[Federal Register Volume 63, Number 239 (Monday, December 14, 1998)]
[Notices]
[Page 68782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33089]



[[Page 68782]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program

    The National Toxicology Program (NTP) and the National Institute of 
Environmental Health Sciences (NIEHS) announces the establishment of 
the NTP Center for the Evaluation of Risks to Human Reproduction; 
solicits nominations of chemicals and/or chemical mixtures to be 
evaluated by the Center; and requests suggestions for scientists to be 
added to an Expert Registry from which reviewers will be appointed to 
serve on ad hoc panels that will assess the reproductive and 
developmental toxicity of selected agents.

Background

    There currently is no readily and publicly available, 
scientifically authoritative mechanism for the evaluation of human and 
experimental evidence for adverse effects on reproduction, including 
development, caused by agents to which humans may be exposed. In the 
absence of uniform, authoritative, independent reviews, there is a lack 
of consistency in risk evaluations involving reproductive toxicants. 
The need for such evaluations of reproductive hazards is clear, 
especially evaluations that are readily available and understandable to 
the public. Although the etiology is largely unknown, an infertility 
rate of approximately 5-10 percent exists among couples who desire 
children, approximately 50 percent of pregnancies are not successfully 
completed, there is a birth defect rate of 3-5 percent, and a decline 
in human sperm counts over recent decades has been reported but not 
confirmed.
    In line with the goal of the National Toxicology Program to provide 
toxicological evaluation on substances of public health concern, the 
Center is being established to provide a strictly scientifically-based, 
uniform assessment of the evidence for reproductive and developmental 
toxicity of man-made or naturally occurring chemicals or chemical 
mixtures. The reports produced through the Center will provide a 
timely, scientifically sound source of information to the public and 
the scientific communities on the reproductive risks of environmental 
agents. A special effort will be made to summarize these reports in 
terms that can be understood by these who are not scientifically 
trained.

NTP Center Operations

    Nominations of chemicals to be evaluated through the Center are 
solicited from the public and scientific communities, including 
industry, Federal, state, and local governments, academia, 
environmental groups, citizens, and workers. All nominations will be 
considered and prioritized based on a preliminary evaluation which will 
include literature searches and review by the core committee described 
below. A listing of exposures under consideration for evaluation will 
be published in the Federal Register, the NTP newsletter, and through 
press advisories with the request for public review and comment.
    The initial capacity for conducting assessments will be limited to 
2-3 per year. Chemicals selected for evaluation will be reviewed by 
expert panels of approximately 10-15 scientists selected for their 
expertise in various aspects of reproductive toxicology and other 
relevant areas. These panels will develop reports addressing the 
reproductive health risks to the human population of a specific 
chemical or a chemical mixture. Panel meetings will be open to the 
public and will include the opportunity for public comment.
    The goals of the individual assessments are to (1) interpret for 
and provide to the general public information about the strength of 
scientific evidence that a given exposure or exposure circumstance 
poses a hazard to reproduction and the health and welfare of children; 
(2) provide regulatory agencies with objective and scientifically 
credible assessments of reproductive/developmental health effects 
associated with exposure to specific chemicals or classes of chemicals, 
including descriptions of any uncertainties associated with the 
assessment of risks; and (3) identify knowledge gaps to help establish 
research and testing priorities.
    The Executive Summary and the final report of the expert panel will 
be published in Environmental Health Perspectives and will be announced 
and disseminated widely. Each assessment will appear as well on the 
CERHR website, linked to the NIEHS and NTP websites.
    Scientists representing NTP agencies and Sciences International, 
Inc., the contractor who will support the Center, will constitute a 
core committee which will provide the initial review for nominations, 
select the expert panel membership and establish the meeting agenda.

External Oversight

    Oversight will be provided through the NTP Board of Scientific 
Counselors, a chartered peer review group of scientific experts 
primarily outside the government, who will provide advice on 
priorities, directions, and the adequacy of the process and will 
facilitate public input into the process. Center activities and 
priorities will be presented to the Board at least annually. All Board 
meetings will be held in open session and will include opportunity for 
public comment.

Public Input Solicited and Encouraged

    The process includes opportunities for the public to (1) nominate 
chemicals for evaluation, (2) comment on nominations and the 
prioritizing and selecting of chemical nominations for evaluation, (3) 
comment on the evaluation of any particular chemical at the time of the 
expert panel meetings. The public is encouraged in this initial phase 
of the Center operations and on a continuing basis to nominate 
chemicals or chemical mixtures for review through the Center and/or 
suggest scientists to be added to an Expert Registry from which 
reviewers will be appointed to serve on ad hoc panels that will assess 
the reproductive and developmental toxicity of selected agents.
    Nominations of chemicals or chemical mixtures should be accompanied 
by the reason for the nomination and, whenever possible, appropriate 
background information, data, or literature citations.
    Suggestions for scientists to be added to the Expert Registry 
should be accompanied by a description of their expertise and a 
curriculum vitae.
    All chemical nominations and suggestions for scientists to be added 
to the Expert Registry should be forwarded to: NTP Center for the 
Evaluation of Risks to Human Reproduction, 1800 Diagonal Road, Suite 
500, Alexandria, VA 22314.
    The Center Program will be directed by Dr. Michael D. Shelby of the 
NIEHS, RTP, NC. Center support and scientific expertise will be 
provided through a contract with Sciences International, Inc. 
Alexandria, VA where Dr. John A. Moore is principal investigator on the 
project.

    Dated: December 4, 1998.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 98-33089 Filed 12-11-98; 8:45 am]
BILLING CODE 4140-01-M