National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/607

How to Nominate a Substance or Issue for Study

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The nomination and selection for study of chemicals and other substances with the highest potential for adversely impacting public health are essential to the success of the Program. From its inception, the NTP has had an open nomination process. Nominations are solicited from sources in academia, Federal and State regulatory and health agencies, industry, and unions, as well as from advocacy groups and the general public. Particular assistance is sought with the selection of studies that address issues such as testing of hypotheses to enhance the predictive ability of NTP studies, mechanisms of toxicity, or filling significant gaps in knowledge of the toxicity of chemicals or classes of chemicals.

Substances are studied for a variety of health-related effects, including but not limited to, reproductive and developmental toxicity, genotoxicity, immunotoxicity, metabolism and disposition, and carcinogenicity. The possible public health consequences of exposure remain the over-riding factor in the decision to study a particular substance. Selections for government testing are based on the principle that responsible industries will evaluate their own products for health and environmental effects as mandated by Congress under legislative authorities. Nominations to the NTP should be based on one or more of the principles listed below.

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Nomination Principles for NTP Studies

The NTP is an interagency program whose mission is to evaluate chemical, biological, and physical agents (collectively referred to as "substances") of public health concern by developing and applying tools of modern toxicology and molecular biology. The NTP operates under the general principle that industry will evaluate substances for health and environmental effects as intended and mandated by Congress under legislative authorities. Therefore the NTP, acting to carry out its mission, solicits nominations for NTP studies from the following categories:

  1. Substances found in home, workplace, or ambient environments that are not associated with a single commercial organization.
  2. Naturally occurring substances that may not be adequately evaluated without federal involvement.
  3. Commercial products with significant exposure that were first marketed prior to current testing requirements or those that generate too little revenue to support further evaluations.
  4. Potential substitutes for existing chemicals or drugs that might not be developed without federal involvement.
  5. Mixtures of substances for which evaluations are not required of industry.
  6. Substances that will aid our understanding of chemical toxicities, or our understanding of the use of test systems to evaluate potential toxicities.
  7. Substances that should be evaluated to improve the scientific understanding of structure-activity relationships and thereby help limit the number of substances requiring extensive evaluations.
  8. Emergencies or other events that warrant immediate federal government evaluation of a substance.

Prior to committing to specific studies, the NTP assesses the needs for studies by: evaluating existing literature and testing data, assessing ongoing evaluations in the government and private sector, and determining how the nomination fits into an overall plan for improving current test methods. The selection of a substance or issue for study by the NTP does not automatically commit the NTP to its evaluation. The NTP considers priorities for nominated studies at many phases: when the nomination is reviewed and evaluated for possible study, when the study is being designed, and again when the NTP considers the most appropriate intramural or extramural mechanism to conduct the study. The NTP may defer a study during any of these phases if suitable data become available, if higher priority studies are identified, or if the study proves to be impractical.

Nominations should be addressed to:

Office of Nomination and Selection
National Toxicology Program/NIEHS
MD K2-02
P.O. Box 12233
Research Triangle Park , NC, 27709
[ Send Email ]

Nominations may also be submitted using the Online Nomination Form.

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NTP Nomination Sources

Member agencies of the National Toxicology Program (FDA, NIEHS, and NIOSH) and other sources (including other Federal agencies, state agencies, the public, labor, and industry) submit nominations of substances and issues to the NTP for toxicological testing.

All nominating sources are asked to identify when possible: the particular toxicological information needed; the rationale for the nomination; any available background data on production, use, exposure, environmental occurrence; and the extent of available toxicological information (See Nomination Elements below). However, it is recognized that all potential nomination sources do not have the resources to obtain all the requested information. Therefore, all nominations are considered regardless of the extent of the information submitted.

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Nomination Elements

  1. Chemical Identification
    1. Chemical Abstracts Service (CAS) preferred name
    2. Common or generic name and synonyms
    3. CAS Registry Number
    4. Chemical class and related compounds
    5. Physical and chemical properties
      1. Physical description
      2. Structural and molecular formula and molecular weight
      3. Melting and boiling points
      4. Solubility
      5. Stability and reactivity
      6. Other relevant information
    6. Commercial product(s) composition
  2. Production, Use, Occurrence, and Analysis
    1. Production
      1. Source and synthesis
      2. Current production and pathway
    2. Uses
    3. Occurrence in the Environment
      1. Naturally occurring
      2. Air, water, and soil
    4. Analysis
  3. Toxicology
    1. Human data, case reports, and epidemiological studies
    2. Experimental animal studies
    3. In vitro and other short-term tests
    4. Other relevant information
  4. Disposition and Structure-activity relationships
    1. Absorption, distribution, metabolism and excretion
    2. Structure-activity correlations and considerations
  5. Ongoing Toxicological Studies in the Government, Industry, and Academe
  6. Rationale for Recommendation and Suggested Studies
  7. References
The NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.