Document ID: EPA-HQ-ORD-2007-0216-0025
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-09-19T04:00Z

Minutes of the

United States Environmental Protection Agency (EPA) 

Human Studies Review Board (HSRB) 

August 14, 2007 Public Teleconference

Docket Number: EPA-HQ-ORD-2007-0216

Committee Members:	(See EPA HSRB Members list – Attachment A) 

Dates and Times:  	Tuesday, August 14, 2007, 3:00 PM – 5:00 PM 

(See Federal Register Notice – Attachment B) 

Location: 		via teleconference 

Purpose: 	The EPA Human Studies Review Board (HSRB) provides advice,
information, and recommendations on issues related to the scientific and
ethical aspects of human subjects research. 

Attendees: 	Chair: 			Celia B. Fisher, Ph.D. 

Board Members: 	Gary L. Chadwick, PharmD, MPH, CIP 

Janice Chambers, Ph.D., D.A.B.T. 

Richard Fenske, Ph.D., MPH 

Susan S. Fish, PharmD, MPH

KyungMann Kim, Ph.D., CCRP 

Michael D. Lebowitz, Ph.D., FCCP

Jerry A. Menikoff, M.D. 

Sean M. Philpott, Ph.D. 

Meeting Summary:	Meeting discussions generally followed the issues and
general timing as presented in the meeting Agenda (Attachment C), unless
noted otherwise in these minutes. 

Introductory Remarks, Meeting Administrative Procedures, and Meeting
Process

Dr. Celia Fisher (HSRB Chair) opened the teleconference meeting with an
introduction and identification of the HSRB, or Board, members
participating in the call.  Dr. Fisher explained that the purpose of the
meeting was to review and approve the April 18-20, 2007 draft HSRB
meeting report (Attachment D) and respond to questions raised by EPA’s
Office of Pesticide Programs (OPP).  

Dr. Paul Lewis (Designated Federal Officer [DFO], HSRB, Office of the
Science Advisor [OSA], EPA) thanked Dr. Fisher and the Board for their
participation in the teleconference and for their review of the draft
April 18-20, 2007 HSRB meeting report.  Dr. Lewis explained that the
HSRB is subject to Federal Advisory Committee Act (FACA) requirements. 
As the DFO, Dr. Lewis serves as liaison between the HSRB and EPA.  He
works with the appropriate officials to ensure compliance with all
appropriate ethics regulations.  Each member of the Board has filed a
standard government financial disclosure form that has been reviewed by
EPA to ensure that all ethics requirement have been met.

Dr. Lewis asked Board members and public commenters to identify
themselves each time they speak for the purposes of the audio recording
and meeting minutes.  He requested that members of the public hold their
remarks until the designated public comment period and limit their
remarks to 5 minutes.

Dr. Lewis stated that the documents discussed by the HSRB, including the
draft April 18-20, 2007 HSRB meeting report, are available at the
public docket; the address for the docket was included in the Federal
Register notice announcing this teleconference meeting.  As per FACA
requirements, the meeting minutes will include descriptions of matters
discussed and the conclusions reached by the Board.  As the DFO,
Dr. Lewis will prepare the minutes and have them certified by the HSRB
Chair within 90 calendar days of the meeting.  In addition, the minutes
will be available at the public docket and posted on the HSRB Web site. 

Public Comments

Dr. Fisher invited oral public comment on the draft April 18-20, 2007
HSRB meeting report.  No oral public comments were presented.  

Board Discussion and Decision on Report

Dr. Fisher introduced the written comments submitted by EPA/OPP and
stated that the Board discussion during the teleconference would focus
on questions and points of clarification raised by OPP.  Dr. Fisher
suggested that the Board adopt all OPP recommendations that were factual
or editorial corrections.

