National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of Plans for Updated Evaluations of Genistein and Soy Formula; Request for Public Comments and Nomination of Expert Panel Members, 57360-57361 [E8-23173]
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Federal Register / Vol. 73, No. 192 / Thursday, October 2, 2008 / Notices
TABLE 1—TESTING RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES—
Continued
Substance [CAS No.]
Nominated by 1
Nomination rationale
Preliminary study
recommendations 2
Triclosan [3380–34–5] ...................
Private Individual and U.S. Food
and Drug Administration.
Widespread use in consumer
products; frequent and longterm exposure for all age
groups; lack of adequate toxicity data for dermal exposures.
—Carcinogenicity studies via dermal administration.
—Phototoxicity studies.
—Reproductive toxicity studies.
1 National
Institute of Environmental Health Sciences (NIEHS).
term ‘‘comprehensive toxicological characterization’’ in this table refers 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 biomolecular screening, in vitro mechanistic, in vitro and in vivo genotoxicity, absorption, disposition, metabolism, and elimination, short-term repeat dose (2–4 weeks) in vivo studies, 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).
2 The
To facilitate review of proposed
research projects by the NTP 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, but also
encompass studies that may address
larger public health issues or topics in
toxicology that could be addressed
appropriately through studies on the
nominated substance(s). Draft research
concepts for the new nominations listed
in Table 1 will be available on the NTP
BSC meeting page (https://
ntp.niehs.nih.gov/go/165) by October 9,
2008.
Attendance and Registration
mstockstill on PROD1PC66 with NOTICES
The meeting is scheduled for
November 20–21, 2008, beginning at
8:30 a.m. on each day and continuing to
5 p.m. on November 20 and on
November 21 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 NTP BSC meeting Web site
(https://ntp.niehs.nih.gov/go/165) by
November 13, 2008, to facilitate
planning for the meeting. The NTP is
making plans to videocast the meeting
through the Internet at https://
www.niehs.nih.gov/news/video/live.
Request for Comments
Written comments submitted in
response to this notice should be
received by November 6, 2008.
Comments will be posted on the NTP
BSC meeting Web site and persons
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17:52 Oct 01, 2008
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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 NTP 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 NTP 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
allowed for presentation by on-site
registrants may be less than that for preregistered 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 NTP BSC
(see ADDRESSES above) by November 13,
2008, to enable review by the NTP 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 NTP BSC and NIEHS/
NTP staff and to supplement the record.
Background Information on the NTP
Board of Scientific Counselors
The NTP BSC is a technical advisory
body comprised of scientists from the
public and private sectors that provides
primary scientific oversight to the
overall program and its centers.
Specifically, the NTP BSC advises the
NTP on matters of scientific program
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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. NTP BSC
meetings are held annually or
biannually.
Dated: September 23, 2008.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E8–23181 Filed 10–1–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Announcement of Plans for Updated
Evaluations of Genistein and Soy
Formula; Request for Public
Comments and Nomination of Expert
Panel Members
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Notice of expert panel
evaluation of the reproductive and
developmental toxicities of genistein
and soy formula.
AGENCY:
SUMMARY: The CERHR plans to convene
an expert panel to conduct updated
evaluations of the scientific evidence
E:\FR\FM\02OCN1.SGM
02OCN1
Federal Register / Vol. 73, No. 192 / Thursday, October 2, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
regarding the potential reproductive
and/or developmental toxicity
associated with exposure to genistein
and soy formula begun in 2006. The
expert panel will consist of
approximately 10–12 scientists selected
for their scientific expertise in various
aspects of reproductive and
developmental toxicology and other
relevant areas of science. CERHR invites
the submission of information about
ongoing studies or upcoming
publications on these substances that
might be considered for inclusion in the
evaluations and the nomination of
scientists to serve on the expert panel
(see SUPPLEMENTARY INFORMATION
below). This meeting is tentatively
scheduled for spring or summer 2009,
although the exact date and location are
not yet set. As plans are finalized, they
will be announced in the Federal
Register and posted on the CERHR Web
site (https://cerhr.niehs.nih.gov). CERHR
expert panel meetings are open to the
public with time scheduled for oral
public comment.
DATES: Comments received by
November 17, 2008 will be made
available to CERHR staff and the expert
panel for consideration in the
evaluation and posted on the CERHR
Web site. Nominations of scientists
received by November 17, 2008 will be
considered for this panel and for
inclusion in the CERHR Expert Registry.
ADDRESSES: Public comments and any
other correspondence should be
submitted to Dr. Michael D. Shelby,
CERHR Director, NIEHS, P.O. Box
12233, MD EC–32, Research Triangle
Park, NC 27709 (mail), 919–541–3455
(phone), 919–316–4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier
address: CERHR, 79 T.W. Alexander
Drive, Building 4401, Room 102,
Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
Genistein (CAS RN: 446–72–0) is a
phytoestrogen found in some legumes,
especially soybeans. Phytoestrogens are
non-steriodal, estrogenic compounds
that occur naturally in some plants. In
plants, nearly all genistein is linked to
a sugar molecule and this genisteinsugar complex is called genistin.
