2010-674. National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Final Expert Panel Report on Soy Infant Formula; Request for Public Comment

AGENCY:

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

ACTION:

Announcement of report availability and request for comment.

SUMMARY:

CERHR announces the availability of the final expert panel report on soy infant formula on January 15, 2010, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in hardcopy from CERHR (see ADDRESSES below). The expert panel report is an evaluation of the developmental toxicity of soy infant formula conducted by an independent, 14-member expert panel composed of scientists from the public and private sectors convened by CERHR. CERHR invites the submission of public comments on this report (see SUPPLEMENTARY INFORMATION below). The expert panel met in public session (December 16-18, 2009) to review and revise the draft expert panel report and reach conclusions regarding whether exposure to soy infant formula is a hazard to human development. The expert panel also identified data gaps and research needs.

DATES:

The final expert panel report on soy infant formula will be available for public comment on January 15, 2010. Written public comments on this report should be received by March 1, 2010.

ADDRESSES:

Comments on the expert panel report and any other correspondence should be submitted to Dr. Kristina A. Thayer, Acting CERHR Director, NIEHS, P.O. Box 12233, MD K2-04, Research Triangle Park, NC 27709 (mail), 919-541-5021 (telephone), or [e-mail] (e-mail). Courier address: NIEHS, 530 Davis Drive, Room K2154, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Background

Soy infant formula is fed to infants as a supplement or replacement for human milk or cow milk formula. Soy infant formula contains isoflavones such as genistein (CAS RN: 446-72-0), daidzein (CAS RN: 486-66-8), and glycitein (CAS RN: 40957-83-3). Genistein, daidzein, glycitein, and the daidzein metabolite equol are non-steroidal, estrogenic compounds that occur naturally in some plants and are often referred to as “phytoestrogens.” In plants, nearly all genistein, daidzein, and glycitein are linked to a sugar molecule and these isoflavone-sugar complexes are called genistin, daidzin, or glycitin.

On December 16-18, 2009, CERHR (74 FR 53508) convened an expert panel to conduct an updated evaluation of the potential developmental toxicity of soy infant formula and its predominant isoflavone constituents. CERHR selected soy infant formula for evaluation because of (1) The availability of numerous developmental toxicity studies in laboratory animals and humans, (2) the availability of information on exposures in infants, and (3) public concern for effects on infant or child development.

Following receipt of public comments on the final expert panel report on soy infant formula, CERHR staff will prepare the NTP monograph. NTP monographs are divided into three major sections: (1) The NTP Brief that provides the NTP's interpretation of the potential for the substance to cause adverse reproductive and/or developmental effects in exposed humans, (2) a roster of expert panel members, and (3) the final expert panel report. The NTP Brief is based on the expert panel report, public comments on that report, public and peer review comments on the draft NTP Brief, and any new, relevant information that becomes available after the expert panel meetings.

Request for Comments

CERHR invites written public comments on the expert panel report on soy infant formula. Written comments should be sent to Dr. Kristina A. Thayer (see ADDRESSES above). 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). Any comments received will be posted on the CERHR Web site and the commenter identified by name, affiliation, and sponsoring organization, if applicable. All public comments will be considered by the NTP during preparation of the NTP Brief (see “Background” above).

Background Information on CERHR

The NTP established CERHR in 1998 (63 FR 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 multiple 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. Thayer (see ADDRESSES above). 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.

Dated: January 8, 2010.

John R. Bucher,

Associate Director, National Toxicology Program.