Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB) 

August 15, 2014 Public Teleconference/Webinar Meeting

Docket Number: EPA–HQ–ORD–2014-0564

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

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

Date and Time:	Friday, August 15, 2014, 2:00 p.m. – 3:30 p.m. EDT

(See Federal Register Notice—Attachment B) 

Location: 	Via Teleconference and Webinar

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: 			Rebecca Parkin, Ph.D., M.P.H.

Board Members: 	Liza Dawson, Ph.D.

George C.J. Fernandez, Ph.D.

Kyle L. Galbraith, Ph.D.

Edward Gbur, Jr., Ph.D.

Sidney Green, Jr., Ph.D., Fellow, ATS

John C. Kissel, Ph.D.

Randy Maddalena, Ph.D.

William J. Popendorf, Ph.D.

Kenneth Ramos, M.D., Ph.D., Pharm.B.

Leonard Ritter, Ph.D., ATS

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. 

COMMENCEMENT OF PUBLIC MEETING and Identification of Board Members

Mr. Jim Downing, Designated Federal Officer (DFO) of the HSRB, commenced
the teleconference/webinar meeting and welcomed Board members on behalf
of EPA. He noted that the Agency appreciates the Board members’ time
and diligence in preparing for the meeting and during the deliberations.
He also welcomed EPA colleagues and members of the public. The purpose
of this teleconference/webinar meeting is to review the decisions made
by the Board at the June 11, 2014 HSRB meeting and to finalize the
Board’s report from that meeting. 

Mr. Downing called roll to determine which members were present on the
call; a quorum of members was present. The members introduced themselves
with their names and affiliations.

Meeting Administrative Procedures

As DFO, Mr. Downing, serves as the liaison between the HSRB and EPA and
ensures that Federal Advisory Committee Act (FACA) provisions are met
with regard to the operations of the HSRB. 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. 

At the teleconference/webinar meeting, the Board will review the draft
final report from the June 2014 HSRB meeting and will finalize the
report for submission to EPA’s Science Advisor. Mr. Downing reminded
participants that meeting times listed on the agenda would be
approximate, and that participants should state their names before
speaking to ensure proper attribution. Copies of the meeting materials,
supporting documents and public comments will be available at  
HYPERLINK "http://www.regulations.gov "  http://www.regulations.gov 
under docket number EPA-HQ-ORD-2014-0564, and most are available on the
HSRB website at   HYPERLINK "http://www.epa.gov/osa/hsrb" 
http://www.epa.gov/osa/hsrb . At the appropriate time, members of the
public may provide public comments; these must be limited to 5 minutes.
No individuals preregistered to provide public comments. The draft final
report will be displayed, reviewed and modified on the website at  
HYPERLINK "https://epa.connectsolutions.com/hsrbtele" 
https://epa.connectsolutions.com/hsrbtele  during the
teleconference/webinar. Mr. Downing encouraged the participants to log
in to the webinar, which will enable the Board to follow along as
revisions to the draft document are made in real time during the
deliberations.

According to FACA requirements, meeting minutes will be prepared,
including descriptions of the topics discussed and conclusions reached
by the Board. These minutes will be reviewed and certified by the Chair
within 30 days of the meeting and posted at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  and on the
HSRB website. Mr. Downing expressed appreciation to the Board members
for their participation and eagerness to finalize the report from the
June 2014 meeting. Mr. Downing turned the meeting over to the HSRB
Chair, Dr. Rebecca Parkin. 

Meeting Process

Dr. Parkin, HSRB Chair, thanked all of the Board members for their
diligent work at the June 2014 meeting and their efforts in developing
the draft meeting report and preparing for the teleconference/webinar.
She reiterated Mr. Downing’s request for the Board members to log in
to the webinar. Dr. Parkin explained that Mr. Downing will edit the
document in real time in response to Board members’ comments.

