[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80938-80940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33156]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2011-0954; FRL-9611-6]
Human Studies Review Board; Notification of a Public Meeting
AGENCY: U.S. Environmental Protection Agency.
ACTION: Notice.
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SUMMARY: The EPA Office of the Science Advisor announces a public
meeting of the Human Studies Review Board to advise the Agency on the
EPA scientific and ethical reviews of research with human subjects.
DATES: This public meeting will be held on January 26, 2012, from
approximately 9 a.m. to approximately 5:30 p.m. Eastern Time. Comments
may
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be submitted on or before Thursday, January 19, 2012.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0954, by one of the following methods:
Internet: http://www.regulations.gov: Follow the online
instructions for submitting comments.
Email: [email protected].
Mail: The 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, at
1301 Constitution Avenue NW., Washington, DC 20460. The 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 [email protected]. for instructions. Updates to
Public Reading Room access are available on the Web site http://www.epa.gov/epahome/dockets.htm.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0954. 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 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 http://www.regulations.gov or email. The 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 email comment directly to the EPA without
going through 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 comment and with
any electronic storage media 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 member of the public who wishes to
receive further information should contact Jim Downing at telephone
number (202) 564-2468; fax: (202) 564-2070; email address:
[email protected] or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax (202) 564-2070; email address [email protected]v;
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 http://www.epa.gov/osa/hsrb/.
SUPPLEMENTARY INFORMATION:
Location: The meeting will be held at the EPA Conference Center--
Lobby Level, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA 22202.
Meeting access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability, please contact the
persons listed under FOR FURTHER INFORMATION CONTACT 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. This notice
might also be of special interest to participants of studies involving
human subjects, or representatives of study participants or experts on
community engagement. Since many 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?
In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
Docket: All documents in the docket are listed in the 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 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, at 1301 Constitution Avenue NW., Washington, DC 20460. The
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 [email protected] for instructions. Updates
to Public Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm).
The Agency's position paper(s), charge/questions to the HSRB, and
the meeting agenda will be available by the first week of January 2012.
In addition, the Agency may provide additional background documents as
the materials become available. You may obtain electronic copies of
these documents, and certain other related documents that might be
available electronically, from the regulations.gov Web site and the EPA
HSRB Web site at http://www.epa.gov/osa/hsrb/. For questions on
document availability, or if you do not have access to the Internet,
consult either Jim Downing or Lu-Ann Kleibacker listed under FOR
FURTHER INFORMATION CONTACT.
C. What should I consider as I prepare my comments for the EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
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2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data that you
used to 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 number EPA-HQ-ORD-2011-0954 in the subject
line on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to Thursday, January 19, 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 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
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT no later than noon, Eastern Time, Thursday, January
19, 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 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. Submit your written comments prior to the
meeting. For the Board 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 meeting. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that
the HSRB 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, Thursday, January 19, 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
the 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 Sec. 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
EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through the Agency's Science Advisor.
1. Topics for discussion. At its meeting on January 26, 2012, the
EPA's Human Studies Review Board will consider scientific and ethical
issues surrounding these topics:
a. A new scenario design and associated protocol from the
Agricultural Handler Exposure Task Force describing proposed research
to measure dermal and inhalation exposure to workers who mix, load, and
apply liquid pesticides with powered handgun equipment. The Agency
requests the advice of the HSRB concerning whether, if it is revised as
suggested in the EPA's review and if it is performed as described, this
research is likely to generate scientifically reliable data, useful for
assessing the exposure of those who mix, load, and apply liquid
pesticides with powered handgun equipment, and to meet the applicable
requirements of 40 CFR part 26, subparts K and L.
b. The report of a completed scenario monograph and study report
from the Antimicrobial Exposure Assessment Task Force II in which the
dermal and inhalation exposure of professional janitorial workers was
monitored as they applied a liquid antimicrobial pesticide product for
indoor surface disinfecting using a pressurized aerosol can. The EPA
seeks the advice of the HSRB on the scientific soundness of this
completed research and on its appropriateness for use in estimating the
exposure of professional janitorial workers who apply liquid
antimicrobial pesticide products to indoor surfaces using pressurized
aerosol cans, and on whether available information supports a
determination that the study was conducted in substantial compliance
with subparts K and L of 40 CFR part 26.
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 http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information regarding the Board's final meeting report, will be found
at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR
FURTHER INFORMATION CONTACT.
Dated: December 19, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-33156 Filed 12-23-11; 8:45 am]
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