[Federal Register: October 23, 2009 (Volume 74, Number 204)]
[
Notices]
[Page 54821-54823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc09-45]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Office of Liaison, Policy and
Review; Meeting of the NTP Board of Scientific Counselors
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health, HHS.
ACTION: Meeting announcement and request for comments.
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SUMMARY: Pursuant to Public Law 92-463, notice is hereby given of a
meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a
Federally chartered, external advisory group composed of scientists
from the public and private sectors that provides primary scientific
oversight to the NTP Director and evaluates the scientific merit of the
NTP's intramural and collaborative programs.
DATES: The BSC meeting will be held on December 9-10, 2009. The
deadline for submission of written comments is November 25, 2009, and
for pre-registration to attend the meeting, including registering to
present oral comments, is December 2, 2009. Persons needing
interpreting services in order to attend should contact 301-402-8180
(voice) or 301-435-1908 (TTY). For other accommodations while on the
NIEHS campus, contact 919-541-2475 or e-mail niehsoeeo@niehs.nih.gov.
Requests should be made at least 7 business days in advance of the
event.
ADDRESSES: The BSC meeting will be held in the Rodbell Auditorium, Rall
Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle
Park, NC 27709. Public comments on all agenda topics and any other
correspondence should be submitted to Dr. Barbara Shane, Executive
Secretary for the BSC, NTP Office of Liaison, Policy and Review, NIEHS,
P.O. Box 12233, K2-03, Research Triangle Park, NC 27709; telephone:
919-541-4253; fax: 919-541-0295; e-mail: shane@niehs.nih.gov. Courier
address: NIEHS, 530 Davis Drive, Room K2138, Morrisville, NC 27560.
FOR FURTHER INFORMATION CONTACT: Dr. Barbara Shane (telephone: 919-541-
4253 or e-mail: shane@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Preliminary Agenda Topics and Availability of Meeting Materials
Report of the NTP Director.
NTP Update.
NTP Testing Program: Nominations and proposed research
projects on Butterbur, Evening primrose oil, Hydroquinone, Silica
flour, and Valerian extracts and oil.
Review of the NTP Host Susceptibility Program.
NTP's Use of Contracts in the Testing Program.
Concept Contract Review for Chemistry Services to the NTP.
Concept Contract Review for NTP Reproductive and
Developmental Toxicology and Perinatal Carcinogenicity Studies.
NTP Evaluation Process.
Update from the Center for the Evaluation of Risks to
Human Reproduction.
NTP's Dietary Supplements and Herbal Medicines Initiative.
The preliminary agenda, roster of BSC members and ad hoc reviewers,
background materials for agenda topics, public comments, and any
additional information, when available, will be posted on the BSC
meeting Web site (http://ntp.niehs.nih.gov/go/165) or may be requested
in hardcopy from the Executive Secretary for the BSC (see ADDRESSES
above). Updates to the agenda will also be posted to this site.
Following the meeting, summary minutes will be prepared and made
available on the BSC meeting Web site.
NTP Testing Program: Nominations and Proposed Research Projects
The NTP actively seeks to identify and select for study chemicals
and other substances for which sufficient information is not available
to adequately evaluate potential human health hazards. The NTP
accomplishes this goal through a formal, open nomination and selection
process. Substances considered appropriate for study generally fall
into two broad, yet overlapping categories: (1) Substances judged to
have high concern as possible public health hazards based on the extent
of human exposure and/or suspicion of toxicity and (2) substances for
which toxicological data gaps exist and additional studies would aid in
assessing potential human health risks, e.g., by facilitating cross-
species extrapolation or evaluating dose-response relationships.
Nominations are subject to a multi-step, formal process of review
before selections for testing are made and toxicological studies are
designed and implemented. The nomination review and selection process
is accomplished through the participation of representatives from the
NIEHS, other Federal agencies represented on the Interagency Committee
for Chemical Evaluation and Coordination (ICCEC)--the NTP Federal
interagency review committee for NTP study nominations, the BSC, the
NTP Executive Committee--the NTP Federal interagency policy body, and
the public. The nomination review and selection process is described in
further detail on the NTP Web site (http://ntp.niehs.nih.gov/, select
``Nominations to the Testing Program'').
Table 1 lists new nominations to be reviewed at the BSC meeting.
Background documents for each nomination are available on the NTP Web
site http://ntp.niehs.nih.gov/go/nom. The NTP invites interested
parties to submit written comments, provide supplementary information,
or present oral comments at the BSC meeting on the nominated substances
and preliminary study recommendations (see ``Request for Comments''
below). The NTP welcomes toxicology study information from completed,
ongoing, or anticipated studies, as well as information on current U.S.
production levels, use or consumption patterns, human exposure,
environmental occurrence, or public health concerns for any of the
nominated substances. The NTP is interested in identifying appropriate
animal and non-animal experimental models for mechanistic-based
research, including genetically modified rodents and high-throughput in
vitro test methods, and as such, solicits comments regarding the use of
specific in vivo and in vitro experimental approaches to address
questions relevant to the nominated substances and issues under
consideration. Although the deadline
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for submission of written comments to be considered at the BSC meeting
is November 25, 2009 (see ``Request for Comments'' below), the NTP
welcomes comments or additional information on these study nominations
at any time.
Table 1--Testing Recommendations for Substances Nominated to the NTP for Toxicological Studies
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Preliminary study
Substance [CAS No.] Nomination source Nomination rationale recommendations
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Butterbur (Petasites hybridus) National Institute of Use as a dietary Comprehensive
extract [90082-63-6]. Environmental Health supplement; lack of toxicological
Sciences\1\. toxicological data; characterization.
suspicion of toxicity
based on
pharmacological
activity of
constituents;
potential presence of
toxic pyrrolizidine
alkaloids.
