[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Pages 74834-74835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7412]


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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 Genistein and 
Soy Formula Expert Panel Meeting; Availability of the Draft Expert 
Panel Reports on Genistein and Soy Formula and Request for Public 
Comment on the Draft Reports

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

ACTION: Meeting announcement and request for public comment.

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SUMMARY: The Center for the Evaluation of Risks to Human Reproduction 
(CERHR) announces availability of the two draft expert panel reports on 
genistein and soy formula on January 16, 2006, from the CERHR Web site 
(http://cerhr.niehs.nih.gov) or in printed text from CERHR (see 
ADDRESSES below). CERHR invites public comments on sections 1-4 of both 
draft expert panel reports (see SUPPLEMENTARY INFORMATION below). An 
expert panel will meet on March 15-17, 2006, at the Radisson Hotel Old 
Town in Alexandria, Virginia to review and revise each draft expert 
panel report and reach conclusions regarding whether exposure to 
genistein or soy formula is a hazard to human development or 
reproduction. 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 space in the meeting room. Following the expert panel 
meeting and completion of the expert panel reports, CERHR will post the 
final reports on its website and solicit public comment on them through 
a Federal Register notice.

DATES: The expert panel meeting for genistein and soy formula will be 
held on March 15-17, 2006. Sections 1-4 of both draft expert panel 
reports will be available for public comment on January 16, 2006. 
Written public comments on the draft report must be received by March 
1, 2006. Time will be set-aside at the expert panel meeting on March 
15, 2006, for oral public comments. Individuals wishing to make oral 
public comments are asked to contact Dr. Michael D. Shelby, CERHR 
Director, by March 8, 2006, and if possible, send a copy of their 
statement or talking points at that time. Persons needing special 
assistance, such as sign language interpretation or other reasonable 
accommodation in order to attend, should contact 919-541-2475 voice, 
919-541-4644 TTY (text telephone), through the Federal TTY Relay System 
at 800-877-8339, or by e-mail to [email protected]. Requests 
should be made at least 7 days in advance of the meeting.

ADDRESSES: The expert panel meeting for genistein and soy formula will 
be held at the Radisson Hotel Old Town, 901 N. Fairfax Street, 
Alexandria, Virginia 22314-1501 (telephone: 703-683-6000, facsimile: 
703-683-7597). Comments on the draft expert panel reports 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, NIEHS, 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, such as soybeans and clover, or in products obtained from 
animals ingesting genistein-containing feed. Phytoestrogens are non-
steroidal, estrogenic compounds that occur naturally in plant products. 
Genistein is found in food and over-the-counter dietary supplements and 
is the primary phytoestrogen in soy formula. Soy formula is 
administered to infants as a supplement or replacement for maternal 
breast milk or cow's milk. CERHR selected genistein and soy formula 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.
    At the meeting, the expert panel will review and revise the draft 
expert panel reports and reach conclusions regarding whether exposure 
to genistein or soy formula is a hazard to human reproduction or 
development. Each draft expert panel report has the following sections:

1.0 Chemistry, Use, and Human Exposure
2.0 General Toxicological and Biological Effects
3.0 Developmental Toxicity Data
4.0 Reproductive Toxicity Data
5.0 Summary, Conclusions, and Critical Data Needs (to be prepared at 
expert panel meeting)

Request for Comments

    CERHR invites the submission of written public comments on sections 
1-4 of the draft expert panel reports on genistein and 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 reports and preparing for the 
expert panel meeting. 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 send them to Dr. Shelby (see ADDRESSES above) 
for receipt by March 1, 2006.
    Time is set-aside on March 15, 2006, for the presentation of oral 
public comments at the expert panel meeting. Seven minutes will be 
available for each speaker (one speaker per organization). When 
registering to comment orally, please provide your name, affiliation, 
mailing address, telephone and facsimile numbers, e-mail, and 
sponsoring organization (if any). If possible, send a copy of the 
statement or talking points to Dr. Shelby by March 8, 2005. This 
statement will be provided to the expert panel to assist them in 
identifying issues for discussion and will be noted in the meeting 
record. Registration for presentation of oral comments will also be 
available at the meeting on March 15, 2006, from 7:30-8:30 a.m. Persons 
registering at the

[[Page 74835]]

meeting are asked to bring 20 copies of their statement or talking 
points for distribution to the expert panel and for the record.

Preliminary Agenda

    The meeting begins each day at 8:30 a.m. . On March 15 and 16, 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 anticipated to adjourn 
by noon on March 17; 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.

March 15, 2006

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

March 16, 2006

 Discussion of Section 5.0 Summary, Conclusions, and Critical 
Data Needs
 Preparation of draft summaries and conclusion statements

March 17, 2006

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

Expert Panel Roster

    The CERHR expert panel is composed of independent scientists 
selected for their scientific expertise in reproductive and/or 
developmental toxicology or other areas of science relevant for these 
evaluations.

Karl K. Rozman, Ph.D., D.A.B.T. (Chair)--University of Kansas Medical 
Center, Kansas City, KS
Jatinger Bhatia, M.B.B.S.--Medical College of Georgia, Augusta, GA
Antonia M. Calafat, Ph.D.--National Center for Environmental Health, 
Centers for Disease Control and Prevention, Atlanta, GA
Christina Chambers, Ph.D., M.P.H.--University of California San Diego 
Medical Center, San Diego, CA
Martine Culty, Ph.D.--Georgetown University Medical Center, Washington, 
DC
Ruth Ann Etzel, Ph.D.--Alaska Native Medical Center, Anchorage, AK
Jody Anne Flaws, Ph.D.--University of Maryland School of Medicine, 
Baltimore, MD
Deborah K. Hansen, Ph.D.--National Center for Toxicological Research, 
Jefferson, Arkansas
Patricia B. Hoyer, Ph.D.--University of Arizona, Tucson, AZ
Elizabeth Hutt Jeffery, Ph.D.--University of Illinois, Urbana, IL
James S. Kesner, Ph.D.--National Institute for Occupational Safety and 
Health, Cincinnati, OH
M. Sue Marty, Ph.D.--The Dow Chemical Company, Midland, MI
John A. Thomas, Ph.D.--University of Texas, San Antonio, TX
David M. Umbach, Ph.D.--National Institute of Environmental Health 
Sciences, Research Triangle Park, NC

Background Information on the 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 environmental and/or 
occupational exposures. Expert panels conduct scientific evaluations of 
environmental chemicals, drugs, physical agents, or mixtures 
(collectively referred to as ``substances'') selected by the CERHR in 
public forums.
    The CERHR invites the nomination of substances for expert panel 
evaluation 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. Shelby (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.
    CERHR follows a formal, multi-step process for review and 
evaluation of selected chemicals. The formal evaluation process was 
published in the Federal Register on July 16, 2001 (Volume 66, Number 
136, pages 37047-37048) and is available on the CERHR Web site under 
``About CERHR'' or in printed copy from the CERHR.

    Dated: December 5, 2005.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and the 
National Toxicology Program.
 [FR Doc. E5-7412 Filed 12-15-05; 8:45 am]
BILLING CODE 4140-01-P