In the summary letter to Dr. George Gray (Science Advisor, EPA) (p. 3,
lines 45-46 and p. 4, lines 1-2), OPP requested clarification of the
Board’s conclusion concerning the Repeated Insult Patch Test (RIPT). 
“The Board concluded that, because (1) there was insufficient IRB
[Institutional Review Board] review of all products to which subjects
were exposed, (2) information concerning research procedures within the
consent form itself was inadequate, and (3) the limited if any
scientific validity of the study did not produce a positive risk-benefit
ratio, there was clear and convincing evidence that the conduct of the
study was significantly deficient relative to the ethical standards
prevailing when the study was conducted.”  OPP inquired whether it was
fair to apply these tests ex post facto to the conduct of research and
if the Board’s conclusion addressed the conduct of the research itself
or the adequacy of IRB review.  Dr. Sean Philpott clarified that the
first two points concerning IRB review and information on the test
products pertained to the adequacy of the IRB review and the third point
was based on assessment of the science.  Dr. Fisher proposed the text be
revised as follows:  “The Board concluded that there was insufficient
IRB review of all products to which subjects were asked to agree to be
exposed.  In addition, information concerning research procedures within
the consent form itself was inadequate, and the limited if any
scientific validity of the study did not produce an a priori positive
risk-benefit ratio.  For these reasons, the Boarc concluded there was
clear and convincing evidence that the conduct of the study was
significantly deficient relative to the ethical standards prevailing
when the study was conducted.”  Board members agreed to delete the
final sentence of the paragraph describing prevailing ethical standards.

Completed Repellent Efficacy Studies:  IR3535 Aerosol (EMD-003.3 and
EMD-004.3)

EMD-003.3: Tick Repellency with Aerosol Spray Formulations

OPP commented that the phrase “as suggested by the HSRB” should be
deleted (p. 15, line 29), as well as the word “passive” (p. 15,
lines 29 - 30).  Dr. Janice Chambers agreed with these deletions.  Dr.
Fisher asked if any Board members wanted to suggest changes to the HSRB
Consensus and Rationale related to scientific considerations (p. 18,
lines 22-26).  No Board members requested changes.  There also were no
changes to the HSRB Consensus and Rationale related to ethical
considerations (p. 21, lines 12-13).

EMD-004.3: Mosquito Repellency with Aerosol Spray Formulations

The Board agreed to accept factual changes suggested by OPP concerning
clarification of test sites for EMD-004.3 (p. 21, lines 45-46 and p. 22,
lines 1-2).

Dr. Fisher asked if Board members had comments or changes for the HSRB
Consensus and Rationale related to scientific considerations (p. 23,
lines 37-39).  No changes were suggested.  There also were no changes to
the HSRB Consensus and Rationale related to ethical considerations for
this study (p. 27, lines 9-11).

Carroll-Loye Mosquito Repellent Efficacy Protocol WPC-001

OPP’s written comments clarified that the sample size proposed for
Mosquito Repellent Efficacy Protocol WPC-001 was 10 treated and 2
untreated subjects per field site, rather than 6 treated and 1
untreated subject as stated in the Board’s draft report (p. 27, line
36).  While Dr. KyungMann Kim agreed with this clarification; he
advised that the Board’s conclusion concerning the potential
inadequacy of the sample size remains accurate.

Dr. Fisher requested comments or changes from Board members concerning
the HSRB Consensus and Rationale related to scientific considerations
(p. 28, lines 13-20) and ethical considerations (p. 29, lines 26-28) for
the protocol WPC-001.  There were no changes to either conclusion.

Completed Patch Test Studies

Part I.  48-Hour Dermal Irritation Patch Test

Dr. Fisher asked Board members for comments or changes concerning the
HSRB Consensus and Rationale related to scientific considerations for
the completed 48-Hour Dermal Irritation Patch Test (p. 33, lines 28-42).
 There were no changes to the Board’s conclusion.

OPP’s written comments clarified that three of the test materials used
in the 48-Hour Dermal Irritation Patch Test were research and
development samples, not “currently marketed cosmetic products” (p.
34, line 26).  Dr. Susan Fish agreed with OPP’s proposed change to the
meeting report.

Dr. Fisher requested comments or changes from Board members concerning
the HSRB Consensus and Rationale related to ethical considerations for
this study (p. 37, lines 25-33).  No changes were made to the Board’s
conclusion.

OPP’s written comments requested clarification on the Board’s
concern about inadequate justification for use of human subjects in the
48-Hour Dermal Irritation Patch Test (p. 36, lines 21-23).  “The only
rationale provided by the submitter for testing the combination in
humans is a policy of avoiding unnecessary experimentation with animals
and thus the sponsor chose not to do the usual studies in animals prior
to testing it in humans.”  OPP inquired as to why this concern was not
raised for the RIPT study.  Dr. Fish agreed that although this matter
was not discussed by the Board, this issue does apply to the RIPT study
as well as the 48-Hour Dermal Irritation Patch Test.  Dr. Jerry Menikoff
agreed that the lack of animal testing before testing on human subjects
was an important point for the ethics assessment and should be added to
the discussion of the RIPT study.

