
by EPA in assessing the proposition that exposures to
pyrethrins/pyrethroids may be associated with allergic contact
dermatitis or sensitization responses?

Is there clear and convincing evidence that the conduct of the Lisi
study was fundamentally unethical, or significantly deficient relative
to the standards of ethical research conduct prevailing when it was
conducted?

3:00 PM	Break   

3:15 PM	Draft Summary of Board Conclusions - Sean Philpott, Ph.D. (HSRB
Chair)

Proposed AEATF-II research on exposure of janitorial workers applying
antimicrobial pesticides formulated as aerosol sprays (Protocol AEA04)

3:30 PM	EPA Science and Ethics Reviews – Mr. John Carley  (OPP, EPA),
Mr. Timothy Leighton (OPP, EPA), Cassi Walls, Ph.D. (OPP, EPA), and Ms.
Kelly Sherman (OPP,EPA)

	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair)

			EPA -

			Principal investigator/sponsor –  

4:45 PM	Public Comments 

5:00 PM	Board Discussion

If the proposed AEATF-II aerosol application scenario and field study
protocol AEA04 is revised as suggested in EPA’s review and if the
research is performed as described:

1. Is the research likely to generate scientifically reliable data,
useful for assessing the exposure of handlers who apply antimicrobial
pesticides formulated as aerosol sprays?   

2. Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L? 

6:00 PM	Adjournment – Sean Philpott, Ph.D. (HSRB Chair) and Paul
Lewis, Ph.D. (HSRB DFO)  

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

OCTOBER 20-21, 2009 *

PUBLIC MEETING

OCTOBER 21, 2009

Environmental Protection Agency 

Conference Center - Lobby Level 

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive

 Arlington, VA 22202 

8:30 AM	Opening of Meeting – Paul Lewis, Ph.D. (HSRB DFO)  

8:35 AM	Introduction – Sean Philpott, Ph.D. (HSRB Chair) 

8:40 AM	Follow-up From Previous Day – Mr. William Jordan (OPP, EPA)

Proposed AEATF-II research on exposure of janitorial workers applying
antimicrobial pesticides formulated as aerosol sprays (Protocol AEA04)

8:45 AM	Draft summary of Board conclusions - Sean Philpott, Ph.D. (HSRB
Chair)

Review of June 24-25, 2009 HSRB Meeting Report  

9:00 AM	Review Process -  Sean Philpott, Ph.D. (HSRB Chair)

9:05 AM	Public Comments

9:15 AM 	Board Discussion and Decision on Report - Sean Philpott, Ph.D.
(HSRB Chair)

10:00 AM	Break   

Proposed Carroll-Loye Biological Research, Inc. Study (LNX-003):
Efficacy of Two Picaridin-Based Personal Insect Repellent Formulations
against Ticks 

10:15 AM	EPA Science and Ethics Reviews -  Mr. Kevin Sweeney (OPP, EPA),
 and Ms. Kelly Sherman (EPA/OPP)

	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair)

EPA – 

			Principal investigator/sponsor – 

11:15 AM	Public Comments

11:30 PM	Board Discussion 

If the proposed laboratory tick repellency study protocol LNX-003 is
revised as suggested in EPA’s review and if the research is performed
as described:

1. Is the research likely to generate scientifically reliable data,
useful for assessing the efficacy of the tested materials in repelling
ticks?   

2. Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?  

12:30 PM	Break   

12:45 PM	Draft Summary of Board Conclusions - Sean Philpott, Ph.D. (HSRB
Chair)

1:00 PM	Adjournment – Sean Philpott, Ph.D. (HSRB Chair) and Paul
Lewis, Ph.D. (HSRB DFO)  

Please be advised that agenda times are approximate and subject to
change. For further information, please contact the Designated Federal
Officer for this meeting, Paul Lewis, via telephone: (202) 564-8381 or
email:   HYPERLINK "mailto:lewis.paul@epa.gov"  lewis.paul@epa.gov  

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