National Toxicology Program

A test method nomination consists of a proposal to ICCVAM for review and evaluation for which a complete test method submission is not available. Four examples are:

• Test methods for which adequate validation studies presumably have been completed but lack a complete submission package
• Test methods that appear promising based on limited prevalidation or validation data and are proposed for additional validation studies
• Test methods that have been developed and are proposed for prevalidation or validation studies
• Test methods that are recommended for a workshop or other activity

Test method nominations and submissions may be made via the NTP Online Nomination Form or by contacting NICEATM.

Proposed test method nominations or submissions received by ICCVAM are initially assessed by NICEATM as to the relevance of the nomination or the adequacy and completeness of the submission. ICCVAM then determines the priority the proposed test method will have for technical evaluation. Once a proposed test method has been accepted for evaluation, ICCVAM assembles an interagency working group of government scientists with scientific and regulatory expertise in the appropriate scientific disciplines to collaborate with NICEATM on the evaluation process. Depending on the validation status of the proposed test method, ICCVAM, in conjunction with NICEATM, develops recommendations and priorities for further efforts. Such efforts might include an expert workshop, an expert panel meeting, a peer review meeting, an expedited peer review process, or a validation study.

Test method sponsors are encouraged to consult with NICEATM and ICCVAM throughout the test method development, prevalidation, and validation process, as well as during preparation of submissions. The objective of these interactions is to maximize the likelihood that validation studies and submissions will adequately characterize the usefulness and limitations of the proposed test method. Complete submissions are essential and serve as a basis for assessing the validation status of a proposed test method through an independent ICCVAM peer review process. This interactive process enhances the likelihood that agencies will have sufficient data and information to determine the extent that a test method can generate information that will meet their regulatory needs.

Criteria for the validation and regulatory acceptance for new and alternative test methods are outlined in the report Validation and Regulatory Acceptance of Toxicological Test Methods (ICCVAM 1997) [PDF]