Dr. Fisher asked the Board for ways to clarify that the submitter’s
desire not to test on animals is not a legitimate ethical reason to
perform human testing as defined by current ethical regulations, while
avoiding comment on the submitter’s philosophy against animal testing.
 Dr. Gary Chadwick stated that the submitter’s philosophy against
animal testing was the only reason the submitter cited for justification
for exposure of human subjects to potential risk.  This single reason
was insufficient to make a decision to conduct human testing.  Board
members agreed to revise the statement in the draft meeting report (p.
36, lines 21-23) as follows:  “The Board felt that with respect to
federal regulations, this argument alone provides insufficient
justification for exposure of human participants to potential risk.” 
The Board also agreed to add this statement to the discussion of the
RIPT study (p. 44, lines 35-38).

Part II.  Repeated Insult Patch Test

OPP’s written comments clarified information regarding the removal of
test patches in the RIPT study (p. 40, lines 7-17).  Dr. Fish agreed
with OPP’s corrections, but added that the changes did not affect the
Board’s assessment of the study.  Dr. Richard Fenske commented that
there appears to be ambiguity in EPA’s understanding of the
information provided by the sponsor and that statements to this effect
should be reflected in the text.  Dr. Fenske also agreed that because
the clarifications made by Mr. John Carley (OPP, EPA) were based on
additional information received by EPA, the changes should be accepted.

Dr. Fisher asked Board members for comments or changes concerning the
HSRB Consensus and Rationale related to scientific considerations for
this study (p. 41, lines 32 - 38).  No changes were made to the
Board’s conclusion.

Board members agreed with OPP’s suggestion to mention that different
consent documents reported the schedule of events related to patch
placement, patch removal, and readings in contradictory ways (p. 45,
line 15 - 16).  Dr. Fish also noted a typographical error in the word
“planned” in the last sentence of Point 3 (p. 45, line 15).

In the HSRB Consensus and Rationale related to ethical considerations
(p. 46, lines 32-42), Board members agreed to remove the last sentence
(p. 46, lines 41-42).

Framework for Developing Best Practices for Subject Recruitment for
Handler Exposure Research

In OPP’s written comments it was noted that the draft framework
contained all of the requested additional elements for consent
documents.  Dr. Fenske inquired whether all the additional elements were
described fully in the consent forms.  Dr. Menikoff suggested that
Dr. Lewis determine whether all elements have been included; if so,
Point 9 requesting additional elements could be removed from the meeting
report.  Drs. Lewis and Fisher agreed with this approach, and decided to
change “mention the elements” to “mention each element” if the
additional elements were not included.

Follow-up on AHETF and AEATF Protocols

Concerning the Board Response to the Charge for Follow-up on
Agricultural Handler Exposure Task Force (AHETF) and Antimicrobial
Exposure Assessment Task Force (AEATF) protocols, Board members agreed
that they wished to continue to learn more about EPA’s approach to
this issue and discuss the task forces’ activities at future HSRB
meetings (p. 51, lines 30 – 36).

Dr. Fisher requested comments or changes from Board members concerning
the HSRB Consensus and Rationale related to scientific considerations
for these protocols (p. 53, lines 35 - 45 and p. 54, lines 1-8).  No
changes were made to the Board’s conclusion.

Summary and Next Steps

Dr. Fisher requested other comments on the document; no other comments
were made.  Dr. Fisher asked each Board member for their approval of the
revised April 18-20, 2007 draft meeting report, including acceptance of
the points of factual clarification and grammatical changes raised by
OPP which were not discussed during the teleconference.  All Board
members in attendance at the teleconference meeting approved the report.
 

Dr. Lewis thanked Board members for their participation.  Dr. Lewis
stated that he and Dr. Fisher will revise the report based on comments
made during the teleconference.  The revised report will be released at
regulations.gov and posted on the HSRB Web site.  The next face-to-face
HSRB meeting is scheduled for October 23-26, 2007.  

The meeting was adjourned by the Chair.

Respectfully submitted:

Paul I. Lewis, Ph.D.

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Celia B. Fisher, Ph.D.

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER:  The minutes of this public meeting reflect diverse
ideas and suggestions offered by Board members during the course of
deliberations within the meeting.  Such ideas, suggestions, and
deliberations do not necessarily reflect definitive consensus advice for
the Board members.  The reader is cautioned to not rely on the minutes
to represent final, approved, consensus advice and recommendations
offered to the Agency.  Such advice and recommendations may be found in
the final report prepared and transmitted to the EPA Science Advisor
following the public meeting.

