Human Studies Review Board; Notice of Public Meeting, 54908-54910 [E7-19125]
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54908
Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8474–1]
[EPA–HQ–ORD–2007–0942; FRL–8474–4]
Acid Rain Program: Notice of Annual
Adjustment Factors for Excess
Emission Penalty
Human Studies Review Board; Notice
of Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
Environmental Protection
Agency (EPA).
AGENCY:
Notice of annual adjustment
factors for excess emissions penalty.
ACTION:
SUMMARY: Under the Acid Rain Program,
affected units must hold enough
allowances to cover their sulfur dioxide
emissions and meet an emission limit
for nitrogen oxides. Under 40 CFR 77.6,
units that do not meet these
requirements must pay a penalty
without demand to the Administrator
based on the number of excess tons
emitted times $2000 as adjusted by an
annual adjustment factor that must be
published in the Federal Register.
The annual adjustment factor for
adjusting the penalty for excess
emissions of sulfur dioxide and nitrogen
oxides under 40 CFR part 77 for
compliance year 2007 is 1.6364. This
value is derived using the Consumer
Price Index (‘‘CPI’’) for 1990 and 2007
(as defined at 40 CFR part 72, the 2007
CPI is based on the August 2006 CPI for
all urban consumers), and corresponds
to a penalty of $3273 per excess ton of
sulfur dioxide or nitrogen oxides
emitted.
The annual adjustment factor for
adjusting the penalty for excess
emissions of sulfur dioxide and nitrogen
oxides under 40 CFR part 77 for
compliance year 2008 is 1.6687. This
value is derived using the Consumer
Price Index (‘‘CPI’’) for 1990 and 2008
(as defined at 40 CFR part 72, the 2008
CPI is based on the August 2007 CPI for
all urban consumers), and corresponds
to a penalty of $3337 per excess ton of
sulfur dioxide or nitrogen oxides
emitted.
FOR FURTHER INFORMATION CONTACT:
rwilkins on PROD1PC63 with NOTICES
Robert Miller, Clean Air Markets
Division (6204J), U.S. Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460 at
(202) 343–9077 or
miller.robertl@epa.gov.
Dated: September 20, 2007.
Larry F. Kertcher,
Acting Director, Clean Air Markets Division,
Office of Atmospheric Programs, Office of
Air and Radiation.
[FR Doc. E7–19142 Filed 9–26–07; 8:45 am]
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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 human subjects’
research.
DATES: The public meeting will be held
from October 24, 2007 from
approximately 8:30 a.m. to
approximately 3:30 p.m.; October 25,
2007 from approximately 8 a.m. to
approximately 6:30 p.m.; and October
26, 2007 from approximately 8 a.m. to
approximately 3 p.m. 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 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
Crystal Rodgers-Jenkins, EPA, Office of
the Science Advisor, (8105R),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: (202)
564–5275; fax: (202) 564–2070; e-mail
addresses: rodgersjenkins.crystal@epa.gov. General
information concerning the EPA HSRB
can be found on the EPA Web site at
https://www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written
comments, identified by Docket ID No.
EPA–HQ–ORD–2007–0942, by one of
the following methods:
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Internet: https://www.regulations.gov:
Follow the on-line instructions for
submitting comments.
E-mail: ord.docket@epa.gov.
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 e-mail the ORD Docket at
ord.docket@epa.gov for instructions.
Updates to Public Reading Room access
are available on the Web site (https://
www.epa.gov/epahome/dockets.htm).
Instructions: Direct your comments to
Docket ID No. EPA–HQ–ORD–2007–
0942. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
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 https://
www.regulations.gov or e-mail. The
https://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 https://
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:
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Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices
I. Public Meeting
rwilkins on PROD1PC63 with NOTICES
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
document electronically through the
EPA Internet under the Federal Register
listings at https://www.epa.gov/fedrgstr/.
Docket: All documents in the docket
are listed in the https://
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 https://
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
e-mail the ORD Docket at
ord.docket@epa.gov for instructions.
Updates to Public Reading Room access
are available on the Web site (https://
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 2007. 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
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regulations.gov Web site and the EPA
HSRB Web site at https://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. Public
comments received on the document
titled, ‘‘Scientific and Ethical
Approaches for Observational Exposure
Studies,’’ may be listed under Docket ID
No. EPA–HQ–ORD–2007–0972 or
Docket ID No. EPA–HQ–ORD–2007–
0942.
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–2007–
0942 in the subject line on the first page
of your request.
a. Oral comments. Requests to present
oral comments will be accepted up to
October 17, 2007. 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 the
person listed under FOR FURTHER
INFORMATION CONTACT no later than
noon, Eastern time, October 17, 2007 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
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54909
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, October 17, 2007. 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.29. 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
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Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices
research. The HSRB reports to the EPA
Administrator through EPA’s Science
Advisor.
