[Federal Register Volume 75, Number 193 (Wednesday, October 6, 2010)]
[Notices]
[Pages 61748-61750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25126]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2010-0797' FRL-9211-1]
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 October 27-28, 2010, from
approximately 11 a.m. on October 27, 2010 to approximately 5:30 p.m. on
October 28, 2010, Eastern Time.
Location: Environmental Protection Agency, Conference Center--Lobby
Level, One Potomac Yard (South Bldg.), 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 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 section
I., under subsection D., ``SUPPLEMENTARY INFORMATION'' of this notice.
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/.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2010-0797, 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 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-
2010-0797. 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://
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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 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 Ave., NW., Washington, DC 20460.
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 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 early October 2010. 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-2010-0797 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, October 21, 2010. 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, FOR FURTHER INFORMATION
CONTACT, no later than noon, Eastern Time, Thursday, October 21, 2010,
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, October 21, 2010. 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 Kleibacher listed under FOR FURTHER INFORMATION
CONTACT. There is no limit on the length of written comments for
consideration by the HSRB.
E. Background
1. Topics for discussion. At its meeting on October 27-28, 2010
EPA's Human Studies Review Board will
[[Page 61750]]
consider scientific and ethical issues surrounding these topics:
a. A proposal for new research to be conducted by Carroll-Loye
Biological Research to evaluate in the field the repellent efficacy
against mosquitoes of a registered product containing 16% para-methane-
3,8-diol and 2% lemongrass oil. EPA requests the advice of the HSRB
concerning whether, if the protocol 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
efficacy of the tested material in repelling mosquitoes, and to meet
the applicable requirements of 40 CFR part 26, subparts K and L.
b. A new scenario design and associated protocol from the
Agricultural Handler Exposure Task Force (AHETF) describing proposed
research to measure dermal and inhalation exposure to applicators who
use backpack sprayers or hand gun sprayers to apply pesticides in
utility rights-of-way. 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 apply pesticides in utility rights-of-way with backpack
sprayers or hand gun sprayers, and to meet the applicable requirements
of 40 CFR part 26, subparts K and L.
c. A revised 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 in water-soluble packaging. This
scenario was previously reviewed favorably by the HSRB in June 2009,
but has since been revised to use different surrogate chemicals. These
changes forced other revisions in turn; the proposed changes, taken
together, are significant enough to warrant a new review by the HSRB.
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 in water-soluble packaging,
and to meet the applicable requirements of 40 CFR part 26, subparts K
and L.
d. The report of a completed scenario monograph and study report
from the Antimicrobial Exposure Assessment Task Force II (AEATF-II) in
which the dermal and inhalation exposure of professional janitorial
workers was monitored as they applied liquid antimicrobial products to
indoor floors using a bucket and mop. 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 antimicrobial floor-cleaning products with
mops, 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: September 29, 2010.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2010-25126 Filed 10-5-10; 8:45 am]
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