[Federal Register: October 2, 2008 (Volume 73, Number 192)]
[Notices]
[Page 57360-57361]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc08-70]
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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 Plans for Updated
Evaluations of Genistein and Soy Formula; Request for Public Comments
and Nomination of Expert Panel Members
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Notice of expert panel evaluation of the reproductive and
developmental toxicities of genistein and soy formula.
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SUMMARY: The CERHR plans to convene an expert panel to conduct updated
evaluations of the scientific evidence
[[Page 57361]]
regarding the potential reproductive and/or developmental toxicity
associated with exposure to genistein and soy formula begun in 2006.
The expert panel will consist of approximately 10-12 scientists
selected for their scientific expertise in various aspects of
reproductive and developmental toxicology and other relevant areas of
science. CERHR invites the submission of information about ongoing
studies or upcoming publications on these substances that might be
considered for inclusion in the evaluations and the nomination of
scientists to serve on the expert panel (see SUPPLEMENTARY INFORMATION
below). This meeting is tentatively scheduled for spring or summer
2009, although the exact date and location are not yet set. As plans
are finalized, they will be announced in the Federal Register and
posted on the CERHR Web site (http://cerhr.niehs.nih.gov). CERHR expert
panel meetings are open to the public with time scheduled for oral
public comment.
DATES: Comments received by November 17, 2008 will be made available to
CERHR staff and the expert panel for consideration in the evaluation
and posted on the CERHR Web site. Nominations of scientists received by
November 17, 2008 will be considered for this panel and for inclusion
in the CERHR Expert Registry.
ADDRESSES: Public comments and any other correspondence should be
submitted 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 shelby@niehs.nih.gov (e-mail). Courier
address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 102,
Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
Genistein (CAS RN: 446-72-0) 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. Genistin and genistein 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.
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. 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. The expert panel reports were released for
public comment on May 5, 2006 (Federal Register Vol. 71, No. 94, pp.
28368, May 16, 2006). Next, on November 8, 2006 (Federal Register Vol.
71, No. 216, pp. 65537, November 8, 2006), 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 and CERHR has determined that updated evaluations of
genistein and soy formula are needed.
Request for Comments
The CERHR invites the public and other interested parties to submit
information and comments on genistein and soy formula including
toxicology and epidemiologic information from completed and ongoing
studies, information on planned studies, and information about current
production levels, human exposure, use patterns, and environmental
occurrence.
Request for the Nomination of Scientist for the Expert Panel
The CERHR invites nominations of qualified scientists to serve on
the expert panel. Panelists are primarily drawn from the CERHR Expert
Registry and/or the nomination of other scientists who meet the
criteria for listing in that registry which include: formal academic
training and experience in a relevant scientific field, publications in
peer-reviewed journals, membership in relevant professional societies,
and certification by an appropriate scientific board or other entities.
Nominations should include contact information and current curriculum
vitae (if possible) and be forwarded to CERHR (see ADDRESSES). Final
selection of individuals to serve on the expert panel will be made in
accordance with the Federal Advisory Committee Act and Department of
Health and Human Services implementing regulations.
All panel members serve as individual experts and not as
representatives of their employers or other organizations. Scientists
on the expert panel represent a wide range of expertise including, but
not limited to, developmental toxicology, reproductive toxicology,
epidemiology, general toxicology, medicine, pharmacokinetics, exposure
assessment, and biostatistics.
Background Information on the CERHR
The NTP established CERHR in 1998 (Federal Register, December 14,
1998, Vol. 63, No. 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 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. Michael Shelby, CERHR Director (see ADDRESSES).
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: September 23, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-23173 Filed 10-1-08; 8:45 am]
BILLING CODE 4140-01-P