National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Genistein and Soy Formula Expert Panel Reports; Request for Public Comment, 28368 [E6-7434]
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Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Notices
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Dated: May 10, 2006.
David R. Sadowski,
Acting Director, Division of Technology
Development and Transfer, Office of
Technology Transfer, National Institutes of
Health.
[FR Doc. E6–7435 Filed 5–15–06; 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 the Availability of
the Genistein and Soy Formula Expert
Panel Reports; Request for Public
Comment
National Institute for
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH), HHS.
ACTION: Request for comments.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: CERHR announces the
availability of the genistein and soy
formula expert panel reports on the
CERHR Web site (https://
cerhr.niehs.nih.gov) or in print from
CERHR (see ADDRESSES below). These
expert panel reports are evaluations of
the reproductive and developmental
toxicity of genistein and soy formula
conducted by a 14-member expert panel
composed of scientists from the federal
government, universities, and private
organizations. CERHR invites the
submission of public comments on
these expert panel reports.
DATES: The final genistein and soy
formula expert panel reports are
presently available and written public
comments on these reports should be
received by July 5, 2006.
ADDRESSES: Public comments and any
other correspondence should be sent to
Dr. Michael D. Shelby, CERHR Director,
NIEHS, P.O. Box 12233, MD EC–32,
Research Triangle Park, NC 27709
VerDate Aug<31>2005
16:06 May 15, 2006
Jkt 208001
(mail), (919) 316–4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier
address: CERHR, 79 T.W. Alexander
Drive, Building 4401, Room 103,
Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
Genistein 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. Genistein
and genistin 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. CERHR selected genistein and soy
formula for expert panel evaluation
because of (1) the availability of
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 CERHR convened an expert panel
on March 15–17, 2006, to review and
revise the draft expert panel reports and
reach conclusions regarding whether
exposure to genistein or soy formula is
a hazard to human development or
reproduction. The expert panel also
identified data gaps and research needs.
Prior to the meeting, CERHR solicited
public comment on the draft expert
panel reports (Federal Register Vol. 70,
No. 241 pp. 74834–74835).
Following receipt of public comments
on the genistein and soy formula expert
panel reports, CERHR staff will prepare
NTP–CERHR monographs on each of
these substances. NTP–CERHR
monographs are divided into four major
sections: (1) The NTP Brief which
provides the NTP’s interpretation of the
potential for the chemical to cause
adverse reproductive and/or
developmental effects in exposed
humans, (2) a roster of expert panel
members, (3) the final expert panel
report, and (4) any public comments
received on that report. The NTP Brief
is based on the expert panel report,
public comments on that report, and
any new information that became
available after the expert panel meeting.
panel report. Written comments should
be sent to Dr. Michael Shelby at the
address provided above. Persons
submitting written comments are asked
to include their name and contact
information (affiliation, mailing address,
telephone and facsimile numbers, email, and sponsoring organization, if
any). All comments received will be
posted on the CERHR Web site and will
be included in the NTP–CERHR
monograph on the chemical. The NTP
will consider all public comments
during preparation of the NTP Brief.
Background Information on CERHR
The NTP established CERHR in June
1998 [Federal Register, December 14,
1998 (Vol. 63, No. 239, pp. 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. Expert panels conduct
scientific evaluations of agents selected
by CERHR in public forums.
CERHR invites the nomination of
agents for review or scientists for its
expert registry. Information about
CERHR and the nomination process can
be obtained from its Web site (https://
cerhr.niehs.nih.gov) or by contacting Dr.
Shelby (see ADDRESSES above). CERHR
selects chemicals 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.
CERHR follows a formal, multi-step
process for review and evaluation of
selected chemicals. The formal
evaluation process was published in the
Federal Register notice July 16, 2001
(Vol. 66, No. 136, pp. 37047–37048) and
is available on the CERHR Web site
under ‘‘About CERHR’’ or in printed
copy from CERHR.
