Book Review

Science and the Law: Analytical Data in Support of Regulation in Health, Food, and the Environment. Town W. G., Currano, J. N., Eds; ACS Symposium Series 1167; American Chemical Society: Washington, 2014. 178 p. +ix, ISBN 978-0-8412-2947-1. Hardcover $150.

This book is the first in the series of the result of two related symposia presented at the fall 2012 ACS meeting in Philadelphia, the second previously reviewed by Bob Buntrock (1). Both remain timely, especially given continuing political developments on these topics. This book is especially prescient given current developments in regulation in the last half year. Most of the symposium presentations are included and often expanded to what are effectively mini-reviews with updated material. Each chapter terminates with a conclusion and a list of references with an index. In most cases, the title acts as a mini-abstract.

Chapter 1, “Looking Forward: Science-Based Policy Making” is by co-editor Bill Town and is not only an introduction to the subject area but also acts as an outline and abstract for the 10 remaining more specialized chapters. Communication between scientists and policy makers is difficult given differences in perception and interpretation on the influence of science on policy making. The typical lack of scientific knowledge of politicians and civil servants has a large and often negative effect on resulting policy. Therefore, “education” of politicians is paramount. All too often legislation is enacted without input from scientists and if input is requested it is often along the lines of “Here’s the policy we want, find the science to support it”. Concepts to aid in the evaluation of research are outlined and include error and bias, control and repeatability, and interpretation of data.

Chapter 2, “Hunting and Gathering: Locating and Evaluating Information on the Cusp between Science and Legislation”, is by co-editor and master searcher Judith Currano. All sides on the debates (scientists, legislators, general public) often exhibit emotional responses and cite “hard facts” to add credibility to their stands (Plus ça change, plus c’est la même chose). In possibly the meatiest chapter, the author not only describes data and information location techniques but methods for evaluation of the information to attempt to determine the reliability. Two case studies are illustrated (fracking in the Marcellus Shale, and health effects of low-level RF energy) with line drawings as reliability guides. These methods were developed for an engineering ethics class at UPenn. Involved are four steps: 1) determining the breadth of the information required, 2) use of appropriate resources for searching, 3) evaluating the retrieval for credibility, and 4) use of ethical analysis to yield informed decisions. In the evaluation, criteria are discussed including accuracy, data integrity, authority, source quality, bias, timeliness, references, impact, and relevance. The line drawings and graphs range from positive to negative attributes with degrees of evaluation in between. In the course of searching and evaluation, sources include scientific information, news sources, sources for legislation, legal, and case law, along with hidden agendas and interests. Query building is also illustrated.

Chapter 3, “Environmental Databases: A Trip Down memory Lane and New Journeys into the 21st Century”, an equally meaty and thorough chapter, is by Fred Stoss (SUNY Buffalo). In the introduction and beginning sections, am extensive history of searching and resources in the age of online information is presented (for more background, see chapters in another Symposium Series book (2)) including the development of STEM databases, computerization, and further developments such as retrieval methods and analysis methods, and the trend toward end-user searching. Table I lists major abstracting and indexing services by beginning year including name changes and notes that all are currently available online. Table II lists environmental science and pollution management databases by year of onset. Newer data analysis programs as well as databases and sources close out the chapter.

(Not to quibble, but the evolution of searching STEM information in academia differed from that in industry. As described, in academia, librarians and information specialists were trained in computer-based searching methods and performed searches at the request of scientist customers which led to end-user training. In industry, chemists and engineers, many already familiar with printed information resources, became self-taught in computerized retrieval methods and provided searches for customers on a cost recovery basis for both searcher billable hours and computer expenses. This latter aspect led to many in industry doing online searches earlier than our colleagues in academia because of cost recovery without pirating library acquisition budgets. Several programs also led to end-user training.)

