[Federal Register Volume 73, Number 192 (Thursday, October 2, 2008)]
[Notices]
[Pages 57360-57361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23173]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 [email protected] (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