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Since 1978, NTP has served as a government agency committed to earning the public's trust. Over time, NTP has evaluated more than 2800 environmental substances for a variety of health-related effects. This research has advanced our understanding of general toxicity, carcinogenicity, reproductive and developmental toxicity, genetic toxicity, immunotoxicity, and neurotoxicity. Researchers and the public rely on NTP's dedication to the careful examination of scientific issues.

The timeline shows key events in NTP's history as a program—from the establishment by the Department of Health, Education, and Welfare to more current initiatives.

  • 1978

    • Department of Health, Education and Welfare established NTP.
    • David P. Rall, M.D., Ph.D., 1st first director.
    • NCI/NTP published 100th technical report.
  • 1980

    • 1st RoC published; 26 listings.
    • NCI/NTP published 200th technical report.
    • Developmental toxicity testing initiated.
  • 1981

    • HHS transferred NCI Carcinogenesis Testing Program to NIEHS.
  • 1982

    • Immunotoxicology incorporated into testing strategy. Comprehensive testing battery defined to evaluate immune system alterations.
    • Reproductive Assessment by Continuous Breeding studies initiated.
  • 1985

    • Technical Reports series on carcinogenesis bioassay broadened to include toxicology evaluations
    • Cellular and genetic toxicity integrated into cancer bioassays
  • 1986

    • Standards for quality assurance for pathology established.
    • 5 categories to define levels of evidence of carcinogenic activity set.
    • 1st systematic evaluation of the predictability of various genetic toxicity screens for cancer published.
    • 300th technical report published.
  • 1990

    • NIEHS/NTP established an interagency agreement with CDC/NIOSH for immunotoxicity of workplace xenobiotics.
  • 1991

    • Kenneth Olden, Ph.D., named director.
    • Toxicity Report series initiated.
  • 1992

    • NIEHS/NTP established interagency agreement with FDA/NCTR for conducting comprehensive toxicological evaluations for substances of concern to the FDA.
  • 1993

    • 400th technical report published.
  • 1995

    • Scientific consensus toward mechanistic-based approaches for understanding toxicity reached.
    • International workshop on validation and regulatory acceptance of alternative toxicological methods convened with ad hoc ICCVAM.
  • 1996

    • HHS approved revised listing criteria for RoC allowing consideration of all relevant information.
    • Formal process for removing a listing from the RoC established.
    • NIEHS/NTP initiated agreement with CDC/NCEH to provide funding for expanded biomonitoring of environmental toxicants in the National Health and Nutrition Examination Survey.
  • 1997

    • ICCVAM established to support the development, validation, acceptance, and harmonization of alternative toxicological test methods.
    • NIEHS/NTP established the interagency agreement with CDC/NIOSH to characterize and evaluate adverse effects of complex occupational exposures.
  • 1998

    • NICEATM established to convene scientific panels to evaluate alternative toxicological methods.
    • CERHR established to conduct scientific assessments of the reproductive and developmental toxicity literature on selected environmental agents.
    • 8th RoC published; 1st report to apply to revised criteria.
  • 1999

    • Regulatory acceptance of the Murine Local Lymph Node Assay and Corrositex® for dermal safety testing achieved through ICCVAM.
  • 2000

    • 9th RoC published; 1st report to apply new criteria to remove listings (saccharin and ethyl acrylate) and to upgrade listing based on consideration of mechanistic data (dioxin and ethylene oxide).
    • ICCVAM became permanent under NICEATM with passage of ICCVAM Authorization Act of 2000.
    • Center for Phototoxicology established.
    • Collaborations with the European Ramazzini Foundation of Oncology and Environmental Sciences formalized through NIEHS/NTP.
    • 500th technical report published.
  • 2002

    • 10th RoC published.
    • NICEATM initiated first international validation study with the European Centre for the Validation of Alternative Methods.
  • 2003

    • NTP-CERHR monograph series initiated.
    • Technical Report series for genetically modified models created.
    • Regulatory acceptance of revised Up-and-Down Procedures achieved through ICCVAM.
    • NICEATM and ICCVAM proposed and defined performance standards concept to allow for regulatory acceptance of proprietary test methods.
  • 2004

