[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Page 28368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7434]


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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.

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SUMMARY: CERHR announces the availability of the genistein and soy 
formula expert panel reports on the CERHR Web site (http://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 
[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 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 (http://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