Attachments 

Attachment A 		HSRB Members 

Attachment B 		Federal Register Notice Announcing Meeting 

Attachment C 		Meeting Agenda 

Attachment D 		April 18-20, 2007 EPA Human Studies Review Board Meeting 

Proposed Final Draft Report 

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS 

Chair

Celia B. Fisher, Ph.D.

Marie Ward Doty Professor of Psychology

Director, Center for Ethics Education

Fordham University

Bronx, NY 

Vice Chair

William S. Brimijoin, Ph.D.*

Chair and Professor 

Molecular Pharmacology and Experimental Therapeutics

Mayo Foundation

Rochester, MN 

Members

Alicia Carriquiry, Ph.D.*

Professor 

Department of Statistics

Iowa State University

Ames, IA 

Gary L. Chadwick, PharmD, MPH, CIP

Associate Provost

Director, Office for Human Subjects Protection

University of Rochester

Rochester, NY 

Janice Chambers, Ph.D., D.A.B.T.

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS 

Richard Fenske, Ph.D., MPH 

Professor

Department of Environmental and Occupational Health Sciences

University of Washington

Seattle, WA 

Susan S. Fish, PharmD, MPH

Professor, Biostatistics & Epidemiology

Boston University School of Public Health

Co-Director, MA in Clinical Investigation

Boston University School of Medicine

Boston, MA 

Suzanne C. Fitzpatrick, Ph.D., DABT*

Senior Science Policy Analyst

Office of the Commissioner

Office of Science and Health Coordination

U.S. Food and Drug Administration

Rockville, MD 

KyungMann Kim, Ph.D., CCRP

Professor and Associate Chair

Department of Biostatistics & Medical Informatics

School of Medicine and Public Health

University of Wisconsin-Madison

Madison, WI 

Kannan Krishnan, Ph.D.*

Professor

Département de santé environnementale et santé au travail

Faculté de médicine 

Université de Montréal

Montréal, QC  Canada

Michael D. Lebowitz, Ph.D.

Research Professor of Medicine & Epidemiology/Public Health

University of Arizona

Tucson, AZ 

Lois D. Lehman-Mckeeman, Ph.D.* 

Distinguished Research Fellow, Discovery Toxicology

Bristol-Myers Squibb Company

Princeton, NJ 

Jerry A. Menikoff, M.D.  

National Institute of Health

Office of Human Subjects Research

Bethesda, MD 

Sean M. Philpott, Ph.D., M.Bioethics

Policy and Ethics Director

Global Campaign for Microbicides

Program for Appropriate Technology in Health

Washington, DC  

Richard Sharp, Ph.D.* 

Assistant Professor of Medicine

Center for Medical Ethics and Health Policy 

Baylor College of Medicine 

Houston, TX 

* Not in attendance at teleconference

Attachment B

Federal Register Notice Announcing Meeting

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the April 18-20, 2007
HSRB Meeting   

[Federal Register: July 26, 2007 (Volume 72, Number 143)]

[Notices]

[Page 41073-41074]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr26jy07-47]

------------------------------------------------------------------------
---------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0216; FRL-8446-6]

Human Studies Review Board (HSRB); Notification of a Public
Teleconference To Review Its Draft Report From the April 18-20, 2007
HSRB Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

------------------------------------------------------------------------
---------------------------------------------

SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public
teleconference meeting to discuss its draft HSRB report from the April
18-20, 2007 HSRB meeting.

DATES: The teleconference will be held on August 14, 2007, from 3 to
approximately 5 p.m. (Eastern Time).

    Location: The meeting will take place via telephone only.

    Meeting Access: For information on access or services for
individuals with disabilities, please contact the DFO at least 10
business days prior to the meeting using the information under FOR

FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.

    Procedures for Providing Public Input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Unit I.D.
of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
obtain the call-in number and access code to participate in the
telephone conference, to request a current draft copy of the Board's
report or to obtain further information, may contact Crystal Rodgers-

Jenkins, EPA, Office of the Science Advisor, (8105), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460;
or via telephone/voice mail at (202) 564-5275. General information
concerning the EPA HSRB can be found on the EPA Web site at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ .

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2007-0216, by one of the following methods: 

      HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
  Follow the on-line instructions for submitting comments.

    E-mail:   HYPERLINK "mailto:ORD.Docket@epa.gov"  ORD.Docket@epa.gov
.

    Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T,
1200 Pennsylvania Ave., NW, Washington, DC 20460.

    Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room,
Infoterra Room (Room Number 3334), EPA West Building, 1301 Constitution
Avenue, NW, Washington, DC 20460, Attention Docket ID No.
EPA-ORD-2007-0216. Deliveries are only accepted from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2007-0216. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov , including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or e-mail. 

The   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
 Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA,
without going through   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov , your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

I. Public Meeting

A. Does This Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies,
especially studies on substances regulated by EPA, or to persons who are
or may be required to conduct testing of chemical substances under the
Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this 

[[Page 41074]]

action. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of This Document and Other Related
Information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
Federal Register listings at   HYPERLINK "http://www.epa.gov/fedrgstr/" 
http://www.epa.gov/fedrgstr/   

  Docket: All documents in the docket are listed in the   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy. Publicly available docket
materials are available either electronically in   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or in hard
copy at the ORD Docket, EPA/DC, Public Reading Room, Infoterra Room
(Room Number 3334), EPA West Building, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the ORD Docket is (202) 566-1752.

    The April 18-20, 2007 HSRB meeting draft report is now available.
You may obtain electronic copies of this document, and certain other
related documents that might be available electronically, from the
regulations.gov Web site and the HSRB Internet Home Page at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ .

    For questions on document availability or if you do not have access
to the Internet, consult the person listed under FOR FURTHER
INFORMATION.

C. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:

    1. Explain your views as clearly as possible.

    2. Describe any assumptions that you used.

    3. Provide copies of any technical information and/or data you used
that support your views.

    4. Provide specific examples to illustrate your concerns.

    5. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

D. How May I Participate in This Meeting?

    You may participate in this meeting by following the instructions in
this section. To ensure proper receipt by EPA, it is imperative that you
identify docket ID number EPA-HQ-ORD-2007-0216 in the subject line on
the first page of your request.

    1. Oral comments. Requests to present oral comments will be accepted
up to August 7, 2007. To the extent that time permits, interested
persons who have not pre-registered may be permitted by the Chair of the
HSRB to present oral comments at the meeting. Each individual or group
wishing to make brief oral comments to the HSRB is strongly advised to
submit their request (preferably via e-mail) to the person listed under
FOR FURTHER INFORMATION CONTACT no later than noon, eastern time, August
7, 2007, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB DFO to review the meeting
agenda to provide an appropriate public comment period. The request
should identify the name of the individual making the presentation and
the organization (if any) the individual will represent. Oral comments
before the HSRB are limited to 5 minutes per individual or organization.
Please note that this includes all individuals appearing either as part
of, or on behalf of an organization. While it is our intent to hear a
full range of oral comments on the science and ethics issues under
discussion, it is not our intent to permit organizations to expand these
time limitations by having numerous individuals sign up separately to
speak on their behalf. If additional time is available, there may be
flexibility in time for public comments.

    2. Written comments. Although you may submit written comments at any
time, for the HSRB to have the best opportunity to review and consider
your comments as it deliberates on its report, you should submit your
comments at least 5 business days prior to the beginning of this
teleconference. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that the
Board members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the Agency strongly encourages you to submit such comments no
later than noon, Eastern Time, August 7, 2007. You should submit your
comments using the instructions in Unit 1.C. of this notice. In
addition, the Agency also requests that person(s) submitting comments
directly to the docket also provide a copy of their comments to the
person listed under FOR FURTHER INFORMATION CONTACT. There is no limit
on the length of written comments for consideration by the HSRB.

E. Background

    The EPA Human Studies Review Board will be reviewing its draft
report from the April 18-20, 2007 HSRB meeting. Background on the April
18-20, 2007 HSRB meeting can be found at Federal Register 72 57, 14101
(March 26, 2007) and at the HSRB Web site   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/ .

The Board may also discuss planning for future HSRB meetings.

Dated: July 20, 2007.

George Gray,

EPA Science Advisor.