She expressed confidence that the Board would finalize the report and
expedite its progress toward public access. Dr. Parkin described the
meeting process, explaining that she would lead the discussion
sequentially through each section of the report to ensure that all
issues are covered. After Dr. Parkin announces a section, the Board
members will have an opportunity to offer comments about that particular
section. The Board will address the draft cover letter at the end of the
discussion. 

Public Comments

Mr. Downing noted that there were no preregistered public comments, and
no public participants had identified themselves on the teleconference
line. He invited participants to comment publicly on the draft June 2014
HSRB meeting report. No public comments were presented to the Board. 

Board Discussion AND DECISION ON THE FINAL REPORT

Dr. Parkin directed the participants to the draft report Introduction.
She asked the Board members to contribute any concerns or suggested
revisions. In response to a question, Dr. Parkin confirmed that the
version under review by the Board is labeled August 13, 2014, with
Dr. Sidney Green’s revision incorporated. Hearing no comments on the
Introduction, Dr. Parkin moved sequentially through the Review Process
paragraphs to solicit comments. Hearing no comments on the Review
Process section, Dr. Parkin directed the Board members to the Paul et
al. report.

A published report by Paul et al. (1988) of an intentional exposure
human study measuring the effects of small increases of dietary iodine
on thyroid function

Moving on to the Paul et al. report, Dr. Parkin asked if there were any
Board member concerns about the Overview of the Study as written. Dr.
Randy Maddalena noted that the units specifying the dosages of the
sodium iodide were incorrect as written in the Board’s report. The
Board members discussed the correct way to represent the sodium iodide
doses. After referring to the original article and debating the
appropriate language, the Board members decided to rephrase the
sentences about the sodium iodide doses as follows:

“While maintaining their usual diets over a 14-day period, the female
participants took sodium iodide dissolved in water at one of three
dosages (250, 500 or 1,500 µg per day) along with 5 mg/day ascorbic
acid. In the same manner the male participants received only the 1,500
µg per day dose.”

All of the Board members were in agreement with regard to the revised
sentences, and they all approved of Dr. Green’s revision. 

Dr. Parkin called for comments within the Science section, including the
Charge to the Board and Board Response to the Charge. She noted that the
HSRB Recommendation points capture the Board decisions during the June
2014 meeting. The HSRB Detailed Recommendations and Rationale were built
on the contributions from the lead discussants, with minor formatting
modifications. Dr. Parkin noted that the recommendations now address the
issue that reliable data do not necessarily generate reliable
conclusions. She solicited additional comments for the Science section.

A participant suggested modifying the quoted phrase in item 1 to read,
“some of the women were studied at two dose levels at least one year
apart” to ensure that the phrase was captured verbatim from the Paul
et al. report.

An HSRB member referenced the question regarding the Paul et al.
study’s inclusion of data from repeat study participants in item 1 in
response to the question, “Is this study scientifically sound,
providing reliable data?” The issue is that 36 observations were
recorded from 32 participants, and the origin of the additional four
measurements is unclear to the Board members. Dr. Parkin asked how the
paragraph should be reworded to address the Board members’ concern.
Drs. Linda Young, George Fernandez, William Popendorf and Edward Gbur
discussed how to capture the Board’s concern within the report. Dr.
Parkin noted that the treatment issue is separate from the confusion
about Table 1 in the Paul et al. report. Several Board members expressed
reluctance to include the Board’s assumptions about the data within
the HSRB report. To lend clarity to the HSRB Detailed Recommendations
and Rationale section, a participant suggested removing the sentence
beginning with “Furthermore…” from point 1. Dr. Young suggested
language to insert after the first sentence in point 2 that would read,
“For example, it is unclear how the total sample size of 32 can be
reconciled with the values in column N of Table 1.” The participants
also agreed to modify point 2 to read, “(1) the duplicate assay values
used in the study were treated as subsamples (not as true
replications).”

Dr. Parkin called for comments or suggested revisions within the Ethics
section of the HSRB report. No comments were offered in the Charge to
the Board, Board Response to the Charge, HSRB Recommendation, and
HSRB’s Detailed Recommendation and Rationale sections. Dr. Parkin
concluded that the Board was in agreement with the Ethics section of the
Paul et al. review within the HSRB report.

