Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB) 

January 11, 2012 Public Teleconference Meeting

Docket Number: EPA-HQ-ORD-2011-0953

HSRB Website: http://www.epa.gov/osa/hsrb

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

Date and Time:  	Wednesday, January 11, 2012, 1:00 p.m. – 4:00 p.m.

(See Federal Register Notice – Attachment B) 

Location: 	Via teleconference

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

Attendees: 	Chair: 			Sean Philpott, Ph.D., M.S., Bioethics

Board Members: 	Janice Chambers, Ph.D., D.A.B.T.

George C.J. Fernandez, Ph.D.

Jewell H. Halanych, M.D.

Dallas E. Johnson, Ph.D.

Michael D. Lebowitz, Ph.D., FCCP

Jerry A. Menikoff, M.D.

William J. Popendorf, Ph.D.

Leonard Ritter, Ph.D.

Virginia Ashby Sharpe, Ph.D.

Linda J. Young, 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. 

CONVENE MEETING AND IDENTIFICATION OF BOARD MEMBERS

Mr. Jim Downing (Designated Federal Officer [DFO], Human Studies Review
Board [HSRB or Board], Office of the Science Advisor [OSA], U.S.
Environmental Protection Agency [EPA or Agency]) opened the
teleconference meeting and welcomed Board members on behalf of the EPA
Science Advisor Dr. Paul Anastas and the Program in Human Research
Ethics. He noted that the Agency appreciates the Board members’ time
in preparing for the meeting. He also welcomed EPA colleagues and
members of the public. The purpose of this teleconference meeting was to
review the decisions made by the Board at the October 19-20, 2011 HSRB
meeting and to finalize the Board report from that meeting. The October
2011 meeting was the first HSRB meeting to be webcast, and this is an
important tool for providing greater transparency and open government.
The Agency would like feedback from those who attended the webcast;
feedback may be submitted via email to Mr. Downing at
downing.jim@epa.gov. 

Meeting Administrative Procedures

As DFO, Mr. Downing serves as the liaison between the HSRB and EPA and
ensures that Federal Advisory Committee Act (FACA) requirements are met
with regard to the operations of the HSRB. As DFO, he also works with
the appropriate officials to ensure that all applicable ethics
regulations are satisfied. Each Board member has been briefed on the
provisions of the federal conflict of interest laws and has filed a
standard government financial disclosure form that has been reviewed to
ensure that all ethics disclosure requirements have been met.
Mr. Downing reminded participants that meeting times listed on the
agenda would be approximate, and that Board members should state their
names before speaking. At the teleconference meeting, the Board will
review the draft final report from the October 2011 meeting, and will
finalize the report for submission to the Science Advisor and the
Agency. At the appropriate time, members of the public may provide
public comments; these must be limited to 5 minutes. No individuals
pre-registered to provide public comments. 

Copies of the meeting materials are available on regulations.gov under
the docket number EPA-HQ-ORD-2011-0953. According to FACA requirements,
meeting minutes including descriptions of the discussions and
conclusions reached by the Board will be prepared. These minutes will be
certified by the Chair within 90 days of the meeting and posted at
www.regulations.gov and on the HSRB website. 

Meeting Process

Dr. Sean Philpott thanked the Board members for their diligent work at
the October 2011 meeting and in completing their sections of the meeting
report, and thanked the Agency staff for their help and comments. He
explained that the Board would discuss the draft Board report, focusing
on the charge questions presented to the Board and the HSRB’s
recommendations. Dr. Philpott requested that the HSRB focus on
substantive changes to the report that directly affect the Board’s
recommendations. Board members should submit any typographical or
grammatical corrections to Dr. Philpott and Mr. Downing via email. He
requested that Board members identify the section of the report to which
they were referring by line number, and to identify themselves before
speaking. The report is intended to be a summary of the HSRB’s
consensus recommendations and not a detailed technical document. The
Agency and study sponsors have access to detailed meeting minutes for
additional information. 

	He noted that a number of members of the public were participating in
the teleconference, and that the meeting was being recorded for purposes
of drafting the meeting minutes. 

 

Public Comments

Dr. Philpott invited public comment on the draft October 2011 HSRB
meeting report. No public comments were presented. 

