Regulatory Testing To Inform Decisions: National and International Requirements

Abstract

The chapter attempts to convey the complexity and multi-faceted nature of regulatory safety testing to help those interested in improving regulatory testing approaches as they plan and conduct their work to make it most acceptable and useful to the regulatory authorities. National and international government agencies and key non-governmental organizations that use and/or require toxicity testing are described in the context of legislative, legal and historical factors that shaped the development and use of testing to inform decisions. Major testing requirements are described in the context of efforts to move from conventional animal testing approaches to non-animal approaches, and some of the key advances made to date are highlighted. Some of the biggest challenges that must be overcome to advance the refinement, reduction and replacement of animal tests with appropriate non-animal tests in terms of regulatory testing requirements are discussed.