A published report by Gardner et al. (1988) of an intentional exposure
human study measuring the effects of low dose oral iodide
supplementation on thyroid function

Dr. Parkin solicited comments for the Overview of the Study section for
the Gardner et al. review. Hearing none, she read the HSRB
Recommendations for the Science section aloud:

The Board concurred that the study is scientifically sound, providing
reliable data. However, the lack of details in the analytic methods and
less than robust statistical analysis weakened the HSRB’s ability to
evaluate all aspects of the study’s scientific soundness. Thus, the
Board did not find clear and convincing evidence that this study’s
data are not reliable.

The HSRB concluded that this study is relevant for quantitative use in
support of an assessment of the oral risk of exposure to iodine.
However, the hormone levels and changes in T4 observed in this study
should be viewed as qualitative in nature. In contrast, the changes in
thyroid function are sufficiently reliable to be used in a
weight-of-evidence analysis.

Dr. Leonard Ritter suggested removing the word “thus” from the first
bullet point of the recommendations. Dr. Gbur commented that the lack of
details about the analytic methods might be an issue. Dr. Parkin
reminded the participants that the HSRB report reflects the decisions
voted by the Board at the June 2014 meeting. Dr. Young suggested
changing the wording of the last sentence in the first bullet to read:
“The Board did not find clear and convincing evidence that the
conclusions drawn from this study are not reliable” to assuage the
members’ concern about the reliability of the data versus the
reliability of the conclusions. Several Board members expressed
reluctance to use a double negative in the sentence, but Mr. Downing
noted that such language has been used in previous reports. 

A HSRB member questioned the meaning of the phrase “this study is
relevant for quantitative use” in the second bullet. He expressed
caution in endorsing wording that is unclear. Dr. Young explained that
EPA uses data for qualitative and quantitative purposes in a
weight-of-evidence approach. Dr. Fernandez asked for clarification of
the term “weight-of-evidence.” Dr. Parkin clarified that
weight-of-evidence is an approach used by EPA. It is not a statistical
term. The term is used in the HSRB report for consistency with EPA’s
charge question. A participant elaborated that EPA uses the term
“weight-of-evidence approach” interchangeably with
“weight-of-evidence analysis” and “weight-of-evidence
evaluation.” According to draft EPA guidance, “a weight-of-evidence
evaluation is a process where potentially relevant studies are judged in
a professional manner for quality.” Even when data are not
quantitatively useful, they might provide qualitative information on the
nature of toxicity or exposure.

Dr. Parkin proceeded through the HSRB Detailed Recommendations and
Rationale within the Science section. Hearing no comments, Dr. Parkin
concluded that the Board was satisfied with the Gardner et al. Science
section of the HSRB report with the proposed changes. The Board members
also approved of the Gardner et al. Ethics section of the HSRB report
with no changes.

A published report by Lemar et al. (1995) of an intentional exposure
human study measuring the effects of chronic tetraglycine hydroperiodide
water purification tablet use on thyroid function

Dr. Parkin directed the Board members to the Lemar et al. article. There
were no comments offered on the Overview of the Study. Dr. Parkin read
the three HSRB Recommendations:

Subject to the limitations noted below, the Board concluded that:

The study is scientifically sound and provides reliable data.

This study would be relevant in a weight-of-evidence approach for
establishing the reversibility of high dose iodine exposure.

This study would be relevant in a weight-of-evidence approach for
establishing that there are no sustained adverse effects from high dose
iodine exposure.

Dr. Parkin asked for any comments or revisions to the recommendations,
and none were offered. She then proceeded through the HSRB Detailed
Recommendations and Rationale. A participant suggested that the quoted
phrase be modified to include hyphens: “Student-Newman-Keuls.” There
were no further edits suggested within the Science section. Mr. Downing
affirmed that he would check pagination when he prepares the final
version of the HSRB report. 

