[Federal Register Volume 74, Number 200 (Monday, October 19, 2009)]
[Notices]
[Pages 53508-53509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Availability of the Draft Expert Panel Report on Soy Formula; 
Request for Public Comment on the Draft Report; Announcement of the Soy 
Formula Expert Panel Meeting

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

ACTION: Availability of draft report, request for public comment, and 
announcement of a meeting.

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SUMMARY: The CERHR announces the availability of the draft expert panel 
report on soy formula on October 19, 2009, on the CERHR Web site 
(http://cerhr.niehs.nih.gov) or in printed text from CERHR (see FOR 
FURTHER INFORMATION CONTACT below). The CERHR invites the submission of 
public comments on chapters 1-4 of the draft expert panel report (see 
SUPPLEMENTARY INFORMATION below). The expert panel will meet on 
December 16-18, 2009, at the Hilton Alexandria Old Town, 1767 King 
Street, Alexandria, VA 22314 (Tel: 1-703-837-0440) to review and revise 
the draft expert panel report and reach conclusions regarding whether 
exposure to soy formula is a hazard to human development. The expert 
panel will also identify data gaps and research needs. CERHR expert 
panel meetings are open to the public with time scheduled for oral 
public comment. Attendance is limited only by the available meeting 
room space. Following the expert panel meeting and completion of the 
expert panel report, the CERHR will post the final report on its Web 
site and solicit public comment on it through a Federal Register 
notice.

DATES: The expert panel meeting for soy formula will be held on 
December 16-18, 2009. Chapters 1-4 of the draft expert panel report 
will be available for public comment on October 19, 2009. Written 
public comments on the draft report must be received by December 2, 
2009. Time is set aside at the expert panel meeting on December 16, 
2009, for oral public comments. Individuals wishing to make oral public 
comments are asked to register online (http://cerhr.niehs.nih.gov) or 
contact Dr. Kristina A. Thayer, CERHR Acting Director, by December 9, 
2009, and if possible, send a copy of the statement and/or slide 
presentation at that time. Persons wishing to attend are asked to 
register by December 9, 2009 via the CERHR Web site (http://cerhr.niehs.nih.gov).

ADDRESSES: Public comments and any other correspondence should be 
submitted to Dr. Kristina A. Thayer, CERHR Acting Director, NIEHS, P.O. 
Box 12233, Mail Drop 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.

FOR FURTHER INFORMATION CONTACT: Dr. Kristina A. Thayer (telephone: 
919-541-5021 or e-mail: [email protected]). Persons needing 
interpreting services in order to attend should contact (301) 402-8180 
(voice) or (301) 435-1908 (TTY). Requests should be made at least seven 
business days in advance of the meeting.

SUPPLEMENTARY INFORMATION:

Background

    Soy formula is fed to infants as a supplement or replacement for 
human milk or cow milk. Soy 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 is linked to a sugar molecule and these isoflavone-sugar 
complexes are called genistin, daidzin, or glycitin.
    On March 15-17, 2006, CERHR convened an expert panel to conduct 
evaluations of the potential developmental and reproductive toxicities 
of soy formula and its predominant isoflavone constituent genistein. 
CERHR selected soy formula and genistein for expert panel evaluation 
because of (1) the availability of numerous 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 expert panel reports were released for public comment 
on May 5, 2006 (71 FR 28368). On November 8, 2006 (71 FR 65537), CERHR 
staff released draft NTP Briefs on Genistein and Soy Formula that 
provided the NTP's interpretation of the potential for genistein and 
soy formula to cause adverse reproductive and/or developmental effects 
in exposed humans. CERHR has not completed these evaluations, finalized 
the briefs, or issued NTP-CERHR monographs on these substances. Since 
2006, a substantial number of new publications related to human 
exposure or reproductive and/or developmental toxicity have been 
published for these substances. CERHR has determined that updated 
evaluations of genistein and soy formula are needed. However, the 
current evaluation will focus on soy formula and the potential 
developmental toxicity of its major isoflavone components, e.g., 
genistein, daidzein, and glycitein. This evaluation will not include an 
assessment on the potential reproductive toxicity of genistein 
following exposures during adulthood as was done in the 2006 
evaluation. CERHR is narrowing the scope of the evaluation because the 
assessment of reproductive effects of genistein following exposure to 
adults was not considered relevant in the consideration of soy formula 
use in infants during the initial evaluation in 2006.
    At the meeting, the expert panel will review and revise the draft 
expert panel report and reach conclusions regarding whether exposure to 
soy formula is a hazard to human development. The draft expert panel 
report has the following chapters:

