[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17121-17123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7198]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2011-0124; FRL-9287-1]
Human Studies Review Board (HSRB); Notification of a Public
Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a public meeting of the HSRB to advise
the Agency on EPA's scientific and ethical reviews of research with
human subjects.
DATES: This public meeting will be held on April 13-14, 2011, from
approximately 8:30 a.m. to approximately 5 p.m. Eastern Time.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0124, by one of the following methods:
Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mailcode: 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. Eastern Time, Monday
through Friday, excluding Federal holidays. Please call (202) 566-1744
or e-mail 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-
2011-0124. EPA'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 (CBI) 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 e-mail. 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 e-mail comment directly to EPA without
going through 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
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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.
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; e-mail address:
[email protected], or Lu-Ann Kleibacker at telephone number: (202)
564-7189; fax: 202-564-2070; e-mail address: [email protected];
mailing address: Environmental Protection Agency, Office of the Science
Advisor (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: Holiday Inn National Airport, 2650 Jefferson Davis
Highway, 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 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 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, located 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 e-mail 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). EPA's position
paper(s), charge/questions to the HSRB, and the meeting agenda will be
available by the end of March 2011. 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 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 that you
used to support your views.
4. Provide specific examples to illustrate your concerns and
suggest alternatives.
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-2011-0124 in the subject line
on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to Wednesday, April 6, 2011. 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, Wednesday, April
6, 2011, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB Designated Federal Official
(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 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 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 meeting. If you submit
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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, April 6, 2011. 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 (FACA) 5 U.S.C. App.2 Sec. 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 EPA's Science Advisor.
1. Topics for discussion. At its meeting on April 13 and 14, 2011,
EPA's Human Studies Review Board will consider scientific and ethical
issues surrounding these topics:
a. The report of a completed scenario monograph and study reports
from the Agricultural Handler Exposure Task Force (AHETF) measuring the
dermal and inhalation exposure of professional agricultural workers
applying liquid spray pesticides to tree or trellis crops using open
cab airblast equipment.
b. The report of a completed scenario monograph and study report
from the Antimicrobial Exposure Assessment Task Force II (AEATF) in
which the dermal and inhalation exposure of professional janitorial
workers was monitored as they applied a liquid antimicrobial product to
indoor surfaces using a trigger spray bottle and wipes or ready-to-use
wipes.
c. A published report by Gulson et al (2010) of an intentional
exposure human study measuring dermal absorption of zinc oxides
contained in sunscreen.
d. A reevaluation of an intentional human dosing study with
chlorpyrifos (Kisicki) previously reviewed by the HSRB; pertinent new
information from the sponsor has been made available.
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 concerning a Board meeting report, if applicable, can be
found at http://www.epa.gov/osa/hsrb/ or from the person listed under
FOR FURTHER INFORMATION CONTACT.
Dated: March 23, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-7198 Filed 3-25-11; 8:45 am]
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