Board Discussion and Decision on Final Report

A new scenario design and associated protocol from the Antimicrobial
Exposure Assessment Task Force II (AEATF-II), describing proposed
research to monitor the dermal and inhalation exposure of workers while
pouring liquid antimicrobial pesticide products from both conventional
and reduced-splash containers.

	Dr. Philpott stated that the science charge question was located at
line 315 of the draft report, and asked whether the AEATF liquid pour
study proposal, if revised as suggested in EPA’s review and if the
research is performed as described, would be likely to generate
scientifically reliable data useful for assessing the exposure of
individuals who manually pour liquid antimicrobial products. The Board
concluded that the protocol, as submitted for review and if modified in
accordance with EPA and HSRB recommendations, is likely to generate
scientifically reliable data useful for accessing exposure of
individuals who manually pour liquid antimicrobial products. In addition
to providing several other comments and suggestions, the Board also
pointed out two limitations not identified within the protocol or by the
Agency: the wider range of exposures that could occur when pouring
products outdoors instead of indoors, and the unknown impact of
potential differences in exposures between consumers and professionals.
He asked if any Board members had questions or concerns about this
recommendation and its rationale that begins on line 343. Dr. Linda
Young noted a typographical error on line 364 that created redundancy.
Dr. Philpott agreed to correct it. There were no other comments. 

	Dr. Philpott stated the ethics charge question that begins on line 482
asked whether the AEATF liquid pour study proposal, if revised as
suggested in EPA’s review and if the research is performed as
described, would be likely to meet the applicable requirements of 40
Code of Federal Regulations (CFR) part 26, subparts K and L. The Board
concluded that the protocol, as submitted for review and if modified in
accordance with EPA and HSRB recommendations, is likely to meet the
applicable requirements of 40 CFR part 26, subparts K and L. He asked if
any Board members had questions or concerns on the recommendation and
its rationale that begins on line 498. There were no Board comments or
questions. 

A new scenario design and associated protocols from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
measure dermal and inhalation exposure to workers who use closed system
equipment to load liquid pesticide products from returnable and
non-returnable containers.

	Dr. Philpott noted that the discussion of the study begins on line 643.
The science charge question begins on line 692 and asked the Board
whether the AHETF closed system loading study proposal, if revised as
suggested in the Agency’s review and if research is performed as
described, would be likely to generate scientifically reliable data,
useful for assessing exposure of workers to closed systems to load
liquid pesticide products from returnable or non-returnable containers.
The Board concurred with the Agency’s assessment that the proposed
AHETF scenario and field study proposal, if revised as suggested and
performed as described, is likely to generate scientifically reliable
data, useful for assessing the exposure of workers using closed systems
to load liquid pesticide products from returnable or non-returnable
containers. The Board raised a number of additional concerns for the
Agency and study sponsors to consider when collecting and analyzing the
exposure data. Those detailed recommendations and suggestions begin on
line 712. He asked if there were any Board questions or concerns about
the recommendations and their rationale. Dr. Young pointed out that the
sentence that begins on line 743 should read “Exposure and normalized
exposure are interpretable only when the proportionality constants are
zero and one.” The word “respectively” should be deleted. Dr.
Philpott agreed to make the change. No other members offered comments.

	Dr. Philpott noted that the ethics charge question was located at line
777, and asked the Board whether the proposed AHETF scenario and field
study proposal, if revised as suggested in EPA’s review and if the
research is performed as described, is likely to meet the applicable
requirements of 40 CFR part 26, subparts K and L. The Board concluded
that the protocol, as submitted for review and if modified in accordance
with EPA and HSRB recommendations, is likely to meet applicable
requirements of 40 CFR part 26, subparts K and L. The Board made a few
additional recommendations that are detailed in lines 793 to 935. He
asked if Board members had any questions or comments regarding the
response to the Agency. No Board members offered comments. 

A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas
003) to evaluate the field repellent efficacy against mosquitoes of a
product containing 16% para-methane-3,8-diol (PMD) and 2% lemongrass
oil.

	Dr. Philpott mentioned that Dr. Sidney Green, who was unable to attend
the teleconference meeting, had sent an email noting that on line 955,
there was an error. The line reads “two untreated experienced
volunteers from site 1 also participated as treated controls at site
2.” The sentence should conclude “as treated subjects at site 2,”
and Dr. Philpott has made that change.