    • Use of toxic equivalency factor approach for cancer risk assessment of dioxin mixtures is supported by NTP studies.
    • Roadmap completed and a course planned for the 21st century to include greater use of high- and medium- throughput, mechanism-based assays.
  • 2005

    • 11th RoC published; 1st report to list biological agents.
    • Celebrated a quarter century of toxicology for public health and unveiled a new toxicology for the 21st century.
    • Program to identify and evaluate high-throughput screening assays for toxicity testing initiated.
    • David A. Schwartz, M.D., Ph.D., named director.
  • 2007

    • NIEHS/NTP funded dense single nucleotide polymorphisms mapping of 15 mouse strains to identify genetic variations as a tool for exploring genetic susceptibility to environmental disease.
    • Samuel H. Wilson, M.D., designated as acting director.
    • NRC report Toxicity Testing in the 21st Century echoed themes from NTP Roadmap (2004) in calling for new approaches to toxicity screening.
    • Prenatal exposure as default paradigm in toxicity testing adopted.
  • 2008

    • Collins et al. Perspectives article in Science responded to 2007 NRC report Toxicity Testing in the 21st Century by laying out a comprehensive federal agency response.
    • NIEHS/NTP established formal agreement with EPA and NIH Chemical Genomics Center for high-throughput toxicity testing; Tox21.
    • NTP-CERHR Monograph on Bisphenol A released.
    • Linda S. Birnbaum, Ph.D., named director.
  • 2009

    • New criteria for evaluation of outcomes from studies on reproduction, development, or immune system announced.
    • NIEHS/NTP established ICATM—formal agreement to cooperate on alternative test methods with Europe, Japan, and Canada.
  • 2010

    • Chemical Effects in Biological Systems−new database for housing, integrating, and managing data−published
      Chemical Effects in
      Biological Systems−
      new database for
      housing, integrating,
      and managing data−
      Chemical Effects in
      Biological Systems−
      new database for
      housing, integrating,
      and managing data−
    • FDA joined Tox21.
  • 2011

    • Scientific literature assessments expanded to include all non-cancer toxicities.
    • Korea joined ICATM.
    • Modified one generation reproduction study design adopted.
    • 12th RoC published.
  • 2012

    • Regulatory acceptance of BG1 luciferase estrogen receptor transactivation test method by EPA and 1st OEDC performance-based test guidelines for estrogen receptor agonists (PBTG 455) achieved through ICCVAM.
  • 2014

    • Nonneoplastic lesion atlas as guide for standardizing terminology in toxicologic pathology launched.
    • Systematic review methodology adopted for literature-based scientific assessments.
    • Research to evaluate West Virginia Elk River spilled chemicals combining high-throughput, computational, and traditional toxicology approaches initiated.
    • 13th RoC published.
  • 2015

    • Diversity outbred mouse as a tool for identifying inter-individual variation in toxicity response demonstrated.
    • Collaboration with EPA enabled waivers of animal-based uterotrophic testing for EPA Endocrine Disruptor Screening Program, the first use of Tox21 approached by regulatory agency to replace animal testing.
    • Funding to map gene expression during differentiation in mouse and human stem cells and to standardize zebrafish development protocols awarded.
  • 2016

    • Analysis by NICEATM and EPA showed acute oral toxicity data can reliably assign EPA acute dermal hazard classifications. Supported new EPA policy to waive all acute lethality dermal studies for formulated pesticide products.
    • NTP Monograph on Immunotoxicity Associated with Exposure to PFOA and PFOS, 1st evaluation using a systematic review approach, published
    • Research Report series created
    • 14th RoC published
  • 2017

    • NIST joined ICCVAM
    • Integrated Chemical Environment database that provides high-quality, curated data and analysis tools launched
    • New method for analyzing genomic dose-response data announced
  • 2018

    • ICCVAM’s report A Strategic Roadmap for Establishing Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States published
    • Unveiled a new translational toxicology pipeline to increase NTP focus on predictive toxicology and enhance public health impact
    • NICEATM analysis supported new EPA policy to accept in vitro methods instead of mouse tests for skin sensitization for pesticide ingredients and single chemicals under the Lautenberg Chemical Safety Act
    • Research Report on CLARITY-BPA core study published and grantees’ data released
    • Technical Reports on studies in rodents of radio frequency radiation used by cell phones published; the most expensive and technologically challenging studies ever undertaken by NTP