01-12261. National Toxicology Program (NTP); National Institute of Environmental Health Sciences; NTP Announces the Release of the NTP Final Report From the Endocrine Disruptors Low-Dose Peer Review for Public Comment

Summary

The National Toxicology Program (NTP)/National Institute of Environmental Health Sciences (NIEHS) organized and conducted a scientific peer review at the request of the US Environmental Protection Agency (EPA) to evaluate reported low-dose reproductive and developmental effects and dose-response relationships for endocrine disrupting chemicals. The NTP is soliciting public comment prior to transmitting the final report to the US EPA. Public comments received in response to this solicitation will be included in the final transmittal. The final report is available on the NTP web site at http://ntp-server.niehs.nih.gov or by contacting the NTP Office of Liaison and Scientific Review; 919-541-0530 (phone); 919-541-0295 (fax); [e-mail]; 111 T.W. Alexander Drive, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709.

Background

The NTP final report will be provided to the US EPA to help guide the agency in determining whether or not its guidelines for reproductive and developmental toxicity testing are adequate for endocrine active chemicals. For this meeting, “low-dose effects” referred to biological changes that occur in the range of human exposures or at doses lower than those typically used in the US EPA's standard testing paradigm for evaluating reproductive and developmental toxicity.

The peer review included plenary sessions and several subpanel meetings. The peer review panel was divided into five subpanels: Bisphenol A, Other Environmental Estrogens and Estradiol, Androgens and Anti-Androgens, Biological Factors and Study Design, and Statistics and Dose-Response Modeling. The Panel examined data from major, selected studies (excluding studies on phthalates and dioxin and dioxin-like compounds) supporting the presence or absence of low-dose effects in laboratory animals that could be relevant for human health assessments. The Panel was also asked to evaluate the shape of the dose-response curve for endocrine active substances in the low-dose region. Prior to the peer review, members of the Statistics and Dose-Response Modeling Subpanel analyzed the raw data on selected parameters for 38 studies and provided its analyses to the other subpanels. At the peer review, members from this subpanel participated in other subpanels.

Request for Public Comment on the Final Report

Interested parties are encouraged to submit written comments on the NTP Endocrine Disruptors Low-Dose Peer Review Final Report. Comments should include name, affiliation, mailing address, phone, fax, e-mail and sponsoring organization (if any). The NTP invites written public comment on the final report through July 16, 2001. Comments should be submitted to the NTP Office of Liaison and Scientific Review; 919-541-0530 (phone); 919-541-0295 (fax); [e-mail] ; 111 T.W. Alexander Drive, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709.

Additional Information About the Endocrine Disruptors Low-Dose Peer Review

For additional information about the Endocrine Disruptors Low-Dose Peer Review including the peer review's program, list of participants, literature reference lists, and Federal Register notices, visit the NTP web site at: http://ntp-server.niehs.nih.gov

Previously three Federal Register notices were published about this peer review: January 6, 2000, Volume 65, Number 4, pages 784-787; April 17, 2000, Volume 65, Number 74, pages 20478-20479; September 27, 2000, Volume 65, Number 188, pages 58097-58099.

Dated: May 8, 2001.

Kenneth Olden,

Director, NIEHS, Director, NTP.