	Dr. Philpott stated that the Board’s response to the science charge
question begins on line 997. The Agency asked the Board whether the CLBR
completed study No Mas 003 was sufficiently sound from a scientific
perspective to be used to estimate the duration of complete protection
against mosquitoes provided by the tested repellant. The Board concurred
with the Agency’s assessment that the study provided scientifically
valid results to assess efficacy against mosquitoes for the formulation
tested, and the detailed recommendations and rationale begin on line
1013. Dr. Philpott asked if any Board members had comments regarding the
recommendations and rationale. No Board members offered comments.

	Dr. Philpott stated that the ethics charge question, which begins on
line 1041, asked the Board whether the available information supported a
determination that the study was conducted in substantial compliance
with subparts K and L of 40 CFR part 26. The Board concurred with the
Agency’s assessment that the study submitted for review was conducted
in substantial compliance with subparts K and L of 40 CFR part 26. The
Board’s detailed recommendations and rationale are located on lines
1056 to 1137. He asked if any Board members had comments or concerns
about the recommendations or rationale. No Board members offered
comments. 

A published report by Moiemen et al (2011) of an intentional exposure
human study measuring dermal absorption of silver from the use of
nanosilver-containing wound dressings to treat major burns.

	Dr. Philpott noted that the Agency proposed to use the data reported in
the study to make estimates of systemic absorption of silver as a
nanoparticle through the skin. The Board’s consideration of the study
begins on line 1140. He also noted that this is a “post-rule”
published study, so there are different considerations for the level of
information that needs to be provided to the Board. EPA asked the Board
to consider two science charge questions that begin on line 1180: Is the
Moiemen et al study scientifically sound, providing reliable data? If
so, can the Moiemen et al study be used to support the Agency’s
conclusion that the dermal absorption factor for silver from nanosilver
on human skin is less than 0.1 percent? The Board concluded that despite
several deficiencies identified in the study design, the small number of
subjects and the interpretation of the data, it agreed overall with the
Agency’s assessment that the Moeimen et al study provided some
potentially useful baseline information on dermal absorption of silver
from nanosilver-containing wound dressings. The Board also concluded
that the Moiemen et al study could be used to support the Agency’s
conclusion that the dermal absorption for silver from nanosilver was
less than 0.1 percent as part of an overall weight of evidence. The
Board, however, recommended that the Agency clarify its assumptions in
estimating the dermal absorption of silver from nanosilver, and that the
Agency consider alternatives for estimating dermal absorption based on
the study. The Board’s recommendations and rationale begin on line
1210 and continue to line 1286. Dr. Philpott commented that Dr. William
Popendorf also had submitted a statement to the Agency proposing some
alternative approaches for estimating dermal absorption based on this
study. Dr. Philpott asked if any Board members had questions or comments
about the recommendations and rationale. No members offered comments. 

	The ethics charge to the Board on the Moiemen et al study asked the
Board to consider whether there was adequate information to support a
determination that the study was conducted in substantial compliance
with procedures at least as protective as those in subparts A through L
of 40 CFR part 26. The Board concurred with the Agency’s assessment
that there was sufficient information regarding the value of the
research to society, subject selection, risks and benefits, independent
ethics review, informed consent and respect for potential and enrolled
subjects to conclude that the study was conducted in substantial
compliance with procedures at least as protective as the relevant
subparts of 40 CFR part 26. The Board’s detailed recommendations and
rationale begin on line 1306 and continue to line 1380. He asked if any
Board members had questions or comments on the recommendations and
rationale. No members offered comments. 

Summary and Next Steps

Dr. Philpott commented that the lack of comments reflects well-written
discussions submitted for inclusion in the report, and the high-quality
of both the sponsors’ submissions and the Agency’s review. He
thanked both the Agency and the sponsors for their hard work.
Dr. Michael Lebowitz stated that it was surprising, given the
complicated nature of these studies, that the Board has conducted the
review so well. As a longtime member of the Board, he was very impressed
by the Board’s review at the October 2011 meeting and the Agency’s
review. Dr. Philpott asked if the Agency representatives on the call
had any questions, and they did not. He asked that the Board move to the
procedural vote to approve the final draft pending the modifications
discussed during the teleconference. Dr. Philpott called on each member
in turn for a vote, and all members on the call who had attended the
October 2011 meeting voted to approve the report unanimously. New
members Drs. Jewell Halanych and Leonard Ritter abstained from voting
because they had not been members at the time of the October 2011
deliberations. 

