[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26861-26863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13061]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2009-0183; FRL-8913-9]
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's (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: The public meeting will be held from June 24, 2009 from
approximately 9:30 a.m. to approximately 5:30 p.m., through June 25,
2009 from approximately 8:30 a.m. to approximately 4:30 p.m. Eastern
Time.
Location: Holiday Inn National Airport, 2605 Jefferson Davis
Highway (Crystal City), Arlington, VA 22202 (703-684-7200).
Meeting Access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability please contact the
person listed under FOR FURTHER INFORMATION CONTACT at least 10
business days prior to the meeting, to allow EPA as much time as
possible 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 Unit
I.D. of this notice.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Jim Downing, EPA, Office of the
Science Advisor, (8105R), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-2468; fax: (202) 564-2070; e-mail addresses: [email protected].
General information concerning the EPA HSRB can be found on the EPA Web
site at http://www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2009-0183, 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 Ave., 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 Ave., NW., Washington, DC. 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-
2009-0183. 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 whose
disclosure 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 website
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.
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 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 the person 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
[[Page 26862]]
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 Ave., NW., Washington, DC. The
hours of operation are 8:30 a.m. to 4:30 p.m. EST, 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).
EPA's position paper(s), charge/questions to the HSRB, and the
meeting agenda will be available by early June 2009. 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 website and the EPA HSRB
website at http://www.epa.gov/osa/hsrb/. For questions on document
availability or if you do not have access to the Internet, consult the
person listed under FOR FURTHER INFORMATION.
C. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
a. Explain your views as clearly as possible.
b. Describe any assumptions that you used.
c. Provide copies of any technical information and/or data you used
that support your views.
d. Provide specific examples to illustrate your concerns and
suggest alternatives.
e. 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-2009-0183 in the subject line
on the first page of your request.
a. Oral comments. Requests to present oral comments will be
accepted up to June 17, 2009. 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 the
person listed under FOR FURTHER INFORMATION CONTACT no later than noon,
Eastern time, June 17, 2009 in order to be included on the meeting
agenda and to provide sufficient time for the HSRB Chair and HSRB
Designated Federal Officer (DFO) to review the agenda to provide an
appropriate public comment period. The request should identify the name
of the individual making the presentation, the organization (if any)
the individual will represent, and any requirements for audiovisual
equipment (e.g., overhead projector, LCD projector, chalkboard). Oral
comments before the HSRB are limited to five minutes per individual or
organization. Please note that this limit applies to the cumulative
time used by 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 these time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, there may be flexibility in
time for public comments. Each speaker should bring 25 copies of his or
her comments and presentation slides for distribution to the HSRB at
the meeting.
b. Written comments. Although you may submit written comments at
any time, 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 the 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, June 17, 2009. You should submit your
comments using the instructions in Unit I.C. of this notice. In
addition, the Agency also requests that person(s) submitting comments
directly to the docket also provide a copy of their comments to the
person listed under FOR FURTHER INFORMATION CONTACT. There is no limit
on the length of written comments for consideration by the HSRB.
E. Background
A. Topics for Discussion
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.
The June 24-25, 2009 meeting of the Human Studies Review Board will
address scientific and ethical issues surrounding:
Four unpublished reports of research completed before
enactment of the 2006 expanded EPA Regulation 40 CFR part 26
(Protection of Human Subjects rule) on the organophosphate pesticide
chlorpyrifos:
a. A study by Coulston et al. (1972) of the subacute oral toxicity
of chlorpyrifos to adult male prisoners.
b. A study by Nolan et al. (1982) of the metabolism and excretion
of chlorpyrifos and cholinesterase activity in adult males after a
single oral or dermal exposure.
c. A study by Honeycutt and DeGeare (1993) monitoring the
Acetylcholinesterase activity and urinary metabolites of chlorpyrifos
in agricultural workers who re-entered chlorpyrifos-treated citrus
groves.
d. A study by Kisicki et al. (1999) of the acute oral toxicity of
chlorpyrifos to adult male and female volunteers.
A proposal for new research to be conducted by Carroll-
Loye Biological Research to evaluate the repellent efficacy to biting
flies in the field of two
[[Page 26863]]
registered products containing 20% picaridin.
The report of a completed laboratory study conducted by
ICR, Inc., to evaluate the repellent efficacy to stable flies of two
registered products containing 20% picaridin.
A new scenario design and associated protocol for field
studies at five sites from the Agricultural Handlers Exposure Task
Force (AHETF), describing proposed research to monitor exposure of
professional pesticide handlers who mix and load pesticides formulated
as wettable powders in water-soluble packaging.
In addition, the Board will be reviewing its draft February 17,
2009 meeting report for subsequent Board approval. Finally, the HSRB
may also discuss planning for future HSRB meetings.
B. 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.
Dated: May 29, 2009.
Kevin Teichman,
EPA Acting Science Advisor.
[FR Doc. E9-13061 Filed 6-3-09; 8:45 am]
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