[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2107-2109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-625]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2011-0970; FRL-9252-3]
Human Studies Review Board; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency)
Office of the Science Advisor (OSA) announces a public meeting of the
Human Studies Review Board (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 January 26, 2011, from
approximately 8:30 a.m. to approximately 5 p.m. Eastern Time. The
meeting will be held at the Environmental Protection Agency, Conference
Center--Lobby Level, One Potomac Yard (South Bldg.), 2777 S.
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Crystal Drive, Arlington, VA 22202. 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 10 business days prior to the meeting to allow EPA adequate time
to process your request.
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.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0970, 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-
2011-0970. 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
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:
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 am to 4:30 p.m. EST, 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 mid January 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
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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-2011-0970 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, January 19, 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
e-mail) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT, no later than noon, Eastern Time, Wednesday,
January 19, 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 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, January 19, 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 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 EPA's Science Advisor.
1. Topics for discussion. At its meeting on January 26, 2011, EPA's
Human Studies Review Board will consider scientific and ethical issues
surrounding these topics:
--A scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
monitor exposure of workers who mix and load pesticides formulated as
wettable powders. EPA requests the advice of the HSRB concerning
whether, if it is revised as suggested in 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 and load pesticides formulated as wettable powders, and
to meet the applicable requirements of 40 CFR part 26, subparts K and
L.
--The report of a completed scenario monograph and study reports of
five field studies from the Agricultural Handler Exposure Task Force
(AHETF) measuring the dermal and inhalation exposure of workers
applying liquid spray pesticides to tree or trellis crops using closed
cab airblast equipment. The studies were conducted in five states in
the U.S. where closed cab airblast equipment is commonly used in
production agriculture. 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 workers who apply
liquid spray pesticides using closed cab airblast equipment, 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 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: January 7, 2011.
Fred S. Hauchman,
Acting EPA Science Advisor.
[FR Doc. 2011-625 Filed 1-11-11; 8:45 am]
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