National Toxicology Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

National Institute of Environmental Health Sciences; National Toxicology Program; Fiscal Year 1996 Annual Plan Now Available

The National Toxicology Program (NTP) announces the availability of National Toxicology Program; Fiscal Year 1996 Annual Plan, solicits comments on it, and urges all interested persons to propose chemicals for possible toxicological evaluation.

The eighteenth edition consists of two parts. First, the National Toxicology Program; Fiscal Year 1996 Annual Plan describes FY 1996 NTP plans in research, applied studies, methods development and validation efforts, as well as resources and FY 1995 program accomplishments. Second, the Review of Current DHHS, DOE, and EPA Research Related to Toxicology FY 1996 lists chemicals being studied by the various Department of Health and Human Services (DHHS) agencies, the Department of Energy (DOE), and the Environmental Protection Agency (EPA), and describes toxicology research and toxicology methods currently being developed by these agencies.

The format for the FY 1996 Annual Plan differs somewhat from previous years in that there are two versions. New is the Fiscal Year 1996 Annual Plan Summary which was prepared in response to a perceived need for a briefer and simpler version. The summary version is being sent to the larger mailing list and in response to general requests for information about the National Toxicology Program. The full version is similar to previous Annual Plans in length and detail and will be sent with the companion document, the Review of Current DHHS, DOE, and EPA Research Related to Toxicology FY 1996.

BACKGROUND

The National Toxicology Program was established within the Public Health Service of the Department of Health and Human Services in November 1978. The continuing broad goals of the NTP are to coordinate and strengthen DHHS basic and applied toxicology research and methods development and validation, and to provide toxicological information for use by health research and regulatory agencies and others in protecting the public health. Overall objectives are to:

• broaden the spectrum of toxicological information obtained on selected chemicals;
• develop and validate more sensitive and specific test methods;
• develop improved strategies for generating scientific data that strengthen the scientific foundation for risk assessments; and
• communicate NTP plans and results to government agencies, the medical and scientific communities, and the public.

To achieve these objectives, a balanced program, which uses chronic bioassays, short-term tests, collection and application of mechanistic information, model development, alternative methods, and human studies, has been created.

The NTP coordinates selected toxicology activities of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health; the National Center for Toxicological Research, Food and Drug Administration; and the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. The Director of the NTP is also the Director of the National Institute of Environmental Health Sciences.

Primary program oversight is provided by the NTP Executive Committee, which links DHHS health research institutes and centers with Federal health regulatory agencies to ensure that the basic and applied toxicology research and development activities are responsive to regulatory and public health needs. Agencies represented on the Executive Committee are:

• Agency for Toxic Substances and Disease Registry
• Consumer Product Safety Commission
• Environmental Protection Agency
• Food and Drug Administration
• National Cancer Institute
• National Institute for Occupational Safety and Health
• National Institute of Environmental Health Sciences
• National Institutes of Health
• Occupational Safety and Health Administration

The NTP Board of Scientific Counselors provides scientific oversight, advising the NTP Director and the NTP Executive Committee on scientific content and evaluating the scientific merit and overall quality of NTP science. The Board has two standing Subcommittees, the Biennial Report on Carcinogens Subcommittee and the Technical Reports Review Subcommittee. The members are appointed by the Secretary, DHHS.

Scientific activities are divided into several major program areas: Carcinogenesis; genetic toxicology; risk assessment research; alternative methods; and toxicology. The latter area covers activities in immunologic, neurobehavioral, and respiratory toxicologies, as well as reproductive and developmental toxicology. There are special projects on studying toxicities of AIDS therapeutics and toxicity of Superfund chemicals. Program and project leaders, along with addresses and telephone numbers, are identified in the Annual Plan.

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The chemical nomination and selection process is integral to the effective long-term operation of the NTP with respect to toxicological studies of chemicals using modern techniques and to the development and validation of new assay methods. Thus, the NTP welcomes nominations of chemicals for study from everyone. At a minimum, the nominator should give the name of the chemical or substance, the rationale for the nomination, and recommend the type study(s) to be considered. In addition, it is desirable, but not essential, to supplement each nomination with the following information, if known:

• chemical and physical properties;
• production, use, occurrence, and analysis data;
• toxicology information, including human data;
• chemical disposition and structure-activity relationships; and
• planned, ongoing, or recently completed toxicological and environmental studies.

To receive the National Toxicology Program Fiscal Year 1996 Annual Plan and the accompanying Review of Current DHHS, DOE, and EPA Research Related to Toxicology FY 1996, or the Fiscal Year 1996 Annual Plan Summary version, please contact the NTP Central Data Management, NIEHS, P.O. Box 12233, MD E1-02, Research Triangle Park, NC 27709, (telephone 919/541-3419, fax 919/541-3687, Internet e-mail CDM@NIEHS.NIH.GOV.

Comments on the above documents are requested and welcomed and should be addressed to Dr. Larry Hart, NTP, P.O. Box 12233, MD A3-07, Research Triangle Park, NC 27709, (telephone 919/541-3971, fax 919/541-0295, Internet e-mail to HART@NIEHS.NIH.GOV.

__________________________________
Kenneth Olden, Ph.D.
Director, National Toxicology Program

[FR Doc. 97-2486 Filed 1-30-97; 8:45 am]
[BILLING CODE 4140-01-M]