National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Final Expert Panel Report on Soy Infant Formula; Request for Public Comment, 2545 [2010-674]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Availability of the Final Expert Panel
Report on Soy Infant Formula; Request
for Public Comment
jlentini on DSKJ8SOYB1PROD with NOTICES
AGENCY: National Institute of
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH); HHS.
ACTION: Announcement of report
availability and request for comment.
SUMMARY: CERHR announces the
availability of the final expert panel
report on soy infant formula on January
15, 2010, from the CERHR Web site
(https://cerhr.niehs.nih.gov) or in
hardcopy from CERHR (see ADDRESSES
below). The expert panel report is an
evaluation of the developmental toxicity
of soy infant formula conducted by an
independent, 14-member expert panel
composed of scientists from the public
and private sectors convened by
CERHR. CERHR invites the submission
of public comments on this report (see
SUPPLEMENTARY INFORMATION below).
The expert panel met in public session
(December 16–18, 2009) to review and
revise the draft expert panel report and
reach conclusions regarding whether
exposure to soy infant formula is a
hazard to human development. The
expert panel also identified data gaps
and research needs.
VerDate Nov<24>2008
17:34 Jan 14, 2010
Jkt 220001
DATES: The final expert panel report on
soy infant formula will be available for
public comment on January 15, 2010.
Written public comments on this report
should be received by March 1, 2010.
Comments on the expert
panel report and any other
correspondence should be submitted to
Dr. Kristina A. Thayer, Acting CERHR
Director, NIEHS, P.O. Box 12233, MD
K2–04, Research Triangle Park, NC
27709 (mail), 919–541–5021
(telephone), or thayer@niehs.nih.gov (email). Courier address: NIEHS, 530
Davis Drive, Room K2154, Morrisville,
NC 27560.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Background
Soy infant formula is fed to infants as
a supplement or replacement for human
milk or cow milk formula. Soy infant
formula contains isoflavones such as
genistein (CAS RN: 446–72–0), daidzein
(CAS RN: 486–66–8), and glycitein (CAS
RN: 40957–83–3). Genistein, daidzein,
glycitein, and the daidzein metabolite
equol are non-steroidal, estrogenic
compounds that occur naturally in some
plants and are often referred to as
‘‘phytoestrogens.’’ In plants, nearly all
genistein, daidzein, and glycitein are
linked to a sugar molecule and these
isoflavone-sugar complexes are called
genistin, daidzin, or glycitin.
On December 16–18, 2009, CERHR
(74 FR 53508) convened an expert panel
to conduct an updated evaluation of the
potential developmental toxicity of soy
infant formula and its predominant
isoflavone constituents. CERHR selected
soy infant formula for evaluation
because of (1) The availability of
numerous developmental toxicity
studies in laboratory animals and
humans, (2) the availability of
information on exposures in infants,
and (3) public concern for effects on
infant or child development.
Following receipt of public comments
on the final expert panel report on soy
infant formula, CERHR staff will prepare
the NTP monograph. NTP monographs
are divided into three major sections: (1)
The NTP Brief that provides the NTP’s
interpretation of the potential for the
substance to cause adverse reproductive
and/or developmental effects in exposed
humans, (2) a roster of expert panel
members, and (3) the final expert panel
report. The NTP Brief is based on the
expert panel report, public comments
on that report, public and peer review
comments on the draft NTP Brief, and
any new, relevant information that
becomes available after the expert panel
meetings.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
2545
Request for Comments
CERHR invites written public
comments on the expert panel report on
soy infant formula. Written comments
should be sent to Dr. Kristina A. Thayer
(see ADDRESSES 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). Any comments received will be
posted on the CERHR Web site and the
commenter identified by name,
affiliation, and sponsoring organization,
if applicable. All public comments will
be considered by the NTP during
preparation of the NTP Brief (see
‘‘Background’’ above).
Background Information on CERHR
The NTP established CERHR in 1998
(63 FR 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
multiple 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.
Thayer (see ADDRESSES above). 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.