[FR Doc. E7-14468 Filed 7-25-07; 8:45 am]

BILLING CODE 6560-50-P

Attachment C

8/9/07

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

HUMAN STUDIES REVIEW BOARD (HSRB) 

PUBLIC TELECONFERENCE MEETING 

AUGUST 14, 2007 

3:00 pm -5:00 pm (Eastern Time) 

HSRB MEETING FOR REVIEW AND APPROVAL OF 

DRAFT APRIL 18-20, 2007 HSRB MEETING REPORT *

 

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

Docket Telephone: (202) 566 1752 

Docket Number: EPA-HQ-ORD-2007-0216

Meeting location via telephone only 

Members of the public may obtain the call in number at 202-564-5275

 

• 3:00 PM 	Introduction and Identification of Board Members – Celia
Fisher, Ph.D. (HSRB Chair) 

• 3:10 PM 	Meeting Administrative Procedures - Paul Lewis, Ph.D.
(Designated Federal Officer, HSRB, OSA, EPA) 

• 3:15 PM 	Meeting Process – Celia Fisher, Ph.D. (HSRB Chair) 

• 3:20 PM 	Public Comments 

• 3:30 PM 	Board Discussion and Decision on Report – Celia Fisher,
Ph.D. (HSRB Chair) 

Completed Repellent Efficacy Studies: IR3535 Aerosol (EMD-003.3 and
EMD-004.3) 

EMD-003.3: Tick Repellency with Aerosol Spray Formulations 

a. 	Is this study sufficiently sound, from a scientific perspective, to
be used to assess the repellent efficacy of the formulation tested
against ticks? 

b. 	Does available information support a determination that this study
was conducted in substantial compliance with subparts K and L of EPA
regulations at 40 CFR part 26? 

EMD-004.3: Mosquito Repellency with Aerosol Spray Formulations 

a. 	Is this study sufficiently sound, from a scientific perspective, to
be used to assess the repellent efficacy of the formulation tested
against mosquitoes? 

b. 	Does available information support a determination that this study
was conducted in substantial compliance with subparts K and L of EPA
regulations at 40 CFR part 26? 

Carroll-Loye Mosquito Repellent Efficacy Protocol WPC-001 

a. 	If the proposed research described in Protocol WPC-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear likely to generate scientifically
reliable data, useful for assessing the efficacy of the test substances
for repelling mosquitoes? 

b. 	If the proposed research described in Protocol WPC-001 from
Carroll-Loye Biological Research is revised as suggested in EPA’s
review, does the research appear to meet the applicable requirements of
40 CFR part 26, subparts K and L? 

Research Conducted After April 7, 2006: Meaning of “Substantial
Compliance” with 40 CFR Part 26 

	(no charge question) 

Completed Patch Test Studies 

Part I. 48-Hour Dermal Irritation Patch Test 

a. 	Is this study sufficiently sound, from a scientific perspective, to
be used as part of a weight-of-evidence assessment to evaluate the
potential of the formulations tested to irritate human skin? 

b. 	Is there clear and convincing evidence that the conduct of this
study was fundamentally unethical or significantly deficient relative to
the ethical standards prevailing at the time the research was conducted?

Part II. Repeated Insult Patch Test 

a. 	Is this study sufficiently sound, from a scientific perspective, to
be used to be used as part of a weight-of-evidence assessment to
evaluate the potential of the formulations tested to cause sensitization
of human skin? 

b. 	Is there clear and convincing evidence that the conduct of this
study was fundamentally unethical or significantly deficient relative to
the ethical standards prevailing at the time the research was conducted?

Framework for Developing Best Practices for Subject Recruitment for
Handler Exposure Research 

a. 	What additional elements of the process of recruiting and enrolling
subjects in handler exposure research should be addressed in a “Best
Practices Framework”? 

b. 	For each of the elements in the “Best Practices Framework,”
please identify any additional sources of guidance that could be useful
for an investigator who is designing a process for recruiting and
enrolling subjects in handler exposure research. 

Follow-up on AHETF and AEATF Protocols 

Recognizing that protocol-specific science and ethics issues will be
addressed in later HSRB meetings, EPA has attempted to explain the basis
for its conclusion that additional information on exposure for people
who mix, load, and apply pesticides (handlers) would be useful in EPA's
regulatory decision-making and therefore new research would be valuable.
Do the materials provided by EPA regarding the quality of the scientific
data currently available for assessing exposures for handlers contain
useful information to establish the societal value of proposed new
handler exposure research, assuming individual protocols would generate
scientifically valid information? 

What additional information, if any, would the Board want with respect
either to handler research in general or to individual protocols? 

• 4:45 PM 	Summary and Next Steps - Celia Fisher, Ph.D. (HSRB Chair)
and Paul Lewis, Ph.D. (Designated Federal Officer, HSRB, EPA) 

• 5:00 PM 	Adjournment 

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

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