6/15/09 DRAFT

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

JUNE 24-25, 2009  

PUBLIC MEETING

JUNE 24, 2009 

Holiday Inn National Airport

2605 Jefferson Davis Highway

Arlington, VA 

703 684 7200

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

Docket Telephone: (202) 566 1752

Docket Number: EPA-HQ-ORD-2009-0183

9:30 AM	Convene Meeting and Administrative Procedures – Paul Lewis,
Ph.D. (Designated Federal Officer, EPA Human Studies Review Board,
Office of the Science Advisor)

9:40 AM	Introduction and Identification of Board Members –  Sean
Philpott, Ph.D. (HSRB Chair)

9:50 AM	Welcome – Kevin Teichman, Ph.D. (Acting Science Advisor,
Office of the Science Advisor) 

10:00 AM	Opening Remarks – Debbie Edwards, Ph.D. (Director, Office of
Pesticide Programs, EPA) 

10:10 AM	EPA Follow-up on Pesticide Specific HSRB Recommendations – 
Mr. William Jordan (OPP, EPA)

Chlorpyrifos Human Toxicity Studies

10:15 AM	EPA Science and Ethics Reviews -  Anna Lowit, Ph.D. (OPP/EPA),
John Doherty, Ph.D. (OPP/EPA), Mr. Wade Britton (OPP/EPA), and Mr. John
Carley (OPP/EPA)

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


			EPA -

			Principle investigator/sponsor -

12:00 PM	Lunch  

12:45 PM	Public Comments 

1:00 PM	40 CFR §26.1706 - Mr. William Jordan (OPP, EPA)

1:15 PM	Review and Discussion of HSRB Approaches for Consideration of
Pre-Rule Human Dosing Studies - Sean Philpott, Ph.D. (HSRB Chair)

2:15 PM	Board Discussion 

The Agency is taking a new path in its assessment of chlorpyrifos,
basing the RfD on data from pregnant rats, fetuses, and post-natal rats.
 Since the available human studies address only cholinesterase
inhibition rather than other endpoints, they are not directly relevant
to the forthcoming risk assessment focused on pregnant women and
children.  EPA proposes to use the three human studies listed below to
characterize and help interpret epidemiological and biomonitoring data,
using bounding estimates as described in the White Paper and potentially
using physiologically-based pharmacokinetic (PBPK) models.  

1.1	 Nolan et al. (1982)

  

Are the blood and urine measurements of chlorpyrifos and/or TCP from the
Nolan et al. oral and dermal studies reliable and appropriate for use in
characterizing the results of epidemiological studies with chlorpyrifos?
 

Are the measurements of cholinesterase activity/inhibition from the
Nolan et al. oral and dermal studies reliable? 

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

1.2  Honeycutt and DeGeare (1993)

  

1.2.1	Are the blood and urine measurements of chlorpyrifos and/or TCP
from the Honeycutt and DeGeare worker biomonitoring study reliable and
appropriate for use in characterizing results of the epidemiological
studies with chlorpyrifos?  

1.2.2	Are the measurements of cholinesterase activity/inhibition from
the Honeycutt and DeGeare worker biomonitoring study reliable?  

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

1.3  Kisicki et al. (1999)

1.3.1	Are the blood and urine measurements of chlorpyrifos and/or TCP
from the Kisicki et al. oral study reliable and appropriate for use in
characterizing the results of epidemiological studies with chlorpyrifos?

1.3.2	Are the measurements of cholinesterase activity/inhibition from
the Kisicki et al. oral study reliable?  

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

1.3.4	If the HSRB agrees with OPP that the conduct of the Kisicki et al.
study was significantly deficient relative to the standards of ethical
research prevailing when it was conducted, please provide any additional
comments relative to EPA’s proposal to rely on the data pursuant to 40
CFR §26.1706.

4:00 PM	Break   

4:15 PM	Board Summary  

Review of February 17, 2009 HSRB Meeting Report  

4:45 PM	Review Process -  Sean Philpott, Ph.D. (HSRB Chair)

4:50 PM	Public Comment

5:00 PM 	Board Discussion and Decision on Report - Sean Philpott, Ph.D.
(HSRB Chair)

5:45 PM	Concluding remarks – Mr. William Jordan (OPP, EPA) 

5:50 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)

JUNE 24-25, 2009 *

PUBLIC MEETING

JUNE 25, 2009

Holiday Inn National Airport

2605 Jefferson Davis Highway

Arlington, VA 

703 684 7200

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)

Carroll-Loye Biological Research, Inc. Protocol LNX-002: Efficacy of
Picaridin-Based Personal Insect Repellents against Biting Flies in the
Field 

8:45 AM	EPA Science and Ethics Reviews -  Mr. Kevin Sweeney (OPP, EPA) 
and Mr. John Carley (OPP, EPA)  

9:30 AM	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair) 

			EPA -

			Principle investigator/sponsor -

9:50 AM	Public Comments

10:05 AM	Board Discussion 

If the proposed field repellency study protocol LNX-002 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
biting flies in the field? 

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

10:55 AM	Break

11:10 AM	Board Summary  

ICR, Inc. Study A382: Efficacy of Picaridin-Based Personal Insect
Repellents against Stable Flies in the Laboratory

11:25 AM	EPA Science and Ethics Reviews – Mr. Kevin Sweeney (OPP, EPA)
 and Mr. John Carley (OPP, EPA)

12:00 PM	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair) 

			EPA -

			Principle investigator/sponsor –

12:15 PM	Lunch

1:00 PM	Public Comments 

1:15 PM	Board Discussion

1. Is the ICR study A382 sufficiently sound, from a scientific
perspective, to be used to assess the repellent efficacy of the tested
formulations against stable flies in the laboratory? 

2. Does available information support a determination that study A382
was conducted in substantial compliance with subparts K and L 40 CFR
Part 26?

2:00 PM	Break

2:15 PM	Board Summary  

Agricultural Handlers Exposure Task Force (AHETF) Scenario Design and
Field Study Protocol: Mixing /Loading Wettable Powder in Water Soluble
Packaging  

2:30 PM	EPA Science and Ethics Reviews -  Mr. Jeff Evans (OPP, EPA)  and
Ms. Kelly Sherman (OPP, EPA)

3:30 PM	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair) 

			EPA -

			Principle investigator/sponsor –

3:50 PM	Public Comments 

4:05 PM	Board Discussion

If the proposed mix/load water soluble packing SP field study protocol
AHE120 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 mix and load soluble
or wettable powder pesticides in water-soluble packaging? 

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

5:05 PM	Board Summary  

5:20 PM	Concluding remarks – Mr. William Jordan (OPP, EPA) 

5:25 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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