Chapter 4, “Regulatory Toxicology: Progress in Law”, describes and compares product regulation and animal welfare legislation in both Europe and the United States. Current dependence on animal testing is discussed and the alternatives to it are described in detail, especially the efforts of CAAT, The Center to Alternatives to Animal Testing, at Johns Hopkins. The chapter concludes with 47 references, most authored by T. Hartung, one of the chapter authors.

Chapter 5, “Analytical Procedures and Regulation of New Drug Development”, activities in the Center for Drug Evaluation and Research within the FDA are described. Requirements of submission to the FDA, are set by statue and the Code of Federal Regulations, and other guidance documents. The amount of information required at each stage increases at each stage of the approval process. The example of analytical procedures is described in detail.

Chapter 6, “Steps Towards the Analytical Standards Required for Science-Based Tobacco Product Regulation”, somewhat surprisingly from the British American Tobacco Co. R&D, describes FDA analytical results and their impact on regulation. More than 90 harmful components of tobacco have been identified. Margins of exposure and modes of action for these and other components are determined, and standardization, especially of smoking machines, is developed. Evaluation of smokeless tobacco products and e-cigarettes is becoming important.

Chapter 7, “Regulatory Toxicology: Progress in Science”, covers the topic of non-animal based testing in greater depth. Worldwide, $3 billion is spent on testing of pesticides and drugs (but not food additives), most of it on animals. However, many countries ban animal testing for cosmetics. Beginning with the motto, “Humans are not 70 kg rats”, progress at CAAT and elsewhere is discussed. Previous testing has contributed extensively to public safety, but many false positives and other inaccuracies exist (e.g., aspirin would fail most tests). Testing in the 21st Century should be evaluated on economics, efficacy, and accuracy. Pitfalls in preclinical testing (only 5% of such submissions are eventually marketed) are shown. Predictability of cell culture testing needs improvement and integrated testing and mapping the human genome (a very current hot topic) are discussed as well developments such as ToxCast, which uses high-throughput screening, evaluation of endocrine disruptors, and advances in developmental neurotoxicity. The chapter concludes with 78 references.

Further developments in non-animal testing are discussed in Chapter 8, “Cooperation Between the United States EPA and Industry to Develop an in vitro Ocular Hazard Strategy”. Three alternative tests to the Draize test on rabbits are being evaluated. No one test will suffice and a flow chart for effective evaluation is shown. Chapter 9, “Ensuring that Nutrition and Health Claims in the European Union on Foods and Food (Dietary) Supplements are Justified and Scientifically Substantiated”, discusses achieving consumer protection along with fair trade and promotion of research. Scientific evidence of health claims is paramount and the process in the EU is described, especially for antioxidants and cardiovascular health claims. Communication understandable to the public is very important, and future challenges are discussed.

Chapter 10, “Comprehensive Nuclear Magnetic Resonance Analysis of Honey”, is important to the analysis of mixtures and possible adulterants in general. NMR active isotopes of H, C, and P are analyzed. Chapter 11, “Rapid Screening Methods for Pharmaceutical Surveillance”, discusses the problems of monitoring all ingredients (including inactives) in pharmaceuticals for purity and other factors including adulterants and even counterfeit drugs. Developments in portable or handheld spectroscopy in the field (Raman, IR, XRF, fluorescence) are discussed. I am familiar with such research at the University of Maine.

I also attended the ACS meeting in Philadelphia, presenting at another CINF symposium, and I was able to attend most of the presentations covered here. It’s great to be able to acquire documentation of these valuable and timely presentations. A must read for anyone, chemist or not, concerned with scientific data and information used in the regulatory process.

R. E. Buntrock
Buntrock Associates
Orono, ME

(1) Science and the Law: How the Communication of Science Affects Policy Development in the Environment, Food, Heath, and Transport Sectors; Town W. G., Currano, J. N., Eds; ACS Symposium Series 1207; American Chemical Society: Washington, 2015. (Reviewed in CIB, 2017, 69 (2), p. 34-35)

(2) The Future of the History of Chemical Information; McEwen, L. R., Buntrock, R. E., Eds; ACS Symposium Series 1164; American Chemical Society; Washington, 2014.