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###### Department of Health and Human Services

# 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                               ( print 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