Mr. Downing thanked the members for a successful meeting and for their
diligent work on the final report. He noted that the next face-to-face
HSRB meeting would be held January 26, 2012, at the EPA Conference
Center at Potomac Yard South in Crystal City, Virginia. He adjourned the
meeting at 1:45 p.m.

Respectfully submitted:

Jim Downing

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

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

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER: The minutes of this public teleconference 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
from 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 A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

*Sean Philpott, Ph.D., M.S. Bioethics	Term: 3/27/2006-8/31/2012

Director, Research Ethics

The Bioethics Program

Union Graduate College-Mt. Sinai School of Medicine

Schenectady, NY

Vice Chair

*^Rebecca T. Parkin, Ph.D., M.P.H	Term: 10/1/2007-8/31/2013

Professorial Lecturer (EOH)

School of Public Health and Health Services

The George Washington University

Washington, DC

Members

*Janice Chambers, Ph.D., D.A.B.T.	Term: 3/27/2006-8/31/2012

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine 

Mississippi State University 

Mississippi State, MS 

*George C.J. Fernandez, Ph.D.	Term: 5/1/2010-8/31/2013

Statistical Training Specialist

SAS Institute, Statistical Training and Technical Services

Sparks, NV

*^Vanessa Northington Gamble, M.D., Ph.D.	Term: 10/19/2009-10/31/2012

University Professor of Medical Humanities

Gelman Library

The George Washington University

Washington, DC

*^Sidney Green, Jr., Ph.D., Fellow ATS	Term: 10/19/2009-10/31/2012

Department of Pharmacology

Howard University College of Medicine

Howard University

Washington, DC

*Jewell H. Halanych, M.D.	Term: 11/14/2011-8/31/2014

Assistant Professor

Department of Medicine

Division of Preventative Medicine

University of Alabama at Birmingham

Birmingham, AL

*Dallas E. Johnson, Ph.D. 	Term: 8/31/2007-8/31/2013

Professor Emeritus

Department of Statistics

Kansas State University

Manhattan, KS

*Michael D. Lebowitz, Ph.D., FCCP	Term: 3/27/2006-8/31/2012

Retired Professor of Public Health

(Epidemiology) & Medicine & Research Professor of Medicine

University of Arizona

Tucson, AZ

*^José E. Manautou, Ph.D.	Term: 5/1/2010-8/31/2013

Associate Professor of Toxicology 

Department of Pharmaceutical Sciences

School of Pharmacy, University of Connecticut

Storrs, CT

Jerry A. Menikoff, M.D. 	Term: 3/27/2006-8/31/2012

Director, Office for Human Research Protections

Department of Health and Human Services 

Rockville, MD 

*William J. Popendorf, Ph.D.	Term: 10/19/2009-10/31/2012

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

*Leonard Ritter, Ph.D.	Term: 11/14/2011-8/31/2014

Professor Emeritus (Toxicology)

School of Environmental Sciences

University of Guelph

Guelph, Ontario, Canada

*^Bernard A. Schwetz, D.V.M., Ph.D.	Term: 11/14/2011-8/31/2014

Retired Director

Office of Human Research Protections

Department of Health and Human Services

Cadott, WI

Virginia Ashby Sharpe, Ph.D.	Term: 5/1/2010-8/31/2013	

National Center for Ethics in Health Care

Veterans Health Administration

Department of Veterans Affairs 

Washington, DC

*Linda J. Young, Ph.D.	Term: 3/28/2008-8/31/2012

Department of Statistics

Institute of Food and Agricultural Sciences

University of Florida

Gainesville, FL 

*Special Government Employee (SGE)

^Not in attendance at the January 11, 2012 teleconference meeting

Attachment B

FEDERAL REGISTER NOTICE ANNOUNCING MEETING

[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]

[Notices]

[Pages 77825-77827]

From the Federal Register Online via the Government Printing Office [ 
HYPERLINK "http://www.gpo.gov"  www.gpo.gov ]

[FR Doc No: 2011-32060]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0953; FRL-9506-6]

Human Studies Review Board; Notification of a Public Teleconference

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The EPA Office of the Science Advisor announces a public
teleconference of the HSRB to discuss its draft report from the October
19-20, 2011 HSRB meeting.