Dated: January 8, 2010.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2010–674 Filed 1–14–10; 8:45 am]
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[Federal Register Volume 75, Number 10 (Friday, January 15, 2010)]
[Notices]
[Page 2545]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Availability of the Final Expert
Panel Report on Soy Infant Formula; Request for Public Comment
AGENCY: National Institute of Environmental Health Sciences (NIEHS);
National Institutes of Health (NIH); HHS.
ACTION: Announcement of report availability and request for comment.
-----------------------------------------------------------------------
SUMMARY: CERHR announces the availability of the final expert panel
report on soy infant formula on January 15, 2010, from the CERHR Web
site (https://cerhr.niehs.nih.gov) or in hardcopy from CERHR (see
ADDRESSES below). The expert panel report is an evaluation of the
developmental toxicity of soy infant formula conducted by an
independent, 14-member expert panel composed of scientists from the
public and private sectors convened by CERHR. CERHR invites the
submission of public comments on this report (see SUPPLEMENTARY
INFORMATION below). The expert panel met in public session (December
16-18, 2009) to review and revise the draft expert panel report and
reach conclusions regarding whether exposure to soy infant formula is a
hazard to human development. The expert panel also identified data gaps
and research needs.
DATES: The final expert panel report on soy infant formula will be
available for public comment on January 15, 2010. Written public
comments on this report should be received by March 1, 2010.
ADDRESSES: Comments on the expert panel report and any other
correspondence should be submitted to Dr. Kristina A. Thayer, Acting
CERHR Director, NIEHS, P.O. Box 12233, MD K2-04, Research Triangle
Park, NC 27709 (mail), 919-541-5021 (telephone), or
thayer@niehs.nih.gov (e-mail). Courier address: NIEHS, 530 Davis Drive,
Room K2154, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
Soy infant formula is fed to infants as a supplement or replacement
for human milk or cow milk formula. Soy infant formula contains
isoflavones such as genistein (CAS RN: 446-72-0), daidzein (CAS RN:
486-66-8), and glycitein (CAS RN: 40957-83-3). Genistein, daidzein,
glycitein, and the daidzein metabolite equol are non-steroidal,
estrogenic compounds that occur naturally in some plants and are often
referred to as ``phytoestrogens.'' In plants, nearly all genistein,
daidzein, and glycitein are linked to a sugar molecule and these
isoflavone-sugar complexes are called genistin, daidzin, or glycitin.
On December 16-18, 2009, CERHR (74 FR 53508) convened an expert
panel to conduct an updated evaluation of the potential developmental
toxicity of soy infant formula and its predominant isoflavone
constituents. CERHR selected soy infant formula for evaluation because
of (1) The availability of numerous developmental toxicity studies in
laboratory animals and humans, (2) the availability of information on
exposures in infants, and (3) public concern for effects on infant or
child development.
Following receipt of public comments on the final expert panel
report on soy infant formula, CERHR staff will prepare the NTP
monograph. NTP monographs are divided into three major sections: (1)
The NTP Brief that provides the NTP's interpretation of the potential
for the substance to cause adverse reproductive and/or developmental
effects in exposed humans, (2) a roster of expert panel members, and
(3) the final expert panel report. The NTP Brief is based on the expert
panel report, public comments on that report, public and peer review
comments on the draft NTP Brief, and any new, relevant information that
becomes available after the expert panel meetings.
Request for Comments
CERHR invites written public comments on the expert panel report on
soy infant formula. Written comments should be sent to Dr. Kristina A.
Thayer (see ADDRESSES 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). Any comments received will be posted
on the CERHR Web site and the commenter identified by name,
affiliation, and sponsoring organization, if applicable. All public
comments will be considered by the NTP during preparation of the NTP
Brief (see ``Background'' above).
Background Information on CERHR
The NTP established CERHR in 1998 (63 FR 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
multiple 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. Thayer (see ADDRESSES above). 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.
Dated: January 8, 2010.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2010-674 Filed 1-14-10; 8:45 am]
BILLING CODE 4140-01-P