Dr. Parkin proceeded through the Ethics section of the HSRB report. Dr.
Kyle Galbraith noticed a discrepancy in the spelling of the Fitzsimons
Army Medical Center, and the text was corrected. 

Dr. Liza Dawson noted that the U.S. Department of Defense (DoD) version
of the Common Rule has a different regulatory citation. Drs. Dawson and
Galbraith affirmed that the correct citation for DoD’s Common Rule is
“Title 32 part 219.” Dr. Parkin suggested that the citation follow
the year that the rule was adopted by the DoD to increase clarity. The
changes were made within the HSRB report. Board members offered no
additional comments within the Ethics section.

HSRB Work Group on Return of Individual Research Results Report

Dr. Parkin directed the Board members to review the Overview, Discussion
and Board Consensus on the HSRB Work Group on Return of Individual
Research Results Report section. In response to a question, she
clarified that “Appendix A” refers to the appendix of the Work Group
Report, which is available on the HSRB website. Hearing no further
comments, Dr. Parkin concluded that the Board approved the consensus
statement as written.

References and Cover Letter

Dr. Parkin proceeded to the HSRB report references. A participant noted
inconsistencies in the journal titles within the reference list. Dr.
Parkin asserted that the references would be reviewed for consistency
with EPA’s traditional format.

Dr. Parkin solicited any revisions or clarifications to the cover
letter. She explained that any changes made to the recommendations
during the HSRB’s deliberations would be reflected in the cover
letter. Several Board members noted that their contact information was
incorrect in the HSRB report. Mr. Downing asserted that all contact
information would be corrected in the final draft. Hearing no additional
comments or revision requests to the HSRB report, Dr. Parkin turned the
meeting to Mr. Downing.

Summary and Next Steps

Mr. Downing announced that the next HSRB meeting is scheduled for
November 5, 2014. The meeting will be conducted virtually, and further
details will be provided in the coming months. 

Mr. Downing announced that this is the final meeting for HSRB Chair, Dr.
Parkin. He acknowledged her stellar service on the HSRB as a member,
Vice Chair and Chair. Mr. Downing said that the Agency is indebted to
Dr. Parkin for her service, which started in October 2007.
Dr. Parkin’s steady guidance of the Board and dutiful service will
always be remembered. Mr. Downing also acknowledged the final meeting
of Dr. Young. He thanked her for her contributions to the HSRB, noting
the particular strength of statistical expertise that she brought to the
Board. Mr. Downing explained that EPA staff have commented about the
much-improved statistical power of current studies, which is
attributable to Dr. Young’s input.

Mr. Downing described the new compensation system for the HSRB members.
He requested that all members submit their time sheets every 2 weeks to
Ms. Lu-Ann Kleibacker (EPA). In response to a question, Mr. Downing
agreed to distribute a calendar of time sheet deadlines through the end
of the year. 

Adjournment

Dr. Parkin thanked the Board members for their participation. The
teleconference/ webinar meeting was adjourned by Mr. Downing at 3:30
p.m.

Respectfully submitted:

Jim Downing

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency

Certified to be true by:

Rebecca Parkin, Ph.D., M.P.H.

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER: The minutes of this public teleconference/webinar
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

Rebecca Parkin, Ph.D., M.P.H.

Professorial Lecturer, EOH and Epidemiology and Biostatistics

Milken Institute School of Public Health 

The George Washington University

Washington, D.C.

Vice Chair

Jewell H. Halanych, M.D., M.Sc. 

Assistant Professor

Internal Medicine Residency Program

University of Alabama at Birmingham

Montgomery, AL

Members

Liza Dawson, Ph.D. 

Research Ethics Team Leader

Division of AIDS, National Institutes of Health

National Institute of Allergy and Infectious Diseases

Bethesda, MD

George C.J. Fernandez, Ph.D.

Statistical Training Specialist 

SAS Institute, Statistical Training and Technical Services

Sparks, NV

Kyle L. Galbraith, Ph.D.