DATES: The teleconference will be held on Wednesday, January 11, 2012
from approximately 1 p.m. to approximately 4 p.m. Eastern Time. Comments
may be submitted on or before Wednesday, January 4, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0953, by one of the following methods:

     Internet:   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov : Follow the Web site instructions for
submitting comments.

     Email:   HYPERLINK "mailto:ORD.Docket@epa.gov"  ORD.Docket@epa.gov
.

     Mail: Environmental Protection Agency, EPA Docket Center EPA/DC,
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW., Washington,
DC 20460.

     Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building, located
at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m.

[[Page 77826]]

Eastern Time, Monday through Friday, excluding Federal holidays. Please
call (202) 566-1744 or email the ORD Docket at ord.docket@epa.gov for
instructions. Updates to Public Reading Room access are available online
at   HYPERLINK "http://www.epa.gov/epahome/dockets.htm" 
http://www.epa.gov/epahome/dockets.htm .

     Instructions: Direct your comments to Docket ID No.
EPA-HQ-ORD-2011-0953. The Agency'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 comments includes information claimed to be
Confidential Business Information or other information the disclosure of
which 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 email. The 
 HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov  Web
site is an “anonymous access” system, which means the EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to the EPA
without going through   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov , your email 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, the EPA recommends that you include your name and
other contact information in the body of your comments and with any disk
or CD-ROM you submit. If the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the 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.

FOR FURTHER INFORMATION CONTACT: Any members of the public who wish to
receive further information should contact Jim Downing on telephone
number (202) 564-2468; fax (202) 564-2070; email address   HYPERLINK
"mailto:downing.jim@epa.gov"  downing.jim@epa.gov  or Lu-Ann Kleibacker
on telephone number (202) 564-7189; fax: (202) 564-2070; email address  
HYPERLINK "mailto:kleibacker.lu-ann@epa.gov"  kleibacker.lu-ann@epa.gov
; mailing address Environmental Protection Agency, Office of the Science
Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 
20460. 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 .

SUPPLEMENTARY INFORMATION: 

     Location: The meeting will take place via telephone only.

     Meeting access: For information on access or services for
individuals with disabilities, please contact Lu-Ann Kleibacker at least
ten 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 section
I, “Public Meeting,” under subsection D, “How May I Participate in
 this Meeting?” of this notice.

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 particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by the EPA, or
to persons who are, or may be required to conduct testing of chemical
substances under the Federal Food, Drug, and Cosmetic Act or the Federal
Insecticide, Fungicide, and Rodenticide Act. Since other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult Jim Downing or Lu-Ann Kleibacker listed under FOR
FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other related
information?

    You may use   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov , or you may access this Federal Register
document via the EPA's Internet site 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 at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or in hard
copy at the ORD Docket, EPA/DC Public Reading Room. The EPA/DC Public
Reading Room is located in the EPA Headquarters Library, Room Number
3334 in the EPA West Building, located at 1301 Constitution Avenue NW,
Washington, DC 20460; its hours of operation are 8:30 a.m. to 4:30 p.m.
Eastern Time, Monday through Friday, excluding Federal holidays. Please
call (202) 566-1744, or email the ORD Docket at ord.docket@epa.gov for
instructions. Updates regarding the Public Reading Room access are
available at   HYPERLINK "http://www.epa.gov/epahome/dockets.htm" 
http://www.epa.gov/epahome/dockets.htm .

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 used
that support your views.

     4. Provide specific examples to illustrate your concerns and
suggest alternatives.

     5. To ensure proper receipt by the 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 the EPA, it is imperative that
you identify Docket ID No. EPA-HQ-ORD-2011-0953 in the subject line on
the first page of your request.

     1. Oral comments. Requests to present oral comments will be
accepted up to and including Wednesday, January 4, 2012. 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 during the
meeting. Each individual or group wishing to make brief oral comments to
the HSRB is strongly advised to submit their request (preferably via
email) to Jim Downing or Lu-Ann Kleibacker under FOR FURTHER INFORMATION
CONTACT no later than noon, Eastern Time, Wednesday, January 4, 2012, in
order to be included on the meeting agenda and to provide sufficient
time for the HSRB Chair and HSRB Designated Federal Official to review
the meeting agenda to provide an

[[Page 77827]]

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
generally limited to five 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 the
time limitations by having numerous individuals sign up separately to
speak on their behalf. If additional time is available, further public
comments may be possible.

