E6-18796. National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Briefs on Genistein and Soy Formula; Request for Public Comments

AGENCY:

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

ACTION:

Request for comments.

SUMMARY:

CERHR invites the submission of public comments on the draft NTP Briefs on Genistein and Soy Formula. The draft NTP Briefs are available from the CERHR Web site (http://cerhr.niehs.nih.gov see “CERHR Reports & Monographs”) or in hardcopy from CERHR (see ADDRESSES below). Public comments will be considered during peer review and finalization of the NTP Briefs.

DATES:

Written comments on the draft NTP Briefs on Genistein and Soy Formula should be received by December 8, 2006.

ADDRESSES:

Public comments and any other correspondence should be addressed to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail), [phone] (phone), [phone] (fax), or [e-mail] (e-mail). Courier address: CERHR, 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, especially soybeans. Genistein is 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. The expert panel reports were released for public comment on May 5, 2006 (Federal Register Vol. 71, No. 94, pp. 28368, May 16, 2006). Following this public comment period, CERHR staff prepared draft NTP Briefs on Genistein and Soy Formula that provides in plain language:

• Background information on the substance(s).
• Findings of the expert panel.
• Discussion of any relevant data available after the expert panel meeting.
• NTP's conclusions on the potential for the substance to cause adverse reproductive and/or developmental effects in exposed humans.

Upon finalization, the NTP Briefs on Genistein and Soy Formula will be included in the CERHR Monographs on Genistein and Soy Formula. The draft NTP Briefs on Genistein and Soy Formula and related background materials, including the genistein expert panel report, soy formula expert panel report, and previously received public comments, are available on the CERHR Web site (http://cerhr.niehs.nih.gov see Genistein and Soy Formula under “CERHR Reports & Monographs”).

Request for Comments

The NTP invites written public comments on the draft NTP Briefs on Genistein and Soy Formula. Any comments received will be posted on the CERHR Web site and considered during the peer reviews and finalization of the NTP Brief on Genistein and the NTP Brief on Soy Formula. 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 submit comments to Dr. Shelby (see ADDRESSES above) for receipt by December 8, 2006.

Background Information on 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 exposure to environmental and/or occupational exposures.

CERHR invites the nomination of agents 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 chemicals 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 agents selected by CERHR in public forums. Following these evaluations, CERHR prepares the NTP-CERHR monograph on the agent evaluated. The monograph is transmitted to appropriate Federal and State agencies and made available to the public.

Dated: October 31, 2006.

David A. Schwartz,

Director, National Institute of Environmental Health Sciences and National Toxicology Program.