Human Subjects Protection

Carle Foundation Hospital

Urbana, IL

Members (continued)

Edward Gbur, Jr., Ph.D. 

Professor

Agricultural Statistics Laboratory

University of Arkansas

Fayetteville, AR

Sidney Green, Jr., Ph.D., Fellow, ATS

Retired

Department of Pharmacology

Howard University College of Medicine

Silver Spring, MD

Elizabeth Heitman, Ph.D.

Associate Professor of Medical Ethics

Center for Biomedical Bioethics and Society

Vanderbilt University Medical Center

Nashville, TN

John C. Kissel, Ph.D.

Department of Environmental

	and Occupational Health Sciences

School of Public Health

University of Washington

Seattle, WA

Randy Maddalena, Ph.D.

Physical Research Scientist

Indoor Environment

Lawrence Berkeley National Laboratory

Berkeley, CA

William J. Popendorf, Ph.D.

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

Members (continued)

Kenneth Ramos, M.D., Ph.D., Pharm.B.

Associate Vice President

Precision Health Sciences

Professor of Medicine

Arizona Health Sciences Center

Tucson, AZ

Leonard Ritter, Ph.D., ATS

Professor Emeritus (Toxicology)

School of Environmental Sciences

University of Guelph

Guelph, ON, Canada

Linda J. Young, Ph.D.

Chief Mathematical Statistician and Director

USDA National Agricultural Statistics Service

Research and Development Division

Fairfax, VA

Attachment B

FEDERAL REGISTER NOTICE ANNOUNCING MEETING

[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]

[Notices]

[Pages 44769-44771]

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

[FR Doc No: 2014–18221]

=======================================================================

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2014–0564; FRL-9914–72– ORD]

Human Studies Review Board; Notification of a Public
Webinar/Teleconference

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Office of the Science
Advisor announces a public Webinar/ teleconference of the Human Studies
Review Board (HSRB) to discuss its draft report on the HSRB meeting held
August 15, 2014. 

DATES: The Webinar/teleconference will be held on Friday, August 15,
2014, 

[[Page 44770]]

from approximately 2:00 p.m. to approximately 3:30 p.m. Eastern Time.
Comments may be submitted on or before Friday, August 8, 2014.
Information regarding the HSRB final meeting report will be found at  
HYPERLINK "http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb 
and   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
 or from the persons listed under FOR FURTHER INFORMATION CONTACT.

	Webcast: This meeting may be webcast. Please refer to the HSRB Web site
  HYPERLINK "http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb 
for information on how to access the webcast. If difficulties arise
resulting in webcasting outages, the meeting will continue as planned.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA–HQ–ORD–2014–0564, 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 Reading
Room’s 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   HYPERLINK
"mailto:ord.docket@epa.gov"  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–2014–0564. 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 comment 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 about this Webinar/Teleconference should
contact Jim Downing at telephone number (202) 564–2468; fax (202)
564–2070; email address   HYPERLINK "mailto:downing.jim@epa.gov" 
downing.jim@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 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 the Internet and telephone
only. Access information can be found on the HSRB Web site:   HYPERLINK
"http://www.epa.gov/osa/hsrb/"  http://www.epa.gov/osa/hsrb/  or by
contacting the persons listed under the FOR FURTHER INFORMATION CONTACT
section of this Notice.

	Meeting access: For detailed information on access or services for
individuals with disabilities, please contact Jim Downing 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 EPA 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 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   HYPERLINK
"mailto:ord.docket@epa.gov"  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.