     2. Written comments. Please submit written comments prior to the
meeting. 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 five 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, Wednesday, January 4, 2012. You should
submit your comments using the instructions in section I, under
subsection C, “What Should I Consider as I Prepare My Comments for
EPA?” In addition, the Agency also requests that persons submitting
comments directly to the docket also provide a copy of their comments to
Jim Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT. There is no limit on the length of written comments for
consideration by the HSRB.

E. Background

 

   The HSRB is a Federal advisory committee operating in accordance with
the Federal Advisory Committee Act 5 U.S.C. App.2 section 9. The HSRB
provides advice, information, and recommendations to EPA on issues
related to scientific and ethical aspects of human subjects research.
The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports of
completed research with human subjects; and (3) how to strengthen EPA's
programs for protection of human subjects of research. The HSRB reports
to the EPA Administrator through the EPA Science Advisor.

     1. Topics for Discussion. The HSRB will be reviewing its draft
report from the October 19-20, 2011, HSRB meeting. The Board may also
discuss planning for future HSRB meetings. Background on the October
19-20, 2011 HSRB meeting can be found at the HSRB Web site:   HYPERLINK
"http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb . The October
19-20, 2011 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   HYPERLINK
"http://www.regulations.gov/regulations.gov"  regulations.gov  Web site
and the HSRB Web site 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 Internet access, consult the persons listed under FOR
FURTHER INFORMATION CONTACT.

     2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/  and  
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov . In
addition, information regarding the Board's final meeting report will be
found at   HYPERLINK "http://www.epa.gov/osa/hsrb" 
http://www.epa.gov/osa/hsrb  or from the persons listed under FOR
FURTHER INFORMATION CONTACT.

    Dated: December 7, 2011. 

Paul T. Anastas,

EPA Science Advisor. 

[FR Doc. 2011-32060 Filed 12-13-11; 8:45 am] 

BILLING CODE 6560-50-P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING AGENDA

Wednesday, January 11, 2012

1:00 pm - 4:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE DRAFT OCTOBER 19-20, 2011
HSRB MEETING REPORT

HSRB Website:  HYPERLINK "http://www.epa.gov/osa/hsrb/" \h
http://www.epa.gov/osa/hsrb/  

Docket Telephone: (202) 566-1752

Docket Number: EPA–HQ–ORD–2011–0953

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 questions presented at the October
19-20, 2011 meeting.

A new scenario design and associated protocol from the Antimicrobial
Exposure Assessment Task Force II (AEATF-II), describing proposed
research to monitor the dermal and inhalation exposure of workers while
pouring liquid antimicrobial pesticide products from both conventional
and reduced-splash containers.

Charge to the Board:

If the AEATF liquid pour study proposal is revised as suggested in
EPA’s review and if the research is performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of individuals who manually pour liquid
antimicrobial products?

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

A new scenario design and associated protocols from the Agricultural
Handler Exposure

Task Force (AHETF) describing proposed research to measure dermal and
inhalation exposure to workers who use closed system equipment to load
liquid pesticide products from returnable and non-returnable containers.

Charge to the Board:

If the AHETF closed system liquid loading study proposal is revised as
suggested in EPA’s review and if the research is performed as
described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of workers using closed systems to load
liquid pesticide products from returnable or non-returnable containers?

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

A completed Carroll-Loye Biological Research, Inc. (CLBR) study (No Mas
003) to evaluate the field repellent efficacy against mosquitoes of a
product containing 16% para- methane-3,8-diol and 2% lemongrass oil.

Charge to the Board:

Is the CLBR completed study No Mas 003 sufficiently sound, from a
scientific perspective, to be used to estimate the duration of complete
protection against mosquitoes provided by the tested repellent?

Does available information support a determination that the study No Mas
003 was conducted in substantial compliance with 40 CFR part 26,
subparts K and L?

A published report by Moiemen et al (2011) of an intentional exposure
human study measuring dermal absorption of silver from the use of
nanosilver-containing wound dressings to treat major burns.

Charge to the Board:

Is the Moiemen (2011) study scientifically sound, providing reliable
data?

If so, can the Moiemen (2011) study be used to support the Agency's
conclusion that the dermal absorption factor for silver from nanosilver
on human skin is less than 0.1%?

Is there adequate information to support a determination that the study
was conducted in substantial compliance procedures at least as
protective as those at subparts A-L of 40 CFR part 26?

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

4:00 PM	Adjournment

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