Understanding the Assessment of Toxic Substances.


Regulating Toxic Substances: A Philosophy of Science and the Law, Carl F. Cranor, (New York: Oxford University Press, 1993), 241 pp.

TOPICS:

Understanding environmental problems; making effective use of technical information; justifying aspirations; administrative procedures; litigation; of general applicability to environmental problems; written for the first party or third party participant.

ABSTRACT:

Regulating Toxic Substances: A Philosophy of Science and the Law is an examination of the need for, and methods of, assessment of toxic substances. The author addresses the legal, legislative, administrative and tort, issues surrounding toxic substances.

Regulating Toxic Substances: A Philosophy of Science and the Law will be of interest to those who seek an understanding of the complexities of toxic substance assessment. The author begins in the introduction with an overview of the topic, wherein he likens assessment of toxic substances to the experience of peering through a glass, darkly. The work is divided into five chapters, each with an overarching subject. The first of these is an exploration of the scientific background necessary to the subject at hand. The author examines the practice of predicting risks from animal bioassays. He addresses the normative implications of the scientific uncertainties in risk assessment. Additionally, and the bulk of the chapter, the author examines the problems in the statistics of human epidemiological studies and animal bioassay. Specifically, he considers: practical evidence-gathering problems, theoretical difficulties, traditional practices in interpreting epidemiological studies and offers an alternative to traditional practices. The final focuses of the chapter are, professional ethics and public policy issues.

Chapter two examines scientific evidence in the Tort law. Cranor begins with institutional background information and proceeds to the consideration of the challenge posed by litigation over toxic substances to present evidentiary procedures, and arguments for scientific standards tests. Further, the author focuses on the common conceptual framework for evaluating scientific and legal burdens of proof and offers an alternative view. Chapter three examines the relationships among joint causation, torts and administrative law. The considerations which must obtain when joint causation is possible, or likely, are given special focus. The author's examination of administrative law addresses, the practice of no moral or policy bars to regulation when joint causation exists, and the case for regulation of toxic substances when such causation obtains.

Chapter four addresses scientific procedures in regulatory agencies. By way of introduction, the author offers consideration of: major laws regulating carcinogens, pre-market and post-market statutes, procedural requirements and substantive statutory requirements. A lengthy portion of the chapter is devoted to an examination of approaches to risk assessment in regulatory agencies. Herein, Cranor presents the current agency risk assessment practices and offers two unacceptable approaches among these. He asserts that the complete and accurate science approach, and the science-intensive approach are both unacceptable. Following a critique of the shortcomings of both the present and recommended approaches, the author presents an alternative approach. In this context he examines: coping with scientific uncertainty, mitigating the demanding evidentiary standards of science and expediting risk assessment. The final focus of the chapter is making public policy on expedited risk assessments through the agencies and courts.

The final chapter addresses epistemic and moral justifications for toxic substances assessment. In consideration of the moral justifications Cranor examines principles implicit in the Occupational Safety and Health Act (OSHA) and the philosophical theories of distributions. In this latter context, the author explores: Utilitarianism, the Daniels-Rawls theory of health care protection, and the attraction of such distributively sensitive theories. The text is followed by five appendices, the first of which lists uncertainties in carcinogen risk assessment. The other four appendices cover: cancer potency estimates of the California Department of Health Sciences (CDHS) and the Environmental Protection Agency (EPA), relative risk as a function of Alpha and Beta values, statutes authorizing the regulation of carcinogens, and derivation of TD50 (tumorigenic dose) potency values.

Regulating Toxic Substances: A Philosophy of Science and the Law is a careful examination of the legal complexities of toxic substance assessment. Most useful to the informed reader are the scientific and institutional background information, and the appendices.

T. A. O'Lonergan

G1CRAN

G6CRAN

G9CRAN

G11CRAN

G12CRAN