Evening primrose oil (Oenothera NIEHS.................. Use as a dietary --Initial toxicological
biennis L.) extract [90028-66-3]. supplement, characterization.
particularly for --Immunotoxicity
immune conditions; studies.
lack of adequate --Reproductive toxicity
toxicological data. studies.
Hydroquinone [123-31-9].............. U.S. Food and Drug Use in drugs and --Dermal toxicity and
Administration. cosmetics; evidence of carcinogenicity
carcinogenicity from studies.
oral exposures in --Reproductive toxicity
prior NTP studies; studies.
insufficient
toxicological data for
regulatory hazard
determination.
Silica flour [14808-60-7]............ Private Individual..... Use in industrial and --Initial toxicological
consumer products; characterization via
inhalation exposures oral and dermal routes
associated with of administration.
autoimmune disease; --Immunotoxicity
lack of toxicity data studies.
for oral and dermal
exposures;
insufficient data to
evaluate dose-response
for renal and
autoimmune effects by
any route of exposure.
Valerian (Valeriana officinalis L.) NIEHS.................. Use as a dietary Comprehensive
root extract [8057-49-6]; Valerian supplement; lack of toxicological
oil [8008-88-6]. toxicological data; characterization.
concern for adverse
developmental and
reproductive effects.
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\1\ National Institute of Environmental Health Sciences (NIEHS).
\2\ The terms ``initial'' and ``comprehensive toxicological characterization'' in this table refer to the
approximate scope of a research program to address toxicological data needs. The types of toxicological
studies that would be considered by NTP staff during the conceptualization and design of a research program
are:
Initial toxicological characterization: biomolecular screening, in vitro mechanistic, in vitro and in
vivo genotoxicity, absorption, disposition, metabolism, and elimination, and short-term repeat dose (2-4
weeks) in vivo studies.
Comprehensive toxicological characterization: all of the aforementioned plus subchronic toxicity (13-26
weeks), chronic toxicity (1-2 years), carcinogenicity in conventional or genetically modified rodent models,
organ systems toxicity (immunotoxicity, reproductive and developmental toxicity, neurotoxicity), in vivo
mechanistic, toxicokinetics, and other special studies as appropriate (e.g., chemistry, toxicogenomics,
phototoxicity).
To facilitate review of proposed research projects by the BSC and
the public, NTP staff developed a draft research concept document for
each nomination recommended for study. A research concept is a brief
document outlining the nomination or study rationale, and the
significance, study approach, and expected outcome of a proposed
research program tailored for each nomination. The purpose of these
research concepts is to outline the general elements of a program of
study that would address the specific issues that prompted the
nomination and the preliminary study recommendations. A research
concept may also encompass larger public health issues or topics in
toxicology that could be appropriately addressed through studies on the
nominated substance(s). Draft research concepts for the new nominations
listed in Table 1 will be available on the BSC meeting page (http://
ntp.niehs.nih.gov/go/165) by October 26, 2009.
Attendance and Registration
The meeting is scheduled for December 9-10, 2009, beginning at 8:30
a.m. on each day and continuing to approximately 5 p.m. on December 9
and on December 10 until adjournment. The meeting is open to the public
with attendance limited only by the space available. Individuals who
plan to attend are encouraged to register online at the BSC meeting Web
site (http://ntp.niehs.nih.gov/go/165) by December 2, 2009, to
facilitate planning for the meeting. The NTP is making plans to
videocast the meeting through the Internet at http://www.niehs.nih.gov/
news/video/live.
Request for Comments
Written comments submitted in response to this notice should be
received by November 25, 2009. Comments will be posted on the BSC
meeting Web site and persons submitting them will be identified by
their name and affiliation and/or sponsoring organization, if
applicable. Persons submitting written comments should include their
name, affiliation (if applicable), phone, e-mail, and sponsoring
organization (if any) with the document.
Time will be allotted during the meeting for the public to present
oral comments to the BSC on the agenda topics. Each organization is
allowed one time slot per agenda topic. At least 7 minutes will be
allotted to each speaker, and if time permits, may be extended to 10
minutes at the discretion of the BSC chair. Persons wishing to present
oral comments are encouraged to pre-register on the NTP meeting Web
site. Registration for oral comments will also be available on-site,
although time
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allowed for presentation by on-site registrants may be less than that
for pre-registered speakers and will be determined by the number of
persons who register at the meeting.
Persons registering to make oral comments are asked, if possible,
to send a copy of their statement to the Executive Secretary for the
BSC (see ADDRESSES above) by December 2, 2009, to enable review by the
BSC prior to the meeting. Written statements can supplement and may
expand the oral presentation. If registering on-site and reading from
written text, please bring 40 copies of the statement for distribution
to the BSC and NTP staff and to supplement the record.
Background Information on the NTP Board of Scientific Counselors
The BSC is a technical advisory body comprised of scientists from
the public and private sectors that provides primary scientific
oversight to the NTP. Specifically, the BSC advises the NTP on matters
of scientific program content, both present and future, and conducts
periodic review of the program for the purpose of determining and
advising on the scientific merit of its activities and their overall
scientific quality. Its members are selected from recognized
authorities knowledgeable in fields such as toxicology, pharmacology,
pathology, biochemistry, epidemiology, risk assessment, carcinogenesis,
mutagenesis, molecular biology, behavioral toxicology, neurotoxicology,
immunotoxicology, reproductive toxicology or teratology, and
biostatistics. Members serve overlapping terms of up to four years. BSC
meetings are held annually or biannually.
Dated: October 16, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-25587 Filed 10-22-09; 8:45 am]