The October 24–26, 2007 meeting of
the Human Studies Review Board will
address scientific and ethical issues
surrounding:
• Review of EPA draft document
Scientific and Ethical Approaches for
Observational Exposure Studies. The
document, prepared by researchers in
EPA’s National Exposure Research
Laboratory, identifies the types of issues
that should be considered in planning
and implementing observational human
exposure studies and provides
information and resources to assist EPA
researchers in these studies.
• A published report of a completed
clinical trial measuring the effects of
single and repeated treatments with
sodium azide on blood pressure in
human subjects. Sodium azide is a
pesticidally active ingredient being
proposed as a replacement for the
fumigant methyl bromide.
• A research proposal from CarrollLoye Biological Research to evaluate the
field efficacy in repelling mosquitoes of
three registered products containing
picaridin.
• A research proposal from CarrollLoye Biological Research to evaluate the
laboratory efficacy in repelling ticks of
three registered products containing
picaridin.
• A research proposal from Insect
Control & Research, Inc. to evaluate the
laboratory efficacy in repelling
mosquitoes of the genus Culex of two
registered products containing
picaridin.
• A report of a completed field study
by Carroll-Loye Biological Research of
the mosquito repellent efficacy of a
registered product containing Oil of
Lemon Eucalyptus.
• Three closely related productspecific reports from a single completed
field study by Carroll-Loye Biological
Research of the mosquito repellent
efficacy of four pesticides, all containing
Deet.
• At the Board’s request, discussion
on the frequency and duration of
exposure of subjects to potential
mosquito landings.
In addition, EPA will report to the
Board on its consideration of issues
relating to the design of sampling
strategies for handler research programs
proposed by the Agricultural Handlers
Exposure Task Force and the
Antimicrobials Exposure Assessment
Task Force II.
Finally, the Board may also discuss
planning for future HSRB meetings.
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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 https://
www.epa.gov/osa/hsrb/ and https://
www.regulations.gov. In addition,
information concerning a Board meeting
report, if applicable, can be found at
https://www.epa.gov/osa/hsrb/ or from
the person listed under FOR FURTHER
INFORMATION.
Dated: September 21, 2007.
George Gray,
EPA Science Advisor.
[FR Doc. E7–19125 Filed 9–26–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8474–3]
Notice of Availability of the External
Review Draft of a ‘‘Framework for
Determining a Mutagenic Mode of
Action for Carcinogenicity: Using
EPA’s 2005 Cancer Guidelines and
Supplemental Guidance for Assessing
Susceptibility From Early-Life
Exposure to Carcinogens’’
Environmental Protection
Agency (EPA).
ACTION: Notice of Document Availability
for Public Comment.
AGENCY:
SUMMARY: The Environmental Protection
Agency (EPA) is announcing a 60-day
public comment period for the External
Review Draft of the ‘‘Framework for
Determining a Mutagenic Mode of
Action for Carcinogenicity: Using EPA’s
2005 Cancer Guidelines and
Supplemental Guidance for Assessing
Susceptibility from Early-Life Exposure
to Carcinogens’’ (or Framework). EPA is
releasing this draft document solely for
the purpose of seeking public comment
prior to external peer review. Following
the period for public comment, the
document will be reviewed by an
external panel of experts. The date and
other details about the external review
will be published in a separate Federal
Register notice. EPA will consider both
the public and the external peer review
comments when revising the draft
Framework. Members of the public may
obtain the draft guidance from https://
www.regulations.gov; or https://
www.epa.gov/osa/mmoaframework; or
from Dr. Resha Putzrath via the contact
information below.
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The purpose of the Framework is to
expand and clarify discussions found in
the Cancer Guidelines and
Supplemental Guidance on
characteristics to be evaluated for a
chemical’s potential for a mutagenic
mode of action (MOA). These
documents can be obtained from
https://www.epa.gov/cancerguidelines.
This Framework document is not a
prescriptive guide on how any
particular type of assessment should be
conducted within an EPA program or
regional office. Rather, it is a sciencebased document that is intended to help
EPA’s risk assessors determine whether
data support a finding of a mutagenic
MOA for carcinogenicity. It discusses
mutagenicity only within the context of
a mutagenic MOA for carcinogenicity
and not for other adverse endpoints that
involve mutations. EPA’s Risk
Assessment Forum oversaw the
development of this draft document.
EPA’s Cancer Guidelines emphasize
using MOA information in interpreting
and quantifying the potential cancer risk
to humans. The Supplemental Guidance
discusses the use of age-dependent
adjustment factors (ADAFs) with the
derived cancer slope factors (and
appropriate age-specific estimates of
exposure) in the development of risk
estimates if the weight of evidence
supports a mutagenic MOA. This
default approach is used only when
appropriate chemical-specific data are
not available on susceptibility from
early-life exposures.
ADDRESSES: The draft document is
available electronically through the EPA
Office of the Science Advisor’s Web site
at: https://www.epa.gov/osa/
mmoaframework.
FOR FURTHER INFORMATION CONTACT: For
more information, contact Dr. Resha
Putzrath, Office of the Science Advisor,
Mail Code 8105–R, U.S. Environmental
Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460;
telephone number: (202) 564–3229; fax
number: (202) 564–2070, e-mail:
putzrath.resha@epa.gov.
