[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65537-65538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Availability of the Draft NTP 
Briefs on Genistein and Soy Formula; Request for Public Comments

AGENCY: National Institute of Environmental Health Sciences (NIEHS); 
National Institutes of Health (NIH).

ACTION: Request for comments.

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SUMMARY: CERHR invites the submission of public comments on the draft 
NTP Briefs on Genistein and Soy Formula. The draft NTP Briefs are 
available from the CERHR Web site (http://cerhr.niehs.nih.gov see 
``CERHR Reports & Monographs'') or in hardcopy from CERHR (see 
ADDRESSES below). Public comments will be considered during peer review 
and finalization of the NTP Briefs.

DATES: Written comments on the draft NTP Briefs on Genistein and Soy 
Formula should be received by December 8, 2006.

ADDRESSES: Public comments and any other correspondence should be 
addressed 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 [email protected] (e-mail). 
Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 
103, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

Background

    Genistein (CAS RN: 446-72-0) is a phytoestrogen found in some 
legumes, especially soybeans. Genistein is 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. The expert panel reports were released 
for public comment on May 5, 2006 (Federal Register Vol. 71, No. 94, 
pp. 28368, May 16, 2006). Following this public comment period, CERHR 
staff prepared draft NTP Briefs on Genistein and Soy Formula that 
provides in plain language:
     Background information on the substance(s).
     Findings of the expert panel.
     Discussion of any relevant data available after the expert 
panel meeting.
     NTP's conclusions on the potential for the substance to 
cause adverse reproductive and/or developmental effects in exposed 
humans.
    Upon finalization, the NTP Briefs on Genistein and Soy Formula will 
be included in the CERHR Monographs on Genistein and Soy Formula. The 
draft NTP Briefs on Genistein and Soy Formula and related background 
materials, including the genistein expert panel report, soy formula 
expert panel report, and previously received public comments, are 
available on the CERHR Web site (http://cerhr.niehs.nih.gov see 
Genistein and Soy Formula under ``CERHR Reports & Monographs'').

Request for Comments

    The NTP invites written public comments on the draft NTP Briefs on 
Genistein and Soy Formula. Any comments received will be posted on the 
CERHR Web site and considered during the peer reviews and finalization 
of the NTP Brief on Genistein and the NTP Brief on Soy Formula. 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) and submit 
comments to Dr. Shelby (see ADDRESSES above) for receipt by December 8, 
2006.

Background Information on CERHR

    The NTP established CERHR in June 1998 [Federal Register, December 
14, 1998 (Volume 63, Number 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 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 homepage (http://cerhr.niehs.nih.gov) or by 
contacting Dr. Michael Shelby, CERHR Director (see ADDRESSES). CERHR 
selects chemicals

[[Page 65538]]

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 agents selected by CERHR in public forums. 
Following these evaluations, CERHR prepares the NTP-CERHR monograph on 
the agent evaluated. The monograph is transmitted to appropriate 
Federal and State agencies and made available to the public.

    Dated: October 31, 2006.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program.
[FR Doc. E6-18796 Filed 11-7-06; 8:45 am]
BILLING CODE 4140-01-P