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Organization of JaCVAM

(1) Committees to provide support and advice to JaCVAM

  • JaCVAM Steering committee

    • The evaluation of new and revised testing methods and establishment of guidelines for such methods are processed in the following order: open recruitment, receiving applications, selection for evaluation, preparation of Background Review Document (BRD) by an oversight committee, evaluation by a peer review panel, evaluation by a regulatory acceptance board, and proposal to regulatory bodies.

  • JaCVAM Support Group

    • The support group of JaCVAM consists of representatives of the divisions in NBSRC including Cellular and Molecular Toxicology, Pathology, Pharmacology, Genetics and Mutagenesis, Risk Assessment, and Laboratory Animal Control.

  • The Advisory Committee

    • The advisory committee consists of approximately eight members, including toxicologists not affiliated with NIHS, animal experimentalists, alternative methods experimentalists, representatives recommended by industry groups, clinicians, representatives of citizens, and regulatory officers.


    (2) Groups to participate in the evaluation of new and revised testing methods

  • Oversight committee

    • The oversight committee prepares BRD based on the validation reports on new and revised testing methods, which are prepared by the validation management team. The oversight committee also supports the execution of validation studies by providing advice on improvements for new and revised testing methods and further experiments. The oversight committee consists of the new or revised testing method applicants and several selected experts appointed by the method’s validation management team. A secretariat supports the oversight committee. The secretary submits the BRD prepared by the oversight committee to the peer review panel to request its review. The oversight committee is dismissed upon acceptance of the report by the peer review panel.

    Submission data package documenting the validation status should include:
    • Scientific and regulatory rationale for the proposed test method
    • Rationale for essential test method protocol components
    • A complete description of the substances used in the validation of the proposed method, and the rationale for their selection
    • In vivo or other appropriate reference data for test substances used to assess the test method’saccuracy (where appropriate)
    • All available data and results from the proposed test and reference methods
    • Test method performance (accuracy)
    • Test method reliability (repeatability/reproducibility)
    • Statement assessing test method data quality
    • Other pertinent scientific reports and reviews
    • Assessment of test method refinement, reduction and replacement
    • Evaluation of usefulness and limitations of the test method
    • References
    • Supporting materials


  • Peer review panel

    • The peer review panel reviews the BRD prepared by the oversight committee from a scientific point of view and prepares review reports for new and revised testing methods. The director of JaCVAM selects several experts to evaluate and validate the testing method and organizes the peer review panel. Concurrent assignment with the oversight committee is not allowed. A chair is elected by a vote of panel members. The secretary submits the review report prepared by the peer review panel to the regulatory acceptance board to request its review. The peer review panel is dismissed upon acceptance of the report by the regulatory acceptance board.

  • Regulatory acceptance board

    • The regulatory acceptance board reviews the reports prepared by the oversight committee and the peer review panel, evaluates them from a standpoint of administrative application and social diffusion, and submits board reports to the secretariat.
    The regulatory acceptance board consists of approximately ten members including representatives of NIHS, experts of alternative methods, toxicologists, representatives recommended by industry groups, biostatisticians, and regulatory officers.
    The director of JaCVAM selects the members and the director general of NIHS appoints them. Concurrent assignment with either the peer review panel or the oversight committee is not allowed.

    PRINCIPLES AND CRITERIA FOR REGULATORY ACCEPTANCE OF A NEW OR UPDATED TEST METHOD
    • The submitted test method and supporting validation data should have been subjected to a transparent and independent peer review process.
    • Data generated by the test method should adequately measure or predict the endpoint of interest. For replacement test methods, the data should show a linkage between the proposed test method and an existing test method, and/or the proposed test method and effects in the target or model species.
    • The test method should generate data useful for hazard/risk assessment purposes.
    • The submitted test method and supporting validation data should adequately cover a spectrum of chemicals and products representative of those administered by the regulatory programme or agency for which the test method is proposed, and the applicability and limitations of the test method should be clearly described.
    • The test method should be sufficiently robust (relatively insensitive to minor changes in the protocol) and transferable among properly equipped laboratories with adequately trained staff.
    • The test method should be time and cost effective and likely to be used in a regulatory context.
    • Justification should be provided (scientific, ethical, economical) for the new or updated test method in light of already existing test methods.


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