SUPPLEMENTARY INFORMATION: In
response to requests from numerous
stakeholders following EPA’s release of
the Supplemental Guidance in 2005, the
Risk Assessment Forum has prepared a
framework document that expands and
clarifies characteristics used to
determine a chemical’s potential for a
mutagenic MOA for carcinogenicity.
This determination affects consideration
of adjusting cancer potencies via the
ADAFs when exposures of these
carcinogens occur to children. The
Framework is meant to complement
EPA’s 2005 Cancer Guidelines and
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]]>Agencies
[Federal Register Volume 72, Number 187 (Thursday, September 27, 2007)]
[Notices]
[Pages 54908-54910]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19125]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2007-0942; FRL-8474-4]
Human Studies Review Board; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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 human subjects' research.
DATES: The public meeting will be held from October 24, 2007 from
approximately 8:30 a.m. to approximately 3:30 p.m.; October 25, 2007
from approximately 8 a.m. to approximately 6:30 p.m.; and October 26,
2007 from approximately 8 a.m. to approximately 3 p.m. 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
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 Crystal Rodgers-Jenkins, EPA, Office
of the Science Advisor, (8105R), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-5275; fax: (202) 564-2070; e-mail addresses: rodgers-
jenkins.crystal@epa.gov. General information concerning the EPA HSRB
can be found on the EPA Web site at https://www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2007-0942, by one of the following methods:
Internet: https://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ord.docket@epa.gov.
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 e-
mail the ORD Docket at ord.docket@epa.gov for instructions. Updates to
Public Reading Room access are available on the Web site (https://
www.epa.gov/epahome/dockets.htm).
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0942. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://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 https://
www.regulations.gov or e-mail. The https://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 https://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:
[[Page 54909]]
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 document electronically through the EPA Internet under the
Federal Register listings at https://www.epa.gov/fedrgstr/.
Docket: All documents in the docket are listed in the https://
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 https://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 e-
mail the ORD Docket at ord.docket@epa.gov for instructions. Updates to
Public Reading Room access are available on the Web site (https://
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 2007. 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 https://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. Public comments received
on the document titled, ``Scientific and Ethical Approaches for
Observational Exposure Studies,'' may be listed under Docket ID No.
EPA-HQ-ORD-2007-0972 or Docket ID No. EPA-HQ-ORD-2007-0942.
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-2007-0942 in the subject line
on the first page of your request.
a. Oral comments. Requests to present oral comments will be
accepted up to October 17, 2007. 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 the
person listed under FOR FURTHER INFORMATION CONTACT no later than noon,
Eastern time, October 17, 2007 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, October 17, 2007. 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.29. 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
[[Page 54910]]
research. The HSRB reports to the EPA Administrator through EPA's
Science Advisor.
The October 24-26, 2007 meeting of the Human Studies Review Board
will address scientific and ethical issues surrounding:
Review of EPA draft document Scientific and Ethical
Approaches for Observational Exposure Studies. The document, prepared
by researchers in EPA's National Exposure Research Laboratory,
identifies the types of issues that should be considered in planning
and implementing observational human exposure studies and provides
information and resources to assist EPA researchers in these studies.
A published report of a completed clinical trial measuring
the effects of single and repeated treatments with sodium azide on
blood pressure in human subjects. Sodium azide is a pesticidally active
ingredient being proposed as a replacement for the fumigant methyl
bromide.
A research proposal from Carroll-Loye Biological Research
to evaluate the field efficacy in repelling mosquitoes of three
registered products containing picaridin.
A research proposal from Carroll-Loye Biological Research
to evaluate the laboratory efficacy in repelling ticks of three
registered products containing picaridin.
A research proposal from Insect Control & Research, Inc.
to evaluate the laboratory efficacy in repelling mosquitoes of the
genus Culex of two registered products containing picaridin.
A report of a completed field study by Carroll-Loye
Biological Research of the mosquito repellent efficacy of a registered
product containing Oil of Lemon Eucalyptus.
Three closely related product-specific reports from a
single completed field study by Carroll-Loye Biological Research of the
mosquito repellent efficacy of four pesticides, all containing Deet.
At the Board's request, discussion on the frequency and
duration of exposure of subjects to potential mosquito landings.
In addition, EPA will report to the Board on its consideration of
issues relating to the design of sampling strategies for handler
research programs proposed by the Agricultural Handlers Exposure Task
Force and the Antimicrobials Exposure Assessment Task Force II.
Finally, the Board 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 https://www.epa.gov/osa/hsrb/ and https://
www.regulations.gov. In addition, information concerning a Board
meeting report, if applicable, can be found at https://www.epa.gov/osa/
hsrb/ or from the person listed under FOR FURTHER INFORMATION.
Dated: September 21, 2007.
George Gray,
EPA Science Advisor.
[FR Doc. E7-19125 Filed 9-26-07; 8:45 am]
BILLING CODE 6560-50-P
