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Doody's Review ServiceReviewer: Lorena E. Barck, Ph.D., J.D.(Oregon State University)
Description: This is the second edition of a book on regulatory toxicology first published in 1995. Authors contribute chapters on the regulatory requirements for toxicology testing in a variety of consumer product industries, such as pharmaceuticals, food additives and agricultural chemicals. The authors are described by the editor as being toxicologists with expertise in their respective areas, and appear to be primarily from industry, consulting groups, and commercial laboratories. Each chapter focuses on the history of the governing regulations and the toxicology tests and assessments required by law for the development, marketing, and ongoing safety evaluation of a specific class of consumer products. The book assumes a knowledge of toxicology; it is not a toxicology text.
Purpose: The purpose is to discuss the regulatory framework that requires toxicology testing of a wide variety of consumer products, as well as to describe the required tests and testing procedure themselves. The editor describes it as "a scientist's guide to the regulations." The book meets these objectives.
Audience: The book will be useful to students of the various industries described, as well as serving as a good starting place for scientists in the private sector dealing with the development of new products. It will also be an excellent source of information for those whose concern is consumer safety. Law students studying administrative law will be intrigued to see the different approaches, procedures, and standards used by the various federal agencies regulating these products.
Features: A wide range of consumer products are covered, including animal health products, food additives and nutrition supplements, cosmetics, over the counter drugs, and agricultural and industrial chemicals. There are also chapters on specific federal and state (California) laws and regulations that regulate hazardous materials in the environment. Many chapters include a history of the regulatory laws, often with interesting observations about the times and the customs. The legal concepts are, on the whole, well presented. Many chapters also include a summary of the governing international laws. The chapters direct toxicologists to the primary areas of concern, and manage to cover many details of toxicology testing without taking a cookbook approach. Each chapter focuses on the agency with jurisdiction over the product, their definitions of safety, testing guides, and the types and purpose of required studies. The chapters also usually include basic legal requirements for documentation, production of toxicity data, and risk analysis. The lists of references for each chapter are a little uneven, but most are quite comprehensive.
Assessment: This edition provides a valuable update, thanks to entirely new information included here, as well as updates on laws and regulations passed since the first edition in 1995. This is a book that will have value to a variety of readers. There is a great deal of technical information here which students and scientists in industry will find very valuable, and this book can be highly recommended on that basis alone. However, almost more intriguing are the discussions of how the various agencies define and evaluate safety and how in turn their regulations address safety issues. As well (in spite of a typo in the introduction regarding the codification of laws), students of the law will be well informed by this foray into administrative law.