Genistin and genistein are found in
many food products, especially soybased foods such as tofu, soy milk, and
soy infant formula, and in some overthe-counter dietary supplements. Soy
formula is fed to infants as a
supplement or replacement for human
milk or cow milk.
On March 15–17, 2006, CERHR
convened an expert panel to conduct
VerDate Aug<31>2005
17:52 Oct 01, 2008
Jkt 217001
evaluations of the potential
reproductive and developmental
toxicities of genistein and soy formula.
CERHR selected genistein and soy
formula for expert panel evaluation
because of (1) The availability of
numerous reproductive and
developmental toxicity studies in
laboratory animals and humans, (2) the
availability of information on exposures
in infants and women of reproductive
age, and (3) public concern for effects on
infant or child development. The expert
panel reports were released for public
comment on May 5, 2006 (Federal
Register Vol. 71, No. 94, pp. 28368, May
16, 2006). Next, on November 8, 2006
(Federal Register Vol. 71, No. 216, pp.
65537, November 8, 2006), CERHR staff
released draft NTP Briefs on Genistein
and Soy Formula that provided the
NTP’s interpretation of the potential for
genistein and soy formula to cause
adverse reproductive and/or
developmental effects in exposed
humans. CERHR has not completed
these evaluations, finalized the briefs, or
issued NTP–CERHR monographs on
these substances. Since 2006, a
substantial number of new publications
related to human exposure or
reproductive and/or developmental
toxicity have been published for these
substances and CERHR has determined
that updated evaluations of genistein
and soy formula are needed.
Request for Comments
The CERHR invites the public and
other interested parties to submit
information and comments on genistein
and soy formula including toxicology
and epidemiologic information from
completed and ongoing studies,
information on planned studies, and
information about current production
levels, human exposure, use patterns,
and environmental occurrence.
Request for the Nomination of Scientist
for the Expert Panel
The CERHR invites nominations of
qualified scientists to serve on the
expert panel. Panelists are primarily
drawn from the CERHR Expert Registry
and/or the nomination of other
scientists who meet the criteria for
listing in that registry which include:
formal academic training and
experience in a relevant scientific field,
publications in peer-reviewed journals,
membership in relevant professional
societies, and certification by an
appropriate scientific board or other
entities. Nominations should include
contact information and current
curriculum vitae (if possible) and be
forwarded to CERHR (see ADDRESSES).
Final selection of individuals to serve
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57361
on the expert panel will be made in
accordance with the Federal Advisory
Committee Act and Department of
Health and Human Services
implementing regulations.
All panel members serve as
individual experts and not as
representatives of their employers or
other organizations. Scientists on the
expert panel represent a wide range of
expertise including, but not limited to,
developmental toxicology, reproductive
toxicology, epidemiology, general
toxicology, medicine, pharmacokinetics,
exposure assessment, and biostatistics.
Background Information on the CERHR
The NTP established CERHR in 1998
(Federal Register, December 14, 1998,
Vol. 63, No. 239, page 68782). CERHR
is a publicly accessible resource for
information about adverse reproductive
and/or developmental health effects
associated with exposure to
environmental and/or occupational
exposures. CERHR follows a formal
process for the evaluation of selected
substances that includes opportunities
for public input.
CERHR invites the nomination of
substances for review or scientists for its
expert registry. Information about
CERHR and the nomination process can
be obtained from its homepage (https://
cerhr.niehs.nih.gov) or by contacting Dr.
Michael Shelby, CERHR Director (see
ADDRESSES). CERHR selects substances
for evaluation based upon several
factors including production volume,
potential for human exposure from use
and occurrence in the environment,
extent of public concern, and extent of
data from reproductive and
developmental toxicity studies. Expert
panels conduct scientific evaluations of
substances selected by CERHR in public
forums. Following these evaluations,
CERHR prepares the NTP–CERHR
monograph on the substance evaluated.
The monograph is transmitted to
appropriate federal and state agencies
and made available to the public.
Dated: September 23, 2008.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E8–23173 Filed 10–1–08; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 73, Number 192 (Thursday, October 2, 2008)]
[Notices]
[Pages 57360-57361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23173]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Announcement of Plans for Updated
Evaluations of Genistein and Soy Formula; Request for Public Comments
and Nomination of Expert Panel Members
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Notice of expert panel evaluation of the reproductive and
developmental toxicities of genistein and soy formula.
-----------------------------------------------------------------------
SUMMARY: The CERHR plans to convene an expert panel to conduct updated
evaluations of the scientific evidence
[[Page 57361]]
regarding the potential reproductive and/or developmental toxicity
associated with exposure to genistein and soy formula begun in 2006.