[[44771]]

	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 by providing comments in this meeting by following
the instructions in this section. To ensure proper receipt of your
comments by the EPA, it is imperative that you identify Docket ID No.
EPA–HQ–ORD– 2014–0564 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 Friday, August 8, 2014. To the extent that time
permits, interested persons who have not preregistered 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 under FOR FURTHER INFORMATION CONTACT no later than noon,
Eastern Time, Friday, August 8, 2014, 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 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, Friday, August 8, 2014. You should submit
your comments using the instructions in Section I, under subsection C,
“What should I consider as I prepare my comments for the EPA?” In
addition, the EPA also requests that persons submitting comments
directly to the docket also provide a copy of their comments to Jim
Downing 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 the 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 the
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 June 11, 2014 HSRB meeting. The HSRB may also discuss planning
for future HSRB meetings. Background on the June 11, 2014 HSRB meeting
can be found at the HSRB Web site:   HYPERLINK
"http://www.epa.gov/osa/hsrb"  http://www.epa.gov/osa/hsrb . The June
11, 2014 meeting draft report is available. You may obtain electronic
copies of this document, and certain other related documents that might
be available electronically, from regulations.gov 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 HSRB final meeting report will be
found at   HYPERLINK "http://www.epa.gov/osa/hsrb" 
http://www.epa.gov/osa/hsrb  and   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  or from the
persons listed under FOR FURTHER INFORMATION CONTACT.

	Dated: July 28, 2014.

Robert Kavlock,

Interim Science Advisor.

[FR Doc. 2014–18221 Filed 7–31–14; 8:45 am]

BILLING CODE 6560–50–P

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE/WEBINAR

 MEETING AGENDA

Friday, August 15, 2014

2:00 pm - 3:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

JUNE 11, 2014 HSRB MEETING FINAL REPORT

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

Docket Telephone: (202) 566 1752

Docket Number: EPA–HQ–ORD–2014-0564

2:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer, EPA HSRB, OSA)

2:05 PM*	Meeting Administrative Procedures – Jim Downing, DFO

2:10 PM	Meeting Process – Rebecca Parkin, Ph.D., MPH (HSRB Chair)

2:15 PM	Public Comments

2:20 PM	Board Discussion and Decision on Final Report – Rebecca
Parkin, Ph.D., MPH (HSRB Chair)

The Board’s response to EPA charge questions presented at the June 11,
2014 meeting.

A published report by Paul et al. (1988) of an intentional exposure
human study measuring the effects of small increases of dietary iodine
on thyroid function

Charge to the Board – Science

Is this study scientifically sound, providing reliable data?

If so, is this study relevant for quantitative use in support of an
assessment of the oral risk of exposure to iodine?

Charge to the Board – Ethics

Does the study meet the applicable requirements of 40 CFR part 26
subpart Q?

*Note that agenda times are approximate. For further information, please
contact the Designated Federal Officer for this meeting, Jim Downing via
telephone: (202) 564-2468 or email:   HYPERLINK
"mailto:downing.jim@epa.gov"  downing.jim@epa.gov 

A published report by Gardner et al. (1988) of an intentional exposure
human study measuring the effects of low dose oral iodide
supplementation on thyroid function

Charge to the Board – Science

Is this study scientifically sound, providing reliable data?

If so, is this study relevant for quantitative use in support of an
assessment of the oral risk of exposure to iodine?

Charge to the Board – Ethics

Does the study meet the applicable requirements of 40 CFR part 26
subpart Q?

A published report by Lemar et al. (1995) of an intentional exposure
human study measuring the effects of chronic tetraglycine hydroperiodide
water purification tablet use on thyroid function 

Charge to the Board – Science

Is this study scientifically sound, providing reliable data?

If so, is this study relevant to establish the reversibility of high
dose iodine exposure?

Also, is this study sufficient to establish that there are no sustained
adverse effects from high dose iodine exposure?

Charge to the Board – Ethics

Does the study meet the applicable requirements of 40 CFR part 26
subpart Q?

2:45 PM*	HSRB Work Group on Return of Individual Research Results Report

2:55 PM*	Summary and Next Steps – Rebecca Parkin, Ph.D., MPH (HSRB
Chair) and 

	Jim Downing (DFO)

3:00 PM* 	Adjournment

*Note that agenda times are approximate. For further information, please
contact the Designated Federal Officer for this meeting, Jim Downing via
telephone: (202) 564-2468 or email:   HYPERLINK
"mailto:downing.jim@epa.gov"  downing.jim@epa.gov 

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