[Federal Register Volume 75, Number 10 (Friday, January 15, 2010)]
[Notices]
[Page 2545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-674]


=======================================================================
-----------------------------------------------------------------------

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 (http://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 
[email protected] (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 (http://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