The expert panel will consist of approximately 10-12 scientists
selected for their scientific expertise in various aspects of
reproductive and developmental toxicology and other relevant areas of
science. CERHR invites the submission of information about ongoing
studies or upcoming publications on these substances that might be
considered for inclusion in the evaluations and the nomination of
scientists to serve on the expert panel (see SUPPLEMENTARY INFORMATION
below). This meeting is tentatively scheduled for spring or summer
2009, although the exact date and location are not yet set. As plans
are finalized, they will be announced in the Federal Register and
posted on the CERHR Web site (https://cerhr.niehs.nih.gov). CERHR expert
panel meetings are open to the public with time scheduled for oral
public comment.
DATES: Comments received by November 17, 2008 will be made available to
CERHR staff and the expert panel for consideration in the evaluation
and posted on the CERHR Web site. Nominations of scientists received by
November 17, 2008 will be considered for this panel and for inclusion
in the CERHR Expert Registry.
ADDRESSES: Public comments and any other correspondence should be
submitted to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box
12233, MD EC-32, Research Triangle Park, NC 27709 (mail), 919-541-3455
(phone), 919-316-4511 (fax), or shelby@niehs.nih.gov (e-mail). Courier
address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 102,
Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
Genistein (CAS RN: 446-72-0) is a phytoestrogen found in some
legumes, especially soybeans. Phytoestrogens are non-steriodal,
estrogenic compounds that occur naturally in some plants. In plants,
nearly all genistein is linked to a sugar molecule and this genistein-
sugar complex is called genistin. Genistin and genistein are found in
many food products, especially soy-based foods such as tofu, soy milk,
and soy infant formula, and in some over-the-counter dietary
supplements. Soy formula is fed to infants as a supplement or
replacement for human milk or cow milk.
On March 15-17, 2006, CERHR convened an expert panel to conduct
evaluations of the potential reproductive and developmental toxicities
of genistein and soy formula. CERHR selected genistein and soy formula
for expert panel evaluation because of (1) The availability of numerous
reproductive and developmental toxicity studies in laboratory animals
and humans, (2) the availability of information on exposures in infants
and women of reproductive age, and (3) public concern for effects on
infant or child development. The expert panel reports were released for
public comment on May 5, 2006 (Federal Register Vol. 71, No. 94, pp.
28368, May 16, 2006). Next, on November 8, 2006 (Federal Register Vol.
71, No. 216, pp. 65537, November 8, 2006), CERHR staff released draft
NTP Briefs on Genistein and Soy Formula that provided the NTP's
interpretation of the potential for genistein and soy formula to cause
adverse reproductive and/or developmental effects in exposed humans.
CERHR has not completed these evaluations, finalized the briefs, or
issued NTP-CERHR monographs on these substances. Since 2006, a
substantial number of new publications related to human exposure or
reproductive and/or developmental toxicity have been published for
these substances and CERHR has determined that updated evaluations of
genistein and soy formula are needed.
Request for Comments
The CERHR invites the public and other interested parties to submit
information and comments on genistein and soy formula including
toxicology and epidemiologic information from completed and ongoing
studies, information on planned studies, and information about current
production levels, human exposure, use patterns, and environmental
occurrence.
Request for the Nomination of Scientist for the Expert Panel
The CERHR invites nominations of qualified scientists to serve on
the expert panel. Panelists are primarily drawn from the CERHR Expert
Registry and/or the nomination of other scientists who meet the
criteria for listing in that registry which include: formal academic
training and experience in a relevant scientific field, publications in
peer-reviewed journals, membership in relevant professional societies,
and certification by an appropriate scientific board or other entities.
Nominations should include contact information and current curriculum
vitae (if possible) and be forwarded to CERHR (see ADDRESSES). Final
selection of individuals to serve on the expert panel will be made in
accordance with the Federal Advisory Committee Act and Department of
Health and Human Services implementing regulations.
All panel members serve as individual experts and not as
representatives of their employers or other organizations. Scientists
on the expert panel represent a wide range of expertise including, but
not limited to, developmental toxicology, reproductive toxicology,
epidemiology, general toxicology, medicine, pharmacokinetics, exposure
assessment, and biostatistics.
Background Information on the CERHR
The NTP established CERHR in 1998 (Federal Register, December 14,
1998, Vol. 63, No. 239, page 68782). CERHR is a publicly accessible
resource for information about adverse reproductive and/or
developmental health effects associated with exposure to environmental
and/or occupational exposures. CERHR follows a formal process for the
evaluation of selected substances that includes opportunities for
public input.
CERHR invites the nomination of substances for review or scientists
for its expert registry. Information about CERHR and the nomination
process can be obtained from its homepage (https://cerhr.niehs.nih.gov)
or by contacting Dr. Michael Shelby, CERHR Director (see ADDRESSES).
CERHR selects substances for evaluation based upon several factors
including production volume, potential for human exposure from use and
occurrence in the environment, extent of public concern, and extent of
data from reproductive and developmental toxicity studies. Expert
panels conduct scientific evaluations of substances selected by CERHR
in public forums. Following these evaluations, CERHR prepares the NTP-
CERHR monograph on the substance evaluated. The monograph is
transmitted to appropriate federal and state agencies and made
available to the public.
Dated: September 23, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-23173 Filed 10-1-08; 8:45 am]
BILLING CODE 4140-01-P