1.0 Chemistry, Use, and Human Exposure
2.0 General Toxicological and Biological Effects
3.0 Developmental Toxicity Data
    a. Developmental Toxicity Data for Genistein, Daidzein, Equol, and 
Glycitein
    b. Developmental Toxicity Data for Soy Formula and Other Soy

[[Page 53509]]

Products
4.0 Reproductive Toxicity Data
5.0 Summary, Conclusions, and Critical Data Needs (to be developed at 
the expert panel meeting).

Request for Comments

    CERHR invites written public comments on chapters 1-4 of the draft 
expert panel report on soy formula. Any comments received will be 
posted on the CERHR Web site prior to the meeting and distributed to 
the expert panel and CERHR staff for their consideration in revising 
the draft report and/or preparing for the expert panel meeting. Persons 
submitting written comments are asked to include their name and contact 
information (affiliation, mailing address, telephone number, e-mail, 
and sponsoring organization, if any) and send them to Dr. Thayer (see 
ADDRESSES above) for receipt by December 2, 2009. Comments will be 
identified on the Web site by the submitter's name, affiliation, and/or 
sponsoring organization.
    Time is set aside on December 16, 2009 for the presentation of oral 
public comments at the expert panel meeting. Seven minutes will be 
available for each speaker (one speaker per organization). Online 
registration is available on the CERHR website or persons wishing to 
make oral remarks can contact Dr. Thayer. If possible, send a copy of 
the statement, talking points, and/or slide presentation to Dr. Thayer 
by December 2. This statement will be provided to the expert panel to 
assist them in identifying issues for discussion and noted in the 
meeting record. Registration for presentation of oral comments will 
also be available at the meeting on December 16, 2009, from 7:30-8:30 
a.m. Persons registering at the meeting are asked to bring 30 copies of 
their statement, talking points, and/or slide presentation for 
distribution to the expert panel and for the record.

Attendance and Registration

    In order to facilitate planning for this meeting, persons wishing 
to attend are asked to register by December 9, 2009, via the CERHR Web 
site (http://cerhr.niehs.nih.gov).

Preliminary Agenda

    The meeting begins each day at 8:30 a.m. On December 16 and 17, it 
is anticipated that a lunch break will occur from noon-1 p.m. and the 
meeting will adjourn at 5-6 p.m. The meeting is expected to adjourn by 
noon on December 18, 2009; however, adjournment may occur earlier or 
later depending upon the time needed by the expert panel to complete 
its work. Anticipated agenda topics for each day are listed below.

December 16, 2009

     Opening remarks;
     Oral public comments (7 minutes per speaker; one 
representative per group);
     Review of chapters 1-4 of the draft expert panel report on 
soy formula;
     Discussion of Chapter 5.0 Summary, Conclusions, and 
Critical Data Needs.

December 17, 2009

     Discussion of Chapter 5.0 Summary, Conclusions, and 
Critical Data Needs;
     Preparation of draft summaries and conclusion statements.

December 18, 2009

     Presentation, discussion of, and agreement on summaries, 
conclusions, and data needs;
     Closing comments.

Background Information on the 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 
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. Expert panels conduct 
scientific evaluations of substances selected by CERHR in public 
forums. Following these evaluations, CERHR prepares the NTP-CERHR 
monograph on the substance evaluated. The monograph is transmitted to 
appropriate Federal and State agencies and made available to the 
public.

    Dated: October 8, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-25122 Filed 10-16-09; 8:45 am]
BILLING CODE 4140-01-P