NTP Center For The Evaluation Of Risks To Human Reproduction

National Institute Of Environmental Health Sciences

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Abstract

During FY2008, the Center for the Evaluation of Risks to Human Reproduction (CERHR) worked on the evaluations for four substances: bisphenol A, genistein, soy infant formula and hydroxyurea. [unreadable] [unreadable] The primary activity during this time was the ongoing evaluation of the potential reproductive and developmental toxicity of bisphenol A (BPA). The Expert Panel Report on Bisphenol A (BPA) was finalized and released to the public on November 30, 2007, via the Federal Register (72FR67730); public comments on the final report were accepted through January 25, 2008. CERHR staff prepared the draft NTP Brief on Bisphenol A, which expressed the NTP's conclusions regarding the effects of BPA on human reproduction and the development of children at current human exposures, as well as the scientific support for those conclusions. An April 15 FR notice (73FR20289) announced the June 11-12 meeting of the NTP Board of Scientific Counselors (BSC) and solicited public comment on the draft NTP Brief on BPA, which was made publicly available on the NTP and CERHR web sites. The BSC, supplemented with eight ad hoc subject experts, conducted the peer review of the draft Brief on June 11, 2008. The BSC discussed and voted on the conclusions about the public health concerns expressed in the draft NTP Brief on BPA (See http://ntp.niehs.nih.gov/files/BSCactionsBPA_508.pdf. The five levels of concern used by NTP are, from highest to lowest, "serious concern", "concern", "some concern", "minimal concern" and "negligible concern".) The BSC agreed that the scientific evidence supported the majority of the NTP conclusions, including "some concern" for neural and behavioral effects and for the prostate gland in fetuses, infants and children, at current human exposures. The BSC also agreed that there was "negligible concern" for effects of current exposures of BPA in pregnant women and non-occupationally exposed workers and "minimal concern" for workers exposed to BPA. However, the BSC recommended that the level of concern expressed in the draft brief be changed from "some concern" to "minimal concern" for BPA exposure in fetuses, infants and children at current human exposures (1) for effects on the mammary gland and (2) for an earlier age for puberty in females. The final NTP Brief on Bisphenol A, which reflects the BSC's recommendations, was made publicly available in September 2008.[unreadable] [unreadable] An expert panel meeting for the CERHR evaluation of genistein and soy infant formula was held March 15-17, 2006, and the final expert panel reports for both were released on May 16, 2006 (71FR28368). Draft NTP briefs for both substances were released for public comment and peer review on November 8, 2006 (71FR65537). Due to unanticipated delays, the final NTP Briefs on Genistein and on Soy Formula were not completed in 2007 as planned. During this delay, substantial new literature was published, literature that might affect the final NTP conclusions about the effects of these substances on human reproduction and development. Consequently, plans are underway to convene a second expert panel to consider this new literature and to review and update the conclusions drawn by the previous panel.[unreadable] [unreadable] The draft NTP Brief on Hydroxyurea was released for public comment on March 17, 2008 (73FR14251), followed by peer review by four scientific experts. The NTP considered the public comments and peer review comments in finalizing the NTP Brief on Hydroxyurea. It is included in the NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Hydroxyurea, which is currently in press.