E. Donald Elliott

Needed: a strategy for implementing the vision.

The title of the NAS Report was Toxicity Testing in the 21st Century: A Vision and a Strategy. Both the NAS report itself, and the current synopsis, are long on the “vision thing” but short on the “strategy” part. What is needed next is more thought about how to turn this provocative vision into a reality for actually implementing the new paradigm for toxicity testing in regulatory risk assessments upon which important health and safety decisions are based. How can the new paradigm actually become accepted in regulatory decision making? For example, are we ready to approve new drugs for market, or set regulatory limits for environmental agents, based solely on computational models of toxicity pathways? If the answer is “yes” in some cases, but “no” in others, how are we to distinguish the two? If the answer is “no, not yet,” what’s missing and how will we know when we are ready? This is not to minimize the accomplishments either of the NAS Committee, or of the present authors in summarizing this very important vision for the future of toxicity testing succinctly and accurately. The Committee also deserves credit for going beyond merely outlining a scientific vision. The title of the final chapter of the toxicity testing report promises to address “Prerequisites for Implementing the Vision in Regulatory Contexts,” but the institutional and legal issues are treated in a perfunctory and superficial way. The full report, like the Perspective, largely contents itself with the observation that perhaps the new paradigm could be implemented under the language of existing statutes. While I agree with that conclusion, it is merely the beginning, not the end, of a serious discussion of regulatory implementation. How is a regulator to decide when to use the new paradigm as opposed to the prevailing whole

The clean air act : new enforcement and liability provisions

The Clean Air Act Amendments of 1990 establish new criminal and civil liability provisions that can potentially impose substantial fines and penalties. This article reviews the Acts new enforcement and liability provisions. The authors recommend that because of the new enforcement tools available to the federal government, the regulated community should implement effective self-auditing and compliance programs at facilities to help reduce the risk of criminal liability.