Dated: May 8, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and the
National Toxicology Program.
[FR Doc. E6–7434 Filed 5–15–06; 8:45 am]
BILLING CODE 4140–01–P
Request for Comments
CERHR invites written public
comments on the genistein expert panel
report and on the soy formula expert
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[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Page 28368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Announcement of the Availability
of the Genistein and Soy Formula Expert Panel Reports; Request for
Public Comment
AGENCY: National Institute for Environmental Health Sciences (NIEHS);
National Institutes of Health (NIH), HHS.
ACTION: Request for comments.
-----------------------------------------------------------------------
SUMMARY: CERHR announces the availability of the genistein and soy
formula expert panel reports on the CERHR Web site (https://
cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below).
These expert panel reports are evaluations of the reproductive and
developmental toxicity of genistein and soy formula conducted by a 14-
member expert panel composed of scientists from the federal government,
universities, and private organizations. CERHR invites the submission
of public comments on these expert panel reports.
DATES: The final genistein and soy formula expert panel reports are
presently available and written public comments on these reports should
be received by July 5, 2006.
ADDRESSES: Public comments and any other correspondence should be sent
to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-
32, Research Triangle Park, NC 27709 (mail), (919) 316-4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 T.W.
Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC
27709.
SUPPLEMENTARY INFORMATION:
Background
Genistein 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. Genistein and genistin 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. CERHR selected genistein and soy formula for expert panel
evaluation because of (1) the availability of 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 CERHR convened an expert panel on March 15-17, 2006, to review
and revise the draft expert panel reports and reach conclusions
regarding whether exposure to genistein or soy formula is a hazard to
human development or reproduction. The expert panel also identified
data gaps and research needs. Prior to the meeting, CERHR solicited
public comment on the draft expert panel reports (Federal Register Vol.
70, No. 241 pp. 74834-74835).
Following receipt of public comments on the genistein and soy
formula expert panel reports, CERHR staff will prepare NTP-CERHR
monographs on each of these substances. NTP-CERHR monographs are
divided into four major sections: (1) The NTP Brief which provides the
NTP's interpretation of the potential for the chemical to cause adverse
reproductive and/or developmental effects in exposed humans, (2) a
roster of expert panel members, (3) the final expert panel report, and
(4) any public comments received on that report. The NTP Brief is based
on the expert panel report, public comments on that report, and any new
information that became available after the expert panel meeting.
Request for Comments
CERHR invites written public comments on the genistein expert panel
report and on the soy formula expert panel report. Written comments
should be sent to Dr. Michael Shelby at the address provided above.
Persons submitting written comments are asked to include their name and
contact information (affiliation, mailing address, telephone and
facsimile numbers, e-mail, and sponsoring organization, if any). All
comments received will be posted on the CERHR Web site and will be
included in the NTP-CERHR monograph on the chemical. The NTP will
consider all public comments during preparation of the NTP Brief.
Background Information on CERHR
The NTP established CERHR in June 1998 [Federal Register, December
14, 1998 (Vol. 63, No. 239, pp. 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. Expert panels conduct scientific
evaluations of agents selected by CERHR in public forums.
CERHR invites the nomination of agents for review or scientists for
its expert registry. Information about CERHR and the nomination process
can be obtained from its Web site (https://cerhr.niehs.nih.gov) or by
contacting Dr. Shelby (see ADDRESSES above). CERHR selects chemicals
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.
CERHR follows a formal, multi-step process for review and
evaluation of selected chemicals. The formal evaluation process was
published in the Federal Register notice July 16, 2001 (Vol. 66, No.
136, pp. 37047-37048) and is available on the CERHR Web site under
``About CERHR'' or in printed copy from CERHR.
Dated: May 8, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and the National Toxicology Program.
[FR Doc. E6-7434 Filed 5-15-06; 8:45 am]
BILLING CODE 4140-01-P
