Regulation and evolving science: neurobehavioral toxicology

A number of policy and scientific issues are associated with the introduction of emerging or non-traditional scientific disciplines into the governmental regulatory apparatus. The present discussion derives from the issue of the extent of toxicological testing required for the evaluation of the health and safety aspects of pesticides and other compounds at the Environmental Protection Agency. The area of neurobehavioral toxicology is used as a case study for the introduction of a new biological endpoint into the regulatory arena. In that context, this paper addresses the following policy/regulatory issues: why expand the endpoints for toxicity testing from those currently in use; what is the current regulatory situation; what are the alternative means by which a new endpoint could be incorporated into the regulatory process; what would be the consequences of requiring examination of new endpoints? In the process of evaluating those issues, scientific issues involved with the selection of test systems are discussed. They include the selection of particular tests, the testing strategy, and the validity, reliability and sensitivity of the tests.