National Toxicology Program

ICCVAM conducts interagency technical reviews of proposed new, revised, and alternative test methods and coordinates issues across agencies relating to the validation, acceptance, and national and international harmonization of toxicological test methods. ICCVAM places priority on test methods that may improve predictions of adverse human, animal, or ecological effects and to those that may reduce, refine, or replace animal use.

Advancement of a proposed test method from concept to regulatory acceptance involves a number of stages. The ICCVAM Test Method Evaluation Process addresses the critical stage of independent evaluation of the validation status (i.e., the usefulness and limitation of the test method for a specific purpose), including independent scientific peer review. This process is illustrated in the table below.

Test Sponsors are industry or government entities or other ICCVAM stakeholders that may make nominations or submissions to ICCVAM. Nominations or submissions can consist of a request for a review of proposed test methods, a request for ICCVAM comments on pre-validation/validation studies, or a proposal for a workshop with appropriate rationale.

ICCVAM Working Groups are groups of government scientists with appropriate scientific and regulatory expertise that are assembled by ICCVAM to evaluate the test method. The working group works with NICEATM to prepare a comprehensive draft BRD on the test method under consideration. This draft BRD provides the rationale and scientific basis for use of the test method, components of the test method protocol, and descriptions of substances used to evaluate the test method and comparable in vivo reference data. The draft BRD contains information submitted by the sponsor in support of the nomination or submission. It may also contain relevant data submitted by other interested parties, information on use of the test method obtained from searches of the scientific literature, analyses of accuracy and reliability of the test method, and discussions of animal welfare considerations and other parameters, such as time, cost and infrastructure requirements, to be considered when putting the test method into practice. The ICCVAM working group, working with NICEATM, considers the draft BRD as it develops draft recommendations on the use of the test method.

Independent Peer Review Panels are composed of research scientists, clinicians, test method developers, statisticians, and other professionals with relevant expertise, drawn from industry, academia, animal welfare organizations and regulatory entities that are normally other than those represented on ICCVAM. ICCVAM’s goal is for its Peer Review Panels to have an international scientific composition representing the viewpoints of all interested parties in consideration of the test method. The Peer Review Panel meets in public session, and comments from the public are welcomed during the meeting.