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Independent NIH Panel to Evaluate Human Reproductive Safety of Genistein & Soy Formula

The National Institutes of Health (NIH) is holding a 2.5 day meeting of 14 scientific experts on the potential human reproductive effects of the phyotestrogen genistein and/or soy formula. The meeting is open to the public and will be held this week, starting Wed. Mar 15, 2006 at the Radisson Hotel Old Town in Alexandria, VA.

Details are available at http://www.nih.gov/news/pr/mar2006/niehs-08a.htm or in the information posed below.

U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH NIH News National Institute of Environmental Health Sciences (NIEHS) http://www.niehs.nih.gov/

FOR IMMEDIATE RELEASE: Wednesday, March 8, 2006

CONTACT: Robin Mackar, 919-541-0073, rmackar@niehs.nih.gov

News Advisory

INDEPENDENT PANEL TO EVALUATE WHETHER GENISTEIN OR SOY FORMULA ISHAZARDOUS TO HUMAN DEVELOPMENT OR REPRODUCTION

WHAT:     An independent panel of 14 scientists convened by the Center for theEvaluation of Risks to Human Reproduction (CERHR), of the NIEHS andNational Toxicology Program, will review recent scientific data andreach conclusions regarding whether or not exposure to genistein or soyformula is hazardous to human development or reproduction. The 2.5 daymeeting is open to members of the public and the media. A pressavailability period will immediately follow the meeting at approximatelynoon on Friday, March 17.

WHEN:     Wednesday, March 15, 2006, 8:30 a.m.-5:00 p.m.Thursday, March 16, 2006, 8:30 a.m.-5:00 p.m.Friday, March 17, 2006, 8:30 a.m.- noonPress Availability: Friday, March 17, 2006 approximately 12-1p.m.

WHERE:     Jefferson BallroomRadisson Hotel Old Town901 N. Fairfax Street,Alexandria, VA 22314-1501, USATel: (703) 683-6000Fax: (703) 683-7597http://www.radisson.com/alexandriava

WHY:     Exposure to genistein continues to rise in the United States withestimated soy sales in 2003 approaching $4 billion.* A form of genisteinis a primary, naturally occurring estrogen in soybeans (estrogenicchemicals in plants are called phytoestrogens) and can mimic the effectsof estrogen in the body. Genistein can be found in foods containing soysuch as soy-based infant formulas, tofu, soy milk, soy flour, texturedsoy protein, tempeh, and miso, as well as over-the-counter dietarysupplements. Soy-infant formulas are widely used. It is estimated that10-20 percent of infants in the United States are fed soy formula.**,*** It is often administered to infants as a supplement or replacementfor maternal breast milk or cow's milk.

Soy products are often promoted as a natural, safe way to achieve atleast some of the benefits of hormone replacement therapy in adults, butthere is growing public concern about the long-term effects of consumingsoy. There is a need to look at available evidence from reproductive anddevelopmental animal and human toxicity studies, as well as exposuredata from infants and women of reproductive age, to determine ifphytoestrogens in soy infant formulas adversely affect human growth,development, or reproduction. The draft report on genistein is availablefor review athttp://cerhr.niehs.nih.gov/chemicals/genistein-soy/genistein/Genistein_Report_FR.pdf. The soy formula draft report is athttp://cerhr.niehs.nih.gov/chemicals/genistein-soy/soyformula/Soy-report-FR.pdf.

BACKGROUND:     The Center for the Evaluation of Risks to Human Reproduction (CERHR) wasestablished by the National Institute of Environmental Health Sciences(NIEHS) as part of the National Toxicology Program in 1998. CERHRconvenes a scientific expert panel that meets in a public forum toreview, discuss, and evaluate the scientific literature on a selectedchemical. CERHR selects chemicals for evaluation based upon severalfactors including production volume, extent of human exposure, publicconcern, and the extent of published information on reproductive ordevelopmental toxicity. The NTP is an HHS program established in 1978that is headquartered at the NIEHS, a part of the National Institutes ofHealth. The NIEHS Director, Dr. David A. Schwartz, serves as the NTPDirector.

REGISTRATION:     No registration is required. Members of the press interested inattending or conducting on-site or phone interviews with any of thescientists, please contact Robin Mackar at (919) 541-0073 or by email atrmackar@niehs.nih.gov. She will schedule interviews for the pressavailability period immediately following the meeting. Details about themeeting, including panelists and agenda, are posted on the NTP websitehttp://cerhr.niehs.nih.gov/news/fedreg/fr12-16-2005.pdf.

The National Institutes of Health (NIH) -- "The Nation's MedicalResearch Agency" -- includes 27 Institutes and Centers and is acomponent of the U.S. Department of Health and Human Services. It is theprimary federal agency for conducting and supporting basic, clinical andtranslational medical research, and it investigates the causes,treatments, and cures for both common and rare diseases. For moreinformation about NIH and its programs, visit http://www.nih.gov.  ------------------------------------------------------* Soyfoods-Association-of-North-America. Soyfood Sales & Trends.Available at http://www.soyfoods.org/press/FAQ_sales.htm. SoyfoodsAssociation of North America. 2003.

** Essex, C. Phytoestrogens and Soy Based Infant Formula: Risks RemainTheoretical. "British Medical Journal" 1996; 313: 507-508.

*** Strom, B. L., Schinnar, R., Ziegler, E. E., Barnhart, K. T., Sammel,M. D., Macones, G. A., Stallings, V. A., Drulis, J. M., Nelson, S. E.and Hanson, S. A. Exposure to soy-based formula in infancy andendocrinological and reproductive outcomes in young adulthood. "Jama"2001; 286: 807-14.------------------------------------------------------