VALIDATING NEW TOXICOLOGY TESTS FOR REGULATORY ACCEPTANCE

Before a new or revised toxicology test is considered acceptable for s afety evaluation of new substances, the test users and the industrial and regulatory decision makers must feel comfortable with it, and the decisions it supports. Comfort with, and the acceptance of, a new test comes after knowing that it has been validated for its proposed use. The validation process is designed to determine the operational charac teristics of a test, that is, its reliability and relevance, in additi on to its strengths and limitations. The reliability of a test is meas ured by its reproducibility. Its relevance is judged by its mechanisti c relationship to the health effects of concern, and its ability to pr edict or identify those effects. The U.S. government has recently form ed the Interagency Coordinating Committee on the Validation of Alterna tive Methods (ICCVAM) to work with federal agencies and test developer s to coordinate the evaluation and adoption of new test methods. The I CCVAM will provide guidance to agencies and other stakeholders on crit eria and processes for development, validation, and acceptance of test s; coordinate technical reviews of proposed new tests of interagency i nterest; facilitate information sharing among agencies; and serve as a n interagency resource and communications link with parties outside of the federal government on matters of test method validation. (C) 1998 Academic Press.