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Purpose The NTP and the National Institute of Environmental Health Sciences established the NTP Center for the Evaluation of Risks to Human Reproduction in 1998 to serve as an environmental health resource to the public and to regulatory and health agencies. The Center provides scientifically-based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans may be exposed. This is accomplished through rigorous evaluations of the scientific literature by independent panels of scientists. There is widespread concern among health professionals, environmental scientists, and the public that environmental exposures may be contributing to human reproductive and developmental disorders. Between five and ten percent of couples desiring children encounter problems achieving pregnancy, approximately 35–50 percent of pregnancies are not successfully completed, and 3 to 5% of newborns have major birth defects. The etiology of these problems is largely unknown. There is a clear need for readily accessible, scientifically authoritative evaluations of the human and experimental evidence that adverse effects on human reproduction and development may result from chemical exposures. The Center's goal is to provide such evaluations. A special effort is made to summarize these reports in terms that can be understood by those who are not scientifically trained. Nomination Process Nominations of chemicals to be evaluated by CERHR are solicited from both the public and scientific communities, including industry, federal, state, and local governments, academia, environmental groups, and citizens. The public is encouraged to nominate chemicals or chemical mixtures for evaluation by the Center. Nominations of chemicals or chemical mixtures must be accompanied by the reason for the nomination and, whenever possible, appropriate background information, data, or literature citations. The public may also nominate scientists to be added to the Expert Registry. The CERHR Expert Registry is the primary source of scientists to serve on the Panels that conduct evaluations. Nominations must be accompanied by a description of the nominee's expertise and a curriculum vitae. Expert scientific panels evaluate relevant literature to determine the potential of chemicals to adversely impact human reproductive or developmental health. Such evaluations encompass health effects including impaired fertility, adverse pregnancy outcomes, birth defects, and postnatal functional deficits. Specifically, Expert Panels will:
The Center's evaluation process is outlined below:
Products
The Expert Panel Report provides a consensus scientific judgment of the potential human reproductive and developmental toxicity of the chemical agent or mixture and is a product of the Expert Panel. The goals of these evaluations are:
Two to three Expert Panel Reports will be prepared each year. The final Report of the Expert Panel will be available from CERHR on the website and by mail.
The NTP-CERHR Monograph will be prepared by the NTP staff after the public comment period on the Expert Panel Report. The Monograph has three sections: the NTP Brief, the Expert Panel Report, and the public comments on the Expert Panel Report. The NTP Brief contains:
The NTP-CERHR Monograph will be added to the CERHR website, and distributed to federal and state agencies and interested individuals and organizations. Under the direction of Michael Shelby, Ph.D., Director, CERHR at NIEHS, scientific and support staff at NIEHS and Sciences International, Inc. operate the Center for the Evaluation of Risks to Human Reproduction (CERHR). The Principal Investigator, Anthony Scialli, M.D., leads the scientific and support staff at Sciences International, Inc. Center Organization
Committees The NTP Board of Scientific Counselors provides oversight for CERHR and offers advice on priorities, directions, and the adequacy of the Center's process. The Core Committee is a an advisory body consisting of scientists who represent government agencies represented on the NTP Executive Committee. The current committee members are: Dr. Jennifer Seed, US Environmental Protection Agency, National Center for Environmental Assessment; Dr. Teresa Schnorr, National Institute of Occupational Safety and Health, Centers for Disease Control and Prevention; Dr. David Jacobson-Kram, US Food and Drug Administration; Dr. Marilyn Wind, US Consumer Product Safety Commission; Dr. Coleen Boyle, National Center for Environmental Health, Centers for Disease Control and Prevention, and Dr. Michael Shelby, National Institute of Environmental Health Sciences. The Core Committee's duties are:
Expert Panels are the independent working groups of scientists that produce the individual reports. The Panels are comprised of individuals with expertise in one or several scientific areas integral to a chemical evaluation. These scientists are selected from a registry built and maintained by CERHR staff and represent academia, industry, and government research and regulatory agencies. Suggestions for additional scientists for this Registry may be sent to CERHR accompanied by a description of expertise and a curriculum vitae. The Panel's purpose is:
Comments, questions,
information, contact: webmaster@cerhr.niehs.nih.gov |
